Instructions for Use, Inadequate Support Pose Medical Device Cleaning Challenges for Sterile Processing
By Damien Berg, CRCST
This Perspectives column originally appeared in the January 2020 issue of Healthcare Hygiene magazine.
Sterile processing (SP) professionals face many challenges in today’s complex, ever-evolving instrument processing landscape. One of the greatest obstacles involves complying with manufacturers’ instructions for use (IFU) for cleaning/disinfecting medical devices and, at the same time, dealing with time and resource constraints, difficult conditions in the decontamination area, and more.
Whether a facility or organization calls the department “Sterile Processing,” “Central Service,” “Central Sterile Supply” or another name, the department’s primary responsibility remains the same: reprocessing a wide array of medical/surgical devices that often include complex orthopedic instruments, sophisticated power equipment, narrow-lumened laparoscopic devices, and ever-challenging flexible endoscopes. Each of these devices has specific, often confusing and even conflicting cleaning instructions. Frontline SP technicians must navigate these IFU while also facing increasing and, sometimes, unrealistic demands from the operating room (OR) or another end-user department.1 Often, SP professionals field requests to turn instruments around more quickly than is safe or prudent, and those requests often don’t align with manufacturers’ IFU or even industry standards. If the cleaning process is rushed or any missteps occur, high-level disinfection (HLD) and sterilization will be negatively affected, and patient safety becomes jeopardized; it’s a point underscored in numerous studies, including a recent joint study by Ofstead & Associates that was published.2
When it comes to the confusion and frustration associated IFU compliance and meeting the requirements of The Joint Commission (TJC), the hospital and SP leadership must understand the common challenges that can cause the organization to become noncompliant during surveys. In 2017, 72 percent of surveyed hospitals and critical access hospitals were found to be noncompliant with TJC’s infection control standard, IC.02.02.011;3 the standards require hospitals to reduce infection risks associated with medical equipment, devices and supplies, primarily as it related to steps of HLD and sterilization. This high degree of noncompliance led TJC to revise the standard to include more specific scoring that focuses on areas of highest risk. The changes took effect Sept. 1, 2018.
TJC will continue to score IC.02.02.01 as noncompliant whenever manufacturer instructions are not followed. This includes following the IFU to the letter in the decontamination area (including soak time, sonic time, and manual cleaning and automatic cleaning steps). It is not only critical for SP professionals to understand these tasks and details but also to be able to speak to the IFU and how the medical device is cleaned and disinfected prior to HLD and/or sterilization.
Unfortunately, challenges abound because the IFU are not always clear or easy for the frontline SP technician to understand. Technicians are also frequently pressed for time and often lack adequate instrumentation inventories to meet turnaround time requests from the OR and other patient-care areas. Beyond that, some technicians/facilities don’t have access to the correct processing equipment – or they may lack enough equipment to meet the instrumentation and turnaround demands.
All these gaps create the perfect conditions for failure. The Association for the Advancement of Medical Instrumentation (AAMI) has been working on its technical information report, TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities, which will help manufacturers standardize their cleaning instructions so the end user can better understand and follow them. Developing this document required significant time as it involved the review of more than 250 IFU and explored the commonalities and complexities of cleaning. In doing so, the end goal is to provide manufacturers with a blueprint and understanding of what the modern SPD entails and how it operates, so manufacturers can design their devices for improved cleanability and develop realistic, easily understood cleaning and disinfection instructions that can be performed effectively in today’s instrument processing areas/departments.
Having regulatory agencies, standards-making bodies and manufacturers of complex medical devices on the same page in their understanding of the urgent need for safer, easier to clean devices and easier to improved cleaning instructions will bode well for compliance and patient safety. It is also essential that hospitals and other healthcare facilities ensure they are supporting reprocessing areas with appropriate staffing levels; providing proper and ongoing training; ensuring instrumentation inventories are adequate to meet procedure volume; and committing to providing enough modern processing equipment to meet the needs of today’s modern OR. Technology in the procedural areas is becoming more complex and sophisticated in order to provide the best and safest patient care; therefore, it is imperative that those who perform instrument cleaning and sterilization have the proper tools and training to ensure that those devices are clean, sterile and ready when needed.
Today’s healthcare environment resides in a world of risk assessments and a simultaneous push for cost containment; however, it is critical that healthcare organizations do not overlook the common factors that increase their own risks and, most importantly, the patient’s. Among the greatest risks are the human factors associated with cleaning and disinfecting surgical instruments and complex medical devices. This should be considered the foundation of any successful clinical outcome.
Highly skilled, experienced and well-trained clinicians are the frontline of patient care, but the supporting work of reprocessing professionals ensures the clinical team not only has the correct medical devices when they are needed, but also that each device is properly functioning, clean, disinfected and sterile. This vital need can only be met when SP professionals are adequately supported in their roles. This involves ensuring that these professionals not only possess a proper understanding of all reprocessing steps, but are also provided with clear, easy to understand IFU and enough instrumentation and equipment to perform those IFU consistently and precisely as written.
1. The Joint Commission. Joint Commission Revised IC Devices Standard. October 1, 2018. https://www.reliasmedia.com/articles/143328-joint-commission-revises-ic-devices-standard.
2. Ofstead et al. Endoscope Preprocessing: Current Practices and Challenges in the Field. PROCESS. July/Aug 2019. International Association of Healthcare Central Service Materiel Management.
3. ECRI Institute. If It’s Not Clean, It’s Not Sterile: Reprocessing Contaminated Instruments. April 11, 2017. https://www.ecri.org/components/PSOCore/Pages/e-lert041117.aspx.
