Patient Safety & Quality

Human Factors and Medical Device Safety: A Clinical Perspective to Improve Patient Safety and Reduce Cross-Contamination


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

With recent outbreaks associated with reprocessed medical devices, both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have placed tremendous emphasis on improving medical device safety. Medical devices are routinely used in clinical settings for both diagnostic and therapeutic purposes. Medical devices must be reprocessed according to the manufacturer’s instructions for use (IFU).

The FDA regulates high-level disinfection and sterilant products, while the Environmental Protection Agency (EPA) regulates low- and intermediate-level disinfectants. Medical devices are categorized into three classifications: noncritical, semi-critical, and critical items. Noncritical items are those most frequently used in healthcare settings and include blood pressure cuffs, stethoscopes, etc. These items are used on intact patient skin and include environmental surfaces as well. Noncritical items require the use of a low or intermediate level disinfectant for reprocessing. Semi-critical items are those that contact mucous membranes of the patient and include examples such as laryngoscopes and endoscopes. Semi-critical items must undergo a minimum of high-level disinfection. Finally, critical items are those that enter sterile body cavities such as surgical instruments. Critical items require sterilization.

Recent guidance from the FDA requires many medical manufacturers to conduct human factors validation of their IFU and demonstrate the ability for users to safety and consistently reprocess these medical devices to ensure patient safety and reduce the risk for cross transmission. Reprocessing steps must be concise, easy to follow for users, and validated to be reliability achieved with all user populations. For example, if a flexible endoscope is going to be used in a gastroenterology setting, then all users, which would include nurses, technicians, physicians, and reprocessing professionals, would need to be properly trained on their roles in reprocessing. This validation must be performed under strict clinical research controls to ensure the integrity of the process. This rigorous process validates that properly trained clinical users can reliably reprocess reusable medical devices. Incorporating Human Factors-validated clinical training in healthcare facilities is a critical element for ensuring patient safety and reducing the risk for outbreaks associated with medical devices.

Healthcare facilities should focus on a three-step process that addresses people, processes, and products across the entire continuum of care. This unique approach begins with intense focus on personnel and ensuring that the entire healthcare team involved in the process has received standardized and role-specific training for all associated tasks. In addition, training does not equate to competency with healthcare professionals. Healthcare Leaders must take the necessary responsibility to ensure proper competency management of their direct reports so that breaches in medical device reprocessing are mitigated. While many processes can be automated to reduce the risk for error in reprocessing, some processes still require human interaction, and these can introduce variability and result in patient-safety risk. This is evidenced by the multiple outbreaks associated with breaches in medical device reprocessing.

Recent advancements in human factors engineering has demonstrated a high reliability in validated and standardized reprocessing efforts for flexible endoscopes with properly trained reprocessing personnel and appropriate resources to execute the overall reprocessing process. If healthcare medical device reprocessing processes are highly reliable, then errors will be tremendously reduced. Processes should be independent of specific individuals and the outcomes must be replicated to document success.

Finally, healthcare facilities should have rigorous processes in place to evaluate commercial products prior to them being introduced into the healthcare facility. This process must include disposable and reusable devices and items. Training on new products should be conducted at the time of conversion and then annually thereafter to ensure that each product is correctly used and reaches its desired state of efficacy.

While medical devices are used millions of times daily across the U.S. healthcare system, they are not without risk. Healthcare executives must ensure staff competency with all associated reprocessing processes. Regulators must screen new medical device applications carefully to ensure that the product can be appropriately used by the intended users. This is validated by conducted human factors studies with the input of actual simulated clinical users. Finally, medical product manufacturers play a pivotal role in collaboration and own the product development pipeline to address healthcare’s complex needs. Patients deserve the opportunity to receive healthcare in a safe environment that is free of preventable harm. Interprofessional collaboration is a strategic imperative for all stakeholders in healthcare and requires an intense and ongoing focus on patient safety, infection prevention and control, and ensuring healthcare staff competency.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC. He also is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at:

2019-n-CoV: Lessons Learned from the SARS Outbreak

By Kathy Warye

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

In February 2003, Severe Acute Respiratory Syndrome (SARS), a unique respiratory illness erupted in China. SARS was caused by a coronavirus never before seen in humans. An unusual mutation in the virus enabled ease of transmission. Air travel propelled the spread of SARS rapidly throughout Asia and to 29 other countries including Canada and the U.S. In total, 8,096 people developed SARS and 774 of them died. SARS also wreaked more damage to the global economy than the September 11th terrorist attacks in the U.S. Over a six-month period, SARS cost the world economy approximately $40 billion. Then it disappeared. Since the initial outbreak there have been no reported cases anywhere in the world.

On Dec. 31, 2019, the Chinese health authority notified the World Health Organization (WHO) of a “pneumonia” of unknown cause in the Wuhan, Hubei province with an epidemiological link to a cluster of people who had frequented the Huanan Seafood Wholesale Market where there was sale of live animals.

Health authorities in Hong Kong, Macau, and Taiwan stepped up border surveillance and concern that a novel and serious threat to public health had emerged.

By the third week of January, more than 830 cases had been confirmed worldwide and an additional 8,420 people reported to be under observation. The 2019-nCoV appears to be clinically milder than SARS in terms of severity, case fatality rate and transmissibility.1

While the current situation presents a serious threat to public health, much has changed since the SARS outbreak in 2003.

What’s different between 2003 and 2020?

• Most significant has been the response of the Chinese government to the 2019 n-CoV. China initially denied the SARS outbreak, then downplayed the magnitude of the threat delaying response and handicapping the ability of the global health community to implement appropriate measures. It took months for the true implications of SARS to be exposed. In contrast to 17 years ago, with the current outbreak the Chinese health authority promptly notified the WHO of a cluster of infections of concern and took comprehensive public health measures including closure of the markets implicated in the outbreak, intensive surveillance and prohibition on travel from affected geographies.

• The advent of and use of rapid genetic sequencing also represents a significant advantage. Chinese microbiologists were immediately able to rule out SARS-CoV, MERS-CoV, avian influenza and other respiratory viruses. Most importantly they were able to quickly isolate 2019-nCoV from a patient and perform gene sequencing. On Jan. 12, the Chinese health authority transmitted the genetic sequence of the 2019-nCoV to the WHO. Because of this, public health laboratories around the world have been able to produce rapid diagnostic PCR tests to detect 2019-nCoV infection.

• More robust and connected surveillance globally, supported by communications protocols established during the SARS outbreaks has enabled early response by health authorities and infectious disease experts around the world.

• In the U.S., the coordination between the Department of Homeland (DOH) security and the Centers for Disease Control and Prevention (CDC) since notification of the outbreak is also unprecedented. DOH set up surveillance of arrivals at key U.S. airports and took the additional step of rerouting planes originating from Wuhan through these airports. The routing and surveillance is enabling early detection of individuals potentially infected with n-CoV.

While the eventual trajectory and impact of 2019 n-CoV cannot be known at this time, the lessons learned from the SARS outbreak were many and led to significant reforms in China, new surveillance and response measures throughout Asia and a more robust overall global infrastructure to protect the public health from novel infectious disease outbreaks.

Kathy Warye is the founder and CEO of Infection Prevention Partners where she provides strategic guidance on the commercialization of solutions that detect, prevent or manage infection.

Reference: Hui DS, et al. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health — The latest 2019 novel coronavirus outbreak in Wuhan, China. International Journal of Infectious Diseases, Vol. 91, 264-266.

20 Years After the Patient Safety Revolution

By Kathy Warye

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

November of 2019 marked the 20th anniversary of To Err is Human, the groundbreaking report from the prestigious Institute of Medicine on the state of patient safety in U.S. hospitals. Developed by a panel of highly credible leaders from across the spectrum of care, the report found that approximately 44,000 to 98,000 people died each year from preventable healthcare harm. It was nothing short of a clarion call for transparency and improvement.
At the institutional level, the code of silence around preventable error had been broken.

