Healthcare Textiles & Laundry

Healthcare Linen Processing Starts With Soil-Sort Excellence

By Gregory Gicewicz

Editor's note: This column originally appeared in the June 2021 issue of Healthcare Hygiene magazine.

In software engineering, the cost of detecting and fixing defects increases exponentially the farther they are discovered downstream. A bug found during the design phase is simple and inexpensive to fix. Conversely, a bug found by an end user in a finished system costs orders of magnitude more. The final consequences of downstream defects may even be injury or death as in the case of commercial aircraft or other mass transportation systems. The same principle holds true for the healthcare laundering process. A high-quality soil sort is the first step in producing high quality, hygienically clean healthcare linens for infection prevention and patient safety. Errors in the sort lead to successively more severe and more expensive problems downstream. In a worst case scenario, a bad sort may even lead to serious injury or death for hospital patients or laundry/healthcare workers.

Soil-Sort Purpose
Imagine a complex software system that was built with no design process. It would not work. Now imagine a healthcare laundry with no soil sort process. Imagine a laundry where received soiled goods are emptied together into a washer, unloaded then dried, then sent to the finish for folding and shipping to the hospital. Think of the abysmal quality of the final product. Visualize this contaminated linen touching sick patients. Picture the associated safety issues: Needles, controlled substances, garbage, food, and more all mixed together with the washed but unclean linen!

A quality soil-sort operation prevents this condition. The purpose of the soil-sort operation in any healthcare laundry is to separate received goods into categories so they can next be handled safely and appropriately. A modern large scale accredited healthcare laundry will generally have from 15 to 30 different soil-sort categories. These can be broken down into “bulk” linens, “specialty” items, and non-linen items. Examples of “bulk” linen items include bath blankets; patient gowns; sheets; terry items; pillowcases; and incontinent pads. Examples of “specialty” items include surgical textiles; cubicle curtains; lifter slings; microfiber cleaning devices; lab coats; scrubs; and isolation gowns. Finally, examples of non-linen items include include garbage, sharps, pharmaceutical waste, surgical instruments, patient personal items, pens, and staff personal items. Some non-linen items are harmless, but others must be handled carefully according to local and federal laws. For example, pharmaceutical waste received must follow a strict protocol; see http://www.hlacnet.org/articles-reports-presentations for more information.

Safety
First and foremost, a quality soil sort operation is crucial for the safety of laundry staff, hospital patients, and healthcare providers. Laundry staff must be protected since they are handling contaminated healthcare linen and the dangerous items that may arrive with it. It is most critical to protect soil sorters with appropriate personal protective equipment (PPE). At a minimum, soil sort workers should wear fluid proof gowns, that extend below the knee; fluid proof gloves; face covers; and eye protection. To protect hands from needles and sharps staff should wear puncture proof gloves outside of the fluid proof gloves. This PPE must be donned when entering the contaminated area and doffed when exiting. Please see https://www.hlacnet.org/standards for more information on sort PPE standards. Dangerous items such as needles and pharmaceuticals, that are not caught and segregated in the sort, may end up in finished garments worn by healthcare providers. All it takes is one nurse reaching into a scrub pocket with an unsorted exposed needle and the end result may be catastrophic.

Quality
High-quality, hygienically clean laundered healthcare textiles depend on a high-quality sort process. Wash process formulae are designed for different soil classifications. For example, a bath blanket wash formula is typically designed for a lighter soil load. This means the formula can run shorter and use less chemistry. Now let’s say a highly contaminated surgical OR towel is mis-sorted into the bath blankets. The bath blanket wash formula is now inadequate to thoroughly clean the surgical OR towel. Now there is a high probability that the entire load of bath blankets will be contaminated by the one mis-sorted surgical OR towel. If this is not discovered by the laundry finishers, there is a reasonable chance that a contaminated load of bath blankets will make their way to the hospital and the load of blankets may end up touching sick patients.

Let’s look at another mis-sort quality consequence. Suppose a plastic bag of food waste makes its way into the soiled laundry and is not sorted out. Let’s imagine this bag makes its way into a wash load of incontinence pads. Pads normally require a strong wash formula since they are heavy soil. Let’s assume they are washed in a tunnel washer and make their way to the extraction press. The now clean pads and plastic bag are pressed under pressure and the bag explodes! The entire incontinence pads load is now contaminated! If this is not discovered by the laundry, then these dirty pads will be used in patient care.

Let’s examine one final example. Reusable microfiber products for cleaning require a heavy soil extended formula. Often terry items such as washcloths will be mis-sorted into the microfiber bins. Since terry items have a high cotton blend, if they are washed with microfibers, they will break down and shed lint. Microfiber has such as high positive charge that it will attract and trap the cotton fibers resulting in microfiber cleaning products that are contaminated with cotton fibers and thus not as effective.

Production
A high-performance healthcare laundry operation must produce high quality hygienically clean healthcare textiles cost competitively. Just like with software engineering, larger investments in the early parts of the process yield successively larger dividends downstream. The impact of errors in the early part of the process increases exponentially the farther downstream they are discovered. In most healthcare laundries there are more than five times as many downstream production workers as there are soil sorters. That means, at a minimum, the impact of activities in the sort will be more than five times as great in downstream production. And that is just in the laundry. When the linen reaches the hospital, the impacts of errors rise by an additional order of magnitude. Below are some additional real-world scenarios, which illustrate this:
1. Flat Sheets Sort Error: An employee on the soil sort line is responsible for sorting flat sheets into a bin. He is in a rush and mistakenly mixes several washcloths and towels into the bin for sheets. The sheets are transported to the ironer line. The team feeding the ironers now must stop their sheet feeding and sort out these towels and washcloths. Now they are contaminated so they must go right back to the sort to be sorted and washed again. This error, which could have been avoided in a few seconds, ends up costing the laundry several orders of magnitude more to fix.
2. Scrubs Sort Error: Scrubs must not only be sorted correctly, but pockets much be checked for foreign items such as ink pens, which are common in scrub pockets. If a pen is missed in a scrub pocket, the result is expensive and chaotic. By the time the load reaches the dryer, the ink will likely spill on the other scrubs and ruin the entire load of scrubs. Now one missed task in one day, that takes less than 5 seconds, will result in a financial loss of more than $1,500.
3. Blanket Sort Error: As stated above, bath blankets are normally washed on a shorter light soil formula. A sorter misses some heavily soiled surgical towels and mistakenly the are sorted into the bath blanket bin. These enter the wash and are washed on a light soil formula. Because of the heavily soiled surgical towels, the wash is inadequate to clean the surgical towels and the bath blankets since they are now heavily soiled too. The blankets make their way to the finish where they are fed, folded, and loaded onto a cart. The cart is taken to the hospital where the contaminated blankets may be in contact with an immune compromised patient. From this example, it is apparent that an error in the sort may have severe health and safety as well as financial consequences.

As with any complex software engineering project, the first step in establishing a high-quality healthcare laundry process is to focus resources to get the upstream correct. Invest the time and resources to develop an accurate high functioning sort operation. The few extra seconds is takes employees to sort items accurately will pay exponential dividends in the safety, quality, and productivity of your healthcare laundry operation. More importantly, these relatively small investments will pay immeasurable gains downstream ultimately in infection prevention and patient safety.

Gregory Gicewicz is distinguished in the reusable textile industry as a tireless advocate for increasing awareness of the significant role that having high standards in the processing of healthcare laundry plays in broader infection prevention strategy. He is president and CEO of Sterile Surgical Systems, a full-service accredited healthcare laundry and reusable sterile surgical textile pack manufacturer. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.

Navigating Our New World of Reusable Microfiber Cleaning Products for Use in Healthcare

By Gregory Gicewicz

In an earlier column, “Navigating Our New World of Reusable Protective Gowns for Use by Healthcare Personnel (HCP),” we noted that COVID-19 has caused a dramatic switch from disposable to reusable protective gowns for use by healthcare personnel (HCP).  Reusable gowns offer clear environmental advantages, superior performance and protection, financial benefits, and more predictable availability. Conversely, disposable gowns are discarded in our landfills after one use and typically do not employ local workers in their reprocessing. These same advantages apply to reusable microfiber cleaning products for use in healthcare.

Anyone who has been to a grocery store since COVID-19 has noticed that single use cleaning products, such as disinfectant wipes, are challenging to acquire. These same shortages are being felt in healthcare settings as demand has skyrocketed due to COVID-19. The focus on effective environmental cleaning has never been more critical. According to the Centers for Disease Control and Prevention (CDC), the contaminated environment in healthcare plays a direct role in the transmission of a wide range of healthcare-associated infections, including SARS-CoV-2, the coronavirus that causes COVID-19. Fortunately, reusable microfiber cleaning products are again coming to the rescue. In addition to clear environmental advantages, reusable microfiber cleaning products, when cleaned in an accredited laundry, offer superior performance as well as more predictable availability. Their cost per use is typically far below single use disinfectant wipes and they support local jobs to reprocess.

In this column we will seek to help healthcare practitioners navigate the world of reusable microfiber cleaning products for use in healthcare. First, we will explain some of the science around microfiber and why it is an ideal technology for cleaning the healthcare environment. Next, we will provide guidance on choosing the correct microfiber systems for the required purpose. In a later column, we will explain the processing requirements for microfiber products. We will limit our discussion to reusable microfiber cleaning products for use in healthcare settings. Single-use microfiber products or reusable microfiber products for use in non-healthcare settings will not be discussed.

The Magic Behind the Science of Microfiber

Microfiber refers to a synthetic fiber measuring less than 1 denier, a unit of fineness for synthetic fibers, based on a standard mass per length of 1 gram per 9,000 meters of yarn. For reference, a human hair is approximately 20 denier. Most reusable high-performance microfiber products, used in healthcare cleaning, are made from synthetic polymer materials, most commonly polyester and polyamide (e.g. nylon). These are typically extruded through a mold (called a spinneret) to form a bicomponent filament of a small cross-sectional diameter referred to as segmented pie. The filament is then drawn to stretch and make it smaller. Higher quality microfiber products undergo a second process called “Splitting.” “Splitting” occurs when combining an increase in pH, heat, and mechanical forces used to approach the melting point of the polyamide causing the polyamide to shrink away and separate from the polyester. This process results in superfine polyester triangular fibers resulting in a huge surface area resulting in a dramatic increase in absorption capacity. The synthetic polymer materials and the extrusion and splitting process are responsible for many of the magical properties of microfiber.  These include:

  • Increased tensile strength – High quality bicomponent splitable microfiber products are made from continuous filaments so they are much more durable and lint free. Single use spun bond or melt blown wipers/mops or cotton wipers/mops, which are made from short chopped up fibers, deteriorate quickly. High quality knitted reusable microfiber cleaning products can withstand excessive stresses without losing their structural integrity.
  • Highly durable– High quality reusable microfiber cleaning products will last through many cleaning and processing cycles. Durability and quality vary greatly and are dependent on the quality of the microfiber yarn used, its composition and the knitting technology used (ie: circular knit vs warp knitting). High quality reusable microfiber cleaning products will last through many cleaning and processing cycles.
  • Exceptionally absorbent – Splitable bicomponent (polyester / polyamide) microfiber products have enormous surface areas for their weight. Consequently, they have some of the highest absorption capacities of any material known. Some high-quality microfiber wipers have more than 300 miles of fiber in a 12”X12” wiper and can absorb as much as 8 times their weight in fluid! This means materials in the water including pathogens will also be absorbed by microfiber.
  • Superior cleaning action – Microfiber fibers, due to there size and composition, develop a natural positive electrostatic charge, while most organic particles (e.g., dirt, dust, bacteria, pollen, most pathogens, etc.) are negatively charged. Therefore, microfibers, with their tremendous surface area and microscopic triangular shape can attract (when dry) and trap efficiently most organic matter. The hundreds of miles of ultra-thin fiber mean that germs and pathogens literally get stuck in the web of fiber. This makes microfibers among the most effective surface cleaners known.

