Mitigating Healthcare Hazards as a Risk Management Strategy

By Kelly M. Pyrek

For yet another consecutive year, infection prevention-related issues made the list of the 2019 Top 10 Health Technology Hazards, issued by ECRI Institute, a patient safety and medical technology research organization. The annual list defines the top health technology hazards that ECRI Institute believes warrant priority attention by healthcare leaders. It serves as a starting point for discussions, helping healthcare organizations plan and prioritize their patient safety efforts. 

Contaminated mattresses, retained surgical sponges, and re-contaminated endoscopes are among the infection control-related risks that must be monitored, mitigated and eliminated where possible. 

James Davis, MSN, RN, CCRN-K, HEM, CIC, FAPIC, senior infection prevention and patient safety analyst/consultant with ECRI Institute, encourages healthcare professionals to take these risks seriously, as bloodborne pathogen exposure was not previously identified as a patient risk from mattress fluid exposure. Additionally, there is a concern about staff exposure, as they may not be wearing gloves to make a bed, for example. Also, there is the issue of cross-contamination of workspaces for preventive maintenance (PM) and exposure risks for the biomed/maintenance staff, Davis points out.

Other imperatives on the list include damage to electrical equipment from cleaning fluids, improperly set alarms on ventilators and physiologic monitors, infusion pump errors, mechanical failures with overhead patient lifts, and battery charging errors.

"Healthcare organizations need to take technology safety seriously," says David Jamison, executive director of ECRI's Health Devices program. "That's why our annual report includes practical solutions that can help prevent patient harm."

"For the second consecutive year, ECRI Institute addressed the topic of mattress and mattress cover contamination on its annual Top 10 list of health technology hazards," confirms Amanda Sivek, PhD, senior project engineer with ECRI Institute. "Obstacles to addressing the issue persist, prompting ECRI to not only retain the topic, but to rank it as the No. 2 hazard on its list for 2019. A new hazard on ECRI Institute’s Top 10 list of health technology hazards is cleaning fluids seeping into electrical components, which can cause equipment damage and fires."

She continues, "The issues of mattress contamination and cleaning fluids seeping into electrical components are under recognized issues due to their insidious nature. Mattress contamination may not be apparent unless a patient experiences a body fluid ooze event. Equipment damage and fires caused by cleaning fluid ingress in electrical components is an iterative problem, meaning that equipment may continue to function until additional fluid contamination occurs."

The Hazards 
Let's examine each issue more closely.

The first infection prevention-related issue on the 2019 ECRI Institute list is contaminated hospital mattresses. 

As the ECRI Institute report explains, "Blood and other body fluids that remain on, or within, mattresses or mattress covers after cleaning can contact subsequent patients, posing an infection risk. Reported incidents include patients lying on an apparently clean bed or stretcher when blood from a previous patient oozed out of the surface onto the patient. Mattress covers are intended to prevent body fluids and other contaminants from getting into mattresses. If a cover is not cleaned and disinfected effectively, or if its integrity is compromised in a way that allows the mattress underneath to become contaminated, subsequent patients could be exposed to infectious materials."

The Food and Drug Administration (FDA) classifies hospital beds as Class I and Class II devices used for patients in acute care, long-term care, or home care settings. Technically, a hospital bed system encompasses the bed frame and its components, including the bed side rails, head and foot board, the mattress, and any accessories added to the bed, such a detachable mattress cover. As the FDA explains, "A hospital bed mattress cover provides outer protection to a mattress by preventing blood and other body fluids from entering the inside (inner core) of the mattress. Such covers may be coated with or contain an antimicrobial solution that kills viruses or bacteria or prevents bacterial growth. There are multiple terms used to describe hospital bed mattress covers: water-resistant, water-proof, or water-repellent. Covers are usually detachable from the mattress or the mattress lining, meaning that they can be removed or replaced."

The FDA shares ECRI's concerns, noting, "Over time, hospital bed mattress covers can wear out and allow blood and body fluids to penetrate and get trapped inside mattresses. If blood or body fluids from one patient penetrate and get absorbed in a mattress, the fluids can leak out the next time the mattress is used. Coming into contact with these fluids poses a risk of infection to patients using the bed."
The FDA issued a safety communication in 2013, alerting healthcare providers, healthcare facility staff, and caregivers to these safety concerns. From 2011 through 2016, the FDA received more than 700 reports of a hospital bed mattress cover failing to prevent blood or body fluids from leaking into the mattress.

