Healthcare Hazards From Devices and Systems Drive New Patient-Safety Concerns

By Kelly M. Pyrek

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

COVID-19 supply chain shortages and other PPE- and device-related risks are part of independent non-profit organization ECRI’s annual Top 10 Health Technology Hazards for 2022.

ECRI’s report, now in its 15th year, identifies health technology concerns that warrant attention by healthcare leaders. ECRI’s team of biomedical engineers, clinicians, and healthcare management experts follows a rigorous review process to select topics for the annual list, drawing insight from incident investigations, reporting databases, and independent medical device testing.

Robert Schluth, project officer, device evaluation team at ECRI, acknowledges that technology is helping drive the increasing complexity of the healthcare sector. “Information technology (IT), particularly, is playing a significant role, but it's also the way that healthcare technology has evolved, because more systems are interconnected and relying on IT-based systems can complicate processes. A problem that originates in one system may pop up downstream somewhere through a connected system, so it gets trickier to tease out those obstacles. In general, medical devices are better than they were 30 years ago in terms of the quality of the manufacturing and functionality, but on the other hand, some of the complexities create new challenges for healthcare technology managers.”
Schluth points out that even in a systems-driven environment, the individual – whether it’s a clinician or biomedical engineer – has a critical role in monitoring for healthcare hazards that can jeopardize patient safety.

“One point that we highlight with some of the ancillary materials that we distributed with the Top 10 Health Technology Hazards report this year is the importance of reporting problems,” he says. “Frontline healthcare personnel, anyone in the healthcare environment, or even patients could be key to identifying that something could be wrong and following up on the issue. Sometimes it might seem like an innocuous thing, but when you track down what was really going on, it could be a sign of a larger problem. The reason we must be alert to hazards is to try to prevent any harm in the first place. So, effective and timely problem-reporting is a great way to do that. Healthcare professionals must know what's going on, investigate problems and fix things before they affect patients and other personnel.”

ECRI’s Top 10 Health Technology Hazards for 2022 are as follows:
1. Cybersecurity Attacks Can Disrupt Healthcare Delivery, Impacting Patient Safety
2. Supply Chain Shortfalls Pose Risks to Patient Care
3. Damaged Infusion Pumps Can Cause Medication Errors
4. Inadequate Emergency Stockpiles Could Disrupt Patient Care During a Public Health Emergency
5. Telehealth Workflow and Human Factors Shortcomings Can Cause Poor Outcomes
6. Failure to Adhere to Syringe Pump Best Practices Can Lead to Dangerous Medication Delivery Errors
7. AI-Based Reconstruction Can Distort Images, Threatening Diagnostic Outcomes
8. Poor Duodenoscope Reprocessing Ergonomics and Workflows Put Healthcare Workers and Patients at Risk
9. Disposable Gowns with Insufficient Barrier Protection Put Wearers at Risk
10. Wi-Fi Dropouts and Dead Zones Can Lead to Patient Care Delays, Injuries, and Deaths
An executive brief version Top 10 Health Technology Hazards report is available for complimentary download at

The pandemic has exhausted healthcare personnel, so the challenge is ensuring that their sense have not been dulled by their energy stores being depleted by competing priorities.

“Even before the pandemic, one of the challenges of problem-reporting is the effort that it requires and healthcare workers are very busy people,” Schluth confirms. “In our report ECRI offers some ideas for how to help them, such as when possible, simplifying a process so it doesn't take so much time for someone to notify others of an issue. Healthcare workers have so much going on, and I think they're doing an amazing job, but anytime they can look out for potential hazards and have someone follow up on them, that's helpful.”

The issues on ECRI’s list underscore the importance of communication and collaboration among healthcare professionals from all departments.

“Identifying and managing hazards requires the engagement of a full team of stakeholders,” Schluth says. “Frontline healthcare workers are the ones using the medical devices most often, so they know how they should function properly to perform their jobs effectively, and they must communicate with the clinical and biomedical engineers who maintain the equipment, as well as talk to the healthcare institution’s purchasing department personnel who are procuring medical equipment and supplies, and the IT department personnel who are managing the network and making sure that all the pieces interact together. There are many places along this chain where something goes wrong or where someone could catch something and make it go right again. So, the more you get people working together, the better chance you have of having a solid system for patient care.”

The Hazards
We highlight several of ECRI’s hazards that have the greatest implication for infection prevention.

The No. 2 issue, Supply Chain Shortfalls Pose Risks to Patient Care, is of critical importance to the healthcare sector which suffered through the what ECRI calls the “perfect storm” caused by the COVID-19 pandemic and perpetuated by politics, labor shortages and other factors. ECRI says it is a “crisis of international scale, with multiple product lines suddenly being in high demand, supported by insufficient supply chains designed around lean inventory models.”
ECRI explains in its top 10 health technology hazards that the vulnerability of supply chains, a problem that existed well before the pandemic, stemmed from several factors:
• Downward cost pressures have driven healthcare device manufacturers and distributors to source product from offshore manufacturers and have prompted healthcare organizations to maintain lean inventories that depend on justin-time deliveries.
• Ongoing vendor standardization among healthcare providers has resulted in contracts with fewer manufacturers and distributors. This, combined with the fact that many manufacturers and distributors have been providing only a limited quantity of supplies, has affected product availability.

