Is it possible to improve medical device safety, simply by gathering unique identifier data? According to Ben Moscovitch, the project director for health information technology at Washington, D.C.-based think tank Pew, the answer is yes.
Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.
Medtronic is notifying customers worldwide of a voluntary field corrective action—a software update—for its Puritan Bennett 980 (PB980) ventilator series. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality and the labeling displayed on the GUI during ventilator use, Medtronic said in a statement.
Stakeholders in the medical device manufacturing sector, listen up: The European Medical Device Regulation is a new set of rules that govern the production and distribution of medical devices in Europe—and compliance is mandatory.