 How do I Choose a Microfiber System that Supports Infection Prevention?

Not all microfiber is created equally and therefore it is important to carefully research the many factors that differentiate microfiber quality. The first step in this analysis is to understand the comprehensive environmental cleaning and disinfecting goals and performance indicators in your healthcare facility. For example, what are the cleaning and disinfecting parameters in various locations? What microorganisms is your cleaning program targeting? What is the required room turnaround time? What are the cost constraints? Are there any special cleaning personnel or training considerations? What chemical disinfectants will be used with the microfibers? How/where will the microfibers be processed? Understand the difference between cleaning and disinfecting. Cleaning involves removing dirt, germs, and pathogens and is necessary before disinfecting. Disinfecting involves killing pathogens using an EPA-registered disinfectant. Once the above is understood and documented, it becomes more straightforward to choose the best reusable microfiber cleaning products that help achieve your comprehensive environmental cleaning and disinfecting goals. There are hundreds of factors that determine microfiber system quality. Consult peer organizations to learn their experiences with different microfiber systems. Partner with your accredited healthcare laundry provider. They are experts in providing hygienically clean healthcare textiles for patient and staff use. They are likely also experts in providing high quality microfiber systems that support infection prevention. Most will offer a microfiber system rental program. Other key factors in a microfiber system to investigate include:

  • Durability - Durable high-quality microfiber products should be able to withstand more than 200 healthcare laundering cycles while retaining their performance. Research microfiber durability claims or better yet test them yourself. Pay close attention to disinfecting chemicals used by your healthcare facility. Many contain high bleach concentrations and can break down microfibers and cause them to lose their performance.
  • Absorption rate – Absorption rate is closely tied to the microfiber material composition (a 50 % polyester / 50% polyamide is better), fiber size (lower is better), electrostatic charge (higher is better), and ultimately the surface area per weight (higher is better). A simple test is to weigh the wipers when saturated and compare their weights. Find products that lead in these factors.
  • Cleaning performance – Cleaning performance is also related to the above factors. The best way to assess cleaning performance is with a side-by-side test using several different microfiber products. Measure how they perform cleaning a standardized surface load. The results should become obvious quickly. Explore documentation on cleaning performance for each product being analyzed.
  • Microbial removal – High quality microfiber cleaning products score highest in microbial removal tests. Reputable microfiber manufacturers should have accredited lab test results demonstrating the percentage of various microbes removed by their product. Compare these and choose the product that performs best against targeted pathogens in your facility.
  • Cost – Cost involves more than the cost of the microfiber product and must be looked at comprehensively. Cost per use is a better metric. To find this number, divide the purchase cost of the microfiber by the expected number of uses. Add this to the processing cost per use. Don’t forget to factor in the costs for hardware, such as mop handles and holders, as these can be expensive. Make sure to assess how long it takes to clean a room using the product. More expensive products that cut room cleaning time by a large percentage will end up saving more money in the long run.
  • Color Coding Support – Look for microfiber systems that support color coding. It can be advantageous to segregate microfiber products by functional area. For example, it may make sense to use one color for the bathrooms, one color for the OR, one color for patient rooms, and one color for the kitchen.

The many benefits of reusable microfiber cleaning products for healthcare are undisputable.  Many papers have been published by organizations such as the Environmental Protection Agency (EPA), the CDC, and the Joint Commission extolling the virtues of using microfiber. They are more cost effective, clean better, leave a smaller environmental footprint, and produce better outcomes for patients, to name a few.  COVID-19 has highlighted many of the risks of relying on fragile supply chains where disposable products are manufactured thousands of miles from the end-user in factories with suspect quality practices. As a result, it is easy to understand why an unprecedented number of healthcare organizations have used evidence-based decision making and converted to reusable microfiber cleaning systems with overall positive results.

Gregory Gicewicz is distinguished in the reusable textile industry as a tireless advocate for increasing awareness of the significant role that having high standards in the processing of healthcare laundry plays in broader infection prevention strategy. He is president & CEO of Sterile Surgical Systems, a full service accredited healthcare laundry & reusable sterile surgical textile pack manufacturer. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.

 

 

Processing Reusable Gowns for Use by Healthcare Personnel

By Gregory Gicewicz

This column originally appeared in the December 2020 issue of Healthcare Hygiene magazine.

In an earlier column, “Navigating Our New World of Reusable Protective Gowns for Use by Healthcare Personnel,” we noted that COVID-19 has caused a dramatic switch from disposable to reusable protective gowns for use by healthcare personnel (HCP). Reusable gowns offer clear environmental advantages, superior performance and protection, financial benefits, and more predictable availability. Conversely, disposable gowns are discarded in our landfills after one use and typically do not employ local workers in their reprocessing. With this sudden rise in the use of reusable protective gowns for use by healthcare personnel, it is more imperative than ever that these gowns be processed according to the highest standards of infection prevention, quality, and safety; and preferably in an accredited facility.

Different Requirements
Reusable protective gowns typically have more rigorous processing requirements than bulk healthcare linen items such as sheets, blankets, terry, and patient gowns. Most are more expensive since they are constructed of high-tech materials and manufactured under rigorous manufacturing practices. They are normally more susceptible to damage from improper processing in the washer or dryer. In addition to the normal hygiene cleanliness processing standards that hold for all healthcare textiles, reusable protective gowns must retain their wearer protective properties even after a specified number of uses and processing cycles. If processed incorrectly, they will lose their protective properties, exposing the wearer to risks of infection.

The following seeks to inform healthcare practitioners on how to process reusable protective gowns for use by HCP. We will address all processing steps including soil sorting, washing, drying, inspecting, folding and pack building (if required), sterilization (if required), labeling, and finally distribution. We will address processing requirements for a range of reusable protective gowns from Level 1 isolation gowns to Level 4 sterile surgical reusable gown packs.

Soil Sort
To reiterate, reusable protective gowns have unique processing requirements and therefore must be handled separately from other textile items. The gowns should arrive at the laundry in protective bags, either pre-sorted or mixed with other healthcare textiles (HCT). The first step is to sort them separately from all other textiles. Levels 2, 3, and 4 surgical gowns can be sorted together. Isolation gowns can also be sorted together. But these items should never be mixed with other HCT such as sheets, blankets, towels, or microfiber cleaning products. It is important during the soil sort operation to remove all items that are not reusable protective gowns. Foreign items such as sharp medical instruments, adhesive tapes, soiled rags, garbage, pens, and pharmaceuticals will cause expensive damage to reusable protective gowns. Needless to say, it is more economical to catch these items in the sort than to catch the damage farther downstream during inspections. It is even more expensive if the damaged gowns find their way to a healthcare practitioner.

The Wash Process
Accurate washing of reusable protective gowns ensures that they maintain their protective properties, and last for their designed life cycle. Additionally, it will confirm that they are free of pathogens that can cause human illness. An accurate wash must always begin with a proper washer and a correct load size. It is advisable to wash protective gowns in an open pocket washer extractor (WE) if possible. Load sizes must match the washer capacity. Under loading or overloading will result in insufficient wash chemistry, inadequate mechanical action, and ultimately dirty gowns. Reusable protective gowns should always arrive from the manufacturer with instructions for use including wash instructions. Follow these precisely, especially chemistry, water levels, and temperature. Never use bleach or softener as these may degrade the barrier properties. Barrier chemicals that extend the protective properties of gowns can be used in the wash formula if authorized by the gown manufacturer. Always protect gowns from air, surface, or hand contamination on the journey to the dryer. Never let clean protective gowns sit in a washer for an extended period.

Drying
Most premature damage to reusable protective gowns occurs during drying. Either the temperature is too hot, the time is too long, or there is inadequate air circulation. Most reusable protective gowns are constructed of synthetic fabrics that dry quickly and at lower temperatures (< 150 degrees F.). Over drying will burn or weaken fabrics causing a loss of performance. Be sure to keep dryer lint traps clean to ensure good air circulation. Keep dryer drums clean and free of nicks and cuts to prevent cutting of gowns. Often with isolation gowns and surgical gowns, ribbed sleeves will dry more slowly than synthetic barrier regions of the gown. In this case, dry longer on lower heat to make sure sleeves are dry and barrier fabric does not burn or melt. Always protect gowns from air, surface, or hand contamination on the journey from the dryer to inspection room. Never let clean and dry protective gowns sit in dryers or in an exposed area for long periods of time. Time spent unprotected means a potential risk for contamination.

Inspection
Per Healthcare Laundry Accreditation Council (HLAC) standards (see: https://www.hlacnet.org/standards ), Levels 2-4 surgical gowns must be inspected and folded in a dedicated climate controlled surgical pack assembly room. Non-surgical isolation gowns can be inspected and folded in the bulk laundry clean area. All surgical gowns must have their critical zones inspected with the use of light illumination (e.g., table, bar, tube, etc.) for the presence of stains, residue, physical defects, chemical or thermal damage, and foreign debris and to ensure that appropriate labels are in place and a tracking system is intact. A tracking mechanism suitable for each surgical gown must be used to track the number of uses based on the textile manufacturer’s recommendations. Gowns with physical defects such as tears, stains, holes, or structural weaknesses must be either repaired, rewashed or taken out of service.

Sterile or Non-Sterile Packaging & Labeling
If gowns will be worn in a setting that does not require them to be sterile, then after inspection they can be folded or packaged and placed on a clean protected cart for distribution. Most protective gowns used outside of the OR (non-surgical) do not need to be sterile. Non-surgical Level 1 or Level 2 isolation gowns are usually used non-sterile. Conversely, protective gowns used in a surgical setting must be sterile. Sterilization of gown packs can happen either at the laundry or at the hospital. Therefore, they must be folded and packaged for sterilization after inspection. The barrier product used to complete the pack and provide adequate coverage of the contents must be appropriate for the method of sterilization and must protect the contents from contamination after sterilization. The finished pack and bulk loose textiles must be packaged in a suitable material (e.g., placed in covered carts or wrapped in plastic) to avoid contamination during transport to the customer.

The many benefits of reusable protective gowns are undisputable. They are more cost effective, more comfortable, leave a smaller environmental footprint and produce better outcomes for patients and clinical practitioners, to name a few. But it is imperative that they are processed correctly to function as designed. COVID-19 has highlighted many of the risks of relying on fragile supply chains where disposable products are manufactured thousands of miles from the end-user in factories with suspect quality practices. As a result, is easy to understand why an unprecedented number of healthcare organizations have converted to reusable protective gowns.

