Medical Device-Related Challenges are Among the Top Health Technology Hazards

By Kelly M. Pyrek

Usability challenges with medical devices in the home as well as insufficient cleaning instructions for medical devices in the healthcare setting have topped the list of nonprofit patient safety organization ECRI’s annual detailing of the most pressing health technology safety hazards for 2024.

The report’s data are compiled from the independent medical device evaluations conducted by ECRI, which follows a rigorous review process to select topics, drawing insight from incident investigations, reporting databases, and independent medical device testing.

Evidence shows that more people are receiving medical care at home as the U.S. population ages and the number of adults living with chronic conditions increases. As a result, medical devices such as infusion pumps and ventilators are now being used in the home, sometimes by caregivers and patients who have not been sufficiently trained.

Most medical devices are designed for use by healthcare professionals in a controlled clinical environment and thus may be too complex for laypeople to use safely and effectively, ECRI researchers say.

Marcus Schabacker, MD, PhD, president and CEO of ECRI

“Severe harm can result from the misuse or malfunction of medical devices in the home,” says Marcus Schabacker, MD, PhD, president and CEO of ECRI. “Patients and caregivers who misinterpret device readings may feel a false sense of security. Errors may go undetected or unreported, making it difficult to identify problematic trends.”

ECRI researchers have encountered numerous examples of patient harm from home-use devices. Medication errors can occur when changing infusion pumps. Skin injuries can occur when the electrodes from a cardiac monitor are applied incorrectly. Fatalities can occur if a home ventilator alarm fails to activate or goes unheard, or if the venous needle becomes dislodged during use of a hemodialysis machine.

“When a medical device is designed, it’s critical that human factors and the end user be considered,” Schabacker adds. “As more patients receive medical care outside hospitals and nursing homes, the reality of modern care settings should influence the design of devices and other supplies we need to keep patients healthy.”

ECRI says that these problems can be avoided or risks that can be minimized through the careful management of technologies. Let’s review some of these top health tech hazards for 2024.

Usability challenges with medical devices in the home

This is ECRI’s No. 1 issue on this year’s hazards list.

In 2010, the Food and Drug Administration (FDA) launched the Medical Device Home Use Initiative to support the safe use of medical devices in the home. As part of that initiative, the FDA issued the document, “Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use,” to encourage manufacturers to take into consideration a range of factors when designing, testing, and labeling home use devices to optimize their safe use in the home and other non-clinical settings. Included in this guidance are steps that manufacturers can take to design and test devices for use in the home, and to develop user-friendly instructions (labeling) for home care recipients, consumers, and caregivers. The guidance is intended to improve the design and quality of home use devices to reduce errors that may occur during use. It provides recommendations that consider the device user, the use environment, the device itself, and its labeling.

There are myriad key considerations related to medical devices used in homecare delivery, including:

• Patients should understand how the device works by reading the patient education information
• Homecare providers should also understand how the device functions
• There should be an understanding of what is needed to operate your device (such as electricity, running water, telephone, or computer connections, etc.)
• The home should be suited for the device in terms of electrical wiring, any special space accommodations, etc.
• There should be an understanding of any alarms and/or error messages
• There should be informational access to the medical device supplier/manufacturer
• Report to any problems with the device to the consulting physician of the medical service supplier
• Operate the device according to the manufacturer's instructions
• Understand how the medical device should be cleaned, batteries or filters replaced, etc. as regular maintenance
• Maintain appropriate supplies that may be associated with the medical device
• Report any serious injuries, deaths, or close calls to the FDA and the supplier

As the ECRI report (2024) explains, “The trend toward providing healthcare in the home has led to the increased use of medical devices in that setting. This includes devices that were originally intended for use in a clinical environment, such as infusion pumps and ventilators. The use of medical devices in the home can support more comfortable and convenient patient care, but it is not without risk: Devices often are not designed with home users in mind, and patients and lay caregivers may lack the expertise needed to operate them properly. Plus, the home setting can introduce environmental limitations (e.g., space restrictions, unreliable power supply) that impact device operation. Severe harm can result if patients or their caregivers do not fully understand how to use a device and troubleshoot problems that arise. Over the past decade, ECRI has encountered numerous examples of patient harm in this setting—from medication errors that resulted from a switch to an unfamiliar infusion pump to tragic fatalities that occurred when a ventilator alarm failed to activate, or when a venous needle became dislodged during hemodialysis.”

