Consider the ubiquitous blood pressure cuffs and the glucometer as a microcosm for what is wrong with medical instrument cleaning instructions in healthcare today.
As infection preventionists, we oversee the cleaning and disinfection process for thousands of instruments according to the Spaulding Classification. Each instrument available on the market is accompanied by the manufacturer's instructions for use (IFUs), a requirement of the U.S. Food and Drug Administration. These IFUs are intended to outline the tested, validated processes for effectively cleaning and disinfecting that particular instrument. The infection preventionist must be familiar with all IFUs in their facility and work to ensure that all healthcare workers clean and disinfect each item in accordance with the IFUs.
Blood pressure cuffs, for example, are considered "non-critical" items in the Spaulding Classification because they only come into contact with intact patient skin. All non-critical items require at least low-level disinfection between each and every patient, usually achieved through a multi-step process that includes a disinfectant solution, a rinse, and a drying step. Depending upon the cuff, the drying process can take hours. Now imagine trying to operationalize this in a clinic setting in which dozens of patients have their blood pressure taken each day. And if multiple styles or brands of blood pressure cuffs are utilized, each is likely to have a different process for cleaning and disinfection.
Glucose monitors are another example of a frequently used item with cleaning instructions that simply aren't feasible. For at least one popular glucometer model, the IFUs state that after each glucose check, one specific type of disinfectant wipe should be used for the screen and another for the body of the device, and it must be wiped three times horizontally and three times vertically. Any deviation from this process could result in a regulatory citation.
Overly complex and unfeasible IFUs have long been a frustration to healthcare workers and are the subject of a May 2024 report published by the Association for Professionals in Infection Control and Epidemiology.
Out-of-date, impractical, and overly complex IFUs are ripe for reform so that infection preventionists can spend more time tending to our core responsibilities: preventing and controlling the spread of infectious diseases in hospitals, ambulatory clinics, long-term care facilities, and outpatient surgical centers.
According to the report, more than 70% of the 1,198 infection preventionists surveyed by APIC in 2023 found IFUs unnecessarily complex, difficult, or time consuming. Seventy percent also reported that impractical cleaning instructions seemed to be designed to address product lifespan rather than infection prevention, which is the whole point of cleaning in the first place.
Worse still, 68% of IPs said IFUs are non-specific and unclear about how to clean products ranging from critical devices that enter the bloodstream or sterile tissue and require sterilization; to semi-critical devices such as endoscopes that come into contact with non-intact skin or mucous membrane that require high-level disinfection; to non-critical devices like blood pressure cuffs. Eighty-four percent of infection preventionists surveyed reported having to call manufacturers for clarity on IFUs, only to find that, 36% of the time, manufacturers had no helpful information.
Some well-resourced hospitals with relatively large teams of infection preventionists might be able to effectively manage the oversight of IFU requirements, but more than half of APIC's survey respondents work solo in their facilities and simply do not have the time or resources to translate faulty and confounding IFUs into effective infection prevention. In either case, non-compliance with the IFUs, even if the IFUs are faulty or impossible to perform, can result in regulatory citations.
Even as the survey data was being tallied and the report was being written, APIC was at work to correct the flawed regulatory framework around irrational, brand-specific IFUs. We've begun alerting the FDA, as well as Congress, to the most problematic IFUs among the thousands with which infection preventionists must comply.
APIC is also in the process of developing tools so that infection preventionists, as well as sterile processing departments, can better navigate the cleaning, disinfection, and sterilization requirements to keep high risk items like endoscopes and vaginal dilators free of deadly pathogens. We will be working jointly with other organizations impacted by problematic IFUs to come up with a standardized IFU format and language that reflects the needs of the end users who must interpret and follow IFUs.
Finally, APIC will be advocating for a public repository for IFUs to ensure they are available after a product has been discontinued or a company has gone out of business.
Infection preventionists take their role as safety advocates very seriously and do everything in their power to keep patients safe. But confounding cleaning instructions just get in the way.
Shouldn't instructions for use be at least marginally useful?
Dr. Tania Bubb, PhD, RN, CIC, FAPIC is the 2024 APIC President and the Senior Director, Infection Control, Memorial Sloan Kettering Cancer Center in New York City.