Gregory Gicewicz is distinguished in the reusable textile industry as a tireless advocate for increasing awareness of the significant role that having high standards in the processing of healthcare laundry plays in broader infection prevention strategy. He is president and CEO of Sterile Surgical Systems, a full-service accredited healthcare laundry and reusable sterile surgical textile pack manufacturer. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.

Navigating Our New World of Reusable Protective Gowns for Use by Healthcare Personnel

By Gregory Gicewicz

Editor's note: This column originally appeared in the November 2020 issue of Healthcare Hygiene magazine.

COVID-19 is permanently transforming many practices in our healthcare world. One of these transformations is the dramatic switch from disposable to reusable protective gowns for use by healthcare personnel (HCP). During the last decade, most single-use protective HCP gowns were manufactured overseas. Recently, many of these single use gowns have been plagued by quality issues and supply chain disruptions. Concurrently, demand has skyrocketed due to COVID-19. Consequently, the availability and performance of HCP gowns have become a chronic issue in healthcare settings.

Fortunately, reusable HCP protective gowns are coming to the rescue. In addition to clear environmental advantages, reusable gowns offer superior performance and protection as well as more predictable availability. Their cost per use is typically far below single-use gowns and they support local jobs to reprocess in preferably accredited healthcare laundries. Conversely, disposable gowns are discarded in our landfills after one use and typically do not employ local workers in their reprocessing.

The following seeks to inform healthcare practitioners on how to navigate the world of reusable protective gowns for use by HCP. We will explain protective gown terminology and regulations; provide guidance on how to align the correct protective gown to its required purpose; identify key areas to investigate before selecting the protective gown; and finally how to care for and maintain the investment to ensure quality and patient safety. Discussion is limited to reusable gowns making liquid barrier protection claims and that are intended for use in healthcare settings. Other hospital staff apparel such as scrubs, lab coats, masks, and gloves are not included in the discussion, nor are non-healthcare protective gowns.

Definitions, Regulations and Standards
The Food and Drug Administration (FDA) broadly defines two different categories of protective gowns: those claiming minimal or low levels of barrier protection and those claiming moderate to high barrier protection. More specifically, minimal or low-barrier protection gowns are broken down into ANSI/AAMI PB70 Levels 1 or 2 protection or equivalent standards. Moderate or high barrier protection gowns are broken down into ANSI/AAMI PB70 Levels 3 or 4 protection or equivalent standards.

The FDA classifies protective gowns as either class I devices or class II devices. Class I devices are typically lower risk and are “exempt” from the rigorous premarket notification procedures. Class II devices are higher risk and require special controls as well as FDA premarket notification procedures. It is best to think of Class I gowns as non-surgical gowns and class II gowns as surgical gowns. Per the FDA, a class I “non-surgical gown” must meet all the following criteria:
1. It is labeled as a gown other than a surgical gown (e.g., isolation gown)
2. It is not described in its labeling as a surgical gown
3. If it has statements relating to barrier protection, such statements are for only minimal or low barrier protection.

A Class II “surgical gown” must meet any of the following criteria:
1. It is labeled as such
2. It is described in its labeling as a surgical gown
3. It has statements relating to moderate or high-level barrier protection
4. It has statements that it is intended for use during sterile procedures

The FDA must perform a premarket review of all Class II gowns before these can be cleared for marketing. FDA premarket reviews will address areas such as:
• Performance testing to ensure the gowns resist blood and liquid penetration
• Safety testing for biocompatibility, sterilization method validation, flammability, physical strength, and linting
• Labeling including barrier level identification and instructions for use

In the United States, ANSI/AAMI PB70 establishes a system of classification for protective apparel (including surgical gowns and isolation gowns) used in healthcare facilities, based on their liquid barrier performance. The ANSI/AAMI PB70 standard was accepted by the FDA in 2004. AAMI addresses fluid protection in the critical zone, the gown area where an OR staff member is most likely to come in direct contact with potentially infectious material. In surgical gowns, it includes much of the sleeves and the front panel. Both fabric and construction (seams) are tested. The back of the gown is typically not protective. ANSI/AAMI PB70 Levels are defined as follows:

ANSI/AAMI PB70 Level 1: ANSI/AAMI PB70 Level 1 gowns offer minimal protection and are intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. These can be used for Standard Precautions and Contact Precautions. Patient gowns and non-surgical isolation gowns are classified as ANSI/AAMI PB70 Level 1.

ANSI/AAMI PB70 Level 2: ANSI/AAMI PB70 Level 2 gowns offer minimal to low fluid barrier protection. These are intended only for low-fluid, minimally invasive surgical procedures such as blood draws and suturing. These can also be used for standard precautions and contact precautions. To classify as ANSI/AAMI PB70 Level 2, the gown must undergo impact penetration testing (AATCC 42) as well as hydrostatic pressure testing (AATCC 127). Impact penetration testing must measure <= 1.0 g. The test indicates how the fabric will resist strikethrough when fluids splash or spray onto the fabric. Please see https://www.aatcc.org/impact-penetration-testing-for-textiles/ for the test definition. Hydrostatic Pressure testing must measure >= 20 cm. This test indicates how the fabric will resist strikethrough when water pressure is applied to the surface of the fabric. A higher number indicates better water resistance. See https://members.aatcc.org/store/tm127/535 for the test definition.

ANSI/AAMI PB70 Level 3: ANSI/AAMI PB70 Level 3 gowns offer moderate fluid barrier protection and are used for the widest range of surgical procedures, where moderate fluid protection is necessary. Examples include arterial blood draws, IV insertions, ER staff, and trauma staff. To classify as an ANSI/AAMI PB70 Level 3 the gown must measure <= 1.0 g for AATCC 42 impact penetration testing and >= 50 cm for Hydrostatic Pressure testing.

ANSI/AAMI PB70 Level 4: ANSI/AAMI PB70 Level 4 gowns offer the highest fluid and microbial barrier protection against bloodborne pathogens in the critical zones. These are used for long, fluid-intensive procedures or procedures where there is a high likelihood of bloodborne pathogen contamination. Open heart surgeries, C-Sections, and organ transplants are procedures where ANSI/AAMI PB70 Level 4 gowns would be typically required. Only ANSI/AAMI PB70 Level 4 gowns are tested for viral penetration resistance, and therefore only Level 4 gowns are considered impermeable to viral penetration using ASTM F1671 testing. See https://www.astm.org/Standards/F1671.htm for the testing definition. To classify as ANSI/AAMI PB70 Level 4, gowns must exhibit no penetration at 2 psi(13.8 kPa) using ASTM F1671 testing.

According to the CDC, the gowns complying with the lower levels (Level 1, 2 and 3) cannot be considered impermeable. However, Level 1–3 gowns can provide increased resistance to liquids. ANSI/AAMI PB70 Level 1, 2, and 3 surgical/isolation gown-testing requirements only use water as a challenge. Because the surface tension of water is much higher than that of blood, blood can penetrate through fabrics more readily than water. Therefore, no correlation can be made between AATCC water resistance tests (AATCC 42 and AATCC 127) and ASTM F1671 viral penetration tests, and consequently, protection provided by Levels 1, 2, 3 gowns and that of Level 4 gowns.

A common misunderstanding among many end-users is that they are protected from blood, body fluids, and other potentially infectious materials (OPIM) when they wear any type of fluid-resistant garment or surgical or isolation gown. Another common misunderstanding is around gown testing versus fabric testing. Many gowns are marketed with Level 2 or 3 fabric. This is vastly different from an actual Level 2 or Level 3 surgical gown. To be classified as a Level 2 or Level 3 surgical gown, the entire gown critical zones, including all seams, must pass rigorous hydrostatic testing and impact testing after the marketed number of uses. They also have thorough labeling requirements. Do not expect a reusable gown with Level 3 fabric to perform the same or cost the same as an FDA-cleared Level 3 surgical gown. Always thoroughly read the labels and understand the instructions for use, including processing and sterilization requirements.

Finding the Right Tool and the Right Processor
Before choosing the right reusable protective gowns, it is important to understand, as thoroughly as possible, the life cycle factors impacting the gown choice. Different gown types must be used for different situations. Gown performance is certainly critical but there is more to consider. For example:
• What are the gown-use cases?
• How many gowns will be needed per day?
• What is the current and future availability of the gowns?
• Is your laundry processor accredited?
• For how many uses are the gown certified?
• How much do the gowns cost?

Most importantly, understand the use case and anticipated level of exposure for the wearer. For example, the need for cover gowns for hospital visitors can usually be met with a standard Level 1 isolation gown. But don’t expect much fluid repellency and never use these in situations where higher protection is required. In certain higher risk non-OR settings, standard Level 2 isolations gowns may be required. In all cases in the OR, FDA cleared surgical gowns are required. Choose the appropriate ANSI/AAMI PB70 level depending on the requirement. Choose Level 4 for long, fluid-intensive procedures with a high likelihood of lengthy exposure, Level 3 for moderate fluid barrier protection, and Level 2 for low- to minimal-fluid barrier protection. Try samples from reputable vendors and assess comfort, quality, and style.

Anticipate how many of each type of protective gown your facility will require per day and communicate needs to your laundry provider as early as possible. With COVID-19, reusable protective gown supply chains have been stressed but are catching up. Understanding demands and availabilities early will help you and your laundry provider plan. Shortages can be mitigated temporarily with extra deliveries from your laundry provider.

Make sure you have a quality laundry provider that is accredited by HLAC (http://hlacnet.org). Check that they process reusable protective gowns properly. If they are accredited, they should, but check anyway. Your laundry provider should not use bleach because it can damage gowns. They should not over dry as excessive heat will weaken protective gowns. They should process on standard protective gown wash formulas. They should regularly verify and document gown fluid repellency. Confirm that they purchase high-quality gowns from reputable suppliers with FDA clearance (for Class II gowns). Have them demonstrate that they remove gowns from circulation after their certified number of uses. A gown that is damaged from improper processing will not perform as intended and can become an infection risk for the wearer. Ensure that your laundry provider performs post laundering processing of Class II gowns in an accredited segregated pack room. These steps include gown inspection for cleanliness and integrity; marking usage grids; proper gown folding and packaging; and appropriate labeling. It is always a good idea to inspect your laundry processor regularly to verify they are following the highest standards for infection prevention and patient/staff safety.

Reusable protective gowns generally cost less per use than their disposable counterparts. Understand how your laundry provider charges for reusable protective gowns. Do they charge per each (typical) or per pound. Expect to pay a low price per use for Level 1 or Level 2 non-surgical isolation gowns but expect high usage and high loss. Anticipate paying a premium for high quality Level 3 or Level 4 surgical gowns. Remember, these gowns undergo significant manufacturing steps that are not required for Class I protective gowns. They are also more expensive to process and package by the laundry. To save money and protect the environment, realize that expired Level 3 or Level 4 protective gowns can be re-purposed as Level 1 or Level 2 gowns rather than disposing of them.

