AAMI Working on Key Documents for the Sterile Processing Department

By Kelly M. Pyrek

A ground-breaking meeting of the minds in October 2011 has led to a new draft standard from the Association for the Advancement of Medical Instrumentation (AAMI) that will provide sterile processing professionals with the means to address quality management systems.

In 2013, AAMI began work on a new standard: AAMI ST90: Reprocessing of health care products -- Quality management systems for reprocessing, and recruited users (such as sterile processing professionals, nurses and other clinicians) as well as healthcare technology managers, device manufacturers, independent service organizations, quality-systems experts, hospital leadership, purchasing organizations,  regulatory agencies, and other interested parties to participate in a workgroup to facilitate this new standard.

This standard is being developed by ST/WG 86, Quality systems for device reprocessing working group, under the auspices of the AAMI Sterilization Standards Committee, and the document will specify minimum requirements for quality management systems where an organization needs to demonstrate its ability to effectively, efficiently and consistently reprocessing (clean, decontaminate, disinfect, sterilize) reusable medical devices in order to prevent infections, pyrogenic reactions, or other adverse patient events.  

"For ST90, we have circulated a first working draft document to the committee for comment," says Susan Gillespie, director of standards for AAMI. "At our sterilization meetings in April, we will be discussing those comments and are moving to the next working draft.  I think one of the most important things that will come out of the document is that although usually quality systems are thought of as a management tool, this is really for the sterile processing professional to use with their department management. It's something they can use to improve practices in their own hospitals. It will help them improve conversations with their managers, and help achieve buy-in on what systems are needed for the department to run more smoothly., Usually these quality-systems documents have focused on manufacturers, not on users, so it's a new idea for a lot of people in sterile processing but I think that once the document is done it will be a valuable tool.  We can't predict at this point when the document will be finished but we have a very strong first draft and I think the discussion at the April meeting will give us an indication of where we need to go from here."

Infection preventionists (IPs) have had a hand in developing this document, thanks to representation from the Association for Professionals in Infection Control and Epidemiology (APIC), along with input from the Association of periOperative Registered Nurses (AORN) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM). "We have a strong presence of IPs on our committees," says Gillespie, "APIC has been a partner with us for years and is represented on virtually all of our sterilization committees so they do have a voice in the process."

Much of ST90 takes a page from the October 2011AAMI/FDA Medical Device Reprocessing Summit. The summit built on an FDA public workshop on reprocessing in June 2011. For all participants, the summit proved to be an opportunity for a renewed emphasis on performing all the necessary steps in reprocessing reusable medical devices to ensure clean and disinfected or sterilized devices-not just in the universe of regulations, standards, and best practices, but also in the harried clinical environments and diverse sterile processing centers that are ground zero for reprocessing.

The summit crystallized a compendium of challenges and priority actions for delivering on patients’ basic expectation of cleanliness for reusable medical devices. Indeed, this “patient safety first” focus-with the ideal of ensuring that reprocessing is done correctly every time- was a recurring message from summit participants. So, too, was the overarching challenge for all stakeholders to deepen knowledge and eliminate confusion about reprocessing requirements, to increase communication and collaboration, and to pay closer attention to human and environmental challenges.

The clarion themes that emerged from the summit should serve as a call to action for all stakeholders with roles to play in improving patient safety in reprocessing reusable medical devices. The seven clarion themes are:
1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.
4. Make human factors and work environment factors priorities when developing reprocessing requirements.
5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
6. Improve reprocessing competencies by strengthening training, education and certification.
7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.

Gillespie reports that significant progress has been made on several documents stemming directly from the 2011 summit.

"A notable project relates to the first clarion theme of the summit -- how clean is clean," Gillespie says, referring to summit attendees' lively dialogue about how to define absolute cleanliness as it relates to sterile processing. "Last year we held a stakeholder discussion to start putting some quantitative endpoints in place for how clean is clean enough. We had a very good meeting and we are going to be producing a whitepaper with the findings from that meeting. We hope to have that available later this year."

Gillespie adds, "There are two other documents that came out of the summit that are technical information reports (TIRs). One addresses endoscope reprocessing and the other focuses on human factors engineering for device manufacturers, specifically looking at the reprocessing of devices. Those are both moving along nicely; we hope to have the human factors TIR finished later this year, and the endoscope document probably in 2015."