May 6, 2021

UNC Medical Center performed a deep dive on sterilizing and reusing these valuable protective devices. The results are encouraging but not definitive.

CREDIT: Phillip Clapp, PhD
HANGING OUT A look at the variety of masks used in UNC School of Medicine's study of used and expired N95s.

With demand for PPE higher than ever due to the COVID-19 pandemic, many surgical facilities face the unpalatable option of reusing the N95 masks they have on hand. Just how safe is this practice of sterilizing N95 masks, and what's the best way to perform it? Researchers at University of North Carolina (UNC) Medical Center in Chapel Hill sought to find that out in a broad study that tested the effectiveness of used and expired N95 masks in keeping particles from getting inhaled. They found the masks, even expired masks in good condition, can be sterilized using vaporized hydrogen peroxide and ethylene oxide without getting compromised.

"Sterilization is more effective than disinfection for killing microbes, but we are still learning about the impact these methods have on the effectiveness of the mask," explains Emily Sickbert-Bennett, PhD, director for infection prevention at UNC Medical Center. She says more data is needed on how many times the same mask can be sterilized, a process which takes several hours. EUAs (emergency use authorizations) for some systems have tested the effectiveness of re-sterilization up to 20 times, she notes, but adds that "the impact of repeated use conditions, like long-term wear and humidity from breathing, have not been fully assessed to determine the impact of these challenges on the masks' effectiveness."

All told, after studying more than two dozen masks, the researchers found that certain N95s offer upwards of 95% effective protection. Masks as old as 11 years past their expiration date were tested. The researchers found the expiration dates largely didn't impact their efficiency, although their effectiveness likely depends on how the masks were stored.

"Masks should be stored in accordance with the manufacturer's instructions to preserve the integrity of materials," says Phillip Clapp, PhD, a UNC toxicologist who collaborated with Dr. Sickbert-Bennett on the research. "Storage environments should be clean with temperature and humidity controls."

"We tested up to 11 years past expiration and found them to still be effective masks, but there is not much data on expiration dates and it likely also depends on how the masks were stored," says Dr. Sickbert-Bennett. Also, keep in mind that not all N95 masks are created equal. "Depending on the technology, there are some material incompatibilities with sterilization," she says, recommending you check with each manufacturer about how suitable their masks are for sterilization, and how many times they can be re-sterilized, if that information is available.

The researchers emphasize that the reuse of N95 masks via sterilization should not become a permanent protocol at facilities when supply shortages cease to be an issue.

"The sterilization and reuse of masks is only being considered an acceptable practice under these emergency situations and likely will not continue," says Dr. Sickbert-Bennett. "The resources to sort, prepare, sterilize and package sterilized masks are not insignificant, and when the supply chain recovers, it will likely not be a cost-effective method."

One key factor to keep in mind when donning a re-sterilized mask is its fit, the researchers stress. A snug-fitting mask gives the most effective protection; ear-looped masks were found to be 30% less effective than masks with tie strings that go around your head. A snug mask, in good condition, properly sterilized, can offer high levels of protection. The research team laid out specific steps for UNC medical staff to take while donning an expired or used mask including to check the fit, condition and sterilization each time you put on an old mask to safeguard your personal protection.

Read UNC's published study here.

Laid off from restaurants, hotels and other frontline jobs, displaced hospitality workers are valued by this community college and potential employers for their "soft skills."

CREDIT: Housatonic Community College
FREE AND CLEAN Sterile Processing Technician students learn hands-on skills at Housatonic (Conn.) Community College's on-campus sterilization simulation lab.

A commonly cited problem in sterile processing departments (SPDs) is that staffers aren't always formally trained in their trade, or they are under-educated in key areas. Some help may be on the way, as a community college in Connecticut has teamed up with some big-money backers to retrain workers displaced by the COVID-19 pandemic to become sterile processing technicians (SPTs).

Housatonic (Conn.) Community College (HCC) launched a no-cost, fast-track, reformatted Sterile Processing Technician (SPT) program this fall. The free training is the result of a partnership between the college's foundation, Bank of America and Social Venture Partners. The seven-week, hybrid virtual/in-person course is based on the guidelines established by the Certification Board of Sterile Processing and Distribution (CBSPD). Learning takes place online, while hands-on skills training is provided in the school's state-of-the-art sterilization simulation lab on campus.

The goal of the public-private partnership is to quickly retrain displaced or unemployed workers, particularly from the hospitality field, and arrange employment within hospitals for in-demand healthcare jobs. HCC says graduates are prepared to immediately enter SPDs. Partnerships for clinical and hiring arrangements are in place with Stamford Health, Yale-New Haven Health and Nuvance Health. On October 14, HCC celebrated the first 10 graduates of the program, all of whom already had jobs lined up with program partners.

