APIC New Report Calls for Action: Simplifying Medical Device Instructions for Use


On May 16, 2024, Association for Professionals in Infection Control and Epidemiology (APIC) published its recommendations in a report on updating medical device instructions for use (IFUs).

Trying to Read Instructions for Use  (Adobe Stock 644702379 by megaflopp)

Trying to Read Instructions for Use

(Adobe Stock 644702379 by megaflopp)

Infection preventionists (IPs) are tasked with patient safety. Yet, a common challenge they face revolves around deciphering and complying with medical device instructions for use (IFUs). This issue has garnered significant attention from IPs across various health care systems, prompting a call for reform to streamline the process and prioritize patient well-being.

A recent report, Modernizing Medical Device Instructions for Use(IFUs): Infection Preventionists Speak Up for Patient Safety,” published by the Association for Professionals in Infection Control and Epidemiology (APIC), illuminates the complexities, inefficiencies, and frustrations associated with IFUs. IPs have voiced concerns about needing more clarity, outdated information, brand-specific instructions, and contradictions between device specifications and IFUs. These challenges consume valuable time and pose risks to patient safety.

To learn how the report was born and APIC’s key takeaways, Infection Control Today® (ICT®) spoke with Kelly Zabriskie, MLS, BS, CIC, FAPIC, vice chair of APIC's Public Policy Committee. She explained, “[The goal of the report] is to engage other stakeholders to bring us together and to relook at standardizing the process for cleaning, disinfection, high-level disinfection, sterilization, whatever the recommendations are, that we have a clear tool where it is easily identifiable with the elements needed to successfully provide a clean, safe piece of equipment for the patients.”

Zabriskie, also the enterprise vice president of infection control at Jefferson Health in Philadelphia, Pennsylvania, said that to investigate these issues further, a comprehensive survey was conducted among IPs, seeking their feedback on the difficulties encountered with IFUs. The results were striking, with a significant majority expressing frustrations with the current system. IPs reported difficulties locating IFUs, reconciling device specifications with IFU requirements, and understanding the language used in the instructions.

"We want to standardize this process by labeling each IFU with the same information, [such as] where you find sodium content and calories on an item in the grocery store," Zabriskie said.

To learn what IPs are thinking, APIC conducted 2 focus groups with IPs to identify challenges with IFUs for medical devices and gather recommendations for improvement. The first group assembled at the APIC Annual Conference in June 2022, while the second met virtually in July 2022.

Results were compiled and used to develop a survey distributed to 12,863 IPs by APIC's membership database, eNews newsletter, and social media. The survey, conducted from March 14 to April 24, 2023, received 1198 responses from IPs practicing in US health care facilities.

Eligible respondents expressed frustration with IFU complexities, outdated information, and difficulties locating and understanding instructions. This comprehensive effort highlights the urgent need to address IFU challenges to enhance safety for patients and staff and streamline health care processes.

The survey revealed that many IPs had to contact manufacturers and even the FDA to clarify IFUs, further exacerbating the burden on health care personnel.

The challenges with IFUs extend beyond mere inconvenience. They have tangible implications for patient safety, as discrepancies in cleaning and disinfection protocols can increase the risk of health care-associated infections.

“I've reached out to a vendor and said, ‘We use your disinfectant wipes, but it's not validated for this medical piece of equipment.’ I now have to bring in another disinfectant wipe because it's not validated. So now I have 3 or 4 different products—there may be more than that—because each product [needs] something different. [Sometimes it is] not by a type of chemical, it's by manufacturer. It's not that you can just use bleach. No, you have to use this [brand] of bleach. It's not every situation, but this is what creates our concerns,” Zabriskie said.

She also explained that certain medical specialties, such as ophthalmology and dental care, face unique challenges due to the instruments used and the specific cleaning requirements involved, IFUs needing to be updated or have been lost altogether because the instruments are not used often.

Overall, the IFUs need to be clearer and readable for everyone. “It needs to be laid out in the language that everybody can understand and understand what it means,” Zabriskie said, her frustration evident. “Sometimes we see the language in there [that the instrument] can be cleaned or validated for 17 uses. What does that mean? On the 18th time, I called about this to understand because I struggle with what that means. Does that mean after the 18th time, I can't reprocess it anymore? Or does that mean it's only been validated for 17 uses? Can I keep using it? What does some of this language even mean?”

In response to these findings, in this report, APIC has called for concerted efforts to address the shortcomings in the current regulatory framework governing IFUs. The organization advocates for the development of standardized formats for IFUs, more straightforward language accessible to all health care personnel, and improved accessibility to updated IFUs throughout a device's lifespan.

Additionally, APIC emphasizes the importance of engaging stakeholders, including manufacturers, policymakers, and regulatory agencies, to work collaboratively toward solutions prioritizing patient safety.

The report’s authors wrote, “The survey results indicate that difficulties with device IFUs are widespread and should be revised so that health care facilities have clear and concise instructions necessary to comply with appropriate cleaning, disinfection, and sterilization of medical instruments to keep patients safe.”

As APIC’s report shows, action is urgently needed to reform the IFU process and ensure that cleaning and disinfection protocols are streamlined, effective, and conducive to patient safety. IPs, health care organizations, manufacturers, and regulatory agencies must work together to develop practical solutions that address the challenges outlined in the APIC report. By prioritizing patient well-being and simplifying the IFU process, we can enhance the quality of care delivered in health care facilities nationwide.

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