Implementation of Antibiotic Stewardship Across the Continuum of Care

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the December 2022 issue of Healthcare Hygiene magazine.

Recently, the Centers for Disease Control and Prevention (CDC) released a new and concerning report on the state of antibiotic-resistant pathogens and antibiotic stewardship within the United States. The findings in this report should alarm all healthcare professionals and leaders, particularly as a result of the impact of the COVID-19 pandemic on existing antibiotic stewardship progress:

Resistant hospital-onset infections and deaths both increased at least 15% during the first year of the pandemic.
In a 2021 analysis, CDC also reported that, after years of steady reductions in healthcare-associated infections (HAIs), U.S. hospitals saw significantly higher rates for four out of six types of HAIs in 2020.
Many of these HAIs are resistant to antibiotics or antifungals.
As you can see, the progress that was being made prior to the pandemic has largely been subjected to major declines as a result of the scattered focus and now staffing challenged being faced across the entire healthcare industry. These declines in progress have now put the class of medications of antibiotics at severe risk and subsequently patients are in harm’s way, particularly with serious multidrug resistant pathogens.

The patient is an important part of the the antibiotic stewardship program. Key messaging to patients must be incorporated in any program in order to achieve success. Patient messaging can focus on the following core measures:

Antibiotics can save lives. When a patient needs antibiotics, the benefits outweigh the risks of side effects and antibiotic resistance.
Antibiotics do not treat viruses, like those that cause colds, flu, or COVID-19. Other medications, like antivirals, can treat viruses.
Antibiotics are only needed for treating certain infections caused by bacteria, but even some bacterial infections get better without antibiotics. Antibiotics aren’t needed for many sinus infections and some ear infections.
An antibiotic will not make you feel better if you have a virus. Respiratory viruses usually go away in a week or two without treatment. Ask your healthcare professional about the best way to feel better while your body fights off the virus.
When antibiotics aren’t needed, they won’t help you, and the side effects could still cause harm. Side effects range from minor to very severe health problems. When you need antibiotics for a bacterial infection, the benefits usually outweigh the risk of side effects.
Taking antibiotics can contribute to the development of antimicrobial resistance. Antimicrobial resistance occurs when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. If antibiotics and antifungals lose their effectiveness, then we lose the ability to treat infections, like those that lead to sepsis.
If you need antibiotics, take them exactly as prescribed. Talk with your healthcare professional if you have any questions about your antibiotics.
Talk with your healthcare professional if you develop any side effects, especially severe diarrhea, since that could be a Clostridioides difficile(difficile or diff) infection, which needs to be treated immediately.
Do your best to stay healthy and keep others healthy by cleaning hands by washing with soap and water for at least 20 seconds or using a hand sanitizer that contains at least 60% alcohol; covering your mouth and nose with a tissue when you cough or sneeze; staying home when sick; and getting recommended vaccines, such as the flu vaccine.
Antibiotics aren’t always the answer. Everyone can help improve antibiotic use. Improving the way we take antibiotics helps keep us healthy now, helps fight antimicrobial resistance, and ensures that these life-saving antibiotics will be available for future generations.
When discharging patients or residents from a healthcare facility, careful attention must be paid to the proper transfer of information related to antibiotics, particular the following:

Information communicated across transitions of care may include:
Diagnosis and treatment plan
Antibiotic therapy
List inpatient antibiotic(s) and total number of days received in the hospital.
Specify if antibiotic therapy was completed in the hospital or if continued therapy post-discharge is needed.
For a post-discharge prescription, list the planned antibiotic, dose, and end date.
Results of relevant diagnostic tests (including pending tests)
Instructions for follow-up medical care, including contact information for additional questions
In some cases, the patient may be discharged back to their traditional home environment, and therefore the patient and their caregiver team must be educated about how to continue the proper care protocols including the indication and planned antibiotic course; instructions for follow-up medical care; signs and symptoms of worsening infection, and sepsis; and signs and symptoms of antibiotic-associated adverse events, including Clostridioides difficile infection. One of the best partners for patients being cared for in the home environment is a community-based pharmacist as they can easily review the patient’s entire medical history and work to prevent adverse drug events.

Antibiotics stewardship is a true team sport that involves the patient, the prescriber, nursing, pharmacy colleagues, and relies upon a collaborative care model to ensure that as healthcare providers we are appropriately protecting this critical class of medications. A vertical and horizontal approach to antibiotic stewardship across the entire continuum of care is needed if healthcare as an industry wants to move the needle substantially in the reduction of Multidrug resistant organisms. Together, we can save lives, reduce unnecessary antibiotic use, and reduce preventable healthcare costs.

Garrett is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a Fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. He is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

Infection Prevention Perspectives for Healthcare Value Analysis

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the November 2022 issue of Healthcare Hygiene magazine.

In today’s complex healthcare environment, the evaluation of infection prevention and control products can be a daunting task. As part of the clinical value analysis process, Infection Preventionists and Value Analysis leaders must objectively evaluate new products and technologies using a standardized methodology. The Institute for Healthcare Improvement (IHI) has defined three core elements to define overall healthcare value which includes the experience of care, population health, and per capita cost.

One of the first steps in product evaluation is centered around determining the appropriate regulatory body that is responsible for oversight of the product being evaluated. For example, hand sanitizers such as alcohol-based hand sanitizers are used on the hands and because they are used on the human body, they are regulated by the Food and Drug Administration (FDA).

The FDA regulates:
• Medical devices
• Drugs (OTC and Rx)
• Blood
• Biologics
• Vaccines
• Food
• Sterilization
• High-level disinfection

The Environmental Protection Agency (EPA), on the other hand, regulates:
• Low-level disinfectants
• Intermediate-level disinfectants
• Cleaning agents

Product Evaluation for most infection control-related products can be reviewed through three unique lens:
• Efficacy: Does it work? Is it going to kill the relevant microorganisms?
• Safety: Is it safe for the patient, healthcare team and environment?
• Compatibility: Will the product work with my other medical items, technologies, etc.?

This approach can easily be leveraged with a variety of products including hand hygiene, disinfectants, cleaning agents, certain medical devices, and personal protective equipment. The product evaluation process should be multidisciplinary and may differ by product type to ensure the relevant expertise (i.e., pharmacy, vascular access, etc.) is an active part of the product evaluation process.

