AAMIBlog

As the former executive director of the Certification Board for Sterile Processing and Distribution, Inc. (1988-2014), I had the opportunity to learn a great deal about certification and its impact on the safety of patients. Few can argue that there is a critical need for competent sterile processing personnel; they perform essential duties that can […]

In what may be a trend, the FDA has again addressed material specifications, this time in a draft guidance document titled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices. As with previous FDA comments on ventilator tubing, and as expressed in a guidance document on dialysis access devices, the issue here is […]

Earlier this spring, I had the opportunity to represent AAMI at a World Health Organization (WHO) meeting on personal protective equipment (PPE) for use in treating the Ebola virus. Though I’m not an expert in infectious disease, I think I have a good understanding of the issues involved in protecting oneself from exposure to highly […]

“How clean is clean enough?” has resurfaced as a pressing question in medical device reprocessing because of national media coverage of superbug outbreaks involving contaminated duodenoscopes. While the intense media interest is new, the issue itself is not. Over the past several years, a number of hospitals have had to send sobering letters to patients […]

As a former manager for a sterile processing unit and a private consultant, I have had the unique privilege of having both presented and attended sessions at various conferences over the years. Professional conferences have so many advantages and just a couple of challenges. The benefits so far outweigh any negative, I cannot recommend them […]

I recently had the opportunity to participate in a tour of the University of Maryland Medical Center. The tour was organized by AAMI member Inhel Rekik, senior clinical engineer at that facility, and Cliff Bernier, a director in the AAMI Standards Department.  I’ve worked on webinars about central sterile processing (CSP) and others healthcare technology […]

It has been nearly a year since the AAMI/FDA Medical Device Reprocessing Summit, and several new AAMI work items that came out of the summit are under way: A small group has been working hard all year to draft new technical information report (TIR) on endoscope reprocessing. And this fall, AAMI will begin work on […]

CJD: Have you challenged your policy and procedure? Yes, we have. The occurrence of prion or transmissible spongiform encephalopathy contamination, such as Creutzfeldt-Jakob disease (CJD), is a once in a lifetime event — if it occurs at your facility.  However, if it does, it is likely to be one of those events that just could be […]

What’s your role with the management of scopes? At a minimum, you are probably following The Joint Commission’s request that you inventory them. Attendees at last October’s AAMI/FDA Medical Device Reprocessing Summit contributed tips and lessons learned that led to a list of 10 Things Your Organization Can Do Now to Improve Reprocessing. The tips, […]

Not too long ago, I had discussions with operating room nurses, infection preventionists, and sterile process personnel who say their management does not think their institutions needs to follow the recommended practice in ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (consolidated text), Comprehensive guide to steam sterilization and sterility assurance in health care facilities, because they do not […]