While the AAMI eXchange 2022 is an industry event most commonly attended by medical device manufacturers and the hospital technicians who maintain those devices, it features a robust track of sessions dedicated to the sterile processing of devices starting from manufacturing, to shipping, to everyday use and reuse in the operating room.
This year, sessions included lessons learned from the pandemic, tips for processing news technologies such as surgical robots, and calls to action from leading thought leaders. Here are just two of the highlights:
Kilmer Innovations in Packaging Group Calls for Members/Next Steps
When the Kilmer Innovations in Packaging Group (KIiP) presented at the 2022 AAMI eXchange, one audience member stood up to address the room even before the session began.
“I just wanted to tell everyone here that this is a great group,” said Jonathan Wilder, Ph.D., managing director of Quality Processing Resource Group LLC, and Max Planck Fellow. “This is a bunch of packaging professionals who are doing this for no vested or selfish reason! That’s a remarkable thing to witness. It’s utterly delightful to work with such smart people.”
As a member of the group, Wilder’s take on KIiP may be a tad biased, but his qualifications and enthusiasm alike provide a good snapshot of what KIiP volunteers are bringing to the table for sterile processing and biological assurance.
The KIiP movement started in 2019 during the lauded Kilmer conference, a global forum hosted by J&J which is focused on sterility assurance and sterilization for professionals from industry, academia, government agencies and healthcare delivery organizations.
According to presenters Ralph Basile of Healthmark and SPD consultant Dave Jagrosse, the group initially began as a LinkedIn page for individuals dedicated to “improving patient outcomes and clinician delight through the science and engineering of sustainable packaging.”
Since then, the closed group has accrued more than 390 members and outlined a specific mission:
“The collaboration, connection, education and promotion of the value of medical device sterility assurance and its maintenance throughout the value chain for protecting patient safety and improving health care outcomes.”
During the worst of the COVID pandemic, “we started meeting virtually a lot,” said Basile. As a result, multiple projects have been started to solve commonly shared problems across the stakeholders’ fields. Ongoing projects include:
1. Standardizing terminology between health care and industry professionals:
- “Figuring out who means what has sometimes been like peeling an onion. There’s too many layers and a lot of crying,” Jagrosse joked, “but this work has led to a lot of necessary discovery and ‘aha’ moments that will make everything easier.”
2. Informing the development of AAMI TIR109 with academic and industry evidence:
- A new AAMI technical information report (TIR) will provide comprehensive guidance on externally transporting medical devices between one health care facility and facility, either for patient use, sterilization, disinfection or decontamination.
3. Ongoing study on repetitive handling of sterile packaging:
- “Health care workers load/unload case carts with required and ‘just in case’ sterile packaged medical devices. We want to know, ‘does repeated handling pose additional risk for the contamination of a device?’ ” the presenters explained.
4. Ongoing study on external transport of medical devices:
- Seeking to inform thorough, “evidence-based decision-making regarding the safe external transport of medical devices/medical packaging.”
The presenters finished by outlining their need for experts on the end-user side, specifically clinicians, to join their efforts. Interested parties should apply to join at linkedin.com/groups/12301596.
Your SPD Needs Dedicated Endoscope Staff, Says ST91 Co-chair
If you or your loved ones are being driven somewhere, you want to make sure that person behind the wheel is trained to drive, right? It should be the same for reprocessing important and complex medical devices, such as endoscopes.
That’s at least according to Garland Rhea Grisby Sr. of Kaiser Permanente and co-chair of the AAMI WG84, the standards development working group responsible for ANSI/AAMI ST91:2021. At AAMI eXchange 2022, Grisby presented “Endoscope Processing: The Importance of Dedicated Staff” to professionals during a special spotlight on the expo hall floor.
Grisby explained how adverse events related to improper scope reprocessing can often be tied back to professionals with outdated training missing fluid channels for these evolving and complex devices. He also pointed to the U.S. FDA’s MAUDE database, which records all reported adverse events related to improper reprocessing.
He noted how many adverse events even as recent as 2021 are so shocking that “they made the hairs on my bald head stand up!” In one facility’s case, for instance, officials recorded that a leak test had not been performed on any equipment in over 20 years.
“When you have blood seeping out of a scope that has supposedly been reprocessed, you should realize something is wrong,” he said to a horrified audience.
But Grisby is also quick to point out that while it sounds like many of these offending departments simply lacked the common sense most responsible SPD departments have, it often comes down to leveraging manpower in a responsible way. It may not be reasonable to spend the time and resources to retrain an entire SPD department after every single update to manufacturer instructions for use and standards such as ANSI/AAMI ST91. However, he argues it does make sense to have one dedicated member of a team to stay on top of this crucial information and inform changes to processes as needed. Staying in the know about changes in the technology and science of your profession, he said, is part-and-parcel of a health professional’s commitment to patient safety.