The many benefits of reusable protective gowns are undisputable. They are more cost effective, more comfortable, leave a smaller environmental footprint and produce better outcomes for patients and clinical practitioners, to name a few. COVID-19 has highlighted many of the risks of relying on fragile supply chains where disposable products are manufactured thousands of miles from the end-user in factories with suspect quality practices. As a result, is easy to understand why an unprecedented number of healthcare organizations have converted to reusable protective gowns.

Gregory Gicewicz is distinguished in the reusable textile industry as a tireless advocate for increasing awareness of the significant role that having high standards in the processing of healthcare laundry plays in broader infection prevention strategy. He is president and CEO of Sterile Surgical Systems, a full-service accredited healthcare laundry and reusable sterile surgical textile pack manufacturer. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.

Processing Monitoring in a Healthcare Laundry: Trust but Verify

By Gregory Gicewicz

Editor's note: This column originally appeared in the October 2020 issue of Healthcare Hygiene magazine.

All of us are inundated daily with studies, claims, certifications, and registrations about infection prevention in the healthcare setting. While it is generally understood that proper healthcare textile hygiene must be an integral part of any infection prevention strategy, here are some common assertions and their claims:
• Claim 1: Our surface disinfectant kills 99.99 percent of germs.
• Claim 2: Our laundry chemical is certified to kill SARS-CoV-2, the virus that causes COVID-19.
• Claim 3: Our laundry plant is certified. We tested samples of finished linen and their CFU counts are < 20.
• Claim 4: The air that touches our clean healthcare textiles is clean enough.
• Claim 5: Our finished linen treatment chemical kills C. diff.

We are living in skeptical times, which forces us to ask: Are these baseless claims or should we trust them? So many questions come to mind.

For example, regarding the first claim: Which germs does the disinfectant kill or arguably more important, which does it not kill? What about the other .01 percent of pathogens? How must this disinfectant be used?

Regarding the second claim: Does that mean if we do not use your laundry chemical, we can’t kill SARS-CoV-2? Will standard healthcare laundry processes kill SARS-CoV-2?

Does the third claim mean that all my healthcare textiles (HCTs) are clean enough? What do the popular third-party certifications and their designations mean and how are they measured?

In the fourth claim: What does “clean enough” mean for air? How was it measured? Is all the air touching clean HCT clean enough?

And lastly, the fifth claim: Does having to use a finished linen treatment chemical to kill C. diff spores mean that standard healthcare laundry processes do not?

The following seeks to answer questions like the above and to inform on what can be done to verify the accuracy of such claims. In doing so, we hope to convince you of the importance of monitoring laundry processes to consistently provide hygienically clean and safe HCTs for sick patients. While there are established standards for HCT processing (see: http://HLACNet.org ) we need to go further and monitor the process to give confidence in the finished product.

We know that microorganisms are ubiquitous. There is essentially no environment where microorganisms cannot exist. Therefore, our goal must be to maintain an environment of high microbial integrity around our HCTs

The Problem: No Agreed Upon Measures of Contamination
The problem is there is generally a lack of agreed upon standards of cleanliness in healthcare laundry processes. There is no definition of hygienically clean linen, carts, water, air, surfaces, and even employee hands. Furthermore, there are no standard methods of measurement of laundry processes. This leads to such logical questions as:

• How clean is clean enough? (This was discussed in the February 2020 Issue of HHM.)
• What contamination values are acceptable throughout the process? There are lots of variables.
• Do HCTs need to be sterile in certain areas?
• Is my laundry processing equipment performing?
• Are my laundry people performing?
• Are my laundry processes performing?

Clearly, without a comprehensive process monitoring program around our HCT system and without objective measures of contamination, we are effectively operating blindly.

The Solution: Process Monitoring
Therefore, the first step is to define the areas to test, the testing frequency, the testing methodology, and the acceptable contamination values for each. Important categories to test in any healthcare laundry include the surfaces that touch clean linen; air; laundry process water; laundry employee hands; and the finished HCT product.

Specifically:
- Surfaces that touch clean linen
Washed HCTs can become re-contaminated when in contact with dirty surfaces such as those found in a laundry. These include folding tables, linen conveyors, linen shelves, and clean linen carts. We cannot realistically test every surface every minute of every day. Therefore, it is a good idea to choose a variety of key surfaces and regularly test for contamination. Define the test method and define the acceptable contamination values. More on this later. Contamination values found above acceptable levels mean cleaning protocols need to be re-evaluated. Disinfectants or cleaning equipment may need to be adjusted (equipment); Cleaning frequency may need to be increased (process); or cleaning personnel may need additional training (people).

- Air
Clean HCTs are exposed to air the second they leave the washer and for the duration of their journey to the patient. Contaminated air can contaminate HCT. Lint and dust can be especially problematic. Areas of a laundry especially susceptible to dirty air include dryers, ironer and piece folder areas, and hand folding stations. As with surfaces, choose a variety of locations and regularly test for contamination. Define the test method and define the acceptable contamination values. Contamination values found above acceptable levels mean air cleaning protocols need to be re-evaluated. Air filters or air handlers may need adjustment (equipment); Blowdown frequency may need to be increased (process); or cleaning personnel may need additional training (people)

- Process water
Clean process water is a necessary ingredient in producing clean HCTs. Good places to test process water cleanliness include the main city water supply, cold process water tanks, and final rinse water zones in a tunnel washer. Water should be tested at least monthly and acceptable contamination values should be set. Water contamination values found above acceptable levels mean water protocols need to be re-evaluated. Dirty city water may need additional filtration or treatment (equipment); Dirty clean water tank storage means tank cleaning procedures must be re-evaluated (people/process); Dirty final rinse zones means dirty water will re-contaminate HCT. Tunnel tank cleaning protocols must be re-evaluated and personnel re-trained on these (people/process/equipment)

- Employee hands
Laundry-finish personnel often touch clean HCT. If their hands are dirty, they will re-contaminate the clean HCT. While it is unrealistic to test every finish-employee’s hands every minute of every day, it is a good idea to sample a few employee hands regularly. Define the test method and define the acceptable contamination values. Contaminated hand values found above acceptable levels mean hand hygiene protocols, equipment, and training must be reassessed (people/process/equipment).

- Finished HCT
The final step in a laundry process monitoring program is to test the bioburden levels on the finished HCT. Once again, strategic sampling is our best solution. Choose several different textile blends including 100 percent cotton items (e.g., OR towels), polyester cotton blends (e.g., blankets, sheets, towels), and 100% synthetic items (e.g., surgery gowns, isolation gowns). Test regularly and be sure they are sampled as close to patient end use as possible. Define the test method and define the acceptable contamination values. Contaminated HCT values found above acceptable levels mean the process needs to be re-assessed. First test the HCT out of the wash to ensure they are within acceptable levels. If not, there is an issue with the wash process that must be addressed. If HCT out of the wash are clean, then the problem lies downstream. Check air, surface, and employee hands for areas where re-contamination may be occurring. Hopefully, our other process monitoring steps have already identified these.

How to test? Tap the latest resources
Any tests for contamination are only as good as the testing methodology employed. Some key test areas to look at include test accuracy/detail, test repeatability, organisms identified, timeliness of results, test labor intensity, and test cost. A test that can identify actual microorganisms is a benefit. That way, it is possible to determine if your process is killing targeted microorganisms such as SARS-CoV-2 or C. diff. Tests that can be performed by your staff onsite will be more timely and less costly. Tests that are more thorough and identify more CFU will be more accurate. Imagine a superficial bioburden test that shows low CFU but misses many microorganism colony counts gives a false sense of security Be sure to understand the above when choosing your testing methodology. Fortunately, there is a newly released Process Monitoring Toolkit (https://www.pmtknet.org ) that meets the above criteria and is made for healthcare laundry process monitoring. I suggest giving it a try.

How do we define acceptable contamination levels?
Generally, acceptable contamination criteria do not exist yet for healthcare laundry. Consequently, they must be defined internally and then measured against. As more laundries implement process monitoring and more data is gathered, our industry can develop more accurate contamination standards. It is a good idea to involve hospital infection prevention personnel in any exercises where acceptable contamination criteria are determined. It is also important to note that not all areas and items will have the same contamination criteria. For example, certain areas of a hospital that house immunosuppressed patients may require sterile HCTs. These items must have zero contamination and thus must be handled differently than normal HCT. Incoming city water will most likely have different acceptable contamination levels than tunnel washer press tank water. Soil sort conveyer acceptable contamination levels will certainly be different from those on clean linen carts. The important practice is to define your acceptable contamination levels, measure to them, and then adjust/manage your process when actual levels fall outside of acceptable levels. Then repeat!

Putting it all together
Healthcare laundry process monitoring is the surest way to ensure standard laundry processes consistently provide hygienically clean and safe HCTs for sick patients. Best practices for implementing a laundry process monitoring program are built around:
1. Defining areas to test. We recommend hard surfaces, air, water, employee hands, and linen
2. Setting testing frequency. We recommend linen at least quarterly; other areas at least monthly
3. Choosing a testing methodology. We recommend the HLAC Process Monitoring Toolkit (PMTK: https://www.pmtknet.org/)
4. Setting acceptable contamination levels across areas – We recommend defining these internally with your hospital infection prevention partners.
5. Managing to acceptable contamination levels – Make process, equipment, and people adjustments when acceptable levels are not met
6. Repeat the process

The end result is that hospital patients and their families will thank you for providing them with consistently clean linen and giving them one less thing to worry about as they heal!.

Gregory Gicewicz is distinguished in the reusable textile industry as a tireless advocate for increasing awareness of the significant role that having high standards in the processing of healthcare laundry plays in broader infection prevention strategy. He is president and CEO of Sterile Surgical Systems, a full-service accredited healthcare laundry and reusable sterile surgical textile pack manufacturer. He is past-president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.

As Senior Living Facilities Weigh Infection Control Solutions, Laundry Precautions Must Be Part of the Discussion

By Linda McCurdy

This column originally appeared in the September 2020 issue of Healthcare Hygiene magazine.

Until there is a vaccine found, those who are battling SARS-CoV-2/COVID-19 on the front lines must often feel like their efforts are repetitious and futile. And, arguably, when it comes to tackling the pandemic, nowhere is this sense of hopelessness more apparent than in nursing homes, veterans’ homes, assisted living and similar long-term care facilities, where grim statistics keep rearing their ugly head.

Just last month, the American Health Care Association and National Center for Assisted Living (AHCA/NCAL) released a report that showed COVID-19-related deaths in senior living facilities had declined significantly but have “started to uptick again in recent weeks.” Likewise, their report, based on data from the Centers for Medicare & Medicaid Services (CMS), shows that senior living facilities in the U.S. have experienced an “alarming spike” in new COVID-19 cases due to community spread among the general population.

Mark Parkinson, president and CEO of AHCA/NCAL, said this latest news is “especially troubling since many nursing homes and other long-term care facilities are still unable to acquire the personal protective equipment (PPE) and testing they need to fully combat the virus.”
Consequently, we have a situation where facilities everywhere are scrambling to find other viable, available safeguards for the increased protection of the 2 million seniors and 1 million employees who live and work in these communities.