ECRI emphasizes that minimizing the risk of harm requires selecting devices that are well matched to the patient and the environment of use, and providing the support that home users need to operate the device successfully. ECRI also challenges manufacturers of devices that may be used in the home to consider the needs of users in this setting, adding that “Device operation should be intuitive, instructions should be written for a lay audience, and user support should be available.”

Gaps in recalls for at-home medical devices that cause patient confusion and harm topped ECRI’s health tech hazards list for 2023.

Insufficient cleaning instructions for medical devices

Some failure in processing or breach in infection control or other sterile processing hazard has frequently been included in ECRI’s annual lists; last year, the growing number of defective single-use medical devices that put patients at risk was No. 2 on the list.

As the ECRI report (2024) explains, “Failure to properly clean and disinfect or sterilize reusable medical devices between uses can lead to the spread of infection, device damage, and other forms of harm. Successful reprocessing is made more challenging, however, by the wide variation in the content, quality, and feasibility of reprocessing instructions provided by product vendors. ECRI is aware of numerous reusable medical devices and healthcare items that have incomplete, impractical, or onerous reprocessing instructions. As a result, healthcare workers who perform reprocessing may find it difficult or impossible to complete this task effectively—or they may suffer harm in the process (e.g., pain or fatigue from repeatedly performing onerous reprocessing procedures).”

ECRI experts acknowledge the staying power that sterile processing-related issues have on the annual hazard lists.

Amanda Sivek, PhD, a-IPC, principal project engineer II at ECRI

“The issue of inadequate or onerous manufacturers’ instructions for use (IFUs) in reprocessing, which is primarily for cleaning, disinfection or sterilization, has been persistent,” says Amanda Sivek, PhD, a-IPC, principal project engineer II at ECRI. “We frequently hear from our members about medical devices or healthcare equipment damage that occurred after reprocessing. When we examine the IFUs for processing those items, we often find that they are incomplete or in some cases they don't even exist. Or we find that they are impractical to complete like a device that requires sterilization in between patient cases. Or they're onerous to complete, like instructions that have more than 50 steps that sterile proceeding techs must perform, such as for some flexible endoscopes. Ultimately, the solution to this problem lies with the vendors of medical devices and healthcare items, and we are requesting that they provide validated, practical reprocessing instructions for their reusable products. And just to be clear, validated reprocessing instructions have been shown to be effective and ensure that the healthcare products can be safely reused over their intended use life.”

In the last decade, there have been numerous calls from clinicians, medical associations and other stakeholders – including the Food and Drug Administration (FDA) through its warning-letter system -- for manufacturers to address complex IFUs, but progress has been very slow.

James Davis, MSN, RN, CIC, HEM, CCRN-K, FAPIC, manager of infection prevention and control services at ECRI

“There are some devices that when manufacturers change the labeling, they're performing a complicated process to update the IFUs, so we have to be sensitive to the vendors,” says James Davis, MSN, RN, CIC, HEM, CCRN-K, FAPIC, manager of infection prevention and control services at ECRI. “That said, however, there are many situations with IFUs that create potential confusion. For example, an IFU may say to change a filter monthly, but given what we learned about COVID and aerosolization of the virus, and debate around droplet and aerosol precautions now, there is the question of whether filter changes are user serviceable, meaning are clinicians on the floor like nurses or a sterile processing tech or a biomed engineer able to conduct routine maintenance on the equipment. Is it about viewing this issue through the human-factors perspective, so maybe it's now changing the filter between every patient because if you do it monthly, it's going to get missed. Things like that come to mind when you talk about the complexity of IFUs and how they can contradict evolving scientific thought.”

Davis continues, “So, when the manufacturer conducted its scientific testing and it says, ‘Well, this lasts a month or two weeks,’ but then we say, ‘Well, why did you choose a month?’ and they say, ‘That's the life cycle.’ If we change it too often, we're spending more money, but now the answer is, ‘We should probably go back and say, ‘Change this between patients from an infection perspective.’ In my opinion, IFUs are not always focused just on infection prevention; there are many factors that go into it. What we try to do right now is work with manufacturers to say, ‘Hey, there are human factors involved here, not just the life cycle of disposable parts.”

ECRI emphasizes that manufacturers of reusable medical devices and healthcare items must provide practical, validated reprocessing instructions for their products. These instructions should adhere to relevant FDA guidance and should involve the use of common healthcare-grade cleaning and disinfection agents.