Many infection control products must demonstrate their ability to be “broad spectrum”, they must be effective against a wide range of pathogens including:
• Broad Spectrum for bacteria
• Viruses (non-enveloped and enveloped)
• Multi-Drug Resistant Organisms (Drug Resistant Strains)
• Pathogenic Fungi (Candida)
• Bloodborne Pathogens (HIV, HBV, HCV)
• Emerging Pathogens (Novel viruses, etc.) as applicable

Evidence-based medicine remains an important part of infection control product evaluation, but there is a necessary prioritization in most situations. First, healthcare facilities must fall regulation as that is considered the law and is enforceable. Next, healthcare facilities should review and follow applicable national evidence-based guidelines and guidance from reputable governmental agencies such as the Centers for Disease Control and Prevention (CDC) or the Association of periOperative Registered Nurses (AORN). Third, there may be practice or specialty-specific professional society guidelines or recommendations which can be helpful to consider such as gastroenterology standards for a new disposable endoscope. Finally, the lowest level of consideration is that of expert opinion, as this is not considered to be evidence-based.

The CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) has developed an Infection Prevention Product Review Worksheet that healthcare facilities, infection preventionists, and healthcare value analysis professionals with an objective methodology to evaluate any product related to infection prevention and control. Before introducing a new product into a healthcare, a complete and thorough review must be performed to ensure patient and healthcare team safety.

A comprehensive value analysis process that incorporates assessment of evidence-based practices, patient and healthcare worker safety, population health management, patient satisfaction, and cost of care delivery will mitigate many risks associated with infection control product introduction across the continuum of care.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

Is Monkeypox the Next Global Pandemic?

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the October 2022 issue of Healthcare Hygiene magazine.

As global cases of Monkeypox quickly approach 60,000, many healthcare professionals are carefully monitoring this outbreak in fear of it becoming a global pandemic. Luckily, monkeypox does not share the same routes of transmission as COVID-19 and is primarily spread through close skin-to-skin contact.

The incubation period of Monkeypox can vary widely but is typically between three to 17 days. During this time, a person does not have symptoms and may feel fine. The illness typically lasts two to four weeks, but lesions may take additional time to heal.

The signs and symptoms of Monkeypox include:
• Lesions are firm or rubbery, well-circumscribed, deep-seated, and often develop umbilication (resembles a dot on the top of the lesion).
• During the current global outbreak:
• Lesions often occur in the genital and anorectal areas or in the mouth.
• Rash is not always disseminated across many sites on the body.
• Rash may be confined to only a few lesions or only a single lesion.
• Rash does not always appear on palms and soles.
• Rectal symptoms (e.g., purulent, or bloody stools, rectal pain, or rectal bleeding) have been frequently reported in the current outbreak.
• Lesions are often described as painful until the healing phase when they become itchy (crusts).
• Fever and other prodromal symptoms (e.g., chills, lymphadenopathy, malaise, myalgias, or headache) can occur before rash but may occur after rash or not be present at all.
• Respiratory symptoms (e.g., sore throat, nasal congestion, or cough) can occur.

Unlike in previous clinical guidance from the Centers for Disease Control and Prevention (CDC), the most current Monkeypox guidance specifies who healthcare professionals are to ensure that consistency in infection control practices is adhered to. Healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel). Finally, healthcare settings refers to places where healthcare is delivered and includes, but is not limited to, acute care facilities, long-term acute-care facilities, inpatient rehabilitation facilities, nursing homes, home healthcare, vehicles where healthcare is delivered (e.g., mobile clinics), and outpatient facilities, such as dialysis centers, physician offices, dental offices, and others.

Given the many lessons learned from COVID-19 about the appropriate use of personal protective equipment (PPE), healthcare professionals can remain confident that PPE is protective against Monkeypox transmission when properly utilized. Current CDC guidance for the care of patients with Monkeypox recommends the use of:
• Gown
• Gloves
• Eye protection (i.e., goggles or a face shield that covers the front and sides of the face)
• NIOSH-approved particulate respirator equipped with N95 filters or higher

The widespread availability of diagnostic testing and vaccinations has significantly decreased cases in the United States, but the momentum towards this reduction must be maintained. Monkeypox has very low mortality, but it can cause scarring lesions and significant pain to infected patients. As such, our goal as a healthcare community must be in the prevention of the disease through a multi-modal infection control and public health strategy.

Given the limited transmission routes for Monkeypox, it is unlikely that the outbreak will reach pandemic proportions. That said, a concerted effort toward educating high-risk individuals and offering pre-exposure vaccination can significantly curb Monkeypox cases globally. As with any ongoing outbreak, healthcare professionals and public health departments must carefully monitor case counts and severity of illness and adjust infection control efforts as needed. By working collaboratively, Monkeypox and other emerging infectious disease threats can be mitigated.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

Sniffles, Snorts, Coughs, and Hacks: The Era of Modern Respiratory Infectious Diseases

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the September 2022 issue of Healthcare Hygiene magazine.

Currently, the most common respiratory infections include COVID-19, influenza, pneumococcal disease, and colds. Some pathogens follow a more seasonal distribution pattern, such as influenza and RSV, and can even target the most vulnerable patient populations, such as newborns and the elderly. For respiratory pathogens to infect patients in healthcare settings, only a few things need to happen to result in transmission. Luckily, with basic and consistent infection prevention measures, many of these infections can be mitigated successfully. The chain of infection transmission includes:
• Infectious Agent: the bacteria, fungi, or virus that is pathogenic
• Source: people, equipment, water
• Exit: such as aerosols and splatter
• Means of Transmission: contact, inhalation, airborne, or vector-borne
• Portal of Entry: mucous membranes, respiratory tract, or broken skin
• Susceptible Host: a patient with a compromised immune system.

There are several primary routes for infection transmission, which include:
• Contact: This isolation level requires hand hygiene, gloves, and a gown.
• Droplet: This level of isolation requires a surgical mask and preferably eye protection.
• Airborne: This level of isolation requires the use of a NIOSH-approved respirator.

In addition to the patient-specific issues regarding respiratory infections, healthcare providers must also consider patient exposure, symptoms, the availability of laboratory testing, the availability of efficacious treatment options, and vaccines.
• Patient exposure
• Symptoms
• Availability of laboratory testing
• Availability of efficacious treatment options
• Vaccines

RSV is a common respiratory infection that has historically infected the infant population and has caused many outbreaks in neonatal intensive care settings. RSV can be problematic and deadly to premature infants or those with severely compromised immune systems. Luckily, with good adherence to core infection control measures such as hand hygiene, appropriate use of personal protective equipment, particularly masks, and frequent environmental cleaning and disinfection, healthcare professionals can normally stop outbreaks in their tracks.

While some respiratory pathogens have prophylactic vaccines available, these vaccines have varying levels of efficacy, particularly that of the annual Influenza vaccine. The development of vaccines, in and of itself, is an extraordinarily complex science that requires tremendous research and development. Vaccines, however, have significantly reduced overall mortality and morbidity in many instances.