Terminal Cleaning in the SPD: A Critical Step in Infection Prevention
By Julie E. Williamson
This column originally appeared in the January 2020 issue of Healthcare Hygiene magazine.
Ensuring that surgical instruments are cleaned, disinfected/sterilized and safe for patient use involves many steps, processes, check and balances. One critical step is making certain surfaces are properly disinfected and other housekeeping tasks are routinely performed in accordance with guidelines, standards and facility policies and procedures. Sterile processing departments (SPDs) must be routinely cleaned to minimize microbial population; the cleaner the work area(s), the more likely the items prepared in the SPD will be safe for use in a sterile environment.1
Reaching that important goal is often a shared responsibility of Environmental Services (EVS) personnel and Sterile Processing (SP) professionals, with facilities determining the appropriate cleaning tasks and schedules for each. While EVS often bears much of the actual terminal cleaning responsibility, SP professionals often routinely clean sterile storage cabinets, carts and racks.1 SP professionals must also ensure they and their colleagues don’t further contaminate work areas or engage in practices that can lead to cross-contamination or contribute to healthcare-associated infections (HAIs).
Contaminated items and surfaces, including door handles, faucets, light switches, keyboards, telephones, work tables and more, can transmit infection-causing bacteria called fomites; therefore, work areas should be routinely and thoroughly cleaned – and SP professionals must aim to minimize the amount of contaminants throughout the departments. The presence of dust, lint and bacteria on devices that need to be high-level disinfected or sterilized may negatively impact those critical processes, and particles or bacteria that make their way into a sterile set may enter the patient’s body and cause an infection.1
Microorganisms can survive on surfaces for long periods of time. For example, Clostridium difficile can survive from weeks to months and Staphylococcus aureus can survive for months on a dry surface.2 If surfaces are not properly cleaned and disinfected, these organisms can become a continuous source of contamination. A study of 23 acute care hospitals found that, on average, only 49 percent of surfaces that were believed to have been properly cleaned actually were.3
Eating or drinking should never be performed in SPD work areas (on both dirty and clean sides). Beverages may spill, leading to potential contamination of devices, surfaces, reference books and other items, and food crumbs can attract disease-causing insects or rodents to the work area. Additionally, food oils and residues can be passed from hands to instruments and other surfaces, which may impede effective cleaning and sterilization.
All fixtures and furnishings in the SPD must be made of materials that can be cleaned and disinfected on a regularly scheduled basis. Sterile storage areas may have either open racks or closed cabinets; however, closed cabinets are best for high-traffic areas. Open shelving should have a solid bottom, so items stores on lower shelves are protects from contaminants during housekeeping tasks.1 Corrugated cardboard boxes and external shipping containers should not be allowed in storage areas or other parts of the SPD because they may harbor microorganisms and introduce other contaminants to the areas.4 If anti-fatigue floor mats are used in the department, they must be designed to withstand daily cleaning and disinfection and should be discarded when they show visible wear or breakdown that can inhibit proper cleaning or introduce particles into the environment.
Terminal cleaning and disinfection of the SPD should not be performed while instruments are being cleaned and sterilized/high-level disinfected. Also, clean-to-dirty flow should always be followed, beginning with sterile storage, then moving to preparation and packaging and, finally, to the decontamination area to reduce the risk of spreading contaminants from “dirty” areas to “clean” areas of the department. Cleaning should also be approached with a “top-down” method and some facilities may also adopt a left-to-right method to ensure no items are missed during the cleaning process.
Floors should be cleaned at least daily with a damp mop; dry sweeping or mopping should not be done because dust and other contaminants will become airborne and can land on instruments, work tables and other surfaces.1,4 Contaminants on sterile packages can fall onto package contents upon opening and jeopardize patient safety. Separate and dedicated cleaning equipment, such as mops and buckets, should be used for the decontamination area, which is the dirtiest area of the SPD. This cleaning equipment should never be used elsewhere.
Lighting fixtures or their covers and air vents should be cleaned at least every six months or as needed.1 Note: This task is typically performed by EVS or plant maintenance, as opposed to SP professionals. Horizontal work surfaces should be cleaned daily or, preferably, at the end of each shift. Walls, cabinets, shelving or other surfaces should also be regularly cleaned, at an interval determined by the facility, and as needed. Checklists and audits can be helpful for ensuring all areas of the department are properly cleaned and at the correct intervals.
Any individual with cleaning responsibilities requires targeted, ongoing training to ensure departmental policies and procedures are consistently followed; this includes ensuring that proper personal protective equipment is being used during departmental cleaning, proper chemical dilution rates and contact times are being followed in accordance with manufacturers’ instructions for use, and surface compatibility is taken into consideration.4
Julie E. Williamson, BA, is communications director/editor for the International Association of Healthcare Central Service Materiel Management (IAHCSMM).
1. International Association of Healthcare Central Service Materiel Management. Central Service Technical Manual, Eighth Edition. Chapter 6. 2016.
2. Kramer, et al. How Long Do Nosocomial Pathogens Persist on Inanimate Surfaces? A Systematic Review. BioMed Central. 2006.
3. Carling, et al. Identifying Opportunities to Enhance Environmental Cleaning n 23 Acute Care Hospitals. Infect Control Hosp Epidemiol. January 2008, 29(1): 1-7.
4. Huber L. Surface Disinfection and Departmental Housekeeping in Central Service. CIS Lesson Plan 253, Communiqué. Jan./Feb. 2016. International Association of Healthcare Central Service Materiel Management.
Proactive Device Care Helps Eliminate Biofilm Threat, Aid Cleaning Process
By Julie E. Williamson
This column originally appeared in the December 2019 issue of Healthcare Hygiene magazine.
