Supply Chain/Technology
FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software
Editor's Note The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious. The System aids in precisely locating anatomical structures in neurosurgical procedures. The recall was initiated…
FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device
Editor's Note The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious. The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of…
FDA: Class I recall of Puritan Bennett 980 Series Ventilator
Editor's Note The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious. The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop…
FDA: Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
Editor's Note The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients…
Four problems and solutions with physician preference cards
As representatives of a global healthcare solutions company, we talk and listen to clinicians at hospitals around the country. One of the issues that continually surfaces is that physician preference cards (PPCs) are a challenge at their hospitals. We hear many frustrations related to supply chain documentation. In the end, it all comes…
FDA: Class I recall of Teleflex percutaneous thrombolytic device kit
Editor's Note The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious. The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was…
FDA: Nationwide recall of certain SterRx drug products
Editor's Note The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products. The recall was initiated because of the lack of sterility assurance due to equipment and process issues. The recalled drugs include: l mg/ml Midazolam in…
Raising awareness of “Near-Miss,” retained surgical sharps
In 2018, Sam Weprin, MD, started his first year of residency in Urology. During one of his first prostatectomy cases, he witnessed an impeccable surgery performed by the attending surgeon. Unfortunately, a surgical needle went missing inside the patient. The surgeon and her team spent an hour searching for it,…
Block time strategies help maximize robot utilization, service line
Improving patient outcomes and providing a superior experience for patients were at the forefront of the decision to grow the robotics service line at Northeast Georgia Medical Center (NGMC), Gainesville. Expanding from one da Vinci S system by Intuitive and six robotics surgeons covering five specialties in 2008 to four…
Patient safety and the “Internet of Medical Things (IoMT)”
With all of the advantages that come from electronic health records and connected devices, some distinct security risks also exist. Healthcare is seeing these risks grow in the form of ransomware, phishing attacks, and cybersecurity breaches. Healthcare has become one of the industries most vulnerable to cyberattacks, and one with…
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