The stakeholders say they chose an SPT training program specifically because of the growth potential in the field, citing a U.S. Bureau of Labor Statistics report that said the job outlook for SPTs is expected to grow faster than the average for all occupations. The reason hospitality workers specifically are being targeted for participation in the SPT program is what the stakeholders call "the soft skills they already possess, such as attention to detail, teamwork and customer service."

"COVID-19 was an obstacle that we were all confronted with, and we took this great opportunity given to us and turned that obstacle into success," said Daniela Roldan, a program graduate from Bridgeport.

Meeting guidelines for product identification and traceability, record-keeping and monitoring of chemical sterilization.

Standards provide healthcare providers with a set of requirements, specifications and guidelines established and agreed upon by industry experts as the gold standard of care. In the United States, the American National Standards Institute Inc. (ANSI) and the Association for the Advancement of Medical Instrument (AAMI) are recognized authorities and sources of consensus standards for the medical device industry.

For sterilization guidance, there are two primary ANSI/AAMI documents that provide what OR teams need to make good choices about their facility's sterilization processes. These include ANSI/AAMI ST79:2017¹ which is a comprehensive guide to steam sterilization and sterility assurance for facilities. NSI/AAMI ST58:2013/(R)2018² was developed by the AAMI and approved by the ANSI in 2013. It provides standards and recommended practices specifically for the use of low temperature chemical sterilization and high-level disinfection in a healthcare facility. Standard 58 (ST58) covers a broad range of topics including work area design considerations (Section 3), decontamination and preparation of instruments (Section 6), and using chemical sterilant safely and effectively (Section 7).

Advanced Sterilization Products (ASP) can help meet AAMI quality control recommendations specifically for ST58 (Section 9) for cycle documentation and record-keeping through the company's built-in scanner and touch-screen interface that facilitate input of BI (biological indicator), sterilizer and load information, which reduces the need for manual record-keeping.

Together, STERRAD® Systems and STERRAD VELOCITY® fill this need which is discussed in ST58 (Section 9). This covers product identification and traceability, documentation and record-keeping, monitoring of chemical sterilization, product testing, product recalls and quality process improvement.

Another important guideline section, ST58 (Section 9), focuses on using biological indicators and process challenge devices. The AAMI recommendation states "health care personnel should use the BIs and PCDs recommended by the manufacturer of the selected gaseous chemical sterilization system and cleared by the FDA for use with that sterilization system or BIs and PCDs cleared by the FDA as substantially equivalent."²

Here, ASP can also help meet this guideline as the manufacturer of STERRAD® Systems, and only recommends the use of the STERRAD VELOCITY® System with its sterilizers. STERRAD ELOCITY® BI/PCDs were developed by ASP using exclusive proprietary data and technology which results in accurate results and minimizes false positives.

Finally, ST58 (Section 9) also focuses on the frequency of the use of biological indicators and process challenge devices. The AAMI Recommendation states, "A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle."² The condition of the sterilizer equipment, the expertise of the sterilizer operator and other factors determining the success or failure of a sterilization cycle could vary from one cycle to another.

ASP can help meet this guideline with STERRAD VELOCITY® BI/PCD, the only all-in-one Process Challenge Device for STERRAD® Systems that meets AAMI recommended guidelines. This means that when you run a STERRAD VELOCITY® BI/PCD in a sterilization cycle, the load is automatically challenged to a level equal to or greater than your most difficult device to sterilize.

Additionally, ST58 (Section 9) discusses the qualification test procedure with BIs. The recommendation includes these guidelines:

a) Before being exposed to the sterilization cycle, the PCD should be labeled with appropriate sterilizer lot and load information;

b) The PCD should be positioned in the load or chamber according to the sterilizer manufacturer's written IFU, and a normal cycle should be run;

c) Upon completion of the sterilization cycle, the manufacturer's written IFU for removing the PCD from the load or chamber and the BI from the PCD should be followed. The BI should be identified and then incubated according to the IFU of the BI manufacturer;

d) Each day that test BIs are run, at least one BI that is from the same lot and that has not been exposed to the sterilant should be incubated as a control to verify the pre-sterilization viability of the test spores, the ability of the media to promote growth of the test spores, and the proper incubation temperature. Test and control lot numbers should be recorded. Upon completion of the incubation period, the test and control results should be read and recorded. If the control BI from a lot fails to grow, it should be assumed that the test BIs from that lot are not viable or that improper incubation occurred. Therefore, the results from the test BIs should be considered invalid and the test should be repeated.

ASP can help meet this guideline with the STERRAD VELOCITY® System, which guides users through compliant biological indicator (BI) processing and automatically creates audit-ready records and can store up to 22,000 complete records including the information recommended by AAMI.

