Supply Chain/Technology
FDA: Class I recall of Arrow Endurance Extended Dwell Peripheral Catheter System
Editor's Note The Food and Drug Administration (FDA), on June 26, identified the recall by Teleflex, and their subsidiary Arrow International, of the Arrow Endurance Extended Dwell Peripheral Catheter System as Class I, the most serious. The recall was initiated because of the risk of catheter separation and leakage. If…
Contract standardization for endo-mechanical supplies saves millions
Takeaways One of the lessons learned when it comes to data was to make sure you do it right the first time. A big drive for standardization was to leverage the distribution center to send excess inventory that some sites had to sites that needed them. Another drive was the…
Pfizer warns FDA of penicillin shortage
Editor's Note Pfizer alerted the Food and Drug Administration (FDA) on June 12 that its supply of two forms of injectable penicillin—Bicillin L-A and Bicillin C-R—may run out by the end of this month, the June 13 The Hill reports. Pfizer cited a combination of factors for the shortage, including…
FDA: Class I recall of Walnut Wearable Smart Thermometers
Editor's Note The Food and Drug Administration, on June 12, identified the recall of the rechargeable Walnut Wearable Smart Thermometer as Class I, the most serious. BearCare, Inc, is recalling the thermometers after receiving reports of skin burns and irritation resulting from use of the device. The company reports five…
FDA letter on supply shortage of nonsterile, single-use pneumatic tourniquet cuffs
Editor's Note In a June 5 letter to healthcare providers, the Food and Drug Administration (FDA) says it is aware of US healthcare facilities and providers experiencing supply constraints of nonsterile, single-use pneumatic tourniquet cuffs. The cuffs are used in elective limb surgeries and in emergency and trauma settings. During…
Effect of N95 face masks on cardiopulmonary stress
Editor's Note This Chinese study finds that wearing N95 face masks for 14 hours significantly affects physiological, biochemical, and perception parameters. The effect was primarily caused by increased respiratory resistance and subsequent decreased blood oxygen and pH. This randomized clinical trial included 30 healthy participants between March 7 and August…
FDA: Class I recall of certain SD BioSensor Pilot COVID-19 At-Home Tests
Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…
FDA: Class I recall of Draeger Medical’s Seattle PAP Plus, breathing circuit/anesthesia kits
Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…
New EHR generative AI by Microsoft, Epic currently being piloted
Editor's Note On April 17, electronic health records (EHR) vendor Epic and Microsoft announced a partnership to train Azure OpenAI on a large collection of information so it can “asynchronously draft responses to patient messages for providers,” Becker’s Health IT May 25 reports. According to Becker's, there are four major…
FDA: Class I recall of certain ICU Medical infusion system batteries
Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…
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