Instructions for cleaning medical instruments need overhaul, experts say
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Key takeaways:
- Instructions for cleaning medical instruments should be clearer and easier to obtain.
- Roughly 84% of infection preventionists in a survey said they had to contact a manufacturer to clarify instructions.
The leading U.S. professional association for infection preventionists recently called for an overhaul to medical device cleaning instructions based on a survey that revealed confusion, inconsistency and potential danger.
The Association for Professionals in Infection Control and Epidemiology (APIC) survey showed that nearly half of medical facilities have been cited for failure to follow manufacturer’s instructions for use (IFU) and more than three-quarters of infection preventionists (IPs) have had to reach out to manufacturers to clarify or seek updates on proper cleaning, disinfection or sterilization.
Since 1976, the FDA has regulated medical devices and ensured their safety and effectiveness through guidelines for labeling and IFUs. The guidelines require labels to include instructions for setup, use, cleaning, care and storage of devices, regardless of whether they are reusable.
According to Kelly Zabriskie, MLS, CIC, FAPIC, vice chair for APIC’s public policy committee, IFUs can be difficult to understand with scattershot updates that can be hard to track and may impact the delivery of care and safety of a health care facility.
“As infection preventionists, we are always looking at the IFU on different types of products, and this has been an increasing issue for IPs,” Zabriskie told Healio, adding that figuring how to properly use cleaning products or to properly clean products takes away from getting work done.
Additionally, although there are databases and services available to help ease the issue, they can be cost prohibitive for some facilities, she said.
APIC surveyed 1,198 IPs currently practicing in a U.S. health care facility between March 14, 2023, and April 24, 2023. Among them, 20% of respondents worked at a facility with one to 50 beds and just over 50% were the only IP in their department.
More than 70% of IPs said they found IFUs unnecessarily complex, difficult or time consuming and that instructions seemed designed more to extend product lifespan that to prevent health care-associated infections, and just under 70% said IFUs lacked specificity or clarity on how to appropriately clean the product.
Roughly 84% of IPs said they needed to contact a manufacturer to clarify an IFU — just 60% said they received helpful information. Additionally, 8% of IPs contacted the FDA for greater clarity, although less than half — 42% — said they received it.
Among respondents, 42% had been cited by a supervisor for failure to follow an IFU, among whom 54% were unable to successfully challenge the citation with evidence to back up their practice.
To improve IFUs, APIC’s report recommends new regulatory frameworks for cleaning, disinfection and sterilization of devices that include:
- standardized format for IFUs;
- language in IFUs that considers the requirements of infection prevention, environmental services and end users;
- device labels that are easily accessible for the product’s lifespan, dates of updates to IFUs and who to contact with questions about the device; and
- a public repository for IFUs for devices that are no longer manufactured or whose manufacturer has gone out of business.
Zabriskie said many IPs think they are missing or misunderstanding something, but the survey confirmed things many IPs experience and the need to improve IFUs.
“You realize, ‘It’s not just me — this is an inherent issue that we’re facing,’” she said. “People want to do the right thing, including the vendors and manufacturers, but I don’t think people realize what is put out there and how people are receiving that information.”
References:
- Cleaning instructions for medical instruments need an overhaul. https://apic.org/news/cleaning-instructions-for-medical-instruments-need-an-overhaul/. Published May 16, 2024. Accessed May 16, 2024.
- APIC. Modernizing medical use device instructions for use (IFUs). https://apic.org/modernizing-medical-device-instructions-for-use-ifus/. Published May 16, 2024. Accessed May 16, 2024.
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