“Not only was the pandemic a perfect storm that challenged healthcare supply chains, but the world is grappling with the aftermath of a health crisis on an international scale which led to multiple product lines suddenly being in high demand everywhere across the globe,” acknowledges Schluth. “That stressed the system like it hasn't been stressed ever, probably. Even with the COVID-19 pandemic, there were existing vulnerabilities within the healthcare supply chain and the crisis just brought this situation to the breaking point.”

Schluth continues, “Some of those vulnerabilities included the supply chain being built around lean-inventory models and dependent on just-in-time (JIT) deliveries. There are very good reasons for JIT inventory, but there are downsides, and the pandemic brought some of those to light.

Also, there's a trend among healthcare facilities standardizing on one or two vendors for a particular product, which can be a good cost-saving measure and that has benefits, but the drawback, of course, is that you might not have a broad base of alternate suppliers. So, when supplies get tight, and product manufacturing is occurring in China, there will be significant disruption in the pipeline, aggravated further by pandemic-related shutdowns. Somewhat related to that is the lack of visibility around the sources of the raw materials and the components that go into healthcare products that can impact manufacturing and make it grind to a halt if key materials are dependent upon one region or one source and that source goes offline. We are still working through these issues and there’s an important opportunity for learning here. The good news is that people have come up with new ways to do things, or they re-examine old ways of doing things to identify areas for improvement, and hopefully everyone is building upon that and recognizing the value of having flexibility within your supply chain so that we are in better shape before the next crisis hits.”

The No. 9 issue, Disposable Gowns with Insufficient Barrier Protection Put Wearers at Risk, taps into the challenge for facilities and systems that ran out of PPE during the pandemic was accepting the risks associated with PPE from non-traditional suppliers, as it was presumed that some PPE was better than no PPE, even though the quality and barrier protection levels might not have been optimal.

As the ECRI hazards report explains, “Product selection errors and gown manufacturing flaws can lead to the use of medical protective gowns that do not adequately protect the wearer from body fluids and other potentially harmful substances. Gown wearers can be put at risk of cross-contamination if the wrong type of gown is purchased and worn for the intended application, or if the gown does not provide the level of protection that is claimed. Selecting the appropriate gown (isolation, surgical, or cover) for any given application, however, is not as simple as looking at its labeling. The nomenclature used by suppliers to designate the gown type or protection level is not consistent. Terms may be used interchangeably, or in a manner that does not align with standards that define barrier protection levels. Additionally, ECRI’s testing of disposable gowns has raised concerns about manufacturing quality, particularly in gowns from non-traditional suppliers (i.e., new, or non-U.S. manufacturers). Roughly half of the tested gowns failed to meet required protection levels.”

“The gown topic that is on our list this year grew out of testing that we had conducted of gowns from non-traditional suppliers,” Schluth says. “Throughout the pandemic, when supplies were tight, facilities couldn't procure the gowns they were used to getting, so they needed to try to find them from other sources. Some of those gowns ended up being fine, but some of them were not great quality, and that's maybe not surprising if a manufacturer is new to producing this kind of product; their quality may not be as good as that from a company which has been manufacturing this product forever. So, hospitals were concerned, and they asked ECRI to conduct some testing and we did find that there were some problems. We continued our examination of the issue, testing gowns from traditional suppliers just to see if this was a universal issue or was it just a problem with these new suppliers who perhaps weren't manufacturing up to standards. That testing is ongoing. We're still seeing some issues, but it's too early to tell; I think it's fair to say for any product -- and certainly for any disposable product – that there could be manufacturing-quality issues with gowns.”

Schluth adds that even gowns from traditional suppliers can create confusion for healthcare personnel.

“Our infection prevention specialists and our engineers who were conducting the testing relayed this to me that even with traditional gowns from institutions’ normal suppliers, it’s not always easy for the end user (the clinician) to know which gown they should wear for a particular situation. There are isolation gowns, surgical gowns, cover gowns, and, depending on what you might be exposed to, that's going to determine what sort of protection is needed. A clinician might think, ‘That should be simple. I'm going into the COVID ward, so I put on an isolation gown. I go find it on the shelf and look at the label, and maybe it says isolation gown, so I'm good, right?’ What our research has shown is that is not the case. You can't depend on product labeling or marketing to know what sort of protection it's going to provide. The nomenclature that might be used by manufacturers is not always tied to a standard definition of what an isolation gown and the level of protection it should provide, which is 360-degree coverage. There are products in the marketplace that claim to be isolation gowns, but they don't meet the standards, or they don’t provide sufficient coverage, or they don’t tell you the level of barrier protection. So, if hospitals bought those gowns thinking they were getting isolation-level protection, they are mistaken, and the wearers may not be protected the way they think they are. Other products we found were not rated and had no barrier protection claims; in that case if you were procuring them to have cover gowns for low-risk situation, maybe you're fine. But if you thought you were buying an isolation gown, you need to know it's not rated and therefore you can't be certain of the level of protection. We want to raise awareness that your facility’s infection preventionist should take a close look at the gowns that are in your inventory to ensure they are appropriate for use.”