Sivek adds that the regulation of medical devices often comes into play. “The FDA requires a 510(k)-pre-market review process for FDA Class 2 products. The vast majority of 510(k) products are not required by the FDA to have the validation of the reprocessing instructions with the submission of their 510(k) paperwork. Another thing to consider is that a lot of products used in a healthcare facility are not undergoing FDA 510(k) review; many of them are exempt as being Class 1 products. There are so many other kinds of products and it's almost the Wild West regarding pre-market review. We want to bring that awareness to healthcare facilities, and we want to push manufacturers of these products to improve their IFUs. We want sterile processing technicians to be able to complete the reprocessing effectively as well as safely for them, the workers, so they don't develop musculoskeletal disorders over time, for example. And we want their process to be effective so that the patient isn't being contaminated with various pathogens on the device that wasn't reprocessed properly.”

The complexity of today’s medical devices and instrumentation is a significant factor in suboptimal processing, many experts point out.

“When you think about the different types of instrumentation and equipment that is reprocessed, it's a few different types to a few thousand instruments in the inventory that you see every day in the sterile processing department (SPD),” Davis confirms. “There are different levels of complexity with these instruments, from a pair of scissors to the complex instruments that might have three or four parts that must be disassembled, so the educational training is ongoing and we work with our members during consultations, trying to identify ways to put in job aids and there's third-party warehouses of IFUs. It’s electronic format versus the old-school binders of pages, so we worked with them to put the resources which techs and the nurses and others need at the decontamination step because certain things need to be disabled in Decon and there could be multiple pieces.”

Davis continues, “It's a tough, high-pressure, high-production, high-demand area, and it's mission critical to healthcare delivery.  And a lot of it comes down to comfort, and how processing is impacted by human factors engineering and ergonomics, and a lack of this can be linked to employee injuries. Hospitals are asking their technicians to do difficult work in a hot, moist environment in Decon where there’s steam, blood, tissue, and other bodily substances. So, the educational piece is not only all instruments that must be reprocessed properly, it's also about keeping the technicians doing the work safe. Some facilities are more resourced than others and have an SPD educator.  We've been in scenarios where they don't have an SPD educator, but they have an operating room (OR) educator who knows the OR but doesn't know SPD. We've had managers and directors of ORs and materials management who run SPDs who aren’t necessarily the best ones to provide education and training in the SPD. There’s a wall, culturally, between the OR and the SPD, and the OR might receive training from vendors, but the SPD needs a different approach. So, there's some cultural issues, design issues and then resource issues around education and training, keeping it current, keeping it structured, and keeping it relevant.”

Exacerbating the issue further, in addition to pre-existing stressors on the healthcare sector, was the pandemic.

“I have colleagues, masters-prepared, advanced-practice nurses, friends of mine who during and even post-pandemic have walked away from healthcare because of the lack of personal protective equipment, the high stress, the lack of recognition,” Davis says. “There has been a huge talent drain post-pandemic and the same thing has happened in the SPD.”

He continues, “In my mind and in my experience, there's a significant inequity with the pay scale in this kind of a mission-critical job. That's not the hospital’s fault per say, because we all know that in healthcare in America, people are striving to meet a zero-profit margin; if they get to 1, that's good, right? But how can we find new ways to get pay scales up to reflect appreciation of the work that SPD techs do and to level the playing field? An OR tech has the same importance as an SPD tech, or even more sometimes, so how can we work with the pay scales? How can improve conditions in the SPD? One of the biggest pet peeves I have is, a hospital will remodel its ORs, a profit center, going from 11 ORs to 25 ORs. But the SPD remains the same but now it must double its capacity of output with the same number of employees.”

Throughout this year’s healthcare tech hazards report, ECRI emphasizes shared accountability between stakeholders as one means to address and mitigate these hazards.

“The shared accountability part of it comes into play especially during regulation- or accreditation-related inspections and surveys,” Davis says. “It does fall eventually on the SPD manager/director and the staff because they're standing there with the surveyor in the SPD and the surveyor asks to be shown around, and they feel unprepared. So, management is a huge concern, because SPD personnel and even the infection preventionist are being held accountable for the almost-unmanageable task of keeping everything current within the workflow of the techs, whether they use actual manuals and binders, or third-party electronic systems so they can pull things up on the computer screen and know they're working off the most current information. A lot of times the IFU will change, and a letter goes out, but it goes to purchasing or nursing or the C-suite, but it doesn’t reach the SPD. So there needs to be an internal process for those letters and someone who is responsible for handling that. It’s like the wrong people are being held accountable because that's the only way they receive the information, and it breaks down and the SPD gets blamed.”