Prior to the report, "the general belief was that medical errors came about because of impaired physicians," said William C. Richardson, PhD, MBA, president-emeritus of Johns Hopkins University. But, in contrast to that belief, To Err Is Human shed light on the systems of care, finding that medical errors occur because of problematic healthcare systems or "non-systems" as the report stated, marked by a combination of factors including decentralization, fragmentation, faulty processes and conditions that caused healthcare workers to make mistakes.

Notable is the fact that the report gave scant attention to healthcare-associated infections (HAIs). Several years after publication of the report, estimates of HAIs alone eclipsed the estimate of total number of medical errors. While progress has been made, HAIs still present a formidable challenge to safety. Due in part to the application of systems thinking, reduction of central line bloodstream infections (CLABSI) represents an improvement bright spot. In 2018, CDC reported a 45 percent reduction in CLABSIs nationwide. According to the Agency for Healthcare Research and Quality (AHRQ) National Scorecard, healthcare-associated conditions (HACs) decreased overall by 21 percent between 2010 and 2015. This represented a total of 3.1 million fewer HACs contracted by hospitalized patients over five years, saving an estimated 125,000 lives and $28 billion. Together, these findings represent substantial progress.

However, the data around SSIs and other forms of harm paints a very different picture. AHRQ reported no reduction in the set of SSIs reported to the National Healthcare Safety Network between 2015 and 2018. And new challenges have emerged such as those related to ambulatory care.

Almost two decades after the research was conducted that formed the basis of the report, a study in the Journal of Patient Safety estimated the true number of premature deaths associated with preventable harm at more than 400,000 per year.1 And serious harm was estimated to be 10- to 20-fold more common than harm resulting in death.

In 2015, a panel of top health leaders gathered at the National Academy of Sciences to review the progress since To Err Is Human was released, and to discuss challenges and opportunities in patient safety. The group issued nine specific recommendations:

1. Establish a federal agency for safety in medical care similar to the Federal Aviation Agency (FAA)
2. Include patients and families in efforts to improve patient safety. CMS now involves patients and families in all its quality measurement and development work
3. Ensure that medical facility CEOs and boards of directors make patient safety and quality care top priorities
4. Develop agreement on how much and what needs to be reported in order to standardize quality-of-care metrics and transparency
5. Extend efforts to improve quality and safety beyond hospitals to ambulatory and long-term care settings
6. Ensure non-punitive, supportive cultures that foster patient safety, including incorporating nurses in the planning and implementation of patient safety efforts
7. Establish more coordination of care to prevent medical errors, including interoperability of electronic medical records
8. Use a systems-engineering approach to health care delivery, which aims to prevent errors through safety-oriented design
9. Take advantage of healthcare workers’ intrinsic motivation to improve patient safety and quality of care.

To the list above, I would add one more recommendation. By shining a spotlight on our healthcare institutions, the media played a critical role in driving new standards of transparency and accountability. For a decade after the release of To Err is Human, there was considerable media attention to the problem of healthcare-associated infections and medical harm in general. In the intervening decade, however, our national attention has turned primarily to the issue of insurance, the uninsured, underinsured, the fate of the Accountable Care Act and finding a sustainable solution to access and cost. Other than occasional, mostly negative headline worthy incidents, preventable harm and HAIs are no longer in the news. While there is perhaps no more important challenge in healthcare today than access to affordable care, as patient safety advocates, we need to keep the issue of preventable harm in the forefront of our national healthcare dialog. With the emergence and growth of resistant organisms, few issues are of greater consequence; and while much progress has been made since 1999, there is still much to be done.

Kathy Warye is the founder and CEO of Infection Prevention Partners where she provides strategic guidance on the commercialization of solutions that detect, prevent or manage infection.

1. James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. J Patient Saf. Vol. 9, No. 3. September 2013.

Combating AMR: The Importance of Transparency in Reporting

By Kathy Warye

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

The recent update to the Center for Disease Control and Prevention (CDC)’s AMR Threat Report, published in early November, has garnered considerable attention. It contains both good news and bad news in the battle against resistant organisms and healthcare-associated infections (HAIs) in general. but the key message is not a good one. Since the last report in 2013 AMR has been rising far more rapidly than previously understood.