Infection prevention solutions run the gamut among facilities, including trying to keep the virus from getting in the door with checkpoints to screen workers when they arrive; stopping communal dining; devising in-house solutions to cope with PPE shortages; establishing internal COVID-19 internal task forces; and even offering staff financial incentives to live on-site in what has been called a “closed-off, whole-home quarantine.”

Inexplicably, what’s notably absent in the search for solutions is any significant discussion of healthcare textiles. Inexplicable, because the healthcare textile is the one common factor of every patient’s experience in his or her encounter with a hospital or senior living facility. Indeed, in virtually every facility, every patient’s skin will touch a sheet, towel, bed pad, washcloth, bedspread, blanket; and every employee’s skin will touch scrubs, isolation gowns, lab coats, and the list goes on.

No one is immune from this, which is why last July the Healthcare Laundry Accreditation Council (HLAC) issued a warning that improperly laundered linens can raise the risk of the spread of infection in senior living facilities and that its – readily available, already proven – standards provide viable infection control safeguards to those facilities looking to tackle pandemic challenges and beyond. HLAC is a nonprofit organization formed 15 years ago to inspect and accredit laundries processing healthcare textiles (HCTs) for hospitals, nursing homes, and other healthcare facilities, including assisted-living establishments.

HLAC-accredited laundries process HCTs based on the highest standards for patient safety and infection prevention. These HLAC Accreditation Standards have been developed based on federal regulations and guidelines as well as best industry practices. HLAC accreditation affirms that a laundry organization that processes HCTs has successfully passed inspection of the following: its facility, policies and procedures, training programs, and its relationship with its healthcare customers.

Of relevance to senior living facilities is the HLAC standards document, “Accreditation Standards for Processing Reusable Textiles for Use in Healthcare Facilities,” (available to download for free at www.hlacnet.org). For example, in the broadest of terms, HLAC’s standards contained in the document can bring to light a myriad of issues related to healthcare laundries that are most likely not even on a typical facility’s radar, like the need to maintain functional separation at all times when processing HCTs. This means ensuring that clean textiles, ready for patient use, are never in contact with contamination from soiled textiles, dirty surfaces, dirty air, or even dirty hands. The document provides different methods (e.g., partitioning, signage, hand washing stations) to ensure this in the physical layout and through maintenance procedures.

Relatedly, soiled textiles need to be sorted into appropriate wash loads by classification (i.e., color, type of fabric, soil type or soil load) and/or type of goods. Guidelines such as these are particularly relevant because there are many levels of soiled textiles in senior living facilities and they must be washed differently. For example, one would not want to wash a load of lightly soiled bedspreads with a bundle of heavily soiled incontinent pads. These items should be washed in separate loads on separate wash formulas to ensure that each load is optimally cleaned.

Another example: Wash processes need to be monitored regularly to verify that they are consistently producing hygienically clean HCTs. This guideline is particularly relevant to senior living facilities because they may not have the in-house knowledge, experience, and equipment necessary to maintain such consistency. Here, HLAC’s document provides essential guidelines regarding proper wash temperatures, chemical delivery systems, wash formulas, and wash equipment.

The message here is that laundry needs to be part of the discussion as senior living facilities weigh infection prevention solutions. Where in the past “doing the laundry” may have been a secondary management matter, in today’s environment it should be of foremost importance. Facilities that have either on-premise or outsourced laundries must be cognizant of all the issues like those aforementioned. A good place to start is to ask the simple question, “Is our laundry accredited?” Upon inspection, HLAC accreditation is available to senior-living facilities that launder on-premise, or for their outsourced laundry. The willingness to enforce safety measures to produce hygienically clean HCTs will make all the difference in the world.

Linda McCurdy is president of the Healthcare Laundry Accreditation Council (HLAC).

Healthcare Laundry Processes and COVID-19

By John Scherberger, FAHE

Editor's note: This column originally appeared in the May 2020 issue of Healthcare Hygiene magazine.

According to current evidence, SARS-CoV-2 virus is primarily transmitted between people through respiratory droplets and contact routes. Transmission of the SARS-CoV-2 virus can occur by direct contact with infected people and indirect contact with surfaces in the immediate environment or with objects used on the infected person such as stethoscopes, thermometers, or healthcare textiles).

A virus, particularly a coronavirus, can be removed from the healthcare environmental by using time-honored processes: the use of healthcare-grade microfiber infection prevention textiles in conjunction with EPA-registered hospital-grade disinfectants (EPA List N), proper collection and bagging techniques for used healthcare textiles (HCTs), proper functional separation of clean and soiled/contaminated HCTs, and laundering soiled/contaminated HCTs according to CDC Guidelines for Environmental Infection Control in Health-Care Facilities (2003), Laundry and Bedding.

Commercial laundries have consistently provided hygienic HCTs to healthcare facilities, particularly in the U.S., with very rare exceptions. Here are the facts about the laundering processes used by healthcare and other accredited and certified laundries.

Commercial laundries are expected to follow the CDC laundering processes referenced above, follow manufacturers guidelines for all chemicals used in processing HCTs, ensure staff adhere to the use of PPE in handling both soiled/contaminated HCTs, and transport hygienic HCTs to healthcare facilities in a manner that ensures the textiles remain hygienic and assure delivery to facilities following functional separation of textiles. In addition to the CDC Guidelines, all local, state, provincial, and municipal statutes and requirements are followed.

Accredited laundries ensure their staff follows best practices during the entire process, from picking up laundry at the facilities, to delivery to the laundries, and returning of hygienic HCTs. This includes ensuring that the equipment and transportation used is properly maintained, cleaned, and disinfected.

In the U.S., healthcare textiles are disinfected through the use of chemicals and thermal processes. The use of surfactants, disinfectants, and high water and drying temperatures ensures that HCTs are processed to the highest possible standard attainable. When laundries choose to use low-temperature water, additional steps and different chemicals are used that results in hygienic results. HCTs that require sterilization are processed in the same manner as are all HCTs with the added step, typically taken by the hospital sterile processing department.

Accredited and certified laundries assure hospitals that their HCTs are properly collected, sorted, processed, packaged and delivered according to the highest hygienic standards. Following evidence-based practices and scientific principles that include following the current CDC guidelines, ensures a reduction or elimination of microorganisms, including SARS-CoV-2.

Commercial laundering differs drastically from home laundering practices, and those differences are what ensures that scrubs and all other HCTs are consistently more hygienic and better for staff and patients than scrubs and lab coats laundered at home. Commercial healthcare laundries incorporate the following components in the laundering process:
1. Commercial washing machines that ensure time, temperature, agitation, dilution of soils and contaminants to facilitate loosening of bioburdens trapped in textiles, and sufficient rinses based upon load content. CDC guidelines also mandate water temperatures of greater than or equal to 160 degrees Fahrenheit. Low temperature water of 71 to 77 degrees Fahrenheit (22-25 degrees Celsius) with a 125-part-per-million (ppm) chlorine bleach rinse is also an effective way to process laundry.
2. Proper pH chemicals – both high pH (alkaline) and low pH (acid) – to deactivate organisms and viruses. Proper introductions of chemicals at the proper time for the proper amount of time negatively affects both dirt and bioburdens. Controlling the pH levels also ensures that HCTs have a neutral pH and present no issues to sensitive patient skin.
3. Proper oxidation agents also kill and/or destroy pathogens. Commercial laundries have the expertise and chemicals to produce desired results, unlike home washing machines or coin-operated machines for those inclined to launder their scrubs and uniforms at home.
4. Rinsing is a vital step in proper laundering of HCTs and cannot be stressed enough. Rinsing ensures that contaminants are deposited into the waste drain.
5. The final step in the laundering process includes drying HCT at a temperature that exceeds 160° F at the dryer exhaust. That means that the internal drying temperature will far exceed the temperature needed to deactivate or kill any pathogens that potentially have survived the washing cycles. Additionally, sheets and pillowcases are exposed to the heat of a flatwork ironer that typically is 365 degrees, depending upon the equipment manufacturer’s recommendations and the best practices of the laundry facility.

Commercial healthcare laundries and laundries that process scrubs, lab coats, and healthcare textiles such as infection prevention microfiber have been and continue to be significant partners with hospitals and other healthcare facilities. Their processes ensure hygienic HCTs and they are up to date with the latest CDC guidelines.

John Scherberger, FAHE, is the owner of Healthcare Risk Mitigation in Spartanburg, S.C. He is a subject matter expert in healthcare environmental services, healthcare linen and laundry operations, and infection prevention.

Safer, Smarter, More Sustainable: Reusable Healthcare Textiles Outperform Disposables

By Linda McCurdy

Editor's note: This column originally appeared in the March 2020 issue of Healthcare Hygiene magazine.

According to Greek mythology, Prometheus enraged Zeus by stealing fire from the gods and giving it to man. In this tale, fire represents civilization and knowledge, which the gods fear would be dangerous in the hands of mortals.

In modern times, the greater danger is that mankind does not make full use of the tools and knowledge at its disposal.

We know, for example, that single-use items have contributed to explosive growth in landfills and to the pollution of waterways. Yet globally, we find continued resistance to the idea of replacing those disposable products with reusable alternatives despite their superior performance.

We know that in a mobile world, a deadly infection can erupt into a global epidemic in a terrifyingly short time. Yet just weeks into the onset of the coronavirus, China’s National Health Commission issued a statement acknowledging that the country was contending with, as Reuters reported, “a severe shortage of equipment, including suits, masks and goggles.”

To those outside our industry, these may appear to be unrelated events. But we see a strong connection between the threats of greenhouse gas emissions and deadly infections.

In the face of its shortage, the Chinese government issued a directive conserving the use of disposable protective equipment among healthcare professionals. Its communication was an unintentional reminder that all those disposable items were being added to the world’s refuse and adding to greenhouse gas emissions because they could not be sanitized, disinfected, and made safe for reuse.

These events point to an opportunity not merely to promote more widespread adoption of reusable surgical textiles including gowns, towels, and drapes, and other reusable medical products, but also to take a leadership position in the protection of our planet, its people, and its sustainable future.

As the China crisis has shown us, in the face of an epidemic, we cannot afford to rely on single-use gowns and other disposable medical products. All non-renewable resources are, by definition, finite in their availability—and they’re in shortest supply when demand and need are greatest.

If reusables were the standard, healthcare professionals in China would not have to make difficult decisions about reusing or forgoing use of personal protective equipment such as single use gowns and googles. They would not have to hoard supplies. They would not have to take chances with their own health and the health of their families, co-workers and patients.

And yet, this is precisely what they’ve been forced to do by both government policy and by the shrinking stock of disposables available for use as this health crisis continues. This is a manmade complication to already extraordinary healthcare circumstances—a complication that could be eliminated by the adoption of reusables and of our industry standards for their processing and sterilization.

Of course, reusables deliver superior value in terms of cost of use, as well. The price/performance differential has been well established for at least 15 years, as seen in an industry whitepaper, “New Innovations in Reusable OR Textiles: An overview of environmental, cost, and provider comfort issues.”

