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. […]
In what may be a trend, the FDA has again addressed material specifications, this time in a draft guidance document titled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.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 […]
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 […]
“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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