Preventing contaminated instruments from being used in a subsequent procedure should be a top priority for every professional in sterile processing (SP), the operating room (OR) and other end-user departments. Any bioburden that remains on an instrument can cause devastating, potentially deadly infections if that contaminated device or piece of equipment is used on another patient. It’s important that all caregivers and reprocessing professionals understand that instrument contamination can’t always be detected with the naked eye, and that proactive instrument care is a shared role that must be consistently and diligently performed.
Biofilm is an often-invisible threat to patient safety and its presence can rapidly progress to a significant problem if not promptly and properly addressed. Biofilm is a collection of microorganisms that attaches to surfaces and itself to form a colony1 that then produces a protective gel matrix on device surfaces. This matrix cannot be easily penetrated with detergents and disinfectants – an especially important fact considering instruments that are not thoroughly cleaned cannot be effectively high-level disinfected or sterilized.
Wava Truscott, BS, MBA, PhD, of Truscott MedSci Associates, explained there are six stages of biofilm development and each stage is increasingly difficult to eradicate.2 Stages 1 and 2 can be easily removed, however, any biofilm that remains quickly sends out a signal to multiply further. Stages 3 and 4 are even more resilient and resistant to eradication, and Stage 5 is very mature biofilm that is especially difficult to destroy. Stage 6, the highest level, is when biofilm becomes hardened on devices such as endoscopes that have undergone reprocessing. In this stage, the biofilm builds upon itself and forms what Truscott describes as a matrix fortress.
“When bacteria determine that the surface they landed on has an organic food supply and is physically a good place to construct a biofilm, they signal other bacteria to join them. The favorable response also triggers its 'appendages' to attach to the surface and to other bacteria, while physically enhancing the strength of the attachments’ grip," she explains, adding that endoscopes, catheters and narrow tubes and channels are just some of the places where bacteria can hide and quickly multiply.
Biofilm is designed to survive and thrive; therefore, proper proactive instrument care and treatment is vital for preventing its development and proliferation. Although instrument and equipment cleaning, high-level disinfection (HLD)/sterilization takes place in dedicated reprocessing areas, point-of-use care is necessary for preventing blood, tissue, secretions and other types of bioburden from drying on surfaces. Dried bioburden makes cleaning in the SP department and other designated reprocessing areas far more challenging.
Point-of-use treatment should begin immediately following the procedure (and in the location where the procedure occurred). This treatment involves wiping gross blood and bioburden from instruments and keeping devices moist with an approved wetting agent (an enzymatic or moisturizing gel or spray, for example), all the way through transport to the dedicated decontamination area. If moisturizing products are unavailable, instruments should be covered with a water-moistened towel (saline should never be used, however, because it can corrode or otherwise damage instruments). Note: A single surviving bacterium can multiply to 2 million in just seven hours; therefore, it is imperative that devices be transported to the decontamination area as soon as possible following the procedure.2
The latest industry standards and guidelines, including those from AAMI, AORN and AST recommend point-of-use instrument care to remove gross debris and aid the cleaning process. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Section 6.3.1, states that instruments should “be wiped throughout the surgical and invasive procedure, as needed, with sterile moistened surgical sponges to remove gross soil. Cannulated or lumened instruments should be irrigated with sterile water, as needed.”
Once contaminated devices enter the decontamination area, proper cleaning tools and application are essential. Cleaning brushes should be neither too small (which can scratch or gouge instruments and create a place for microorganisms and bioburden to hide and thrive) or too large (which prevents the bristles from cleaning properly). Using proper pressure while brushing is also key because too rigorous brushing can damage instrument surfaces and too-gently brushing can prevent proper removal of bioburden. Water quality also factors into reprocessing outcomes. Contaminated water can cause infection and water with high mineral concentration or the presence of organic matter can cause buildup on instruments that can make disinfectants and sterilants ineffective. Truscott reminds us that faucet aerators also provide an opportune location for microorganisms and biofilm to hide and flourish.2
Facilities that fail to follow the latest industry standards and guidelines – and manufacturers’ instructions for use – are not only jeopardizing patient safety, but also increasing the odds for citations and fines from surveyors such as those from the Joint Commission and Centers for Medicare and Medicaid Services. Increasingly, surveyors are well versed on the latest standards and guidelines and are looking to ensure that facilities are following them. Internal policies and procedures are also being carefully reviewed; therefore, if a point-of-use care policy is in place, surveyors will want to see that it is being consistently followed.
Julie E. Williamson, BA, is IAHCSMM’s communications director and editor.
- International Association of Healthcare Central Service Materiel Management. 2016. Central Service Technical Manual, Eighth Edition.
- Truscott W. April 2019. Biofilm Housing Development: Work Surfaces, Devices, Cleaning Equipment. Session at the 2019 IAHCSMM Annual Conference.
The Tip of the Iceberg: It’s Not Just Goshen
By Hank Balch
This column originally appeared in the December 2019 issue of Healthcare Hygiene magazine.
On Nov. 18, 2019, hospital administrators at Goshen Health in Goshen, Ind. notified nearly 1,200 surgical patients that they may have exposed to hepatitis B, hepatitis C and HIV due to improperly processed surgical instruments. 1 The story itself is one that we've heard again and again in recent years, from places like Seattle Children's Hospital, Detroit Medical Center, and Porter Adventist Hospital in Denver.
While the locations for these quality breakdowns change, the overarching script does not. Some process was not followed, some step in Sterile Processing was not taken, and now thousands of patients are given the news that instead of healing them, their hospital visit may have infected them with a deadly virus. Not the kind of news any patient ever deserves. Unfortunately, most patients have no idea how systemic these challenges really are.
