Considerations for Reusable Instrument and Device Cleaning and Verification

Kelly Zabriskie, vice chair of the APIC Public Policy Committee and enterprise vice president, Infection Control for Jefferson Health, spoke to the significance of the research findings, noting how they validate on a broad scale the struggles IPs – and SP professionals – face in their individual work to ensure patient safety.

“The research revealed how so many people are feeling the same way – that IFUs are a problem,” said Zabriskie. “The majority of IPs feel IFUs are difficult to find, read, and interpret. And this feedback was from IPs in all sizes of institutions – large ones with multiple IPs, small ones with a single IP, and those in between.”

More than half of IPs surveyed (65%) agreed or strongly agreed that the primary challenges they faced were for devices that fall into the low and intermediate levels of disinfection based on the Spaulding criteria. 

When reporting on common problems, the top two complaints among IPs were IFUs that are unnecessarily complex, difficult, or time consuming to read, and instructions that are designed to address product lifespan more than prevention of healthcare acquired infections (HAIs). 

With regards to cleaning and disinfection, challenges raised by IPs include:

• Lack of specificity/clarity about how to appropriately clean the product
• Information that is out-of-date/inconsistent with currently available products or technologies
• Unnecessarily targeted to a specific brand of cleaner
• Recommendations for cleaning products that are not hospital grade
• Require use of a product that is unavailable or difficult to purchase in the U.S.

“A personal pet peeve of mine is IFUs that recommend cleaning products that are unavailable,” Zabriskie commented. “This can happen when the IFU is outdated or when the item to be cleaned/disinfected is from outside the U.S. For example, some IFUs call for a product that is 70% alcohol, which cannot be found on the U.S. Environmental Protection Agency (EPA) list of approved disinfectants. In these cases, end users are left questioning, ‘what should I do?’”

When asked what SP professionals and IPs should take away from the report, Zabriskie stated:

“The report is intended to communicate validation of IFU issues among IPs and other IFU end users, and how APIC is taking steps to drive change in this area. We hear you. We understand there is a problem, and we are trying our best to engage others to move forward with a more standardized approach to IFUs.”

The new water quality standard

Published in August 2023, the ANSI/AAMI ST108 Water for Processing Medical Devices standard is the first of its kind.³ It establishes requirements for the quality of water used to process medical devices; revises and replaces AAMI TIR34:2014/(R)2021; and provides clear requirements for every stage of medical device processing.

“It makes the use of critical water for the final rinse a requirement and ups the game for bacterial and endotoxin levels for critical water and water for endoscopy processing to a maximum of 10 cfu/ml bacteria and 10 Endotoxin units/ml,” Jonathan A. Wilder, Ph.D., managing director, Quality Processing Resource Group, explained. “In my water audits, I have seen a number of failures in facilities where one would not expect failures. If you aren't testing, and since there is an American National Standard concerning these items, you don't know if you are endangering patients.”

Seth Hendee, AS, CRCST, CIS, CHL, CER, CSPDT, SLH Consulting, spoke to the importance of water quality in cleaning and sterilization activities, stating:

“Water is a major factor in both cleaning and sterilization activities, but when it comes to cleaning reusable devices, the negative impact of poor water quality is widespread. It can have adverse effects on cleaning equipment and its performance, cleaning chemistry performance, and the instruments themselves.”

Speaking to compliance with the ANSI/AAMI ST108 Water for Processing Medical Devices standard, Hendee said:

“Bringing water quality responsibilities to the ‘point-of-water-use’ will mean involving SPD staff in something they have previously had little experience with. It is an important update as more and more stories come out of poor water quality halting surgeries in facilities across the country. Understanding the quality of the water touching your devices, regularly monitoring it, and fixing issues when they are identified are key components to delivering high quality instrumentation to your patients.”

Opportunities for improvement

Hendee and Wilder also offered key considerations for cleaning and verification and recommendations for improvement. 

Cleaning

“If you have a tool, use it,” said Wilder. “Lumen racks are a great help in avoiding cleaning failures in lumened items or even in items as simple as suctions. If you do not use these for lumened devices, you will have less than effective cleaning of their interiors. This applies to any cannulated device, as discussed by Cori Ofstead at the last HSPA national meeting. However, I have seen a number of facilities who own washer racks that are specifically designed processing lumened devices but do not use them.”

Wilder pointed out how this is “bad practice” for two reasons:

“One is that if you inspect a lumened device after cleaning and you didn't use the proper tool to clean it, you will have rework and decreased productivity.”

“The second is, if you own a washer rack and don't use it, and a patient gets an HAI that could be expected to have been eliminated by proper cleaning of the interior of a lumened device, personal injury attorneys will have a field day in court.”

“Inspection of lumened items using borescopes and improved inspection of non-lumened devices using lighted magnifiers for proper cleaning is a growing practice,” Wilder added.

Speaking on the topic of washer/disinfectors and cleaning indicators, Wilder stated:

“Every SPD wants to increase productivity, and therefore would like faster washer cycles. Washer manufacturers are willing to do what they can to shorten cycles, but it is critical to ensure that the shorter cycles are actually doing a good job cleaning the instruments.”