Building and maintaining relationships is also an important part of addressing sterile processing-related challenges and hazards.

“It's critical that representatives from infection prevention and control, sterile processing, environmental services, risk management and biomedical engineering are on the facility committee that oversees purchasing of reusable healthcare items and medical devices,” Sivek confirms. “That could be the medical device committee, healthcare value analysis, product evaluation, whatever committee is responsible for purchasing those products. So, the first thing for them to do is, if needed, request representation on that committee. Once they have representation, that committee is going to conduct a risk assessment for products being considered for purchase, as well as some products in their current inventory that have known reprocessing issues. As part of that risk assessment, the committee is going to consider if the vendor provided validated reprocessing instructions for the product, and the committee will assess if the processing instructions are practical for the healthcare workers to perform, considering their workflow and work environment. We want medical device and healthcare item reprocessing instructions that are effective in removing contamination from the product which supports patient safety and is practical to complete to support healthcare worker safety.”

ECRI advises that the best time for healthcare organizations to address this issue is before purchasing any reusable medical devices or healthcare items: “Reprocessing considerations should be evaluated during the pre-purchase risk assessment of a product. Questions to consider include: Will the vendor provide validated reprocessing instructions for the product? Validated reprocessing instructions have been shown to be effective and ensure the safe reuse of a product over its life. And are the reprocessing steps practical to complete in your environment? If the answer to either question is ‘no,’ ECRI recommends considering alternative vendors and products.”

One of the most important stakeholders in this process is the healthcare facility’s leadership.

“We want the C-suite to be aware that somewhere in the healthcare facility, whether it’s a hospital, ambulatory surgery center, long-term care facility or specialty medical office, there is very likely an issue with the reprocessing instructions of medical devices and healthcare items,” Sivek continues. “We want the C-Suite to be aware of this issue so that they can support the work of the purchasing committee and only procuring products that have validated, practical reprocessing instructions if possible. The C-Suite should also be aware of the consequences of ineffective reusable healthcare item reprocessing, which include potential citations from accreditation organizations, potential reimbursement issues from the Centers for Medicare & Medicaid Services (CMS), because CMS expects that reprocessing instructions for medical devices and healthcare items will be followed. There's also the potential for lawsuits due to ineffective processing, something that the C-suite should be aware of. The bottom line is they must support their staff in only procuring products that have validated, practical reprocessing instructions.”

Davis concurs, adding that, “Frequently, members of the C-suite are responsible for reviewing contracts with vendors and suppliers -- or at least somebody near the suite is looking at contracts -- and they should be looking to build some of these safeguards into their contracts to hold the manufacturers accountable as well.”

Davis says he sees some bright spots on the horizon, in that dialogue is happening between stakeholders.  For example, last year, the Association for Professionals in Infection Control and Epidemiology (APIC) developed a survey to help the organization quantify infection prevention-related challenges with medical device instructions for use (IFUs). APIC says the survey responses will help inform U.S. regulatory agencies of these challenges.

“We work with vendors all the time, we have conversations with them about things we find, and we compare vendors as we're talking to them,” Davis says. “I was just on a call with two separate ECRI members this week about the same issue with equipment and there's varying responses from the vendors; some are warming up to this idea, they're getting a lot of attention and there have been certain associations with some surveys around this with infection preventionists and they're starting to listen. We're starting to understand the human factors pieces, especially around things like filter changes so I do think the needle is moving. Is it moving as quick as clinicians would like? Probably not, but at least they're hearing us and, you know, a lot of that comes from if I can purchase something that has a validated IFU versus not, I'm aware of this now, and I'm not going to go with that product. So, there are multiple reasons for manufacturers to respond, including the fact that our top healthcare tech hazards list lets clinicians know what to look for and ask about when they interact with vendors. Manufacturers that are not responding to clinical end users will not be getting their market share anymore. There's pressure on them, they’re listening, and I think right now they're responding so that they don’t get hit in the pocketbook.”

“I do think this is a solvable problem,” Sivek adds. “If healthcare facilities have a device-related issue, we have a free problem-reporting network. There are engineers that investigate each problem that's submitted to us, completely free. Do you have issues? Report them to us. We're here to help you.”