Note: Sophia Czechowicz, PhD, is ASP's Associate Director, R&D – Technical Business Solutions and she leads ASP's Technical Business Solutions R&D team in support of the development, implementation and use of ASP products and technologies for reprocessing medical devices. She authored this article on guidelines for sterilization (see: https://www.asp.com/media/sophia-czechowicz-phd). For more information, visit www.asp.com.

Practical advice for adding an extra layer of protection against surgical site infections.

The complex designs of reusable duodenoscopes render them particularly susceptible to the risk of transmitting pathogens, as recent outbreaks of multidrug resistant pathogenic organisms (MDROs) have demonstrated. The FDA suggests either double high-level disinfection (DHLD) or liquid chemical sterilization (LCS) as supplemental reprocessing measures for these devices. A new prospective, randomized study compares these two options.

Researchers at Indiana University spent nearly a year prospectively evaluating the two different modalities. Nearly 900 duodenoscopes used for endoscopic retrograde cholangiopancreatography (ECRP) were randomly segregated to be reprocessed by either DHLD or LCS, and then randomly cultured afterwards. Only 17 duodenoscopes, or 1.9%, tested positive for any organism.

The researchers found no significant difference of positive cultures when comparing the two modalities: eight of the scopes that underwent DHLD tested positive, while nine that underwent LCS tested positive. Both groups had two cultures that grew high-concern organisms, but no MDROs, including carbapenem-resistant enterobacteriaceae (CRE), were detected.

The researchers concluded, "DHLD and LCS both resulted in a low rate of positive cultures, both for all organisms and for high-concern organisms, but neither process completely eliminated positive cultures." The full study can be accessed here.

You might be wondering what the advantages of DHLD are compared to single HLD for reprocessing duodenoscopes. So was a team of Egyptian researchers, who recently performed a meta-analysis of the available English-language randomized clinical trials on the subject. They found that DHLD "offered no significant difference over single HLD for duodenoscope disinfection."

Because there doesn't yet appear to be a "silver bullet" solution for duodenoscope reprocessing, these studies reinforce the need for a robust reprocessing protocol, including bedside cleaning, as well as a reminder that culturing scopes for residual pathogens when possible is vital to see how well your reprocessing protocol is working.

The education and training standards for high-level disinfection (HLD) reprocessing of flexible endoscopes continue to evolve. Are yours evolving with them?

Are you educating and training your staff as well as you can on the high-level disinfection (HLD) reprocessing of your flexible endoscopes? You might not be, given the results of a 2020 AORN poster that rigorously evaluated existing programs and found them lacking.

The study, led by Albert Knight, BSN, RN, MAJ, AN, of the Daniel K. Inouye Graduate School of Nursing at the Uniformed Services University of the Health Sciences in Bethesda, Md., was undertaken with the goal of rolling out an evidence-based, standard protocol for HLD reprocessing for endoscopes across the entire U.S. Defense Health Agency. The project took inspiration from both a 2018 Society for Healthcare Epidemiology of America finding that all infections associated with gastrointestinal endoscopy were due to either defective equipment or a failure to follow proper reprocessing guidelines, as well as The Joint Commission's recent findings of an acute need for facilities to implement standardized endoscope reprocessing educational programs.

Without standardized education, the researcher says, the probability of variability in clinical practice rises, and in turn so does the risk of infection or even death to the patient. The additional organizational costs and liabilities that come with those negative events are also impacted.

Throughout the second half of 2019, five existing flexible endoscope reprocessing education and training programs were studied and compared. An evidence-based recommended practice audit checklist, comprised of 17 training and education categories and totaling 171 individual elements, was employed to score the five programs. Two programs were from industry associations: the Certification Board for Sterile Processing and Distribution (CBSPD) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The other three were from vendors.

Discrepancies and omissions were identified across the board. For example, the research found four of the five did not address visual inspection of scopes for damage during the precleaning phase. For duodenoscopes, only two programs addressed cleaning and brushing the elevator and its surrounding recesses, which the study identified as the process associated with the most lethal infections. Overall, the five programs only covered 63% of the researchers' 171 elements. Crucial steps were missing. The depth, clarity and comprehensiveness of the educational and training content varied markedly.

One red flag for the researchers was that the content lacked evidence-based rationales that provide the "whys" for trainees.

The researchers are still in the process of establishing their desired evidence-based standard of practice. But the study is an eye-opener for surgery centers for this reason: If you are relying on "standard" education and training programs from your vendors or associations for HLD reprocessing of scopes, you might not be giving your staff the full picture they need. Staying on top of the latest developments and updating your programs accordingly, you can stay ahead of the curve and equip your staff with the most up-to-date knowledge and skills.