While significant progress has been made in reducing rates of MRSA, C. difficile and certain device-related HAIs, rates of the one of the most serious emerging organisms, Carbepenem resistant Enterococci (CRE), was underestimated by 50 percent. In an interview with The Washington Post, Micheal Craig, CDC senior advisor, stated that, “A lot of progress has been made, but the bottom line is that antibiotic resistance is worse than we previously thought.”  This situation is not without precedent.

In 2006, the Association for Professionals in Infection Control and Epidemiology (APIC) conducted the first, national study of MRSA prevalence. The study found significantly higher rates of MRSA in U.S. hospitals than had been previously estimated. With the emergence of a community-associated strain and reports of deaths from MRSA among those with no previous hospitalization, the study generated considerable attention from the media and contributed to pressure on policy-makers to ensure more accurate tracking.

Beginning in 2009, hospitals were required to report MRSA bacteremia to the National Healthcare Safety Network (NHSN), a comprehensive HAI database managed by the CDC, as a condition of participation in Medicare and Medicaid. The federal policy had two important, features: the requirement for acute-care hospitals to routinely submit data on MRSA bacteremia to the NHSN, and transparency. In addition to the tracking provision, rates of MRSA by institution were made available to the public. Prior to enactment of this policy, the real burden of MRSA was largely unknown to national healthcare leadership and little information on MRSA rates and deaths was available to the public.

In most countries with well-developed healthcare systems, reporting of organisms of concern is a key component of broader programs to protect public health. In 2006, with MRSA on the rise, the United Kingdom made reporting of MRSA bloodstream infections to the National Health Service mandatory. Reporting was the initial phase of a more comprehensive strategy to prevent transmission and deaths which resulted in a drop of close to 40 percent in MRSA isolates. Across Europe, The European Centre for Disease Prevention and Control (ECDC) promotes the transparent reporting of outbreaks and organisms of concern. Reporting is viewed as an important catalyst in driving attention to the problem, an effective component of a larger reduction effort and a foundation for regional coordination.

While it could be argued that public reporting is burdensome for hospitals, accurate tracking of resistant organisms is critical if we are to have the data upon which to base containment and other strategies. And if CRE or another resistant organism yet to emerge mutates into a community-associated strain, as with flu outbreaks, the public will have the right to know where it is emerging.

More importantly, it is well accepted in management and quality circles that what gets measured, gets managed. In the context of MRSA, the federal reporting mandate enabled not only more accurate measurement of the burden of MRSA but made the problem of MRSA front and center on the healthcare leadership radar. The public availability of hospital specific data drove leadership accountability and initiated a decade long improvement in infection prevention resourcing and infrastructure in U.S. hospitals.

Currently, only two resistant organisms are subject to reporting, MRSA bacteremia and C. difficile.   CRE was designated by CDC in the 2013 CDC AMR Report as an “urgent” threat and described by the Director at the time as the “nightmare, triple threat bacteria.” Unlike MRSA and C. difficile, there is no federal requirement for reporting of CRE or repository of data on the emerging resistant organisms of greatest concern. This obstructs efforts at comprehensive national surveillance and leads to a less than accurate picture of the magnitude of the problem.

More importantly, without accurate estimates and transparency, healthcare institutions may downplay the threat and de-prioritize the investments in infection prevention and laboratory capacity that will be needed to prevent transmission, morbidity and mortality and future growth in resistance.

It is time for CRE and Candid auris, another rapidly growing resistant organism, to be added to federal reporting requirements because what gets measured, gets managed. Transparency drives accountability. And accountability drives the attention and resources that infection prevention programs at the institutional and regional levels must have if they are to effectively act as the front line in defense against these threats to public health.

Kathy Warye is the founder and CEO of Infection Prevention Partners where she provides strategic guidance on the commercialization of solutions that detect, prevent or manage infection. 