Given the ongoing threat posed by the COVID-19 pandemic, healthcare facilities should also be given special consideration to the risks associated with aerosol-generating procedures or AGPs. According to the current Centers for Disease Control and Prevention (CDC) guidance, AGPs include but are not limited to:
• open suctioning of airways
• sputum induction
• cardiopulmonary resuscitation
• endotracheal intubation and extubation
• non-invasive ventilation (e.g., BiPAP, CPAP)
• bronchoscopy
• manual ventilation

Even though AGPs can heighten the risk of transmission to healthcare staff, adherence to proper personal protective equipment practices can effectively eliminate this risk. Other measures such as using anti-viral filters in circuits can trap potentially infectious aerosols and prevent them from escaping into the air. There will always be inherent risks of infection transmission in healthcare, but with aggressive infection prevention efforts, many of these can be mitigated.

Respiratory pathogens are here to stay, but by consistently following infection control best practices, healthcare facilities can substantially reduce the risk for infection in both patients and healthcare staff members alike. There are many lessons to be learned from the COVID-19 pandemic and most can be applied to the general prevention of respiratory infections. As we continue to experience respiratory pathogens such as COVID-19, RSV, and seasonal influenza, now is the time to formalize the infection prevention core measures to decrease risks, improve clinical outcomes, and remove preventable costs from healthcare.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

A New Era of Safety in the Operating Room: Truly Treating Surgical Smoke

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This article originally appeared in the August 2022 issue of Healthcare Hygiene magazine.

Surgical smoke in the operating room remains a regular health and safety risk for both patients and healthcare staff. The Association of periOperative Registered Nurses (AORN) defines surgical smoke as “the vaporous and gaseous by-product of the use of surgical energy devices (e.g., electrosurgical units, lasers, ultrasonic devices, high-speed powered instruments).” Furthermore, the Occupational Safety and Health Administration (OSHA) directs that Under the General Duty Clause, Section 5(a)(1) of the Occupational Safety and Health Act of 1970, employers are required to provide their employees with a place of employment that is “free from recognizable hazards that are causing or likely to cause death or serious harm to employees.” Even though OSHA’s General Duty Clause can be leveraged as a catch-all standard for healthcare surgical smoke initiatives, there is not a specific OSHA regulatory standard that addresses surgical smoke in the perioperative setting.

Surgical smoke is sometimes referred to as smoke plume, surgical plume, bio-aerosols, lung-damaging dust, and laser-generating airborne contaminants. Surgical smoke is known to contain particles and can contain certain substances including aromatic hydrocarbons, volatile organic compounds (VOCs), polycyclic aromatic hydrocarbons (PAHs), hydrogen cyanide, inorganic gases such as hydrogen monoxide, nitriles, viruses, bacteria, blood, and potentially viable cancer cells.

The need for mitigating surgical smoke is not a new recommendation, but rather one where the true consequences for patients and perioperative staff have been poorly misunderstood until recent data highlighted the widespread impacts. The overarching goal for the perioperative environment is to create a smoke-free environment. This will require a multi-modal approach consisting of the use of air purification and disinfection technologies that have multiple stages to mitigate surgical smoke. Technologies that treat contaminated air beyond traditional HEPA filtration will be more effective in reducing the negative consequences of surgical smoke when used according to the device's instructions for use.

The hierarchy of controls can be used as a systematic approach to identify the most effective method of risk reduction:

- eliminating the hazard (e.g., avoiding use of smoke-generating surgical devices)

- substituting the hazard (e.g., using alternative devices)

- using engineering controls (e.g., surgical smoke evacuation and filtration, room ventilation of 20 total air exchanges per hour, work practices)

- using administrative controls (e.g., policies and procedures, education and training)

- wearing personal protective equipment (PPE) (i.e., respiratory protection)

When managing the risks associated with surgical smoke, healthcare facilities should utilize a variety of methods to mitigate the potential impacts and evaluate effectiveness. As part of the surgical plan, if surgical smoke is anticipated, the team should discuss mitigation steps to be taken during the case.

Current AORN Guidelines for Surgical Smoke recommend that healthcare facilities use smoke evacuation and filtration (i.e., local exhaust ventilation) in addition to room ventilation. This combination approach will most effectively treat the contaminated air and remove harmful particles from the operating room. Additionally, AORN has revised its guidelines to recommend healthcare facilities “Use a smoke evacuator system that contains an ultra-low particulate air (ULPA) filter with an activated carbon filter when surgical smoke is anticipated. When using a medical-surgical vacuum system, place an in-line ULPA filter with an activated carbon filter between the suction wall connection and the suction cannister. An ULPA filter demonstrates an efficiency of no less than 99.999 percent at a most penetrating particle size (MPPS) (e.g., 0.12 μm). An activated carbon filter adsorbs odors and gases (e.g., volatile organic compounds) in surgical smoke.”

In addition to the need for air filtration technologies to mitigate surgical smoke, perioperative departments must also establish policies and procedures regarding surgical smoke and communicate these policies to all impacted team members. Perioperative team members, including surgeons, should receive training on surgical smoke mitigation strategies at the time of initial hire, annually, and anytime a process or procedure changes. This training should be role-specific and competency-driven. In addition to training, perioperative leaders should engage with the facility quality, safety, engineering, and infection prevention teams on surgical smoke initiatives.

Surgical smoke in the perioperative setting continues to be a true safety concern, but luckily some technologies will mechanically treat the contaminated air and render it safe through multi-modal filtration. This safety threat requires constant attention from perioperative leadership and healthcare facility leadership. The time for action is now as our patients and healthcare team members deserve a safe healthcare environment that is free of these preventable airborne risks. For more information on surgical smoke prevention, visit the AORN website at www.aorn.org.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

What Are Medical Devices and How Are They Regulated?

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This article originally appeared in the July 2022 issue of Healthcare Hygiene magazine.

Infection preventionists are routinely consulted for guidance on medical device products and infection control risk assessments. Medical devices are used across all of healthcare and range from non-complex to extremely complex and high-risk devices. Basic devices such as blood pressure cuffs are routinely used during patient care and their safety is taken for granted by patients and healthcare providers. Food and Drug Administration (FDA)-cleared medical devices, however, have been repeatedly implicated in both infection outbreaks and also patient harm. Healthcare facilities must perform a rigorous risk assessment before implementing any medical device and monitor device utilization even after usage begins. The FDA is the federal regulatory agency responsible for medical device regulation in the United States.

FDA is the oldest comprehensive consumer protection agency in the U.S. federal government. Our mission is to promote and protect public health. This scope is broad and covers foods, drugs, biologics, cosmetics, animal and veterinary medicines, tobacco, and, of course, medical devices and radiation-emitting products, the last two of which are regulated by the Center for Devices and Radiological Health, (CDRH). FDA's authority to regulate medical devices originates from the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1976. The agency has continued to evolve its laws to ensure that it regulates these products in the most efficient way as our scientific knowledge advances over time. Starting in 2002, CDRH began implementing a medical device user fee program in which the regulated device industry provides user fees to CDRH with the goal of advancing regulatory decision-making.

