FDA: Class I recall of Medtronic's HVAD Pump Implant Kits
Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…
Diligence in implant processing will decrease infection risks
Implants are foreign bodies, and they increase the risk of a surgical site infection. Processing implants requires strict adherence to the required steps because implants have sustained contact with sterile tissue. An implant is defined as a device that is placed into a surgically or naturally formed cavity of the…
Is a robotics program right for your ASC?
Global adoption of robotics technology has exploded in healthcare institutions, promising a less invasive and more precise means of conducting procedures. Although hospitals command the largest share of this market, analysts predict that ambulatory surgery centers (ASCs) will adopt this technology at a rapid clip. Robotics technology has changed greatly…
ECRI issues 2021 Top 10 Health Technology Hazards, managing EUA devices tops list
Editor's Note ECRI , on January 28, issued its Top 10 Health Technology Hazards for 2021. First on the list is the complexity of managing devices that have Food & Drug Administration (FDA) emergency use authorization (EUA) because of the COVID-19 pandemic. ECRI experts caution that hospitals need to watch…
FDA reduces N95 decontamination cycles from 20 to 4
Editor's Note The Food & Drug Administration (FDA), on January 22, lowered the number of times an N95 mask can be cleaned and reused to 4, down from a previous maximum of 20 reuses, the January 25 Fierce Biotec reports. The FDA reissued emergency use authorizations for 10 N95 decontamination…
New negative-pressure ventilator to help treat COVID-19 patients
Editor's Note A new negative-pressure ventilatory support device, similar to the “iron lung” used to treat polio patients in the 1950s, provides an additional treatment option for COVID-19 patients, finds this study by researchers in the UK’s Exovent Task Force, formed in March 2020 in response to the COVID-19 pandemic.…
Supply chain strategies shift to meet pandemic-induced demands
Resiliency, a term that has cropped up repeatedly during the COVID-19 pandemic, is often considered a key defense against burnout. But it is also important in the context of the healthcare supply chain, says Ed Hisscock, senior vice president of supply chain management at Trinity Health, a 22-state healthcare system…
Editorial
The rollout of COVID-19 vaccines starting in December 2020 was the one bright spot in an otherwise tragic year with a rapidly rising death toll currently over 385,000. Distribution of the 20 million doses promised by year end was thwarted by problems such as lack of coordination and lack of…
Expanding reprocessing programs can yield cost savings
The financial impact of COVID-19 on healthcare providers has been considerable. With experts predicting that half of all US hospitals would be operating in the red by the end of 2020, healthcare leaders have had to seek multiple ways to cut costs. The expansion of single-use medical device (SUD) reprocessing…
Joint Commission questionnaire identifies COVID-19 impact on organizations
Editor's Note The Joint Commission on January 6, 2021, reported on an online questionnaire sent to organizations in September 2020 to learn about their challenges and needs during the COVID-19 pandemic. A total of 735 respondents, representing a variety of healthcare settings, reported: a medium to high impact on their…