As the ECRI Institute report states, "Healthcare facilities must take care to use appropriate products and procedures for cleaning and disinfecting mattress covers, and they should regularly inspect mattresses and covers for signs of damage or contamination. One key challenge, however, is that not all mattress cover suppliers recommend products and procedures that will successfully remove the likely surface contaminants without compromising the cover’s integrity (i.e., creating weak spots that could allow leaks). This situation needs to be remedied."

The FDA's recommendations, based on guidelines for environmental infection control in healthcare facilities issued by the Centers for Disease Control and Prevention (CDC), are as follows:
1. Develop an Inspection Plan
- Create an inspection plan for all hospital bed mattresses and mattress covers in your facility.
- Check the manufacturers’ guidelines for an expected life time on the hospital bed mattress and mattress covers and follow any additional recommendations listed there.
- Contact the mattress cover manufacturer for any additional questions not covered here.
2. Inspect
- Regularly check each hospital bed mattress cover for any visible signs of damage or wear such as cuts, tears, cracks, pinholes, snags, or stains.
- Routinely remove the hospital bed mattress cover and check its inside surface. Once the mattress cover is removed, inspect the mattress for wet spots, staining, or signs of damage or wear. Check all sides and the bottom of the mattress.
- Be aware that it may be difficult to identify damaged or soiled mattresses without removing the mattress covers first. Mattress covers tend to be dark in color, making it hard to see what lies underneath.
3. Remove and Replace
- Remove any damaged, worn, or visibly stained hospital bed mattress according to the health care facility’s procedures and manufacturer’s instructions.
- Immediately replace any hospital bed mattress cover with visible signs of stains, damage or wear to reduce the risk of infection to patients.
4. Maintain
- Clean and disinfect undamaged hospital bed mattress covers according to the manufacturer’s guidelines.

"To reduce the risk of body fluid contamination of your facility’s current mattress inventory, ECRI Institute recommends conducting a house-wide inspection of mattresses to identify and remediate any contaminated units," Sivek says. "Afterward, facilities should focus on effective mattress cover cleaning and disinfection; Environmental Services (EVS)/Housekeeping staff training and room cleaning checklists; and mattress and mattress cover inspection and service lives. For future procurement of mattresses and mattress covers, facilities should favor mattresses and covers that facilitate effective cleaning, inspection and tracking."

The second infection prevention-related issue is retained sponges as a surgical complication. The technical term, gossypiboma is used to denote a mass of cotton material, usually, gauze, sponges and towels, inadvertently left in the body cavity at the end of a surgical operation. These kinds of retained objects can occur after virtually any type of operation; this hazard has been reported after intrathoracic, orthopedic, intraspinal and neurological procedures, but the most common is after intra-abdominal or pelvic surgery. Kaiser Permanente found 55 percent of retained sponges after abdominal surgery and 16 percent after vaginal delivery. 

Five years ago, the Joint Commission issued a safety alert about retained surgical objects; the agency recommends that facilities develop effective processes and procedures for preventing unintended retained foreign objects. Their recommendations include a standardized and highly reliable counting system; development of policies and procedures; practices for counting, wound opening, and closing procedures; performance of intraoperative radiographs; use of effective communication to include briefings and debriefings; documentation of counts; and assistive technologies (i.e., RF tags, RFID, radiopaque, bar coding). Also, the hospital should define a process for conducting RCA for sentinel events, such as URFO.

As the ECRI Institute report explains, "Surgical sponges that are unintentionally left inside the patient after the surgical site is closed can lead to infection and other serious complications, including the need for secondary operations. Manual counts-in which the surgical team verifies that all sponges are accounted for before concluding the procedure-are standard practice, but they are prone to error. If such errors result in a retained sponge, complications can ensue, with consequences for both the patient and the healthcare facility. Accurate data on the incidence of retained surgical sponges is hard to come by; for one thing, incidents may not be identified unless (or until) the patient returns with a complaint of pain or discomfort. Nevertheless, we know the problem persists. Available data suggests that every year thousands of U.S. patients could experience a retained surgical item (RSI), with surgical sponges being the most commonly retained item. Technologies that supplement the manual counting process are available and have been found to be effective when used correctly. ECRI Institute contends that broader adoption of these technologies could further reduce the risk that a surgical sponge will be unintentionally retained during a procedure."