Learning from the Past to Protect the Future

By Kathy Warye

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

It has been approximately 20 years since the publication of To Err is Human, the landmark study that gave birth to the patient safety movement.  And while there has been much progress made in the management of healthcare associated infections, we are facing a growing crisis that will demand that we do even better.

While the threat of antimicrobial resistance is well known, in the practice of infection prevention, and the delivery of healthcare in general, there is often a wide gap between knowledge and action.  There are many reasons for this, from insufficient resources to resistance to change to imperfect evidence.

Whatever the factors, when confronted with the rise in healthcare-associated MRSA in the late 1990s, the U.S. was late to act in comparison to other countries. And when the action did occur, it was not as comprehensive as other developed nations and lacked regional coordination.  When confronted with a rapid rise in MRSA early in the decade, the UK took decisive action at a national level. The UK plan was comprised of a combination of integrated components which addressed the entire system of infection prevention from elevation of IP leaders to positions of greater influence, to mandatory reporting of MRSA to universal screening of patients via newly available rapid diagnostic technology.

In 2001, the rates of MRSA isolated from infections in the U.S. and the UK were almost identical, but over the next 15 years, the two different strategies produced dramatically different results. From 2001 to 2015, the UK achieved a decline in MRSA isolates from 45 percent in 2001 to just over 10 percent in 2015.  Over the same period of time, in the US rates of MRSA isolates increased to approximately 55 percent before returning to just under 45 percent.1  While it must be noted that the U.S. has achieved significant reduction in MRSA-related bloodstream infections and deaths since 2005, MRSA is endemic in our healthcare institutions.

The emergence of Carbapenem-resistant or Carbapenemase-producing entererococci (CRE), a family of organisms that is highly resistant to antibiotics, poses a new and potentially far more dangerous threat. Carbapenemases, which include the KPC enzyme which has been most prevalent in the U.S., are plasmid-mediated. This attribute makes horizontal transfer easier and the spread of resistance and infection faster than with either MRSA or C. difficile.  Estimates of mortality with CRE-related bloodstream infection are as high as 50 percent.  In 2015, the combination of resistance to antibiotics and the potential for community-associated strains of CRE to emerge led then-director of the CDC, Tom Frieden, to refer to CRE as the “nightmare bacteria.”

Today, the CDC estimates that there are approximately 100 patients colonized with CRE for every infected patient. This means that standard infection control practice, which relies on clinical cultures from patients suspected of harboring MDROs to trigger intervention, will miss the vast majority of CRE colonization.  Since addressing the tip of the iceberg alone will not contain the spread of CRE, CDC is recommending that hospitals establish screening programs for high-risk patients to identify what would otherwise be a hidden reservoir of CRE colonization.2  This is a notable departure from CDC’s approach to MRSA, wherein little, if any, guidance was provided on optimization of detection methods to prevent transmission.  New technologies are also entering the market which will make detection of MDROs, such as CRE, on the front line of healthcare and in the first episode of care possible for the first time. Placed in units where risk is highest, these technologies promise will make active surveillance faster, easier and more affordable.

In parts of Europe, South America and Asia where CRE is tracked, rapid increases have been observed.  While rates in the U.S. are still low, we know they are on the rise.  If past is prologue, the consequences for public health could be dire.  While the CDC has raised the alarm and encouraged a coordinated regional approach to prevention, screening protocols for CRE are inconsistent across U.S. hospitals allowing a potentially large percentage of CRE to go undetected and unmanaged. In many hospitals, infection prevention still struggles for resources and leadership support. And in hospitals across the country, new, potentially life-saving technologies face increasingly high bars for adoption. While much has been learned from MRSA, there is still much to do to close the gap between knowledge of CRE’s emergence and the actions that must be taken to limit the consequences of this nightmare bacteria to public health.


  1. Resistance Map, Center for Disease Resistance and Policy, Washington, DC. UK: European Antimicrobial Resistance Network (EARSNet) U.S.: The Surveillance Network (TSN) 1999-2012; National Healthcare Safety Network (NHSN) 2013-14.
  2. CDC CRE Toolkit, 2015.