As frightening as this news is for the public at large and surgery patients in particular, inside the sterile processing (SP) industry we are not surprised when we see a headline like this hit the evening news. In fact, many of us are surprised that we don't see more of them. Discussions around non-compliance for point-of-use cleaning, challenges around manual cleaning protocols, breakdowns in automatic cleaning equipment, and staff competency concerns are constantly discussed during our national annual meetings and local seminars. Research is regularly being presented via whit papers, industry magazines, and posters that highlight serious shortcomings related to current cleaning, disinfection, and storage practices in the field.
For SP consultants who visit multiple facilities a month across the country, there is no question that the kinds of quality headlines we see from hospitals like Goshen are far more common than the public is aware. Simply put, we all know that we are just beginning to scratch the surface of the real depth and breadth of these infection control risks. While the mainstream media reports on the occasional tip of the iceberg that floats on the surface, there is a massive problem lurking just underneath that has the attention of many SP professionals, microbiologists and regulatory agencies.
When specific process breakdowns like this are identified in hospitals, there is an immediate rush to calm public fears, get accurate information out to media agencies, and try to explain how something like this could happen in SP. In fact, the CDC has an entire resource page dedicated to walking facilities through this notification process in a transparent, yet controlled manner.
One of the central phrases from the CDC resources instructs hospitals to tell patients, “We believe the risk to be extremely low.” If you closely review the communications from the hospitals listed at the beginning of this article, and other examples of surgical sterilization problems, you will see this refrain used again and again. While the comparatively low risk of exposure is true enough in a purely statistical sense, when we hear interviews from the patients who receive these notifications there is near unanimous concern, fear, and anger. One patient from the Goshen example said it this way, “I was mad, I was really, really mad because when you tell somebody that they could be at risk for something like that, it not only involves you, it involves your family, your significant other. I mean I have grand kids and kids. I have a life."2
This patient feedback is a far better indicator for what the public finds value in knowing about how their surgical care is delivered to them. Patients who have been notified of an infection control breach do not care about cold, dry statistics from some government agency. They want to know why this happened in their town, during their surgery, and if the results of their test is going to change the rest of their life.
So how do we bridge this disconnect between tremendous ongoing quality struggles in SPDs around the country, and public awareness of the situation before it leads to a wide-scale patient notification scenario? One of the best opportunities before us is to bring our internal industry conversations out into the public arena. This will mean a pivot from talking primarily to ourselves about ourselves, to talking and educating a public who has very little understanding of the current state of medical device reprocessing.
A great example of this type of public facing approach can be seen in the work of Aakash Agarwal, PhD, who has conducted recent media interviews and publications around contamination concerns with surgical implants. Through these platforms, and other social media outlets, Agarwal is engaging with this topic in the public sphere, where potential patients can encounter and respond to the content from an educational perspective. This is just one of a hundred different topics that touch the Sterile Processing industry which could be more actively and transparently discussed, with the goal of stirring up awareness of and support for additional resources to find real solutions for the challenges that currently plague us.
The longer we respond to situations like Goshen Hospital as if they were the rare exception, instead of an ominous symptom of a deeper problem, the larger the risks grow to see more patients receive notifications of potential exposure. Instead, we should pull back our industry curtains, and let the light of public transparency melt the quality iceberg in our path.
Hank Balch is an internationally recognized thought leader in the sterile processing industry, as well as podcast host, and founder of Beyond Clean.
IFUs: The Challenges and Opportunities for Compliance
By Kelly M. Pyrek
This article originally appeared in the November 2019 issue of Healthcare Hygiene magazine.
Healthcare Hygiene magazine spoke with Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS, clinical educator with the International Association of Healthcare Central Service Materiels Management (IAHCSMM), about the importance of following manufacturers’ instructions for use (IFUs) as part of the overall strategy for proper medical device reprocessing and upholding patient safety.
HHM: Talk to us about the importance of following IFUs.
SK: IFUs share with us the key details about how to properly process a medical device or instrument. IFUs are developed based on the scientific validation on that specific medical device; the devices are soiled with a certain kind of soil that is reflective of soil it will be exposed to. There are measurements taken around the level of soil and how this soil is eradicated from the device, and how exactly to do so. Testing labs determine the cleaning and disinfection protocol, and manufacturers list out these steps for removing the soil. IFUs are becoming so detailed now, that manufacturers are even indicating what kind of brushes to use. This is especially good information, especially if a facility is going to buy a new medical device – that’s the information we need up front so that when we have the medical device in front of us, we don’t say, ‘Oops, we don’t have the right brush on hand.”
HHM: With more detailed IFUs comes new challenges of compliance, right?
SK: Right, and the IFUs do change, compounding the challenge even more. We must keep them updated but it is a challenge because some of them are very, very detailed and they are difficult for techs to follow. We often must use our critical thinking skills. For much more complex medical devices, we really must follow IFUs to the letter because that’s where all the validation information is contained. Labs inoculate the device, and they know exactly what it takes to clean it and sterilize it, and if we aren’t following the IFUs, we can harm patients. Also, we risk damaging the device if we don’t follow the IFUs. The bottom line is, we don’t want to have any debris remaining on or in the device because we don’t want to give our patients infections, and that’s why we must follow the IFUs.
HHM: Can healthcare facilities do a better job of explaining these imperatives and improving techs’ comprehension of the science?