The third infection prevention-related issue is mishandling flexible endoscopes after disinfection, which can lead to patient infections.

As the ECRI Institute report indicates, "Cleaning and disinfecting flexible endoscopes between uses is known to be a challenging process. Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections. Less well known is that improper handling and storage practices can re-contaminate previously disinfected scopes, heightening the risk of patient infections."

"Patient infections caused by endoscopes can be serious and, in some instances, have led to deaths, as illustrated by the 2015 CRE outbreak related to duodenoscopes," emphasizes Chris Lavanchy, engineering director of the Health Devices Group at ECRI Institute.  "The seriousness of the infection can depend on the condition of the patient and whether they are immunocompromised, the part of the body colonized, and the specific infectious organism. In the case of the CRE infections, these were patients that already had serious comorbidities (e.g., cancer) that compromised their immune system and the particular infectious agent was a bacterium resistant to even the most potent antibiotics." 

The ECRI Institute report adds, "If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments. To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process. The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves-a practice that ECRI Institute has observed. Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; thus, gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine. Recontamination can also occur when transporting and storing endoscopes. Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces."

"The risk of endoscope-related infections has been a perennial concern for a number of reasons and is especially challenging to address," Lavanchy acknowledges. "Flexible endoscopes are among the most complex medical instruments in their design and their features like internal channels running the length of the scope can make it especially challenging to disinfect every surface. Although reprocessing often involves the use of automated equipment, there are still many steps in reprocessing which are manually intensive and technique dependent. Experts have also noted that reprocessing procedures offer very small margins of safety, which means even small deviations can result in contaminated scopes. Because the scopes are costly, healthcare facilities often have lean inventories, which means that when demand is high reprocessing staff are under pressure to turn the scopes over quickly. These factors when combined, create a situation that invites compromised reprocessing." 

Lavanchy points to the numerous obstacles that hamper efforts to redesign flexible endoscopes to make them simpler to reprocess, and although this seems like the obvious solution to address the concern, it's easier said than done.

"The reasons issues persist with endoscope reprocessing are multifactorial," he explains. "To begin with, ECRI believes there has generally been a low level of awareness about how critical it is for reprocessing staff to closely follow recommended procedures.  Some staff may even have the attitude that if I miss something its no big deal because the disinfection or sterilization process will take care of it. ECRI Institute has worked hard to change this thinking and to emphasize the importance of adhering to procedure by regularly discussing related reprocessing issues in our annual Top 10 Health Technology Hazards. As with many things related to work performance, drawing attention to the importance of adherence to procedure by itself is rarely successful and requires monitoring and regular refreshing to achieve consistent results." 

Lavanchy continues, "How healthcare facilities handle reprocessing though is only one part of the challenge. Endoscope vendors have invested significant resources to develop flexible scope designs that that meet the needs of physicians performing minimally invasive diagnostic and therapeutic procedures. We've recently seen the introduction of ultra-high definition cameras, 3-D images, and other technologies intended to improve diagnostic performance. Yet, it appears that designing these devices to enable easy and effective reprocessing has always come secondary to clinical functionality. This makes sense given the influence physicians have on endoscope selection. As endoscopes exist today it may not be possible to simply make design revisions to address the reprocessing issues. Changing these instruments to make them easy to reprocess may require starting over and introducing revolutionary changes. In a highly competitive market where there are only a few endoscope manufacturers and the barriers to entry are high, there is not much of a business incentive to invest the considerable time and research to radically change a well-established technology." 

"However, this may be changing," Lavanchy adds. "A few companies are emerging in this market with a different approach and introducing single-use, disposable scopes.  The challenge is designing an instrument that offers the same level of clinical function as a reusable version and at a cost that isn't prohibitive.  We are beginning to see some disposable scopes entering the market, but adoption has been slow in part because of concerns that the single-use products might have more limited utility. Our studies have also shown that they may be cost-effective only for a narrow range of usage levels. We are hopeful though that as more affordable and effective disposable scopes emerge, and as market pressure compels reusable scope manufacturers to develop more practical reusable models, we will soon see less need to include this topic in our annual Top 10 list."

