Gaining Consensus on Device Reprocessing

A spirited discussion among clinicians, sterile processing experts, design experts and manufacturers took place during the first day of the two-day AAMI/FDA Summit on Medical Device Reprocessing. The event was designed as a follow-up to a series of workshops held earlier this summer that examined the role of reprocessed reusable medical devices in healthcare-associated infections and patient safety. Taking place at the FDA's White Oak campus in Silver Spring, Md. about 260 people gathered to hammer out by consensus a set of priorities that would help inform practice and policy moving forward.

Unless you were here in person, it's almost impossible to capture in this blog the energy that was in the room. AAMI's Mary Logan set the tone the morning of the first day, Tuesday, by reminding attendees of the shared investment that we all have in good patient outcomes. That theme was continued by a keynote presentation from HONOReform's Evelyn McKnight, a crusader for better patient safety after she contracted hepatitis C from unsafe injection practices.

The day proceeded with a series of presentations that kicked off dialogue among attendees following the lectures. After each session, attendees came together to discuss essential factors impacting practice, the challenges and barriers to change, and the priorities to address for the future. The first presentation, which focused on "Defining Clean," featured members of industry Chuck Hughes from SPSmedical and Ralph Basile from Healthmark Industries, as well as Victoria Hitchins from the FDA and Daniel Schwartz from the Centers for Medicare and Medicaid Services. They addressed the fact that the definition of clean is currently spelled out in a numb er of standards from AAMI and professional organizations like AORN, but that ambiguity still exists in the sterile processing department. Attendees then launched into a passionate discussion about the importance of ensuring that sterile processing professionals followed manufacturers' instructions for use (IFUs) in their quest for clean, with the acknowledgementof the many barriers that SPD personnel face when attempting to decipher and understand complex instructions contained in the IFUs.

A second panel, "Design Issues with Reusable Medical Devices," featured presentations from Mark Duro, a hospital-based sterile processing professional, as well as from industry members Thomas Gilmore from Olympus and Mike Wiklund from a human factors engineering firm. They covered the most common cleaning challenges associated with design features of reusable medical devices, with attendees later debating how industry can design better instruments that facilitate good preprocessing practices, coupled with clearer instructions and improved validation methodologies.

The afternoon brought a follow-up session, "Human Factors Considerations in Reprocessing Procedures and Instructions," in which panelists discussed human factors issues in device reprocessing and repair, including feasible cleaning processes abd the content and format of instructions for reprocessing. Hospital-based sterile processing professionals Sue Klacik and Linda Condon each outlined the realities of the sterile processing profession -- inclusing time, resource and staff limitations -- contrasting with the high expectations that are established for the job. Emily Hildebrand and Darin Ellis, represnting two separate entities involved in human factors engineering projects, shared with attendees how technology and research could benefit the SPD's processes.

And finally, the day wrapped with a presentation on "Competency Requirements for Reprocessing Staff," with AORN representative Ramona Conner, APIC representative Marilyn Hanchett, sterile processing expert Sue Klacik and Eileen Young from Olympus discussed competencies currrently being applied in hospitals and the disparities between them that better training and education can help address. In the ensuing discussion, attendees discussed the need for greater certification of healthcare professionals working in the sterile processing department, as well as increased resources to better staff, fund and resource these departments for better outcomes.

As Chris Dinegar, vice president of conferences and certification for AAMI, told me, it was a terrific opportunity for "synergy and cross-pollination of ideas" and that it was something special to be able to sit in the same room where a nurse or a sterile processing professional can interact directly with a manufacturer or a device designer, and hash out their frustrations and exchnage ideas.

Stay tuned for an update on Wednesday's proceedings, as well as in-depth coverage on this summit and the priorities that attendees recommended for further consideration.