SK: The challenge around educating continues. It’s always best to explain the “why” behind why we do what we do; because then CS/SPD personnel perform their jobs better when they understand more about the “why.” So, I think the “why” is very important. Techs must understand that validation is based on the science, which drives everything that we do.
HHM: Is the onus on the manager?
Yes, sterile processing leaders are responsible for the education and training of their personnel. We need to hold a lot of in-services as new medical devices and instruments come into the healthcare facility, and the manufacturer must help in-service staff as well. These new devices and instruments shouldn’t be used until the sterile processing staff is in-serviced, period. The sterile processing leader can also identify their problem items and start in-serving techs on those IFUs. Many manufacturers offer online resources, as does IAHCSMM, which provides instructional resources including webinars and now podcasts. Time is also a factor because we are so busy.
HHM: Could providing techs with feedback about HAIs and facility infection rates could help?
SK: We need to educate them around why we must process based on scientific validation – it’s not just infections, it’s overall patient safety.
HHM: Has there been any progress on removing the barriers to improvement in sterile processing?
SK: The biggest barriers remain, such as limited processing capacity due to shortages in staff, tools, equipment and resources. Or unrealistic turnaround times. For example, some IFUs mandate a 20-minute soak time, but the operating room needs it faster than that. We must get with the surgical services department and educate them around the numerous steps in the average IFU, and that we need adequate time from when the device or instrument first lands in the decontamination department to when it gets packaged and sent back to the OR. We must better educate our customers in the OR so that they are not pressuring us. Maybe the healthcare institution needs to buy more equipment. When IFUs change, or involve things like robotics, a lot of hospitals increase their instrument inventory because it extended their processing time. We need to communicate clearly with our OR customers because they don’t understand all the complicated steps required to process a medical device or instrument.
Researcher Cori Ofstead and her team conducted a study that showed it takes about 74 minutes to clean a scope, yet sterile processing is continually pressured to deliver in half that time, despite complicated IFUs. We must educate around IFU compliance and emphasize that the OR must schedule patients differently or buy more scopes. We must work with our OR customers better for them to understand what is involved in processing these increasingly complex medical devices and instruments.
HHM: Speaking of Cori Ofstead; her recent survey of IAHCSMM members revealed numerous challenges that persist in CS/SPD.
SK: We are moving toward improvement, we just aren’t getting there as fast as I wish we would and should. Barriers to better practice are not being entirely eliminated and we have a ways to go, but I don’t want to discourage anyone because we have worked so hard to get where we are. We need to keep going; to me, the survey results tell me we are making progress but not as fast we wish we could go.
HHM: Are manufacturers realizing they can help make devices that are easier to process, and IFUs that might be easier to understand, as part of the solution?
SK: The dial is moving slowly; there are some companies that are providing better resources for sterile processing. We’re moving slowly but we’re not quite there yet. The problem with IFUs is that some lack information. In most cases, it’s the older ones that lack critical information we need, while others are so detailed that they are almost impossible to follow completely, so we have both ends of the spectrum. In 2015 the FDA published their latest labeling guidance and that provided some help. We have the FDA’s ear and they are trying to address these issues, and I think they will help us move the needle. Manufacturers make the devices and we process them, but we both have the same objective – we want that medical device to work perfectly every time that it is used. And for that to happen we need to partner with the manufacturers who must show us how to process that device, walk us through every step, so that every time we process it, we do it correctly and when the surgeon uses it, it is perfect. And that’s good patient care.
HHM: Can certification of sterile processing techs boost compliance with IFUs?
SK: Certification has a bearing on IFU compliance because it provides the “why” in what we do, so when we talk about cleaning a certain way, and validation, etc. techs who go through the certification program understand why all of the steps in the IFUs are necessary. By understanding the “why,” they are inclined to perform the steps correctly. It also helps them to question the process; so if a tech is performing a step in the reprocessing protocol, they can say, “This doesn’t look quite right to me,” and report the issue to their supervisor. In my experience, it’s usually the certified techs who identify the problems and raise the issues; having that additional knowledge that certification provides, they function at a higher level.
HHM: How is technology evolving the sterile processing profession?
SK: Medical devices are so much more complex, and as they continue to evolve, the tools we use in sterile processing must evolve as well to keep up. It’s no longer the flat, hinged, stainless steel instruments we used to process; many more of them are now complex medical devices and it’s not just a simple assemble and package process. There is a great deal of inspection required for these devices –and we must use cleaning validation tools like borescopes. We can use borescopes on almost everything, and not just flexible scopes. A lot of IFUs require lighted magnification and inspection and outline what to look for, so whatever it is we are doing, we must always check the IFUs and make sure we are following them exactly. A key issue is involving the sterile processing department in the healthcare facility’s new product decision-making. A sterile processing leader should look at the product and make sure that the department has the equipment to process the device, as well as adequate time and personnel to do so. We are often not even considered in the product-procurement process, and as a result, we find out too late that the IFU may be difficult or impossible to follow. I have heard many stories where a new medical device is purchased by a hospital and it just sits there because techs can’t process it, they don’t have the tools and equipment specified in the IFU. Also, the cost of processing a new medical device should be taken into consideration in the purchase-related costs of the product. We need the competency of staff as well, to make sure they can process the device. Get us involved at the very beginning.
Newly Revised AORN Guideline on Sterilization Packaging
By Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
This column originally appeared in the November 2019 issue of Healthcare Hygiene magazine.
Research has led to many improvements in patient care, including those involving sterilization packaging. Sterilization packaging plays a critical role in patient care. Use of the correct sterilization packaging permits the sterilant from entering and exiting the package, maintains the sterility, and allows for aseptic presentation.