Drug compounding without technology safeguards

Another significant hazard on this year’s ECRI list is drug compounding, which is required when a commercially available formulation does not come in a ready-to-administer form or does not otherwise meet patients’ needs, such as dosing requirements. It involves combining, reconstituting, repackaging, or otherwise modifying a drug product to create a new preparation.

The Institute for Safe Medication Practices (ISMP) reports that in the past two decades, there have been well over 200 adverse events involving 70-plus compounded products. One of the most serious recent events was in 2011, when more than 200 patients contracted fungal meningitis after receiving methylPREDNISolone acetate injection prepared by a compounding pharmacy that was contaminated with Exserohilum (a brown-black mold) and Aspergillus species. The compounding pharmacy in this case was not registered with the FDA and was being investigated for crossing the line into full-scale manufacturing by taking bulk orders for methylPREDNISolone without proof of individual prescriptions and shipping large batches of drugs nationwide, a practice the FDA had previously warned the company about regarding other drugs.

As the ECRI report (2024) notes, “Errors made during the compounding of injectable medications can have severe—sometimes deadly—consequences if they are not detected before the drug is administered to the patient. Unfortunately, such errors are exceedingly difficult for nurses or others who administer the preparations to detect. Consequently, errors that are not caught before the preparation leaves the pharmacy have a high likelihood of reaching the patient.”

While accurate compounding is important for all preparations, the ECRI report (2024) emphasizes that “Injectable preparations are of particular concern because of their need to be sterile, the frequency with which compounding is required, the opportunities for error, and the potential for significant harm. Errors can include using incorrect or expired ingredients (e.g., medications, diluents), using an incorrect dose or concentration, using an incorrect volume, or mislabeling the medication.”

Both ECRI and the ISMP recommend that pharmacy departments implement technological safeguards—like workflow management systems—to minimize opportunities for human error in the sterile compounding process. These systems offer a range of capabilities (such as bar coding or gravimetric analysis) both to help prevent errors during the manual steps in the process and to help catch errors before they reach the patient.

The ISMP’s Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology were developed to help healthcare facilities identify best practices to support safe use of technology and automation in sterile compounding and to recommend best practices associated with sterile compounding when technology cannot be used.

Environmental harm from patient care

In 2022, ECRI included supply chain shortfalls as posing risks to patient care as its No. 2 hazard on the list. While so many essential articles of personal protective equipment (PPE) as well as cleaning and disinfectant products were nearly impossible to procure during the COVID-19 pandemic, this year, a different supply chain concern – the medical waste stream -- makes the 2024 list.

The healthcare sector is one of the largest contributors to the national waste stream, but this was greatly exacerbated by the COVID-19 pandemic. As Lee, et al. (2022) report, “The increased volume of plastic waste due to COVID-19-related practices has significant ramifications that pose challenges with respect to ensuring a sustainable environment. Penga, et al. predicted that 193 countries worldwide would generate an additional 8.4 million tons of plastic waste due to COVID-19-related activities, a 10 percent increase from the baseline since the World Health Organization (WHO) declared the disease a global pandemic in March 2020. Of the additional plastic waste generated during the pandemic, approximately 87.4 percent was discharged from healthcare institutions, including PPE (such as masks, sanitary gloves, and face shields), online packaging materials (due to increased online shopping), and virus test kits, accounting for 7.6 percent, 4.7 percent, and 0.3 percent, respectively.”

Lee, et al. (2022) add, “Healthcare institutions generally use disposable products to minimize infection while treating patients. This strategy seems logical to prevent the spread of COVID-19. However, only 15 percent of all medical waste is considered “hazardous waste” which may be infectious or toxic, whereas 85 percent of the hospital-generated waste is general and non-hazardous waste, comprising food containers, packaging, and medical supplies (gloves and masks, among others) used in the screening process for patients without contagious diseases. Different and more cost-effective approaches can be used to reduce medical waste from healthcare institutions, such as appropriately sorting the discharged waste and promoting the use of systems that employ high-temperature/pressure and chemical processes to sterilize medical equipment and materials.”