Citing the 2005 Comparative Operating Revenues and Expense Profile for the Healthcare Textile Maintenance Industry, which covered 49 percent of all U.S. hospital beds, the whitepaper noted that “approximately 6.5 pounds of surgical textiles are used per bed each day in hospitals with 300 or more beds.” The paper went on to provide this calculation: “If a 300-bed hospital chose to use disposable surgical products rather than reusables, they would incur upwards of an additional $250,000 in costs to trash the disposable products.”

And that’s simply the price of disposal. To gauge the full cost, we must account for the impact on human factors with which China is now contending. The financial implications of relying on disposables are reflected not only in their higher price tag relative to overall use but, more critically, in the cost to human life, public safety, and the health of the planet in the face of a serious viral outbreak.

Add to that the economic advantages generated by local employment—jobs creation that spurs growth in each community served by a hospital, medical center, or nursing home—and there’s simply no financial rationale for continued use of disposables.

The ecological argument is equally airtight. Under the best of circumstances, our planet cannot continue to absorb the daily addition of massive quantities of single-use items to our landfills. When those items are not only disposable, but likely to have had contact with life-threatening viruses or bacteria, the peril escalates.

Conversely, reuse of gowns and other reusable medical products reduces both waste and risk of infection, provided that laundering facilities comply with the sterilization and disinfection Standards established by HLAC and recognized throughout the industry.

Let’s look at the coronavirus both as a healthcare crisis and as a wake-up call—a reminder of our ethical obligations to ourselves and our planet—and take up that leadership position to protect both from avoidable harm. We have long had the facts and information at our disposal, and the grave danger, particularly now, is not making full use of that knowledge.

Linda McCurdy is president of the Healthcare Laundry Accreditation Council (HLAC).

Healthcare Textiles: How Clean is Clean Enough?

By Gregory Gicewicz

This column originally appeared in the February 2020 issue of Healthcare Hygiene magazine.

Healthcare textiles (HCTs) directly touch the largest organ on the human body, the skin. So how clean is clean enough for HCTs? Imagine a grossly soiled unwashed patient gown. Would we ever use this to cover a sick patient? Of course not. Now, picture a different patient gown. This one has gone through processing, utilizing the most stringent HLAC standards for infection prevention and patient safety. Is this gown clean enough to cover a sick patient? Unless they are sterilized, all HCT have some level of microbiological contamination. The Association for the Advancement of Medical Instrumentation defines hygienically clean as free of pathogens in sufficient numbers to cause human illness. But there is no absolute scientifically established quantity for sufficient numbers. Therefore, we don’t really know how clean is clean enough. This article will attempt to guide healthcare practitioners in managing the cleanliness of HCT used on their hospital’s patients.

Outbreaks attributed to laundered HCTs have occurred but are rare. Of the billions of pounds of HCTs processed annually, I am only aware of 13 outbreaks in 48 years worldwide, impacting roughly 356 patients. While any outbreak is tragic, this is an impressive track record. Of some concern, however, research has shown that HCTs can transmit pathogens and reports of microorganisms on HCTs are common. Also, research has proven that multidrug-resistant microorganisms (MDRO) can survive on HCTs for weeks and soiled HCTs can contaminate surfaces, and medical devices.

Our Linen Tested Hygienically Clean – We are Fine Right?
Practitioners often incorrectly assume that if a few linen samples test as hygienically clean, then all HCTs in their facility are safe. If it were only that simple. A few samples of linen that test hygienically clean is one indicator out of hundreds of thousands. It should never give a hospital cause to relax scrutiny. Were the other tens of thousands of pieces processed also hygienically clean every time? From where was the sample taken? What if the previously clean samples were contaminated somewhere along the journey to the patient? What method was used to test the linen for microorganisms? Did the method identify all potential contamination or just a subset of microorganisms? Some methods may identify < 20 CFUs on a sample of linen. Other more granular methods may show >500 CFUs for the same piece of linen!

First Agree on your Acceptance Standards
The first step to ensure consistently patient-safe HCTs is to determine acceptable standards of cleanliness for various items in various healthcare uses. Work with your laundry provider to establish linen standards. Identify and agree on what is acceptable for various items. Which stains are too large? Which tears/holes are unacceptable? What is your contamination threshold? How and how frequently will it be measured? Are there super sensitive areas such as the NICU or an organ transplant unit that need an extra level of clean or even sterilization? Once these are established, partner with your laundry provider to ensure the standards are managed to.

Follow the Process.
Now take a process-based approach and consistently monitor the key processes. There are hundreds of standards that must be followed consistently. Here are a few examples:
1. Be sure soiled HCTs are sorted according to type. Wash formulas are specific to soil classifications and types of linen. If heavily soiled surgical towels are mixed with light soiled bath blankets there is a good chance the light soiled bath blankets will emerge from the wash contaminated.
2. Functional separation keeps soiled HCTs separated from clean HCTs. Enforce functional separation physically and logically.
3. Wash formulas must be titrated regularly for proper chemistry, time, water levels, and temperatures. If any of these variables is off the emerging HCTs may not be clean.
4. Ensure linen rinse water is tested regularly for contamination. A perfect wash formula will not produce clean HCTs if the final rinse water is unclean.
5. Are discharge conveyers clean? Clean HCTs on a dirty conveyer will become contaminated. Be sure conveyers and other hard surfaces that clean HCTs touch have a documented cleaning schedule and a documented testing schedule.
6. Make sure employees handling clean HCTs have clean hands. Have a hand hygiene policy. Test employee hands for cleanliness and document the results.
7. Is the air clean in clean areas of the laundry plant? Pay careful attention to dryer and ironer areas for contaminated air. Have the air tested regularly in these areas.
8. Are clean HCT carts really clean? Dirty linen carts can contaminate clean HCTs. Test them for contamination regularly.
9. Measure bioburden levels of HCTs at multiple points up to their point of use. After the washer; after the dryers; after finishing; after cart loading; in the linen room; in the patient room. This will help determine and eliminate where contamination occurred.

Make the Odds Favor Safe HCTs
By following and monitoring the strictest HCTs processing standards for infection prevention, you are stacking the odds in favor of safe HCTs for your patients every time.

Gregory Gicewicz is president of Sterile Surgical Systems. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.

Striving for Continuous Improvement

By David Potack

This column originally appeared in the January 2020 issue of Healthcare Hygiene magazine.

America’s advanced capability to control infection contributes to our nation’s standard of living. We assert that we prevent healthcare-associated infections (HAIs) better than the rest of the world and conclude that maintaining such performance requires the adoption of American hygiene standards based purely on U.S. research. But this does not consider risk minimization practices superior to our own developed elsewhere, with healthcare textile (HCT) hygiene as an example.

Hospital linen is insignificant to HAIs and probably always will be. Based on the two cases in the U.S. reported by the Centers for Disease Control and Prevention in the 2000s, CDC statistics indicate the chance that an American won’t wake up tomorrow because her/his bed suffocated and strangled the individual to death is 77 times greater than the chance that a U.S. hospital patient will be affected by an HAI transmitted by bed linen.

No matter how small an infection risk may be, however, it’s critical to minimize it. For more than 30 years, the German Certification Association for Professional Textile Services (CAPTS) has established thresholds for HCT cleanliness. Since the 1986 launch of CAPTS’ RAL-GZ 992/2 certification in Germany, the designation has been earned by laundries in 15 other European countries (Eastern and Western), China, Japan, Saudi Arabia and the United Arab Emirates.

TRSA’s inception of Hygienically Clean Healthcare certification introduced CAPTS cleanliness standards to North America in 2012 as an adjunct to robust laundry inspection. Some 150 laundries in the United States, Canada and Mexico have either been certified or have applied for Hygienically Clean. It has become the American microbiological content standard for HCTs.

Europeans have long been ahead of North America in adopting laundry technologies and measures. Tunnel washing was invented in Germany in 1965; with its superior water and energy efficiency and requiring less manual material handling than standalone washers, it was embraced in Europe first. Over the years, visits by North American TRSA members to our overseas counterparts have been invaluable. Now when we tour their laundries, we still see technical advances, but we use essentially the same types of equipment and supplies. This striking similarity validates the adaptation of CAPTS thresholds here.

Calls for U.S. research on HCT cleanliness thresholds overlook the Hygienically Clean certification track record. Certified laundry facilities have tested over 5,500 textile samples using the same or similar protocols and microbiological levels that have been examined, researched, tested and discussed with our global partners for many years.

While sentiment is expressed that an industry benchmark still has not been established, the Hygienically Clean thresholds—on total microbial content (20 colony forming units per square decimeter of fabric in the RODAC plate test), yeast and mold (same) and absence of specified bacteria—have thrived overseas for decades and been accepted by North American healthcare facilities for nearly a decade.

Suggesting other U.S. thresholds are needed could backfire and prompt government rulemaking rather than the stringent self-regulation Hygienically Clean provides. Today in Germany, the Ministry of Health’s Robert Koch-Institute (RKI) sets basic rules for healthcare products and procedures to reduce infection risk in hospitals, including limit values for HCT processing. Microbiological requirements are enforced for hospital linen, hospital laundries, laundry processes and outsourcing to private laundries. Building requirements and recommended procedures and performances are given or referenced.

On a continent-wide level, the European Union standard (EN 14065) on risk analysis and bio-contamination control encourages self-regulation. It fosters a standardized quality management system for RABC for laundries in sensitive sectors including healthcare, food processing, pharmaceutical and medical devices, but isn’t overly prescriptive. Used by most major European healthcare laundry firms, EN 14065 is voluntary, but it guides regulatory, accreditation and certification authorities.

Laundry reflects the positive influence on the U.S. of the worldwide development of international health technology. According to Medical Product Outsourcing magazine 2019 listing of the top global medical device companies, nine of the Top 20 are based outside the United States: seven in Europe and two in Japan.

Europe’s hygiene performance could be considered more successful than ours. Every other year, the World Economic Forum publishes a report that provides a valuable tool for policymakers, companies and complementary sectors to understand and anticipate emerging trends and risks in global travel and tourism. A competitiveness index rates countries on their enabling environment, policy and enabling conditions, infrastructure and natural and cultural resources.

Health and hygiene are pillars in the rating of a nation’s enabling environment. Among the 140 countries, the U.S. is 51st in this category and Canada is 52nd. All European nations (except six) and nine non-European rank higher. Austria and Germany are tied for first. Their rating is 20 percent stronger than that of the U.S. Argentina (14), Japan (16), and the Republic of Korea (17) all are 10 percent better.

Continuous improvement is our goal. With our worldwide counterparts, we anticipate further reducing the already infinitesimal risk of spreading pathogens through HCTs.

David Potack is president of Unitex, a family-owned medical linen and uniform provider. He is the immediate past chairman of TRSA. He currently chairs the board of trustees of Montefiore St. Luke’s Cornwall Hospital and serves on the Yale New Haven Children’s Hospital Council.

Overlooking the Obvious

By John Scherberger, FAHE

This column originally appeared in the December 2019 issue of Healthcare Hygiene magazine.

When the familiar becomes commonplace, it becomes overlooked until it becomes a movement.