The Association of periOperative Registered Nurses (AORN)’s Guideline for Sterilization Packaging Systems has been relied upon as a best practice since it addresses all activities related to sterilization packaging and has recently undergone key revisions. To update this guideline, AORN assessed peer-reviewed literature published in English from January 2013 until December 2018. The articles were evaluated, rigorously reviewed and appraised for the quality of the evidence. This article will highlight some of the key changes to this guideline.
The sterilization packaging system begins with the pre-purchase evaluation of a packaging system. The guideline provides a listing of considerations such as:
- Product quality assurance testing results
- Compatibility with the intended sterilization method(s) and cycles used within the facility
- Requirements for cleaning according to the instructions for use (IFU) (e.g., laundry for textiles, equipment for cleaning rigid containers)
- Requirements for tracking use
- Method for tracking use
Compatibility with a sterilization process is a primary consideration. This updated guideline includes packaging for sterilization using hydrogen-peroxide combined with ozone, which was recently introduced in the U.S.
Guidance for the preparation for packaging was revised to recommend that packaging for sterilization be performed in an area intended, designed and equipped for sterilization packaging activities, such as the packaging area of the Sterile Processing department (SPD). Prior to packaging, users are advised to verify that instruments and other medical devices have been cleaned, inspected and assembled according to the manufacturer’s IFU.
This updated guideline recommends use of colored or tinted tip protectors for sharp items to protect instrumentation from damage and to protect personnel from injury. The main concern is that colored or tinted tip protectors make it easier for personnel to see, which is important on a sterile field. Clear tip protectors are difficult to see and can pose a risk for a retained surgical item.
The importance of hand hygiene during instrument preparation is also addressed in the guideline. As instrumentation is handled during preparation, there is concern of transferring what is on the hands of the assembler to the instrumentation. Research has shown that contaminants, oils and soils transferred to instruments from the hands of personnel can compromise sterilization. Due to this research, AORN’s updated guideline recommends that personnel who inspect, assemble and package reusable surgical instruments perform hand hygiene within the hour or wear clean gloves to perform these tasks. AORN also recommends performing hand hygiene before handling instruments and medical devices for sterilization.
The updated AORN packaging guideline includes guidance on the packaging of loaned instrumentation, including the recommendation to obtain (from the vendor that provides the instrumentation) sterilization packaging information for loaned instrument sets.
The practice of placing count sheets inside instrument sets has sparked some controversy and there is insufficient evidence for making a recommendation on this practice; therefore, each healthcare organization will need to determine if count sheets may be placed in trays. The decision should consider the limited research available regarding the safety of subjecting toners, inks and various papers to any sterilization method. Chemicals used in the manufacturing of paper, toners and inks pose a theoretical risk of reaction in some sensitized individuals. One research study concluded that the label and toner ink transferred during sterilization was not cytotoxic; however, further study is needed to incorporate a larger sample, various sterilization methods, and instruments of a variety of compositions.
Checking IFU for products used for sterilization is a key principal of sterilization and packaging. AORN’s updated guideline now includes what to look for in the IFU when selecting a single-use, nonwoven sterilization wrapper. In addition, the IFU can provide information for the correct use and maintenance. It is important to note that not all single-use, nonwoven packaging systems are validated for all sterilization methods and cycles.
The guideline also includes recommendations regarding use of corner protectors for wrapped trays. To prevent tears when using flat wrappers for instrument trays, especially those with sharp edges, many facilities use corner guards. The use of corner guards prevents the tears that occur on corners, especially if they are sharp. A tear or hole in a wrapper destroys the integrity of the packaging system since it creates a pathway for microbes to enter a sterilized package and contaminate it. As with all sterilization packaging, it is important to check the IFU of the corner protector manufacturer for information regarding the type of validated sterilization method.
The updated guideline also recommends that users establish and implement a schedule for routine rigid sterilization container inspection, maintenance and repair. Also, new factors have been added regarding what to look for in the container’s IFU that provides information on their correct use.
The complete guideline is available for purchase at www.aorn.org.
Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS, is clinical director at IAHCSMM.
Recent Survey Reveals Reprocessing Challenges
In a survey of the membership of the International Association of Healthcare Central Service Materiel Management (IAHCSMM), just two-thirds believed that manufacturers’ instructions for use (IFU) were understandable. This and other eye-opening findings were unearthed last year by the experts at Ofstead & Associates, who conducted the inquiry to learn which methods are currently used to reprocess endoscopes and what is being done to manage quality. Additionally, the researchers wanted to better understand what challenges IAHCSSM members face related to endoscope reprocessing and gather ideas about potential solutions that could improve the outcomes of reprocessing. A total of 2,334 IAHCSMM members completed the survey.
Regarding reprocessing practices, the researchers found that:
- 69% of respondents follow at least one guideline
- 49% said their facilities follow multiple guidelines.
- 84% had read IFUs for endoscopes; 69% felt the IFUs were understandable or feasible (66%)
- 67% believed that endoscope IFUs were based on scientific evidence.
Regarding the chemistries used for reprocessing flexible endoscopes, the researchers found:
- 27%: OPA
- 22% Hydrogen peroxide
- 21%: Peracetic acid
- 10%: Glutaraldehyde
- 5%: Products with more than one chemistry
Regarding testing the minimum effective concentration (MEC) of HLD before or during each cycle to ensure the HLD is strong enough:
- 79% reported that MEC tests were done every cycle
- 3% tested several times per day
- 14% tested MEC only daily
- 4% never tested MEC or tested it less than once per day
- 51% said that MEC results were documented.