As the ECRI report notes, “Disposable gowns can’t be judged based solely on their appearance, labeling, or packaging, making it hard for purchasers or wearers to know the level of protection that a gown will provide. Healthcare facilities need to vet prospective suppliers and their products, and they need to educate wearers about which of the gowns in inventory are appropriate for various uses.”

Schluth encourages facilities to evaluate their suppliers.

“We encourage people to do their homework and find out as much information as they can about the materials and the manufacturing quality. During a situation like a pandemic, it can be quite challenging to do so, but facilities must do what they can to determine whether manufacturers have made those gowns before or if they are new to the gown-manufacturing process. Have they at least made other FDA-approved medical products or are they totally new to the medical field? Are there samples you can test? Are there other hospitals that have purchased products from this manufacturer that you can ask about their experience? Those are key points when considering non-traditional suppliers.”

The No. 8 issue, Poor Duodenoscope Reprocessing Ergonomics and Workflows Put Healthcare Workers and Patients at Risk, is a variation of an issue that has appeared many times on ECRI’s hazards lists in the past.

As the 2022 ECRI report observes, “The failure to adequately reprocess contaminated duodenoscopes between uses is a well-known hazard, one that has led to the spread of deadly pathogens. Perhaps less well known are the risks of injury to the healthcare workers who perform this function, and the ways in which ergonomic and workflow factors can compromise reprocessing effectiveness, putting patients at risk.”

Schluth points to a 2021 ECRI survey of healthcare workers who routinely perform duodenoscope reprocessing—the cleaning and high-level disinfection (or sterilization)—identified several significant patient and worker safety hazards:
• Obstacles to effective reprocessing, potentially increasing patient infection risks. Survey respondents cited time pressures and poor work environment ergonomics (e.g., work surfaces at an uncomfortable height) as key concerns.
• The continued use of duodenoscopes with fixed distal endcaps, instead of scopes with single-use components. Duodenoscopes with fixed distal endcaps are more difficult to reprocess effectively, putting patients at increased risk of infection.
• A higher risk of healthcare worker musculoskeletal injuries due to poor workspace ergonomics

“Duodenoscopes are difficult to clean and to disinfect because of the narrow channels and the numerous moving parts,” Schluth emphasizes. “If reprocessing is not performed correctly, there is a risk of spreading pathogens to patients. We surveyed more than 300 healthcare workers who perform pre-cleaning and manual cleaning of duodenoscopes to help us identify which factors come into play. We know complexity of the devices is important, but there are other factors in determining whether a scope gets effectively reprocessed or not. One of the most significant concerns was time pressure. Sterile processing professionals said they felt rushed to complete the job quickly and maybe too quickly, so that made the task even more difficult to complete effectively, and that poses increased risk for scope-related infections in patients. They also cited poor ergonomics in their work environment, so things like the counters at the sinks being at uncomfortable heights. So, poor ergonomics were cited as a factor that makes reprocessing challenging for healthcare workers, in addition to the lack of resources and time pressure. The more challenging the task is, the less likely is they're going to do it effectively, which again increases the risk for patient infections. Poor ergonomics also increased the risk to the workers of musculoskeletal injuries from performing these repetitive tasks.”

Schluth continues, “About three-quarters of the healthcare personnel who responded to our survey reported that they experienced fatigue or discomfort in at least one body part because of their work in decontaminating and cleaning these scopes. So, what we've focused on in the report regarding these ergonomic and workflow issues is encouraging facilities to take the time to examine your processes closely and identify and address problems that might exist. Investigate and implement solutions specifically related to workflow that could be injuring healthcare personnel from an ergonomics perspective and affecting their job performance. Solutions include things like using adjustable carts and sinks.”

As the ECRI report states, “Correcting these problems requires facilities to take a close look at the workflow, the workspaces and surfaces, and the expected turnaround times for duodenoscope reprocessing, as well as re-evaluating the use of reusable duodenoscopes.”

“Regarding the potential transition to single-use scopes or scopes that include single-use components, the Food and Drug Administration does recommend that it's worth looking into doing that as a way to perhaps minimize some of these device-related infections. Scope-related infections is an issue that we’ve addressed in our reports consistently, and this year, we had some new data to speak to. It remains a topic of concern for the future.”