The commonplace in healthcare facilities is healthcare textiles (HCTs). The overlooked in healthcare facilities is healthcare textiles. The movement in healthcare facilities is HCTs.

Why is this a movement?

The movement may begin as a result of real concern on the part of healthcare workers. It may be the result of increased scrutiny by infection preventionists and environmental services directors. Faulty extrapolation of information or disinformation has been the cause of some movements. It may be the reaction to not fully understanding that maintaining hygienic textiles is everyone's responsibility.

It is true that some patients have become unwell and even died due to pathogens traced to healthcare textiles. Illness and death are nothing to trivialize. No person is just a number, a statistic, or inconsequential, mainly if that person is a loved one or a friend.

However, the instances of an HCT being a fomite is minuscule, and as widespread as some studies may lead one to believe. This observation is in no way meant to minimize the possibility or the results of HCT being fomites; it is just a fact.

In June 2015, a study by Lynne M. Sehulster, PhD, M(ASCP), titled “Healthcare Laundry and Textiles in the United States: Review and Commentary on Contemporary Infection Prevention Issues,” was published in Infection Control & Hospital Epidemiology. The study was a retrospective review of outbreaks of infectious diseases associated with laundered, reusable HCTs, primarily in North America, Europe, and Japan. Of the 12 reported instances, they appeared over the past 43 years and involved nearly 350 patients.

Before the reader reaches inaccurate conclusions, one must recognize that, in the United States alone, in 1989, healthcare facilities had over five billion pounds of healthcare textiles are processed. The 2019 estimates are to expect closer to 10 billion pounds. Hard to visualize? How about stacking the Pentagon on to itself five times? Or a pile the height of 22 Willis Tower (a.k.a. Sears Tower) in Chicago.

In her 2015 retrospective study, Sehulster reported:

- Of the 12 outbreaks, 4 (33 percent) reported problems with laundered textile storage in the hospital;

- 7 (58 percent) reported contaminated washing equipment, inappropriate wash cycle or water temperature settings, or recycled water issues;

- 1 (8 percent) attributed the outbreak to inadvertent contamination occurring during transit from the laundry to the hospital.

What are all these findings saying to infection preventionists and environmental services directors about their healthcare textiles?

Very clearly, mitigation of infections from HCTs is possible by closer attention to processes both in the healthcare laundry facility and the healthcare facility.

 

But how? How can infection preventionists, environmental services, and laundry experts ensure that HCTs received from healthcare laundries are hygienic? What are they to do to maintain the sanitary status of the HCTs once introduced into a healthcare facility? How can those entrusted with providing hygienic products to patients earn the trust of patients and healthcare workers?

Healthcare textiles are the one product provided to patients, and many healthcare workers, that are so ubiquitous they are conceded as being appropriate, i.e., "safe" and hygienic, for use by everyone. Right? However, that concession is without its limitations. The limitations are dependent upon processes being in place; in the healthcare laundry and the healthcare facility. Not only must they be in place, but strict adherence is also necessary.

IPs understand there are six points at which a chain of infection chain is susceptible to disruption. When a link in the chain is severed, germs have a lower potential from becoming a pathogen to a vulnerable person.

As a reminder, the six links include the infectious agent, reservoir, portal of exit, mode of transmission, portal of entry, and susceptible host. The Association for Professionals in Infection Prevention and Epidemiology (APIC) has a compelling and illustrative infographic on breaking the chain of infection: http://professionals.site.apic.org/files/2016/09/Break-the-Chain-of-Infection.pdf

So, how do IPs who are not healthcare laundry experts assure themselves that they have broken a link, or links, in the chain? How can IPs and EVS know what processes and procedures are necessary for a healthcare laundry to provide hygienic HCTs? What procedures are necessary for a healthcare facility to maintain the hygienic integrity of the HCT received from the healthcare laundry?

The first step is ensuring the healthcare facility has adopted and implemented a linen laundry processing policy. By the way, California has mandated that healthcare facilities have linen laundry processing policies in place by Jan. 1, 2020. Further, they stipulate "the facility's linen laundry is required to be processed in compliance with the facility's updated linen laundry processing policy, and CDC and CMS standards."

The Assembly Bill indicates that the healthcare facility must incorporate their contractor's linen and laundry processes into their policy facility policy. How? By stating that their laundry and linen services (contractor or on-premises laundry) have processes and procedures that adhere to CDC guidelines and or CMS regulations/F-tags and referencing the contractor and methods in their policy. Perhaps the easiest way to ensure this is to require the laundry facility to be HLAC-accredited. Although specific to California, the requirement contained in the Assembly Bill should be the in-place standard for all healthcare facilities throughout the United States and Canada. It leaves nothing to chance, speculation, or presumption.

Although not mandated by any regulatory agency, IPs are encouraged by APIC and many other professional organizations to visit the healthcare laundry at least annually. Keeping in mind that a lot can happen over a year, a better suggestion is to visit -- unannounced -- at least quarterly. Knowing what to look for during the visit, a more appropriate term would be inspection, may be daunting, but should not be off-putting or intimidating. The Healthcare Laundry Accreditation Council (HLACnet.org) makes available at no cost on their website a checklist that IPs can become familiar with and use during inspections regardless of the laundry's accreditation or certification status.

Don't expect to find a clean-room environment; after all, a healthcare laundry is a production facility that uses large, state-of-the-art equipment, water, and steam lines throughout the facility, as well as fans and electrical conduit. It will be necessarily a manufacturing facility where professionals take dirty, stained, contaminated healthcare laundry products and turn them into sanitary textiles. Laundering on such a large scale requires following standardized processes and procedures meticulously.

The more often the IP visits the healthcare laundry contractor, the more information and understanding of how their job requires regular visits. Visits and knowledge will also improve communication, cooperation, and collaboration in meeting the needs of the healthcare facility and the contractor.

Regardless of the excellence of a healthcare laundry, if a hospital or healthcare facility fails to receive, transport, store, and distribute the HCTs in ways that will maintain the integrity of the textiles, all will be for naught.

People are prone to believe "it's the other guy" that spreads germs and fails to follow the rules, regulations, and guidelines. "It's the other guy" that doesn't wash their hands before encountering hygienic HCT's. "It's the other guy" that carries the clean textiles against their uniform or scrubs and picks up textiles that have fallen to a floor and uses them for patient care. "It's the other guy, not me," that sneezes onto clean textiles or sneezes or coughs into the crook of their arm then gathers HCTs into the same contaminated arm or uniform. "It's the other guy" that wipes sweat from their brow or face and unconsciously puts the contaminated washcloth or hand towel into a patient room for use. And "It's the other guy" that brings an excess of HCTs into a patient room and leaves them on an unclean counter and used for the newly arriving patient. The reality is that everyone is "the other guy."

When the healthcare textile becomes so commonplace that it becomes overlooked and taken for granted, harm may occur to patients and staff. When taken for granted, things may no longer be valued; thus, the laying of a foundation for injury.

Laundry and linen processing must be valued. Healthcare facilities must elevate the value and importance of transporting, handling, storage, and distribution of hygienic HCTs, if for no other reason that the benefit of patients.

John Scherberger, FAHE is the owner of Healthcare Risk Mitigation in Spartanburg, S.C.  He is a subject matter expert in healthcare environmental services, healthcare linen and laundry operations, and infection prevention. 

 

 

 

Defining and Measuring ‘Hygienically Clean’

By Carol McLay, DrPH, MPH, RN, CIC, FAPIC

This column originally appeared in the November 2019 issue of Healthcare Hygiene magazine.

Laundry services play a critical role in a healthcare facility’s infection prevention and control program. Healthcare textiles (HCTs) include bed sheets, pillowcases, blankets, towels, personal clothing, patient apparel, employee uniforms, scrub suits, gowns, and drapes for surgical procedures. Contaminated textiles often contain large numbers of microorganisms from body substances such as blood, skin, stool, urine, vomitus, and other body tissues and fluids, and it is important to ensure that pathogens are not transferred to patients or healthcare workers.

In addition to normal microbial skin flora, organisms commonly found on HCTs include gram-negative bacteria, coagulase negative staphylococci, and Bacillus species.1 These organisms have the ability to  bind to textiles and may survive  for as long as  90 days.2-3 Staphylococcus aureus and Pseudomonas aeruginosa in particular have high ratios of binding (80 percent) to polyester or acrylic fibers. Nylon fibers bind S. aureus at low ratios, but P. aeruginosa at intermediate ratios. The binding rate for cotton fibers was reported to be less than 10 percent.4

In addition to bacteria, molds and viruses including rotavirus and parainfluenza virus have been cultured from hospital textiles.

HCTs have been implicated in hospital outbreaks of fungal and bacterial pathogens; 12 such outbreaks have been reported worldwide in the past 43 years affecting 350 patients.5

Investigators have examined the connection between healthcare textiles and infectious disease outbreaks and their conclusions emphasize that fact that correct laundering of healthcare textiles is an important measure for preventing healthcare-associated infections (HAIs). Through a combination of soil removal, pathogen removal, and pathogen inactivation, contaminated laundry can be rendered hygienically clean.

Hygienically clean is defined by the Association for the Advancement of Medical Instrumentation (AAMI) as “free of pathogens in sufficient numbers to cause human illness.”6 However, AAMI does not quantitatively define the meaning of “sufficient numbers.”

The Centers for Disease Control and Prevention (CDC) also does not provide a quantitative value for hygienically clean textiles in their “Guidelines for Environmental Infection Control In Health-Care Facilities” but do state  that proper laundering processes should result in a 3-4 log10 reduction  (approximately 99 percent) of microorganisms.7-9  A postprocess level of 10-100 colony-forming units (CFUs) has been suggested.5

The CDC does not currently recommend routine microbiologic sampling of clean textiles, however, sampling during outbreak investigations is appropriate if epidemiologic evidence indicates a role for healthcare textiles and clothing in disease transmission.8

Microbiological testing of laundered textiles is conducted routinely in Europe and Australia as a requirement of their healthcare regulation programs.10-11 The Certification Association for Professional Textiles Services Administration (CAPSTA), which has 400 members in 15 European countries, Japan, China, and the United Arab Emirates, has established safe microbial levels for laundered textiles as 20 CFU per square decimeter (PSD). This microbial threshold has also been adopted by the European Union.

In the United States, microbial levels on hygienically clean textiles have not been reliably measured. To address this gap, Sands, et al. (2019) collected 48 healthcare textile samples from hygienically clean linen on three different patient care units at two separate points in time.12  The researchers reported that only 27 percent of the samples had a total aerobic microbial count below the expected 100 CFU level; the values ranged between  9 and 40,000 CFUs. For yeast and mold counts, more than 81 percent had counts of 100 CFUs or less. Interestingly, the overall average aerobic bacterial, yeast, and mold counts was lower after 24 hours of storage on the patient care units compared to the time of delivery. The authors theorize that the textiles may have been slightly damp, then were folded and placed in plastic carts for delivery allowing microorganisms to proliferate. The textiles would then have had time to dry before the second sample was obtained.

