A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
Without even factoring in the effects of COVID-19, ransomware attacks against healthcare providers have significantly increased. We must be ready to detect and respond to them before damage can be done.
COVID-19 requires us to rethink our current device disinfection procedure.
The more devices are connected, the more that targets are present for remote attackers.
As the saying goes, if it looks too good to be true, it probably is.
Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.