FDA releases list of reusable devices requiring new validated IFU, validation data
Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…
ECRI Institute announces release of CrossCHEQ
Editor's Note ECRI Institute on June 6 announced the release of CrossCHEQ, its new service that offers unbiased guidance on equivalent alternatives for medical-surgical supplies and implants. By comparing key performance indicators, buyers can assess opportunities for standardization and better respond when products are out of stock or recalled. The…
Preference card cleanup projected to cut costs across departments
Fine-tuning physician preference cards to reduce instrument use and sterilization is a well-known way to cut costs, but one that is often hard to implement. At Bassett Healthcare (Cooperstown, New York), we had success with a simple intervention involving collaboration with nearly 50 surgeons across multiple departments. We reviewed more…
ASC reaps rewards of recycling and reprocessing
What began as an employee request to reduce waste and create a “greener” workplace has resulted in an international award for TRIA Orthopedic Center, Bloomington, Minnesota. By conserving materials and energy, the ambulatory surgery center (ASC) not only reduced its environmental impact, but also saved money. The initiative started with…
Action steps for safe use of reprocessed single-use medical devices
In the United States and globally, the use of reprocessed medical devices labeled and marketed by their original equipment manufacturers as “for single use only” has become commonplace. Large health systems have saved many millions of dollars annually and diverted many hundreds of tons of medical waste by using reprocessed…
FDA extends UDI compliance date for certain Class II devices
Editor's Note In a September 6 letter to device labelers, the Food and Drug Administration (FDA) said it is extending unique device identifier (UDI) requirements for certain Class II devices from September 24, 2016 to September 24, 2018. The extension applies to repackaged single-use devices and device convenience kits. The…
Winning converts to SUD reprocessing
Reprocessing of single-use devices is now mainstream, with an estimated 70% of US hospitals using single-use devices reprocessed by third-party companies, according to industry figures. In an opinion piece in the March 2010 Academic Medicine, authors from The Johns Hopkins University School of Medicine call reprocessing a "common sense strategy"…
Staff spearhead's an OR's green effort
Protecting the environment and running an efficient OR aren't mutually exclusive at Oregon Health & Science University (OHSU), Portland, thanks to the commitment of a surgeon, an OR nurse leader, and the OR nursing staff. Clearly labeled bins aid recycling. Trash for recycling is placed in green bags. "Just because…
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