Microbial testing of textiles is a component of the Healthcare Laundry Accreditation Council (HLAC)’s recently introduced Laundry Process Monitoring ToolKit, which validates the effectiveness of a laundry’s processes by measuring the number of microorganisms found in a laundry on hard surfaces, in the air, on linen, in the water and on employee hands.

HLAC is a nonprofit organization that inspects and accredits laundries that process reusable textiles for hospitals, nursing homes and other healthcare facilities. HLAC’s core purpose is to establish and maintain criteria and procedures for accreditation. The HLAC Accreditation Standards are established as the minimum acceptable practice for the preparation of hygienically clean, reusable healthcare textiles for patient care, implemented and executed by accredited laundry facilities processing reusable healthcare textiles.13 The standards incorporate evidence-based, peer-reviewed best practices and recommendations for infection prevention and laundry procedures from federal agencies (e.g., Centers for Disease Control and Prevention (CDC)) and professional entities such as the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Registered Nurses (AORN), the Association for Professionals in Infection Control and Epidemiology (APIC), Facilities Guidelines Institute (FGI), and the Textile Rental Services Association of America (TRSA).

The five specific testing areas that compose HLAC’s process monitoring toolkit include:

  • Surface sampling analysis: Monitoring surface cleanliness prevents contamination of clean products that contact surfaces during finishing, transporting, packaging and storing.
  • Air sampling analysis: Air sampling analysis provides Total Aerobic Microbial Counts (TAMC).
  • Linen analysis: Bioburden testing provides microbial contamination counts measuring the textile provider’s ability to achieve and maintain a state of cleanliness in their products. Products sampled are cotton, polyester and blends, representative of the highest volume materials being processed.
  • Water analysis: Water sampling enables the laundry to identify specific areas of concern such as points of suspected contamination, or to determine if a problem has been corrected.
  • Hand hygiene analysis: Practicing hand hygiene is an effective way to prevent cross-contamination and infection. This test is designed to measure handwashing practices, not individuals. Samples are blind-coded to assure the anonymity of participants. Testing includes pre- and post-wash; a glove test; and a swab test.

Data from these tests enable laundries to adjust their processes to improve overall plant hygiene, which helps to ensure the safety of the HCTs that contact hospital patients.

Microbial testing of textiles is also a component of TRSA’s “Hygienically Clean Certification” program, which requires third-party, quantified biological testing and inspection.14 Hygienically Clean Healthcare certified laundries use processes, chemicals and best management practices acknowledged by the CDC, Centers for Medicare and Medicaid Services, Association for the Advancement of Medical Instrumentation, American National Standards Institute and others.

Testing is performed using United States Pharmacopeia (USP) 62 (Microbial Enumeration of Nonsterile Products) criterion, which necessitates the complete absence of specified microorganisms, including S. aureus, P.aeruginosa, and E. coli. The Pass/Fail criterion is 0 CFU per square decimeter (PSD). The protocol also includes the Replicate Organism Detection And Counting (RODAC) microbiological test to determine the total amount of micro-organisms (less than or equal to 20 CFU PSD).

Laundries pass three rounds of outcome-based microbial testing. To maintain certification, laundry plants must pass quarterly testing to ensure that as laundry conditions change, such as water quality, textile fabric composition and wash chemistry, laundered product quality is consistently maintained.

Healthcare associated infections resulting from contaminated linen are increasingly being recognized in the literature and result in significant morbidity and mortality. Healthcare safety, including the prevention and reduction of healthcare-associated infections is a national priority. To date there has been a lack of validated measures to assess the effectiveness of processes in healthcare laundries that ensure the cleanliness of textiles.

Quantifying microbial levels on the textiles will support evidence-based practices by enabling identification of contamination sources, key control points in the process and provide recommendations for facility specific microbiological process monitoring as it relates to infection prevention. Healthcare laundries strive to maintain the highest standards of infection prevention and to provide their healthcare customers hygienically clean linen and are an integral component of the multidisciplinary team approach necessary to improve patient outcomes.

References:

  1. Fijan S, Turk SS. Hospital textiles, are they a possible vehicle for healthcare-associated infections? Int J Environ Res Public Health 2012 September; 9(9):3330-3343.
  2. Neely AN, Maley MP. Survival of enterococci and staphylococci on hospital fabrics and plastic. J Clin Microbiol 2000;38:724-6.
  3. Neely AN, Orloff MM. Survival of some medically important fungi on hospital fabrics and plastics. J Clin Microbiol 2001;39:3360-1.
  4. Takashima M, Shirai F, Sageshima M, Ikeda N, Okamoto Y, Dohi Y. Distinctive bacterial-binding property of cloth materials. Am J Infect Control 2004;32:27-30.
  1. Sehulster LM. Healthcare laundry and textiles in the United States: review and commentary on contemporary infection prevention issues. Infect Control Hosp Epidemiol 2015;36:1073-88.
  2. Association for the Advancement of Medical Instrumentation. Processing of reusable surgical textiles for use in health care facilities. 2000. ANSI/AAMI ST65:2000.
  3. Blaser MJ, Smith PE, Cody HJ, Wang WL, LaForce FM. Killing of fabric associated bacteria in hospital laundry by low-temperature washing. J Infect Dis 1984;149:48-57.
  1. Centers for Disease Control and Prevention. Guidelines for environmental infection control in health-care facilities. Available from: https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf. 9. Jaska JM, Fredell DL. Impact of detergent systems on bacterial survival on laundered fabrics. Appl Environ Microbiol 1980;39:743-8.
  2. German Certification Association for Professional Textile Services. RAL-GZ992/2–Hospital Linen. Bőnnigheim, Germany. Available at: http://www.waeschereien.de/en/waeschereien/guetezeichen/9922_healthcare_linen/9922_healthcare_linen.html.
  3. Institute for Sustainability and Hygiene International. Certification standards for processing reusable linen. (2011). MacKenzie, Brisbane, Queensland, Australia.
  4. Sands, F, Fairbanks L. How clean is "hygienically clean": Quantitative microbial levels from samples of clean healt care textiles across the United States. Am J Infect Control. 2019 May;47(5):509-514.
  5. Healthcare Laundry Accreditation Council (HLAC). Accreditation Standards for Processing Reusable Textiles for Use in Healthcare Facilities, 2016. Available at: https://www.hlacnet.org/standards-documents.
  6. Textile Rental Services Association of America (TRSA). Standard for producing hygienically clean reusable textiles, 2018. Available at: http://hygienicallyclean.org/wp-content/uploads/2018/03/Standard-for-Producing-Hygienically-Clean-Reusable-Textiles-Healthcare-03012018.pdf.

 

The Modern Healthcare Laundry Will Shoot for the Moon

By Gregory Gicewicz

This column was originally published in the October 2019 issue of Healthcare Hygiene magazine.

This past July marked the 50th anniversary of the first humans landing on the moon as part of NASA’s Apollo lunar mission. Now, NASA is going back to the moon, but it’s not doing it alone. Last May, after a vetting process, the space agency announced its commercial partners in the first phase of its Artemis program to deliver cargo and scientific instruments to the lunar surface in the next few years to support human landings and habitation by the mid-2020s.

In choosing its partners, a NASA spokesperson said, “The companies we have selected represent a diverse community of exciting small American companies, each with their own unique, innovative approach to getting to the Moon.”

I can relate to this, though I’m certainly not in the aerospace industry. Rather, I’m the owner/operator of a healthcare laundry in the greater Seattle area. As such, my company partners with more than 30 acute-care hospitals and surgical centers to annually deliver 10 million pounds of processed, hygienically safe reusable healthcare textiles (HCTs).

Just as NASA has realized through its Artemis program that getting to the moon is no longer a do-it-alone mission, leading hospitals have recognized the role that partners have in their respective successes. And nowhere is this more evident than in their mission to eradicate themselves from the reality of healthcare-associated infections (HAIs), a situation that has reached epidemic proportions.

Where once the selection of a healthcare laundry was a mere decision of choosing the lowest-cost provider, responsible hospitals are now carefully vetting their laundries. What are the laundry’s standards for ensuring infection prevention and patient safety? Do their standards cover the complete textile-processing cycle: from handling and transporting soiled healthcare textiles, to in-plant processing and delivery back to the customer? Do their standards include strict adherence to federal government regulations and guidelines?

A Giant Leap for Healthcare Laundry?
And what about innovation? Indeed, in today’s marketplace, the modern healthcare laundry must be able to demonstrate how it has evolved to better align innovation with a hospital’s infection prevention strategy.

A case in point: innovation in process monitoring. Process monitoring refers to how laundry operators can continually know how well their processes are performing and whether their standards are on target as originally intended.

It used to be that a laundry would establish a baseline of processing standards, followed by documented staff training, and finally proof that the policy was being executed. Monitoring was typically provided in the form of checklists or visual cues, e.g., the carts look clean √; the surfaces look clean √; the hands look clean √; the air looks clean √; the linen looks clean √. The obvious flaw here is that there has never been a way to measure these “checks” with quantifiable data.

That is, until now. A recently introduced innovation in laundry testing and process analysis is enabling laundry operators to recover the most accurate representation of viable organisms (bioburden) on healthcare textiles; and quantifying the sources of potential environmental contamination on textiles that are known to come from air, hands, hard surfaces and in water systems.

Here’s a closer look at the five specific testing areas that compose this next generation of process monitoring:
• Surface sampling analysis: Monitoring surface cleanliness prevents contamination of clean products that contact surfaces during finishing, transporting, packaging and storing.
• Air sampling analysis: Air sampling analysis provides Total Aerobic Microbial Counts (TAMC), or what airborne bacterial contaminants are present in the environment.
• Linen analysis: Bioburden testing provides microbial contamination counts measuring the textile provider’s ability to achieve and maintain a state of cleanliness in their products. Products sampled are cotton, polyester and blends, representative of the highest volume materials being processed.
• Water analysis: Water sampling enables the laundry to identify specific areas of concern such as points of suspected contamination, or to determine if a problem has been corrected.
• Hand hygiene analysis: Practicing hand hygiene is an effective way to prevent cross-contamination and infection. This test is designed to measure handwashing practices, not individuals. Samples are blind-coded to assure the anonymity of participants. Testing includes pre- and post-wash; a glove test; and a swab test.

The high-level of data that come from these tests enable the laundry to adjust accordingly its processes to improve overall plant hygiene, which therefore helps to ensure the ultimate safety of those HCTs that end up in contact with hospital patients. This includes data for:
• Evaluating before and after conditions of cleaning processes
• Isolating problem areas
• Measuring the effects of process modifications and/or system improvements
• Trending over time (e.g., reasons for process variability) for determining process consistency and identifying opportunities for improvements.

I served on a team that helped in the development of this new approach and I can attest to the fact that it’s vastly different in scale from anything else currently available in the industry. It’s a “giant leap,” if you will, that enables operators to demonstrate to their healthcare partners their commitment to quality and patient safety.

If you consider yourself a modern healthcare laundry, maybe you should be shooting for the moon.

Gregory Gicewicz is president of Sterile Surgical Systems. He is past president of the Healthcare Laundry Accreditation Council (HLAC), currently serves as HLAC inspection committee chair, and led a committee that developed the HLAC Laundry Process Monitoring Toolkit.