The 1976 Amendments provide us with the definition of a medical device. The full definition is found in Section 201(h) of the FD&C Act. In summary, a device is an instrument, apparatus, machine, implant, or in vitro reagent that diagnoses, cures, treats or prevents a disease or condition. It does this by affecting the structure or function of the body but doesn't achieve its purpose through chemical metabolism or as a drug. This definition excludes certain software functions, mostly involved with the administrative data storage and support, and transmission of electronic patient records.

Innovative products may feature aspects of devices as defined in the prior slide, as well as components such as drugs or biologics. The FDA refers to these as Combination Products, which, by definition, involve at least two regulatory component types of drugs, devices and biologics. An example of a drug-device combination product is a drug-eluting cardiovascular stent, whose two components work together to keep an artery open and prevent restenosis. Combination products involve the applicable regulatory responsibilities from all the components involved. One FDA Center will usually take the lead and the Agency's Office of Combination Products helps facilitate product jurisdiction.

Our federal laws are intentionally written to be broad. We elaborate on the details and specifics of Laws in regulations. The regulations that are specific to medical devices are found in 21 Code of Federal Regulations, Parts 800 - 1050. Parts 800 - 861 mostly address broad regulations that apply to most types of devices, and Parts 862 - 1050 largely address device-specific requirements. For example, 21 CFR 812 addresses Investigational Device Exemptions, a requirement that is applicable to all medical devices; whereas 21 CFR 876 provides classification information and requirements specific to gastroenterology or urology. In addition, 21 CFR Parts 1- 99 contain general regulations that apply to all medical products regulated by FDA, including medical devices. As a result, depending on your specific device, you may have regulatory responsibilities outlined in all these sections.

Sometimes, the FDA Laws and Regulations are not sufficiently detailed to describe how FDA intends to regulate a device policy. In such cases, FDA will publish a guidance document that describes what FDA is thinking. A guidance document is not binding, but it does reflect FDA's current thinking, so it can often be an excellence source of detailed information and clarification on a particular policy. FDA may initially issue a draft guidance document that describes the Agency's proposed thinking on a topic. During this period, the public is invited to provide comments on the proposal. At the completion of the comment period, FDA will evaluate the public feedback and issue a final guidance document, which reflects the Agency's current thinking.

FDA classifies devices, or more accurately, device types, to identify the degree of regulation for that product area. Classification is largely based on two factors: the device description, that is, its physical characteristics, and the intended use. As a result, to fully understand your device's classification, you need to identify both the device description and intended use. FDA classifies devices into Class I, II, or III. The class of a device generally increases with its degree of risk. In addition, each device type is assigned a product code, which refers to a three-letter coding. This allows FDA to group similar devices and intended uses. Note that the same device with a different intended use may have a different classification, product code, and Class.

Source: Food and Drug Administration

This table describes the key characteristics of each class of medical devices. Moving from left to right, we describe each Class according to the general risk of devices, controls necessary, and submissions required. As the risk of the device increases, so does the regulatory control to ensure its safety and effectiveness. Controls may be general, special, and PMA. Devices may be exempt from submission to FDA, or require 510(k) or PMA, with some alternatives. For example, Class I devices generally present the lowest level of risk. They are subject to general controls only and most are exempt from premarket submission, but some may require a 510(k).

So, what are regulatory controls? These are requirements that apply to a product area, or product code. They provide consistent requirements to predictably foster safe and effective medical devices with the appropriate level of regulatory burden or oversight. Regulatory controls are usually broad, but some may be specific to a product area.

For example, one fundamental general control is labeling. 21 CFR Part 801 provides details involving labeling, which, broadly speaking, requires providing information about the device to ensure its safe and effective use. Another example is establishment registration. As described in 21 CFR 807, businesses are required to register with FDA on an annual basis. Even with these regulatory controls, the system is not perfect, and users of medical devices often fail to follow the manufacturer’s instructions for use which can lead to danger to patients and the user.

While it is impossible to mitigate every risk associated with medical device utilization, it should remain our goal to prevent patient and healthcare team harm. Infection preventionists and other healthcare leaders such as clinical value analysis professionals must become well versed in medical device regulation and evaluation criteria to ensure the safe use of these devices in our healthcare systems. While medical devices provide truly lifesaving diagnostic and therapeutic functions, they carry inherent risks. Through risk mitigation, careful oversight, and proper usage, medical devices can provide an invaluable service to patients.

To learn more about FDA-regulated medical devices, visit www.fda.gov/devices.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a Fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com.

 

Breaking Down Barriers in Healthcare Communication: Applying the TeamSTEPPS Methodology for Quality Improvement

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the June 2022 issue of Healthcare Hygiene magazine.

Multiple data points suggest that breakdowns in communication are major source for healthcare errors that may cause patient harm. TeamSTEPPS, Team Strategies and Tools to Enhance Performance and Patient Safety, is a collaborative education initiative between the Agency for Healthcare Research and Quality (AHRQ) and the Department of Defense. The TeamSTEPPS program focuses on strengthening the specific knowledge, skills, and attitudes of teamwork and can be tailored to meet the needs of any team in any setting both inpatient and outpatient.

The program is based on more than 40 years of research and evidence from high-risk fields and provides specific tools and strategies for:
• Improving communication in teamwork
• Reducing the chance of error
• Enhancing patient safety
• Outcomes of a high-performing team are adaptability, accuracy, productivity, efficiency, and safety

TeamSTEPPS can be used with any member of the healthcare team and is not limited strictly to clinical practitioners. For healthcare communication to be as effective as possible, it must be complete, clear, brief, and timely. The communication is complete when it includes and communicates all relevant information regarding the situation. It is clear when the information is plainly understood and not riddled with complex medical jargon. Healthcare communications need to be brief, concise and focused on the topic at hand. Finally, for these communications to be actionable, they must be timely so that there is still an opportunity to positively influence any potential clinical outcome.

TeamSTEPPS can create several benefits for any healthcare facility and include:
• Significant improvement in communication and supportive behavior
• Significant increase in perceptions of teamwork after training
• Reductions in turnover rate
• Increases in employee satisfaction

Healthcare leaders play a pivotal role in forming highly performing teams and should consider 1) who their team members are and their skillsets, 2) when they need to interact and with whom, 3) how do they currently exchange critical patient information, and 4) what, if anything, would you want to change about your current team structure and performance? Proper leadership and autonomy can create highly resilient teams throughout the entire continuum of care. The TeamSTEPPS model is built on three core tenets: 1) Performance, 2) Attitudes, and 3) Knowledge. Most would argue that attitudes are the most critical component as knowledge can typically be taught and performance can be managed by proper leadership. At the core of the TeamSTEPPS model is a focus on the patient themselves. Engaged frontline leadership is necessary to implement this type of change management program and sustain the positive momentum created.