As the ECRI report (2024) explains, “Medical technologies play a lifesaving role in patient care, but the manufacture, use, and disposal of medical devices, systems, and supplies also have a cost. These activities consume energy, release contaminants, and generate waste, adversely impacting the environment. This in turn creates public health challenges—causing or worsening numerous health problems—and it exacerbates health inequities, since many of the health risks associated with environmental stressors disproportionately impact disadvantaged communities.”

ECRI says that as protectors of public health, healthcare organizations should examine methods to minimize environmental harm potentially caused by the selection, use, and disposal of medical technologies: “Wise decisions in these areas can advance sustainability and improve a healthcare organization’s bottom line. Key for healthcare organizations is to identify areas where improvement is possible without compromising patient care. Sensible strategies, according to ECRI, include reducing the amount of energy consumed by medical imaging equipment; choosing alternatives to anesthetic gases that have high global warming potential; and eliminating purchases of unnecessary single-use items (such as extraneous components in surgical kits) that contribute directly to waste volumes. Consider the three Rs of sustainability: Reduce, reuse, recycle.”

ECRI also challenges medical device manufacturers to design products with sustainability in mind, such as by reducing the use of materials that contribute to environmental harm, by making reusable products easier to clean using minimally damaging processes, and by minimizing waste material (such as packaging) included with each product.

Poor quality control of implantable orthopedic products

Last year’s ECRI list named as the No. 2 hazard an unacceptably high number of defective single-use medical devices that continue to be present in the supply chain. Single-use medical devices—which include products that are used once and then discarded, as well as those that get consumed during use—play a role in virtually every patient encounter, ECRI reminds us, and as a result, defective products can have a broad, negative impact on patient care, causing delays and increasing costs—and most concerningly, contributing to patient harm or death in some circumstances. ECRI says it has received reports of cracked tubing and connectors; compromised sterility of needles, catheters, and procedure kits; and incorrect product labeling. These are just a few examples of product defects that can lead to waste, delays, incorrect treatment, healthcare-acquired infections, or other patient harm. ECRI says it is “concerned that some device manufacturers are not making sufficient efforts to address the problem. In fact, rather than seeing improvements over time, we’ve noticed a continuing increase in problem reports. ECRI urges manufacturers to take decisive steps to improve their quality control (QC) processes. Steps that healthcare organizations can take include encouraging users to report defective products; tracking device usage to identify potential waste due to defects; identifying functionally equivalent products for critical single-use items; and holding manufacturers and distributors accountable for defective products, using the organization’s leverage to push for improvements.”

In 2024, ECRI notes that a “broad concern remains,” but this year has focused on one specific product group -- implantable products intended for use during orthopedic procedures. As the ECRI report (2024) explains, “The prevalence of quality control (QC) issues related to these products and the potential for significant harm warrant particular attention. Implantable orthopedic products range from simple items—such as bone screws, rods, and plates—to complex ones, like knee and hip prostheses. Defects in these products can delay or prolong surgery and can lead to other harm, including persistent pain or infection that may not become evident until long after the patient’s surgery.”

ECRI reports it has received or investigated reports of:

• Incorrect labeling or packaging, which can lead to the selection of the wrong product, resulting in incorrect treatment and subsequent pain or injury.
• Device-device incompatibility and missing components, which are most likely to cause delays in patient treatment or to prolong surgical procedures.
• Breaks, cracks, and other defects, which can lead to implant failure, possibly requiring total revision surgery.

Steps that healthcare organizations can take include instructing users to look for and report signs of defects before use, tracking defects that are reported, and holding manufacturers and distributors accountable, using the organization’s leverage to push for improvements. ECRI challenges manufacturers of implantable orthopedic products—and all single-use medical devices—to strive for zero defects in their manufacturing and packaging processes.

 

References:

ECRI. Top 10 Health Technology Hazards for 2024. Accessible at: www.ECRI.org/2024hazards

FDA. Home Use Devices Initiative. Accessible at: https://www.fda.gov/medical-devices/home-use-devices/home-use-devices-initiative

ISMP. Sterile Compounding Tragedy is a Symptom of a Broken System on Many Levels. Oct. 18, 2012. Accessible at: https://www.ismp.org/resources/sterile-compounding-tragedy-symptom-broken-system-many-levels

ISMP. Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology. 2022. Accessible at: Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology | Institute For Safe Medication Practices (ismp.org)

Lee S and Lee DH. Effective Medical Waste Management for Sustainable Green Healthcare. Int J Environmental Research and Public Health. 19(22):14820. November 2022. DOI:10.3390/ijerph192214820

 

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A Total Systems Safety Approach Can Help Navigate Healthcare Emergencies

The Institute for Healthcare Improvement (IHI) acknowledges that the existing stressors within the healthcare sector have been exacerbated by the COVID-19 pandemic but emphasizes that a return to a pre-pandemic state of safety is essential to reliable care: “Our recovery trajectory requires long-term, intensive focus to create, rebuild, and sustain the foundations for safe care.”

