Supply Chain/Technology
FDA: Class I recall of BASE10 Genetics RNAstill MTM specimen collection kits
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by BASE10 Genetics of its RNAstill MTM specimen collection kits as Class I, the most serious. The specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples…
FDA: Class I recall of E25Bio COVID-19 Direct Antigen Rapid Tests
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by E25Bio (Cambridge, Massachusetts) of its COVID-19 Direct Antigen Rapid Tests as Class I, the most serious. The tests are being recalled for several reasons, particularly because they were marketed and distributed in the US without…
The Joint Commission issues Quick Safety on instrument reprocessing
Editor's Note The Joint Commission on February 14 issued a new Quick Safety on “Ensuring critical instruments and devises are appropriate for reuse.” The Quick Safety highlights reprocessing guidance from the Food and Drug Administration (FDA) as well as special considerations for single use devices reprocessed by third parties that…
Effectiveness of reprocessing ureteroscopes, other endoscopic devices
Each year, there are more studies raising concerns about infections associated with endoscopic procedures and the techniques used to clean and sterilize or high-level disinfect (HLD) endoscopic devices. In this article, in partnership with Boston Scientific, epidemiologist Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, St Paul,…
Acclimating to OR, sterile processing department cultures
The differences between sterile processing (SP) and OR tasks and department cultures are significant. However, they share a collective goal: both work toward the best outcome for every patient. Still, both departments often suffer from having unrealistic goals for each other. One example is that the OR may expect instruments…
New inhaled vaccine delivers broad protection against COVID-19, variants
Editor's Note In this study, Canadian researchers at McMaster University (Hamilton, Ontario) confirm that their newly developed inhaled form of COVID-19 vaccine provides long-lasting protection against the original strain of SARS-Cov-2 and variants of concern. The researchers compared two types of adenovirus platforms for the vaccine. The adenoviruses serve as…
Amazon expands telehealth services
Editor's Note Amazon announced on February 8 that it is expanding its telehealth service, Amazon Care, nationwide. Previously, it was available only to employees and their families in and around its Seattle headquarters. Amazon also is expanding its in-person care services to more than 20 new cities this year. When…
FDA: Class I recall of Empowered Diagnostics COVID-19 tests
Editor's Note The Food and Drug Administration (FDA) on January 28 identified the recall by Empowered Diagnostics (Pompano Beach, Florida) of its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test as Class I, the most serious. Empowered Diagnostics distributed these tests with labeling indicating they were…
Medtronic recalls TurboHawk Plus Directional Athrectomy System
Editor's Note On February 7, Medtronic announced that it had issued a voluntary recall of its 6Fr TurboHawk Plus Directional Atherectomy System because of the risk of tip damage caused by guidewire prolapse. To date, there have been no reports of tip damage and no reports of injuries or deaths…
WHO: Dire need to deal with huge volumes of COVID-19 medical waste
Editor's Note Tons of extra medical waste generated in response to COVID-19 has put tremendous strain on healthcare waste management systems, threatening human and environmental health, according to a February 1 World Health Organization (WHO) report. In this global analysis WHO says: A large share of 87,000 tons of personal…
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