AAMIBlog

It is a regulatory requirement to clean and disinfect medical equipment before being used on a patient. Such a practice is also simply the right thing to do. We need to keep our patients and hospital personnel safe. While that outlook is a no-brainer, the cleaning and disinfection of medical equipment is a complicated responsibility […]

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 […]

A common comparison statement when decrying why we don’t collectively commit ourselves to big endeavors, including better healthcare, is, “If we could send a man to the moon, why can’t we XYZ.” If you are in the moon-landing-never-happened conspiracy theorist camp, this comparison won’t work for you, and you probably will become enraged, so stop […]

In what may be a trend, the FDA has again addressed material specifications, this time in a draft guidance document titled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.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

The reuse of single-use devices (SUDs) has been a controversial topic for some time. The process is distinct from reusing devices that were intended to be reused by the manufacturer, and following the manufacturer’s instructions while doing so—or at least being guided by them. The original device manufacturers of SUDs are opposed to reuse for […]

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 […]