One strategy for combating the fall-out from a pandemic or other major impact, the IHI suggests, is for healthcare organizations to examine their culture of safety beyond patient care to a total systems approach. Propelled by clinical risk management and medical error prevention, progressive healthcare providers can embrace an organizational culture that actively supports a total systems approach to safety, the IHI says.

In May 2022, the IHI issued a declaration to advance patient safety on behalf of the National Steering Committee for Patient Safety (NSC). The IHI convened the NSC as a collaboration among 27 national organizations committed to advancing patient safety.

As the declaration document states, “Together, the persistence of longstanding challenges to patient safety and worrisome setbacks in patient and workforce safety performance during the COVID-19 pandemic have amplified the critical need for all healthcare leaders to take urgent action. It is the responsibility of every executive and governance leader in healthcare to commit to the moral, non-negotiable core value of safety for all and to foster collective action to uphold this value. These actions should establish safe, equitable, and reliable care as a central theme in the organization’s mission, the core competencies of leaders, and standard ways of working.”

Total systems safety involves four key areas, according to the IHI:

1. Culture, leadership, and governance. The IHI (2022) says that “Leaders greatly influence organizational culture by defining and demonstrating set values and norms that guide behavior and activity within the organization. Assessing organizational culture is one way to feel its pulse and identify what and if changes are needed… assessing organizational culture is just the beginning. Establishing priorities for action, identifying and implementing resources, and communicating with staff are key to enabling a true culture of workplace safety.”
2. Patient and family engagement. Facilitating equitable engagement of patients and their support persons in the coproduction of care has proven to improve overall care outcomes and perceived value of care to the consumer.
3. Workforce safety. As the IHI (2022) acknowledges post-pandemic, “Never has it been so critical to build a healthy work environment that fosters joy and a genuine concern and accountability for the physical and psychological wellbeing of staff.” Advancements in the development of resources to support workforce health and safety include the National Plan for Health Workforce Wellbeing published by the National Academy of Medicine and the Total Worker Health approach developed by the National Institute for Occupational Safety and Health (NIOSH).
4. Learning systems. Shifting from a reporting system to a system that fosters a continuous learning approach. According to the IHI (2022), “Learning systems are organizational processes that integrate information, such as adverse events, clinical data, staff and patient feedback, and best practice to strengthen internal processes and promote safety.”

Part of a total systems approach is the hazard vulnerability assessment (HVA), which “proactively helps provider organizations identify a range of potential hazards that may lead to emergencies,” according to ECRI’s recent whitepaper, Total Systems Safety Approach to Hazard Vulnerability Assessment (Madrigale and Rose, 2023). The whitepaper acknowledges that “Emergencies disrupt continuity of care and service delivery by shifting normal day-to-day activities from routine to non-routine, and in the worst cases, pose very real danger and threaten the lives of patients, residents, and staff.”

Madrigale and Rose (2023) explain that the quality of an HVA can determine outcomes of an emergency because “it serves as a framework for overall emergency preparedness and response. After identifying potential hazards, organizations should use a participatory and structured approach to assign value to these hazards before they occur, thus prioritizing potential hazards by considering likelihood, frequency, and severity to better inform emergency planning. This process provides information critical to an organization's mission of protecting residents from harm by having tested policies, procedures, and processes that guide decision-making and action for the duration of an emergency.”

Victor Lane Rose, MBA, NHA, CPASRM, FCPP, executive director of Aging and Ambulatory Care for ECRI, and Cailin Madrigale, risk management analyst for ECRI, share their perspectives in the following Q&A:

Victor Lane Rose, MBA, NHA, CPASRM, FCPP, executive director of Aging and Ambulatory Care for ECRI

Cailin Madrigale, risk management analyst for ECRI

Q: Do you have a feel for whether U.S. healthcare systems are currently conducting an HVA as part of their risk assessment and mitigation strategies? If they aren’t and this is new to them, how important is it for them to do so considering the recent pandemic and likely other public health emergencies to come?