Regarding AER failures:
- 46% observed one or more AER cycle failures in the previous month
- AER cycle failures were frequently attributed to water filter or water flow issues, temperature errors, or leak test failures and channel blockages
Regarding drying and storage of endoscopes:
- 8% acknowledged that they do not dry off the outsides of endoscopes before storage.
For exterior surfaces, survey respondents said they used:
- 59%: single-use lint-free cloths
- 31%: forced air
- 14%: reusable lint-free cloths
- 5%: washcloth
- 4%: paper towels
For endoscope channels:
- 64% indicated they used at least one drying method
- 40% used more than one method (including drip drying)
These drying approaches included:
- 59%: alcohol flush in AER
- 42%: air purge in AER
- 31%: drying cabinet
- 30%: forced-air purge
- 26%: drip dry
- 20%: purge with syringe
Survey respondents reported that their endoscopes were stored the following ways:
- 32%: vertical storage with fan to circulate air
- 29%: vertical storage with ventilation grills, but no fan
- 23%: vertical storage without any ventilation
- 22%: drying cabinet with channel connectors
- 10%: storage bins or drawers
- 7%: other or not sure
Regarding cleaning verification and visual inspection:
- 48% reported using cleaning verification tests to detect residual adenosine triphosphate (ATP), protein or hemoglobin
- 50 % reported using at least one method to visually inspect their endoscopes.
Methods of visual inspection varied, including:
- 36%: visual inspection with the unaided eye
- 18%: visual inspection with a magnifying glass
- 14%: visual inspection with a borescope
- 29% reported performing both visual inspection and cleaning verification
Regarding improving quality, survey respondents suggested:
- Expand opportunities for education and training of technicians and clinicians, including physicians and nurses
- Centralize endoscope reprocessing to one department, to simplify education and competency testing efforts and help ensure each scope is reprocessed by an experienced and competent technician
- Improve working conditions for reprocessing staff personnel who commonly experience health problems and workplace stress that make it difficult to perform their job
- Institute quality management programs that encompass both visual inspection and cleaning verification tests
- Redesign endoscopes and IFUs to simplify the reprocessing process
Survey respondents expressed interest in alternative technologies, including:
- endoscopes that can be disassembled
- sterilizable endoscopes
- single-use/disposable endoscopes
- automation of reprocessing steps
Reference: Ofstead CL, Hopkins KM, et al. Endoscope Reprocessing: Current Practices and Challenges in the Field. Process. 2018.
Sterile Processing Recruiting in an Age of Options: If You Post it, They May Not Come
By Hank Balch
This column originally appeared in the November 2019 issue of Healthcare Hygiene magazine.
There are few better times in the history of sterile processing (SP) to be an experienced professional with a strong resume and industry credentials to back it up. With the U.S. Bureau of Labor Statistics projecting 10 percent to 14 percent growth in the medical device reprocessing field by 2028, all signs point to continued career opportunities for technicians and department leaders.1 This growth, however, brings with it tremendous pressures on hospitals and ambulatory surgery centers to identify, recruit and retain high-quality SP professionals. Many facilities are already feeling the pinch of this competitive job market, seeing their open manager and director positions sit vacant for many months at a time, and spending large percentages of their labor budgets on temporary frontline staffing as the permanent positions go through an extended recruiting process.
There are many contributing factors driving the challenges that we see in today's SP recruiting atmosphere. First, the impact of Baby Boomer retirements is not just a nursing phenomenon but will have similar effects on the shrinking numbers of experienced SP leaders currently in the field. Dr. Peter Buerhaus has projected that a staggering 1 million RNs will retire by 2030 and that “the departure of such a large cohort of experienced RNs means that patient-care settings that depend on RNs will face a significant loss of nursing knowledge and expertise that will be felt for years to come.”2 There is no reason to believe that our departments will be immune to the negative effects of this retirement "brain drain."
Secondly, the known compensation shortcomings of entry-level SP positions are a tremendous barrier for active recruiting out of competitive industries or contiguous geographical areas. With some facilities paying as little as $10 per hour for SP technicians, recruiters end up competing with retail and customer service employers for the same limited pool of candidates. These kinds of limited financial incentives mean that enticing experienced professionals to transfer roles geographically poses an even greater challenge, leaving many facilities with few options but to hire and train on the job.
Thirdly, the market's need for certified and experienced SP professionals 0feeds into the growing ranks of temporary staffing agencies and interim management organizations, creating a kind of self-perpetuating staffing spiral. High-performers who gain their baseline certifications and are willing to travel can make more than double their full-time salaries by becoming SPD "travelers," and department leaders can triple their own salaries by serving as interim managers in facilities who are struggling to recruit a permanent leader. These competitive dynamics will continue to contribute to the vacancy rates of many departments until permanent compensation models are able to catch up to the temporary/interim staffing rates.
Lastly, many hospital recruiters do not understand what they should be looking and recruiting for in a potential SP technician. While the recruiting structures vary, it is not uncommon for so-called "clinical recruiters" to cover recruiting for perioperative staff such as RNs, surgical technicians and anesthesia personnel, but recruiting responsibility for sterile processing is placed under "non-clinical recruiting" which includes other departments such as dietary, environmental services and linen services. Inherent in this structure is the idea that what makes a great candidate for a dietary role might also make a great candidate for SP positions. For many reasons, categorizing Sterile Processing departments as non-clinical recruiting pools leads to an unhelpful narrowing of potential candidates and loss of strategic focus for where these professionals can and should be sourced from.
As dire as this situation may sound and as frustrating as it may feel to experience it as a department leader, there are certain insights that can be leveraged to find success in sourcing high-quality SP candidates.