Since most errors in healthcare involve human beings and breakdowns in healthcare communication, the transfer of care between settings such as hospitals and skilled nursing facilities or even within hospital departments can be risky. When transferring patient care or conducting even something such as an outbreak investigation, a proper handoff can be very helpful in ensuring continuity of care. A proper handoff includes the following components:
• Responsibility: The person is aware of assuming responsibility
• Accountability: You are accountable until both parties are aware of the transfer
• Uncertainty: Clear up all ambiguity before the transfer is complete
• Communicate verbally
• Acknowledged: Ensure that the handoff is understood and accepted
• Opportunity: Evaluate the situation for both safety and quality

By using a standardized tool such as a handoff, healthcare providers can more effectively transfer the care of any patient. Another TeamSTEPPS tool that is extremely helpful is Situation Monitoring. Situation Monitoring is the process of actively scanning behaviors and actions to assess elements of the situation or environment. It also enables team members to identify potential issues or minor deviations. The benefits of Situation Monitoring include fostering mutual respect and team accountability, providing a safety net for team and patient, and finally Includes cross-monitoring.

A shared mental model is an organized knowledge structure of relevant facts and relationships about a task or situation that are commonly held by team members. Team effectiveness will improve if team members have a shared understanding of the situation. In healthcare, if the wrong plan is developed, potentially all actions that follow are wrong, and the patient and caregiver are at risk. The use of the TeamSTEPPS model combined with a shared mental model and engaged healthcare leaders can dramatically reduce patient harm, medical errors, and improve clinical outcomes.

J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

The Journey to Zero CLABSI and CAUTI Infections: Is It Possible?

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the May 2022 issue of Healthcare Hygiene magazine.

Millions of indwelling central venous and urinary catheters are inserted in both acute care and non-acute care healthcare settings annually across the globe. While in many instances, these devices play serve as a critical medical treatment delivery tool, there are unfortunately scenarios where these catheters are not medically necessary and can result in patient harm and associated mortality and morbidity. A new resource guide was released in April by the Agency for Healthcare Research and Quality (AHRQ) directly targeting core interventions to reduce the incidence of catheter-associated urinary tract infection (CAUTI) and central line-associated bloodstream infections (CLABSI). CAUTIs account for 75 percent of all healthcare-associated urinary tract infections.[1] CLABSIs significantly increase the risk of death.[2]

There are some important questions that must be asked by the healthcare team to ensure that all possible preventable risks are mitigated:

Understanding the Science of Safety

Identifying Defects
Engage the Senior Executive
Learn from Defects
Implement Teamwork and Communication
The new recommendations from AHRQ are broken into two tiers, both of which are equally important. Tier 1 is focused on standardizing products, procedures, and bedside processes and Tier 2 which is focused on enhanced practices. Together, these interventions provide healthcare providers and facilities with the most sustained approach to infection control to reduce CAUTIs and CLABSIs.

Tier 1 Interventions Tier 2 Interventions

Tier 1 interventions are technically focused, evidence-based actions that should occur with every patient, every time. Tier 2 interventions are team-based strategies that extend beyond the bedside and can enhance the Tier 1 interventions.
The interventions in Tier 1 will aid in driving the consistent application of evidence-based practices.
Tier 1 interventions are technically focused, evidence-based actions that should occur with every patient, every time.

Part of reducing preventable CLABSI and CAUTI infections is frequent, unit-based rounding. Some of the best practices for catheter rounds include:

Identify key practices to observe or check during planned rounds and specific goal(s) of rounds. This will vary over time as barriers or needs are identified and may vary by ICU.
Identify nurse experts to round and a nurse champion to lead the rounds.
Observe insertions, if the opportunity to observe an insertion occurs.
Develop or adapt a rounding checklist to record findings.
Provide direct, constructive feedback to staff during rounds to educate, compliment, seek information, etc. per goals of rounds, and as opportunities arise.
Aggregate findings from rounds and provide feedback to the ICU and individuals as appropriate.

Source: AHRQ Safety Program for Intensive Care Units: Preventing CLABSI and CAUTI

Regardless of the infection type, there are some important commonalities in reducing the incidence of CLABSI and CAUTI. These strategies can not only reduce the risk for infections but can also improve overall patient safety and reduce the length of stay:

Improve Communication patterns and unit culture relative to urinary catheter use
Increase Nurse comfort with urinary catheter removal protocols
Improve Staff knowledge and skills
Create Respect among nurses and providers
Dedicate personnel to review, remind, and reinforce best practices and analyze infection rates
Use the AHRQ Safety Program Playbook for Intensive Care Units: Preventing CLABSI and CAUTI
Utilize Information technology support for data collection
Provide Feedback using data on catheter use to frontline staff
Celebrate the ICU team’s recognition of the hazard of urinary and central venous catheters
Frontline staff plays a pivotal role in the success of any infection control intervention, but building staff competency in the proper placement, maintenance, and removal of indwelling urinary and central venous catheters. To build competency, the established competencies should be role-specific to the individual clinician type performing the care such as a registered nurse or nursing assistant. Healthcare Facilities should identify what an employee’s role will be related to urinary catheters (insertion, maintenance, transport of patients with urinary catheters, etc.). Then, there should be education and competency are offered to those with the responsibility of insertion. Finally, infection preventionists and unit managers can educate employees on hospital policies, procedures, and expectations for performance.

Sharing data about CAUTI and CLASBI back to frontline staff in real-time can optimize the appropriate use and care of indwelling catheters. This feedback encourages the use of alternatives to catheters, which can greatly reduce the risk of infection and mitigate the risk of future CAUTIs. Strategies to feed data back to staff include but are not limited to multidisciplinary catheter rounds with real-time feedback, and an in-depth review of CAUTIs to identify contributing factors to the infection.

With a sustained, interprofessional approach to infection control, achieving and maintaining zero CAUTI and CLABSI infections is possible. Healthcare leaders must champion these infection control efforts at the highest levels of the organization to remove obstacles and empower frontline staff. At every step on the infection journey, there are opportunities for improvement and together healthcare professionals can solve this ongoing patient safety threat.

Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

References:

[1] Catheter-associated Urinary Tract Infection (CAUTI). Centers for Disease Control and Prevention.

[2] Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. Epub 2014 Oct 21. doi: 10.1007/s15010-014-0689-y. PMID: 25331552.

 

The Road to Safer Flexible Endoscopies: Elimination of Medical-Device Associated Risks

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the April 2022 issue of Healthcare Hygiene magazine.