To mitigate these issues, Lavanchy recommends, "For endoscope reprocessing, ECRI Institute monitors where problems are detected through our review of the literature and through our own investigation into incidents where reprocessing was ineffective. From these sources and discussions with outside experts, we identify emerging issues and best practices to mitigate the risk. This year we chose to focus on post-disinfection endoscope handling because there is evidence that this has been an overlooked aspect of reprocessing that may be contributing to contaminated instruments."

As we have seen, one additional issue found by the ECRI is the overzealous cleaning that can lead to damage of electrical equipment. 

As the report states, "Improper cleaning of electrical equipment can result in equipment malfunction, damage, or fire. Medical devices and other electrical equipment used in healthcare facilities must be cleaned and disinfected to prevent cross-contamination between patients and curtail the spread of infectious organisms. However, some cleaning practices can present risks. The use of cleaning or disinfectant wipes that are dripping with excess fluid, or spraying liquids directly onto powered medical devices and equipment, can cause fluid to enter electrical components such as plugs, sockets, or power supplies. Repeated fluid ingress, and the residue it leaves behind, can create errant current pathways around the electrical component. These additional currents can eventually generate sufficient heat to cause a device failure, or worse. ECRI Institute is aware of multiple instances in which cleaning fluid seeping into electrical components has led to equipment damage or fire. Incidents have involved infusion pumps, OR tables, infant warmers, and electrical equipment such as light switches and power supplies."

When cleaning electrical equipment, ECRI Institute recommends that staff should follow manufacturer instructions, they should avoid spraying fluids directly onto the equipment, and they should use appropriate cloths, wipes, and sponges (squeezing out excess liquid before use).
"To reduce the risks of equipment damage and fires from cleaner fluid ingress in electrical medical devices and equipment, ECRI Institute recommends following the equipment manufacturer's cleaning recommendations," Sivek emphasizes. "Excess cleaning fluid should be squeezed out of cloths, wipes, or sponges prior to applying to equipment. Staff who work with fluids around electrical medical devices and equipment should be regularly trained, which includes reviewing the method(s) of notifying clinical/biomedical engineering if fluid ingress occurs during cleaning."

Collaboration is Key
For all of the issues, increased collaboration between healthcare professionals, infection preventionists and risk managers can go a long way toward helping address these hazards.

"To reduce the risk of our 2019 Top 10 Hazard #2, risk managers can verify that the pads/chucks and disposable or launderable mattress covers used in their facility are compatible with their facility’s mattresses and mattress covers," Sivek says. "Infection preventionists can require that mattress cover suppliers specify effective, compatible antimicrobial products to use after a cover is exposed to blood, body fluids, bacterial spores, and Candida auris. Environmental services (EVS)/housekeeping managers can train their staff to recognize mattress cover problems (e.g., tears, cracks) and verify that relevant cleaning checklists include both recommended procedures and materials for cleaning mattress covers and steps for inspecting mattresses and covers. Clinical/Biomedical Engineers should track the service lives of mattresses and mattress covers and consider implementing electronic tracking of mattress and mattress cover IPM schedules, service lives, and time until replacement."

Sivek continues, "To reduce the risk of our 2019 Top 10 Hazard #9, IPs can review the instructions for use of medical devices and equipment to identify the manufacturers' recommended cleaning and disinfection methods. EVS managers should add this information to relevant room cleaning checklists if needed. Risk managers may help coordinate the training of EVS/housekeeping, nursing, and respiratory therapy staff to learn the risk of equipment damage and fires resulting from cleaning fluid ingress, how they can prevent this damage, and should fluid ingress occur during cleaning, how they should treat affected equipment and notify Clinical/Biomedical Engineering.

As for the reprocessing challenges, "Healthcare facilities today can help address these issues by encouraging reprocessing staff to diligently follow recommended reprocessing procedures and by following guidance coming from organizations like the CDC and ECRI Institute that monitor emerging problems with reprocessing practices," Lavanchy says. "Being aware of the concerns is an important first step and a major component in prevention."

The full hazards report, accessible to ECRI Institute members, provides detailed steps that organizations can take to prevent adverse incidents at their facilities, not just respond to them. The 2019 Top 10 Health Technology Hazards executive brief is available for complimentary download at www.ecri.org/2?019hazards.

Reference: ECRI Institute. 2019 Top 10 Health Technology Hazards. Executive Brief.