A: Conducting an annual HVA is required for organizations that participate in reimbursement programs from the Centers for Medicare and Medicaid Services (CMS), meaning most organizations should be familiar with the concept and process. However, that does not mean that most organizations have optimized their HVAs to get the most out of the effort, such as an all-hazards approach aligned with total systems safety. It is extremely important to undertake this effort. HVAs are key to ensuring an organization’s emergency preparedness and response programs are comprehensive and equipped to effectively manage emergencies as they occur to mitigate potential harm and ensure continuity of care and services. The pandemic showed just how ill-prepared organizations can be when emergencies occur on such a large scale and for long durations when certain contingencies are not in place or certain variables are not considered during the HVA process.

Q: Is an HVA appropriate for helping to manage a smaller-scale emergency as well?

A: Any emergency that disrupts continuity of care, large or small, poses a risk for potential harm. Consider what happens during a search for a missing resident, where staff from all areas of the operation must be deployed to help search a building and grounds, pulling them away from their routine duties. It can create an environment where adverse events are more likely to occur, in addition to the potential harm that might befall the missing resident or patient. An HVA would still outline the organization’s current capability to manage that emergency and reveal improvements that may be necessary to minimize operational/care delivery impact.

Q: Can an HVA get healthcare facilities thinking about new hazards, especially in an age of evolving complexities of care processes and technology, coming together as the perfect storm?

A: Using a total systems safety approach can help identify emerging issues by revealing biases inherent to any process. Past experiences with emergencies, for example, tend to shape where we look for potential hazards, which opens the possibility of either missing certain hazards altogether or missing important elements associated with a potential hazard and resulting emergency. Undoubtedly, many provider organizations identified infectious outbreaks as a potential hazard, but our experiences showed us that few providers were truly prepared for such a pandemic that reached the scope and duration experienced during COVID. Having a multidisciplinary team to collaborate on the HVA process can help overcome such inherent biases as they can identify key evolutions in care processes and technology that may not be familiar to individual departments or medical specialists.

Q: How can an HVA address infection prevention risk and strategies as part of its scope?

A: An infection prevention HVA would outline specific infections that the facility or community is at risk for outbreak, such as routine influenza, healthcare-associated infections (HAIs), or emergent infections like novel coronaviruses. The HVA would then identify infection risk based on probability rate, severity ranges, and mitigation strategies. The scope of HVAs is inherently targeted and comprehensive to best inform improvement, planning, and prioritization efforts.

Q: Is a total systems safety approach compatible with efforts to be high-reliability organizations, and other quality improvement models? How so?

A: Total systems safety is indeed compatible as it ensures that all improvement efforts address core healthcare safety fundamentals. In the context of an HVA, a total systems safety approach provides multiple lenses from which to identify potential threats and shapes an organization’s response to that threat to better prepare and reduce the potential for preventable harm. As mentioned earlier, the COVID-19 pandemic emphasized the care-critical importance of including staff safety and well-being in our emergency preparedness and response activities. Continuity and quality of care is almost impossible without continuity of staffing and scheduling. All hazards that pose a threat to key processes or parts of the care and service continuum should be considered. Additionally, any quality improvement model can incorporate total systems safety by considering how the subject requires improvements from culture and governance, patient and family engagement, worker safety, and learning system perspectives. Doing so helps organizations on their high-reliability journey as well.

Q: Post-pandemic, do you think organizations and healthcare personnel are more receptive to an HVA and its goals? Or might there be some challenges in implementing this due to ongoing staffing deficits, resource shortfalls, etc.? And what are some ways to counteract those?

A: HVAs are fundamentally important to understanding basic risks to healthcare organizations and pave the way for emergency readiness, which is always beneficial. Although ongoing industry struggles indeed present challenges in routine maintenance for emergency programs, such programs should remain a top priority given the devastating impact that emergencies present. Conducting HVAs does not need to be a time or resource-heavy endeavor as all HVAs are scalable to fit the needs of the organization. From a risk management and safety perspective, organizations cannot afford to allow HVAs and emergency preparedness to fall to the wayside.

 

References:

Madrigale C and Rose VL. Total Systems Safety Approach to Hazard Vulnerability Assessment. ECRI. 2023.

National Steering Committee for Patient Safety. Declaration to Advance Patient Safety. Boston: Institute for Healthcare Improvement; May 2022. (Available at www.ihi.org)