Millions of endoscopies are performed annually across the world to both diagnose and treat a wide variety of medical conditions in many different anatomical sites within the human body. Surgical site infection (SSI) risk factors can mostly be controlled, but they are the top cause of nosocomial infections in the perioperative setting. These infections are preventable, and the reprocessing of reusable flexible endoscopes has been repeatedly implicated in both outbreaks and unfortunately patient deaths due to reprocessing failures. Sadly, based on published reports of device-related outbreaks and also FDA MAUDE reports, thousands of patients have contracted infections from these devices and some patients have died because of flexible endoscope contamination.

There are some important questions that must be asked by the healthcare team to ensure that all possible preventable risks are mitigated:
• What does the patient bring to the table at the time of the procedure in the form of
microorganism colonization or active infection? What about existing comorbidities?
• What risks can we as the Healthcare Team mitigate or engineer out of the reprocessing process?
• What risks are there to perioperative and reprocessing personnel? Have these risks increased
due to the ongoing COVID-19 pandemic?
• Does our facility currently assess the cleanliness of our flexible endoscope fleet?

Recently, the Food and Drug Administration (FDA) has published three different safety alerts for flexible endoscopes used in gastroenterology, pulmonology, and urology healthcare settings. These safety alerts must serve as an important alarm for healthcare facilities that are reprocessing these devices and the inherent risk associated with reprocessing. These recent FDA analyses have identified several core trends that, as a profession, must be addressed to maintain patient safety. First, Post-market design changes that do not account for how they impact the ability to properly clean and disinfect the device. There is a general lack of communication between manufacturers and/or between manufacturers and device users when medical devices/equipment used for reprocessing are modified and instructions are revised. Third party servicing and accessories that are not typically validated by the Original Equipment Manufacturer (OEM) of the flexible endoscope or inspected by the FDA. Finally, there may be a lack of standardized Clinical Value Analysis processes for complex medical devices in
some healthcare settings.

During the analysis of the FDA’s Medical Device Adverse Event reports for flexible endoscopes, the FDA and Centers for Disease Control and Prevention (CDC) have compiled a list of problematic design aspects of most reusable flexible endoscopes. These potential hazards include:
• Long, narrow interior channels (lumens), including those with internal surfaces that are not
smooth, have ridges or sharp angles, or are too small to permit a brush to pass-through
• Hinges
• Sleeves surrounding rods, blades, activators, inserters, etc.
• Adjacent device surfaces between which debris can be forced or caught during use
• O-rings
• Valves that regulate the flow of fluid through a device (stopcocks)
• Devices with these or other design features that cannot be disassembled for reprocessing
to successfully and reliably mitigate risks associated with the reprocessing process for flexible
endoscopes, healthcare leaders should prioritize the three P’s: People, Process, and Product. This comprehensive approach provides the best possible outcomes when it is rigorously followed. This three-tiered approach can assist healthcare leaders with identifying risks associated with reprocessing and in decreasing potential patient and healthcare team safety issues.

1) People:
• Do I have the right team members performing the role for which they are most qualified?
• How do I ensure the competency of my perioperative personnel?
• Are my personnel able to meet the demands of our clinical practice with instrument/device
reprocessing?
• Do I have a highly functional team culture within my OR and facility?

2) Process:
• How is my reprocessing process validated and how often?
• How often does the device vendor validate our reprocessing capability?
• What other devices does our facility use that may contribute to reprocessing failures?
• How would I know if I have a reprocessing failure and how many patients would be impacted?

3) Product:
• Do I want to continue to take the known risks associated with reprocessing and the risks for
SSIs?
• How old is my fleet of reusable devices and how often are they inspected, serviced, and
assessed by the actual OEM device manufacturer?
• What other third-party devices might be used through the surgical device that could result in
damage to the device and create a pathway for potential device contamination?

Patients who are readmitted following endoscopies are typically experiencing chief complaints of pain, bleeding, or infection. These are widely preventable complications that increase length of stay and the cost of care delivery. In addition, the patient’s overall experience will be negatively impacted when they contract a device-related infection. There are now FDA-cleared sterile, disposable flexible endoscopes that are readily available in the U.S. market and can assist healthcare professionals and systems with eliminating device-related infections by removing the reprocessing process from the equation completely.

See the April 2022 issue of HHM for a table that compares the use of traditional reusable flexible endoscopes and
sterile, disposable flexible endoscopes. These differences are important to note when evaluating a
facility’s infection prevention and control program as well as overall reprocessing processes.

The FDA has strongly advised healthcare facilities to begin using sterile, disposable flexible endoscopes where available to reduce the risk for device-related infections to patients. As more flexible endoscopes become 510(k)-cleared through the FDA, the use of sterile, single-use devices should become the absolute standard of care to eliminate device-related infections. By eliminating the risky part of the flexible endoscopy procedure, reprocessing the device, the overall infection risk for the patient can be virtually eliminated. Patients expect safe, reliable, and evidence-based care. They don’t expect to contract an infection from a device that is being used to provide clinical care to them. Healthcare systems must carefully evaluate medical-device related risks and take all available steps to mitigate and preferably eliminate these risks in the interests of protecting both patients and the healthcare team alike. To learn more about the FDA’s work in advancing the safety of medical devices, visit: https://www.fda.gov/medical-devices/medical-device-safety.

J. Hudson Garrett Jr. is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine; is a fellow with the Institute for Healthcare Improvement; and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

The Hopeful End of a Pandemic, the Beginning of the Endemic

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the March 2022 issue of Healthcare Hygiene magazine.

The recent trends for the COVID-19 pandemic continue to show overall decreases in cases; the transition to a more endemic virus has commenced in many locations worldwide. The Centers for Disease Control and Prevention (CDC) continues to update its healthcare guidance regarding testing, appropriate levels of personal protective equipment, and vaccination. As this guidance evolves, there are impacts on the healthcare team at multiple levels. A recent analysis by multiple independent staffing agencies and the American Hospital Association demonstrates an impending crisis in maintaining safe levels of healthcare provider staffing to deliver the safest level of care. This challenge is being felt in the acute-care environment and equally so in other healthcare environments, most notably skilled nursing facilities. Staffing crisis, combined with increasing regulatory and accreditations standards related to COVID-19 and infection prevention and control, have caused further unintended consequences for healthcare personnel and systems.

As the acuity of patient care across U.S. healthcare facilities has not decreased, the need for specialized healthcare professionals is more significant now than ever. Many technical healthcare professionals are stepping away from direct patient care or even leaving the healthcare sector altogether. The loss of this experience within the workforce has exponential impacts across all healthcare, especially in specialized settings such as skilled nursing facilities and intensive care settings. In addition, during the pandemic, the availability of training and development opportunities for healthcare professionals has decreased, resulting in varying competency levels for healthcare personnel.