Department leaders must realize they must take an active role in the recruiting process if they want to have the greatest success with opening up a pipeline of potential hires. Relying on a hospital recruiter who does not have the subject-matter expertise of our field to identify these professionals is really asking them to hit a moving target. Even if they want to be successful, they will need your help to clarify exactly what does and does not make a great frontline technician or shift leader.
Related to this, department leaders need to get creative about where and how their candidates are sourced. If “recruiting” in your hospital simply means posting the job on the hospital website, then you should not be surprised that your applicant pool is primarily internal candidates looking to transfer from another department, instead of reaching the broader audience outside of the facility. Taking the time to post fliers at a local community college, healthcare trade school and coffee shops can extend your reach dramatically. Partnering with local organizations such as refugee placement and military veteran groups can also broaden your potential network for candidates with previous related experience in various contexts.
While you may have limited ability to directly impact your compensation rates, you may have success in wrapping in tuition reimbursement packages to cover the costs of SP training programs for staff and/or traditional college degrees, both of which can provide a competitive edge in recruiting.
Confronting staffing challenges will not be easy, and few solutions look to be the silver bullet to solve all the recruiting issues facing our teams. However, knowing the factors that have led to our current state gives us the insight necessary to develop strategies that can have real success. The days of posting a job and waiting for a flood of quality applicants is over. What the future looks like is up to you.
Hank Balch is an internationally recognized thought leader in the sterile processing industry, as well as podcast host, and founder of Beyond Clean.
- Bureau of Labor Statistics. 2018 wage dataand 2018-2028 employment projections. https://www.onetonline.org/link/details/31-9093.00
- Buerhaus PI, et al. Four Challenges Facing the Nursing Workforce in the U.S. http://healthworkforcestudies.com/images/JNR0717_40-46_Buerhaus.pdf
The Missing Science of Sterile Processing: On Credentials and Real Improvement
By Hank Balch
This column originally appeared in the October 2019 issue of Healthcare Hygiene magazine.
Microbiology, chemistry, physics.
Some of us took introduction classes to these subjects in high school, a few went on to take a semester or two in college, but for many sterile processing professionals across the country these hard sciences are mostly relegated to a chapter or two in a certification textbook. After all, do we really need to know chemistry to do our jobs well? How important can physics really be to an SPD technician? Being able to speak the language of microbiology couldn't be that important to surgical instrument reprocessing, could it?
Does anyone know what a biocatalyst is? Or what it has to do with the decontamination process? At the end of the day, do these questions even matter?
In fact, every single one of us in the industry know the answer to this question is "Yes, science matters!" But the near universal absence of credentialed scientists employed in sterile processing departments tells a very different story. Unless your department is led by a B.S. in biology or employed solely by team members with B.S. degrees in chemistry, your exposure to the true science behind how your sterile processing department actually interact with chemistry, physics, and microbiology is limited to whatever self-study you pursued under your own initiative. Admittedly, many CS/SPD leaders and technicians have taken these extra steps to fill in the science knowledge gaps, but the fact that they had to go over and above the industry standards should tell us something very important about the current "industry standards" – namely, they are way too low.
Breaking the Chains and Changing the World
So, you can name the biological spore used in steam sterilization testing -- geobacillus stearothermophilus … so what? Why that spore instead of another? Why do we use spore testing at all? Is there a better way to measure sterility assurance and how would we know? If you ask sterile processing professionals across the country, we want to know the answers to these questions. We know it's important. And we know that our ability to holistically grasp these categories, and do so in a creative, innovative way, will move the industry of CS-improvement firmly in-house, rather than being dependent upon external vendors (who, by the way, employ chemists, physicists and microbiologists to create their nifty new products).
As generations of us learned in Schoolhouse Rock!, “knowledge is power” -- and in the case of the hard sciences, knowledge is also the engine of innovation, the catalyst for product changes, and the great differentiator in industry compensation. CS/SPD professionals talk a lot about facility pay practices and how our counterparts in the OR make somewhere close to 200 percent to 300 percent more than our teams, but what is often left out of the equation is the two- to three-times more education RNs and BSNs have as compared to CS/SPD technicians. That need not be so. There is another way.
The Great Educational Leap: Know Ye the Truth
So, what can deliver our industry from the basement of healthcare compensation, sluggish career growth, and token respect? I believe one of the best ways to get our teams to where we want to be and where our patients need us to be is to take a great educational leap in sterile processing. The recent success we have seen over the last decade in the surge of industry certification through the IAHCSMM and CBSPD organizations (not only the standard certification, but also secondary and tertiary certifications as well) has sparked a deep hunger among CS professionals for continued growth. What we have not yet seen is a dramatic impact of these certifications upon total compensation and demonstrable quality metrics in the country’s CS departments. In other words, even with more credentials, there’s still something missing.
I believe that missing link has to do, in part, with the need to create a science-heavy, higher-education career track that not only prepares CS professionals for every aspect of the role, but also provides our people with recognized degrees that translate into competitive pay-grades as compared with our OR peers. Simply put, if we really want to solve the pay/quality issues of our industry, it will take more mere certifications – even if they are mandated in all 50 states. One certification course doth not an expert make.
And to be fair, these certification bodies do not claim the title of “expert” for their certification holders. Instead the language is usually something like “providing a baseline knowledge” of industry standards. And for what it’s worth, that is a noble and needed cause. But is it enough? Is baseline knowledge enough for the systemic quality issues in our industry? Is one textbook course going to shake the compensation tree in the ways that we desperately need to drive these departments forward?
I think we all know the answers to this. But what are we going to do about it?
Hank Balch is founder and president of Beyond Clean.