“The cleaning indicator space has not seen much change, with the exception of the introduction of the Mesa Labs T-EZ Pro that has recently come to the U.S. market,” Wilder continued. “I do not know how this compares in process resistance to the existing market leaders (TOSI, Verify), but it is similar in design to TOSI.”

Verification

Cleaning verification (CV) for endoscopes is commonly practiced in SP departments, being part of the American National Standards Institute (ANSI)/ Advancement of Medical Instrumentation (AAMI) ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities standard. 

But according to Hendee, far fewer SP departments are performing CV for devices other than endoscopes. He stated:

“The need for cleaning verification for devices other than endoscopes is a topic I often discuss with SPD leadership. Many SPDs are processing endoscopes now, and most that do are performing CV at an established frequency. When I ask if they are performing CV on any other devices, the answer is usually ‘no.’ That always baffles me.”

Hendee continued: “For years ST79 has had a recommendation that departments perform periodic cleaning verification, and we know there are plenty other complex devices out there that are hard to clean and inspect. Shavers, like endoscopes, have been identified as difficult to adequately clean even when the IFU is followed. Why isn’t CV on shavers talked about in the same way as it is with endoscopes? Cleaning verification is a tool in the SPD quality assurance toolkit, and in my opinion, should be used more widely.”

Perhaps lack of CV is related to lack of time in SP departments. The January 2024 issue of Clinical Endoscopy featured a study on the costs and staff time associated with ST91:2021 compliance. The researchers concluded that the new standards “represent a potential 24.3-minute increase in reprocessing,” including an additional 8.4 minutes for endoscope-cleaning verification.⁴

Real world cleaning challenges and best practices from NYU Langone Health SPD Leaders

Members of the New York University (NYU) Langone Health Sterile Processing Department (SPD) work across the health system’s four hospitals and seven ambulatory units in Manhattan, Brooklyn, and Long Island, handling more than 25 million instruments per year.

From 2019 to 2023, NYU Langone Health procedural case volume increased by 31.7% with specialty & complex case volume increasing as follows: Endo ~59%, Neuro ~19%, Ortho-Spine ~21%, Transplant ~69%. This equates to ~4,000 cases performed per month and ~23,700 instrument sets reprocessed by SPD per month.

The NYU Langone Health SPD and OR teams recently engaged in a collaborative effort to reduce reprocessing defects, including bioburden, holes in wraps, case carts delivered without sets, missing instruments, and wrong instruments in sets. 

The result: 99.93% of instruments provided to surgical teams accurately and on time, and a 0.75% defect rate by case volume, down from 12.9%.

When it comes to cleaning improvements, NYU Langone Health Director of Sterile Processing Conner Brazil and Director, Outpatient/Business Initiatives Sterile Processing Department Marc Aquino, point to OR pre-treatment compliance as a key factor.

“There is nothing that can replace pre-treatment at the end of the case,” said Brazil. “When it is performed in the OR, the instruments coming into our department are much easier to clean. We perform audits of pre-treatment compliance, as well as audits on instruments that come through decontamination into the clean side to identify cleaning failures. The OR performs its own audits as well. If they find a defect, which is very rare, we perform an investigation into the root cause and address it, such as by staff re-education.”

One way Brazil and Aquino are helping support pre-treatment compliance of robotic instrumentation, which they note is notoriously difficult to clean, is through the deployment of enzymatic filled caps that OR staff place on the end of these instruments post-procedure. 

Speaking on the topic of manufacturer IFUs, Aquino said the health system has a verification system in place to ensure the SP department receives up-to-date IFUs on all new products entering the system. The challenges come with legacy instruments and devices, as Aquino explained:

“With items that have been in use for many years, it’s likely the original product manufacturer has been acquired or merged with another company at some point, making it challenging to know where to find the latest IFUs.” 

This aligns with APIC research findings where 66% of IPs surveyed either agree or strongly agree that IFUs are difficult to locate.¹

Brazil also spoke to challenges of having device and instrument inventory that contains similar items from different manufacturers with varying instructions for cleaning. He provided these examples:

“We have 40 different types of reuseable vaginal speculums and only two have IFUs that specify they must be reprocessed assembled, while the other 38 must be dissembled prior to reprocessing. It gets confusing so now we are moving to disposable speculums across the board. We are making the same move with Gomco clamps for circumcisions.”

When asked for keys to success in delivering clean instruments to the patient bedside, Brazil stated:

“It is really about the collaboration between SP and the OR. We are fortunate at NYU Langone Health that the OR team is willing to work with us.”

“It has been helpful to have an auditing process and schedule where we routinely review all inventory,” Aquino added. “In the case of peel packs, some have been in circulation and stored in various locations for quite some time, so routine audits provide the opportunity to evaluate their integrity and remove those that are compromised.”

Lastly, Brazil pointed to the importance of ongoing staff education and training, stating:

“We arrange for quarterly in-servicing of items that are complicated to clean, such as scopes. The manufacturers come into our facilities every three months to provide education for everyone. I would highly recommend this practice to other hospitals.”