Several mechanisms can be utilized to improve the current healthcare staffing crisis, which includes:
• Basic ventilator management training for all bedside personnel that might need to care for a ventilated patient during crisis levels of care. Expert respiratory therapists can facilitate this training to bolster the essential skillset across the continuum of care. Healthcare professionals in step-down units, outpatient settings, and skilled nursing can benefit from this type of just-in-time training. The Society for Critical Care Medicine has made ventilator training programs available for healthcare professionals at no charge during the pandemic. To view these free training tools and resources, visit: https://covid19.sccm.org.
• Use of retirees for critical public health functions: Thousands of retired healthcare professionals with a wealth of knowledge may serve in paid or volunteer roles. During the height of pandemics or large-scale outbreaks, these retired healthcare professionals can be tremendous assets to mass vaccination or testing clinics and reduce the workload burden on already taxed acute care environments.
• Just-in-time training delivery and competency assessment program for critical skills and utilize furloughed HCPs to supplement other workstreams: When elective procedures were canceled, many healthcare professionals were furloughed rather than being redeployed to other areas with need. One rationale for not redeploying this personnel was due to lack of specialized training such as Intensive Care or Ventilator care standards of care. This can be alleviated as mentioned above by frequent cross-training opportunities.
• Agency personnel resources and staffing supplementation: While additional healthcare professionals are vital to staffing healthcare facilities, improperly trained healthcare professionals can be problematic. Staffing agencies should cross-train staff to ensure that they are ready for emergency deployment to different patient-care environments.

The CDC has provided detailed guidance on best practices to address healthcare staffing focused on three levels: conventional (normal staffing operations), contingency (staffing challenges are mild to moderate), and finally crisis (staffing is severely compromised). This tiered approach to guidance can provide healthcare facilities with some much-needed flexibility during staffing challenges and potentially put patients and other healthcare clinicians at risk for unnecessary exposure to COVID-19 and other infectious diseases.

While the COVID-19 pandemic has taught the healthcare industry many lessons, one of the most significant impacts of the pandemic is only beginning to be felt by healthcare facilities-the staffing crisis! Without tremendous investments in reinvigorating our healthcare teams, the ability to staff America’s hospitals and healthcare facilities will be in grave peril. The American Hospital Association and other clinical associations have published resources to assist healthcare leaders and administrators with meeting staffing requirements. Still, these efforts alone cannot be sustainable without actual changes in how healthcare personnel staffing is currently addressed across the continuum of care. Without highly competent and engaged frontline healthcare clinicians, the patients could be at risk for healthcare-associated infections, medical errors, and other potential adverse events. The time for action is now, and every healthcare executive must fully engage in resolving the next pandemic of healthcare staffing. Maintaining appropriate staffing in healthcare facilities is essential to providing a safe work environment for healthcare providers and safe patient care.

J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC, as well as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He may be reached at: Hudson.garrett@chaassociates.com

 

A Needed Change in Communications From the CDC

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the February 2022 issue of Healthcare Hygiene magazine.

The COVID-19 pandemic continues to rage on, and its impacts are widespread and far-reaching across all industries, not just healthcare. During the pandemic, the Centers for Disease Control and Prevention (CDC) has offered often conflicting guidance that has led to confusion within the healthcare community. While evidence-based practice demands an evolution of clinical guidance, the delivery of the message must be carefully scripted to be pragmatic and follow a logical path.

Unfortunately, this is not the type of messaging that has been regularly disseminated from the CDC. During this unprecedented pandemic, both healthcare providers and the public are desperate for an understanding of what best practice should consist of from important topics such as the appropriate use of personal protective equipment to how healthcare professionals can safely deliver clinical care during a pandemic. In addition, healthcare facilities are struggling to maintain adequate staffing levels and also the ability to continuously delivery safe patient care.

According to the healthcare communications experts at the CDC, there are some basic principles that healthcare facility leadership should follow to best optimize communications during an emergency such as a facility fire or a more global event such as an infectious disease pandemic. Below are important caveats that healthcare leaders and infection preventionists should adhere to during any communications activities.

Basic Tenants of Crisis Communications:
• Don’t over reassure. The objective is not to placate, but to engender, calm concern.
• Acknowledge uncertainty. Offer what you know versus what you don’t know. Show your distress and acknowledge your audience’s distress regarding the uncertainty of the situation. “It must be awful to hear we can’t answer that question right now . . .”
• Express that a process is in place to learn more. “We have a system (plan, process) to help us respond (find answers, etc.).”
• Give anticipatory guidance. If you are aware of future negative outcomes, let people know what to expect. Example: side effects of antibiotics. If it’s going to be bad, tell them.
• Be regretful, not defensive. Say “we are sorry . . .” Or “we feel terrible that . . .” when acknowledging misdeeds or failures from the agency. Don’t use “regret,” which sounds like you’re preparing for a lawsuit.
• Acknowledge people’s fears. Don’t tell people they shouldn’t be afraid. They are and they have a right to their fears. Don’t tell them they are idiots for their misplaced fear; acknowledge that it’s normal, human to be frightened. They aren’t experts.
• Acknowledge the shared misery. Some people will be less frightened than they are miserable, feeling hopeless and defeated. Acknowledge the misery of a catastrophic event and then help move them toward hope for the future through the actions of your agency and actions they too can take.
• Express wishes. “I wish we knew more.” “I wish our answers were more definitive.”
• Stop trying to allay panic. Panic is less common than imagined. Panic doesn’t come from bad news, but from mixed messages. If the public is faced with conflicting recommendations and expert advice, they are left with no credible source to turn to for help. That level of abandonment opens the door to charlatans and mass poor judgment. Candor protects your credibility and reduces the possibility of panic because your messages will ring true.
• At some point, be willing to address the “what if” questions. These are the questions every person is thinking about and wants to hear answers from experts. It’s often impractical to fuel “what ifs” when the crisis is contained and not likely to affect wide numbers of people; it is reasonable to answer “what ifs” if the “what if” could happen and people need to be emotionally prepared for it. However, if you do not answer the “what if” questions, someone with much less at risk regarding the outcome of the response will answer them for you. If you are not prepared to address “what ifs,” you lose credibility and the opportunity to frame the “what if” questions with reason and valid recommendations.

When dealing with a crisis such as a pandemic, always try to be first and quickly share both the information that you do know, but equally important is to share the information that you don’t know. Next, it is critical to be “right” and establish credibility with your target audience whether that be internal healthcare personnel or external patients and the local community. Healthcare spokespersons should take all necessary steps to remain credible and communicate clear messaging that can be practically implemented. During all communications, a visible display of respect must be noticeable for all parties both healthcare personnel and patients. When delivering recommendations, we must ensure that they are able to be understood by the target audience and that they provide actionable guidance on what steps to take to remain safe.

