Discussions about reusable medical devices often focus on professional caregivers, but it’s essential to include users responsible for processing these devices. This includes sterile processing personnel in healthcare facilities and lay users processing home-use devices. Instructions for Use (IFUs) for reusable medical devices must be tailored to the specific user types they address. The guidelines in AAMI TIR55:2014/(R)2017 emphasize the need for clear IFUs that enable processing personnel to perform the necessary steps accurately. Additionally, the document advises validating that instructions for cleaning, disinfection, and sterilization are readable, understandable, and can be followed correctly.
Infection Preventionists surveyed by the Association for Professionals in Infection Control and Epidemiology (APIC) in 2024 revealed that 42% of their facilities were cited for not adhering to IFUs (Tomlinson, L., et al., 2024). Processing instructions for Sterile Processing Department (SPD) staff frequently pose challenges due to their complexity or ambiguity, potentially leading to improper device processing. SPD teams are diverse in terms of education, experience, and backgrounds; therefore, instructions should be simple enough for even the least experienced staff member to follow correctly. Manufacturers must consider several SPD-specific challenges when drafting processing instructions, such as the complexity of devices, disassembly/reassembly requirements, time constraints, and critical tasks.
The development and validation of medical devices is a rigorous and highly regulated process, but Human Factors Testing for device processing is equally crucial. According to the National Institute of Health (NIH), “Medical device-associated infections are more commonly associated with reusable medical devices, including surgical forceps, endoscopes, bronchoscopes, transesophageal echographs, and laryngoscopes, compared to single-use devices.” It is vital for reusable devices to not only be safe and effective but also capable of being safely processed to protect patients, SPD staff, and the devices themselves. Processing instructions must be validated to ensure they achieve sufficient cleaning, disinfection, and/or sterilization, reducing the spread of Healthcare Acquired Infections (HAIs). Human Factors Testing validates that these instructions can be properly executed.
The success of SPD users depends on the clarity of the instructions. The same APIC survey (mentioned above) noted that 82% of Infection Preventionists contacted manufacturers due to unclear IFUs (Tomlinson, L., et al., 2024). Validating processing instructions allows manufacturers to gather feedback from SPD users and refine instructions for improved adherence. This reduces errors in device processing, leading to fewer HAIs, user injuries, and damaged devices.
What Does Validation of Processing Instructions Entail?
AAMI TIR55 states: “The purpose of a human factors validation study is to demonstrate that the device can be processed by representative processing personnel following the recommended procedures under simulated use conditions without errors or failures that could result in negative impacts to patients or personnel involved in processing.”
Human Factors Test validation evaluates whether IFUs can be effectively followed alongside the final device design in a realistic processing environment. This requires a space equipped with necessary equipment to mimic a healthcare SPD and representative participants who are current SPD employees. Every stage of the process must be assessed—from point-of-use treatment to cleaning, disinfection/sterilization, and storage—using appropriate equipment such as washers/disinfectors, automated endoscope reprocessors, sonicators, drying cabinets, sterilizers, etc. Manufacturers should prioritize Human Factors Testing before validating cleaning, disinfection, and sterilization instructions. Doing so allows for refinements to the instructions beforehand.
The Immediate Benefits of Human Factors Testing
Human Factors Testing directly impacts healthcare users, patients, and manufacturers. Some key benefits include:
- Reduced Risk of HAIs: With 1.7 million HAIs occurring annually in the U.S. and 80% linked to medical devices (Garvey, 2023), improved IFUs for reusable devices can significantly reduce infections.
- Enhanced User Safety: Testing identifies steps that could cause injuries due to unclear instructions, or ergonomic hazards and fatigue due to an unclear understanding of the SPD user environment, enabling manufacturers to refine IFUs to prevent such risks.
- Prolonged Device Life: Properly understood instructions minimize mishandling, safeguarding both users and patients while extending the device’s lifespan.
Inclusion of SPD users in processing instructions development fosters collaboration between healthcare facilities, test labs, and manufacturers. Regular Human Factors Testing ensures reusable medical devices are processed correctly, reducing HAIs, user injuries, and device deterioration. It is an essential practice for patient and user safety as well as the long-term success of medical devices.
References
Garvey, M. (2023, December 22). Medical device-associated healthcare infections: Sterilization and the potential of novel biological approaches to ensure patient safety. National Center for Biotechnology Information. https://pmc.ncbi.nlm.nih.gov/articles/PMC10778788/
Tomlinson, L., Hailpern, N., Alexander, M., Townsend, S., Zabriskie, K., & Luperv, L. (2024, May). Modernizing medical device instructions for use (ifus). Association For Professionals in Infection Control and Epidemiology. https://apic.org/modernizing-medical-device-instructions-for-use-ifus/
