FDA: Promise Pharmacy recalls one lot of Prednisolone, Gatifloxacin Ophthalmic Solution
Editor's Note The Food & Drug Administration (FDA) on October 22 announced the recall by Promise Pharmacy (Palm Harbor, Florida) of one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3 mL vials (Lot Number 09042018@2, Exp 12/03/2018). The recall was issued because the product was found to have…
FDA: Class I recall of Endologix AFX Endovascular AAA System
Editor's Note The Food & Drug Administration on October 15 classified the recall by Endologix, Inc, of its AFX Endovascular AAA System as Class I, the most serious. The recall was initiated because of the risk of Type III endoleaks. When a Type III endoleak occurs, blood continues to flow…
Surgeons to monitor hip, knee patients using Apple Watches
Editor's Note Zimmer Biomet and Apple Inc have begun a multiyear study that will allow surgeons to use Apple Watches to monitor activities, including heart rate, steps taken, and standing hours of up to 100,000 patients before and after hip and knee replacement surgery, the October 15 Reuters reports. Providers…
FDA announces public workshop on management of cybersecurity in medical devices
Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…
FDA, DHS increase coordination for medical device cybersecurity
Editor's Note The Food and Drug Administration (FDA) on October 16 announced that as part of the Administration’s efforts to strengthen cybersecurity in healthcare, the FDA and Department of Homeland Security (DHS) have agreed to greater coordination and cooperation for addressing cybersecurity in medical devices. Under the agreement, DHS will…
FDA: Endo Pharmaceuticals recalls two lots of Robaxin
Editor's Note The Food & Drug Administration on September 28 announced the recall by Endo Pharmaceuticals Inc of two lots of Robaxin 750 mg tablets because of incorrect dosing information on the label. Robaxin contains methocarbamol, which is used as a muscle relaxant. Patients who follow the incorrect dosing information…
Trends, characteristics of health data breaches
Editor's Note Despite ethical and legal obligations to protect patient privacy and efforts to establish best practices for healthcare information security, breach rates have increased since 2010, this study finds. Of 2,149 breaches that involved 176.4 million records, the most common entities breached were healthcare providers, with 1,503 breaches that…
FDA announces framework for strengthening medical device cybersecurity
Editor's Note The Food & Drug Administration (FDA) on October 1 released a “Playbook,” developed by the Medical Device Cybersecurity Regional Incident Preparedness and Response (MITRE) Corp, to assist hospitals and other healthcare providers respond to cybersecurity incidents involving medical devices, the American Hospital Association reports. The MITRE Playbook outlines…
ECRI Institute releases 2019 Top 10 Health Technology Hazards
Editor's Note The ECRI Institute on October 1 released its 2019 Top 10 Health Technology Hazards. Among the hazards: First is cybersecurity attacks Second is blood and body fluids on mattresses after cleaning Third is retained sponges Fifth is mishandling flexible endoscopes after disinfection Ninth is cleaning fluid seeping into…
FDA: Oscor Inc recalls TB-Temporary Bipolar Pacing Leads
Editor's Note The Food and Drug Administration (FDA) on September 27 announced the recall by Oscor Inc (Palm Harbor, Florida) of its TB-Temporary Bipolar Pacing Leads, with 2 mm unshrouded connectors. The recall was initiated because the connector cap housing may slide and expose the connection wire. This may cause…