Ironically, the CDC offers a world-class training curriculum to help healthcare facilities navigate the challenging nuisances of communication during crises such as a pandemic. This CDC-sponsored training is called Crisis and Emergency Risk Communication (CERC) training and can be accessed online via the CDC website: https://emergency.cdc.gov/cerc/training/index.asp. The cause of most medical adverse events is breakdowns and communication, and now more than ever we need our federal public health officials to lead, deliver evidence-based science, and provide clear guidance to keep our healthcare colleagues and patients safe during this extremely challenging time.

J. Hudson Garrett Jr. is president and CEO of Community Health Associates, LLC. He also has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. He is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

 

Is it Time to Ditch Reusable Bronchoscopes Due to Reprocessing Failures? The Future of Medical Device Safety is in the Balance

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the January 2022 issue of Healthcare Hygiene magazine.

Reusable endoscopes are widely utilized by healthcare professionals and facilities in both inpatient and outpatient settings globally. These devices are lifesaving and provide for both diagnostic and therapeutic benefits to the patient’s medical care, but there is one major underlying safety issue related to these reusable endoscopes -- potential contamination of the device itself.

Recent Food and Drug Administration (FDA) studies and analysis of device-related adverse events have identified hundreds of incidents of potential reusable endoscope contamination and subsequent patient harm. These reusable devices have complex cleaning and reprocessing instructions that are difficult to adhere to in a fast-moving reprocessing department. In some instances, reusable endoscopes are not even capable of being properly reprocessed due to a combination of factors including:
• Device design
• Reprocessing failures (human)
• Reprocessing failures (equipment)
• Device maintenance issues
• Device damage issues

While there’s no question that discussions in healthcare around infection control have gained new urgency over the past 18 months as the novel coronavirus upended life across the globe, this important conversation has been happening in flexible endoscopy for some time now at both a regulatory and clinical level. The Food and Drug Administration (FDA) has recently analyzed Medical Device Reports (MDRs) for duodenoscopes, ureteroscopes, and most recently bronchoscopes, and discovered some staggering statistics related to infection risk.

Twice this year, the FDA has issued guidance on reprocessing flexible endoscopes. In June 2021, it updated a safety communication reminding clinicians and healthcare facilities about cleaning and appropriately caring for bronchoscopes. The announcement followed an April 1 letter to healthcare providers focusing on preventing device-related infections associated with reprocessed urological endoscopes; a sharp reminder to healthcare providers that the discussion about infection control is far from over.

Just as there are answers to slowing the spread of SARS-CoV-2 — vaccinations and non-pharmaceutical interventions such as masks and social distancing — there is an evidence-based solution for cross-contamination from medical devices that eliminates potential human factors-related issues. That answer is sterile, single-use, disposable endoscopes. In fact, in its June letter the FDA advised healthcare providers to “consider using a single-use bronchoscope in situations where there is increased risk of spreading infection.”

The use of a sterile device eliminates the need for reprocessing and the associated errors identified in this process. There is no need to reprocess these devices nor to follow lengthy and confusing decontamination steps. There is no searching for an available scope to complete the procedure. They are ready when needed and are also cost-effective.

The cystoscope, for example, is the urologist’s “stethoscope” — it is the primary tool to diagnosis bladder cancer. More than 83,000 Americans are expected to be diagnosed with bladder cancer in 2021 and an estimated 600,000 U.S. patients have at least an annual cystoscopy for bladder cancer surveillance. Some of the common reasons to perform a cystoscopy include hematuria, overactive bladder, and dysuria. Many of these procedures are performed in outpatient settings where reprocessing personnel have minimal if any formal training on how to care for these endoscopes.

The FDA revealed in April that it was investigating “numerous” medical device reports (MDRs) describing patient infections and other possible contamination issues possibly associated with reprocessed urological endoscopes, including cystoscopes and ureteroscopes. Three patients developed Pseudomonas aeruginosa infections after procedures (outside of the U.S.) and later died. One involved a cystoscope, which the report said did not pass a leak test, a preventive maintenance measure required to ensure the device isn’t damaged. The two other deaths were associated with a forceps/irrigation plug, an accessory component used to control water flow and enable access to the endoscope’s working channel.

The FDA is investigating potential causes and contributing factors associated with the reported infections and contamination issues. Some reports have indicated issues with inadequate reprocessing or maintenance. Other potential issues the FDA is evaluating include device design and reprocessing instructions on labeling. The FDA believes the risk of infection is low based on available data. Two manufacturers were cited in reports; the agency, however, “has not concluded that such risks are limited to a particular manufacturers’ devices nor that any specific manufacturer or brand of these devices is associated with higher risks than others.”

In its June safety communication, the FDA updated years of investigation into MDRs related to bronchoscope-associated infection. The agency collected 867 MDRs between July 2015 and January 2021, an almost eightfold increase compared with the 109 bronchoscope-related MDRs from January 2010 to June 2015. According to public FDA reports, there were seven patient deaths reported in that time, but it’s not known if the deaths were causally related to contaminated bronchoscopes.
While the risk of device-related infection is considered rare, the FDA previously determined in its 2015 safety communication that bronchoscopes “pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed.” Flexible endoscopes are notoriously hard to clean — either through high-level disinfection or sterilization — given their long channels and delicate nature. This has been vividly illustrated in the ongoing study of duodenoscopes and the FDA’s recommendations to transition to disposable components and “innovative designs.”

Industry guidelines for reprocessing endoscopes can include more than 100 steps, and the process can take more than two hours to complete. Hospitals have spent millions of dollars building infrastructure to clean and house endoscopes, and yet device contamination and reprocessing failure continues to remain a daily threat to patient safety.

Bronchoscopies and urological procedures requiring the use of an invasive scope occur in various settings with a variety of oversights, potentially increasing the risk of cross-contamination. And whether reprocessing is ultimately effective depends, in part, on the individual following the steps and deciphering the instructions.

A sterile, single-use endoscope relieves the hospital personnel charged with those tasks of the responsibility for infection control. In addition, disposable endoscopes can reduce costs as well as downtime for repairs, and they prevent hospital staff from being exposed to chemicals and other infectious diseases risks such as SARS-CoV-2 during reprocessing.

The FDA said it received more than 450 MDRs between Jan. 1, 2017, and Feb. 20, 2021 describing post-procedure patient infections or other potential contamination issues involving reprocessed endoscopes. These risks are nothing new to the medical community. They exist and will continue to exist as long as endoscopes are manually cleaned by reprocessing personnel and used again on patients with the known variability that exists in reprocessing between different reprocessing personnel. Self-regulating to perfection is an unfair ask of healthcare facilities and providers. Guidelines and instructions for use are constantly changing, and staffing challenges posed by the COVID-19 pandemic only compound the problem. The time to evaluate the use of single-use endoscopes is now. By using these sterile devices, the risk of device-related contamination is eliminated, patient safety is improved, and the costs of care is decreased and optimized.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He is a Fellow in the National Academies of Practice, Society for Healthcare Epidemiology of America, and Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com