All of the issues that ECRI calls out on its list are preventable, so device manufacturers and healthcare providers should take serious note.
URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
Will more medical devices be impacted?
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
Artificial intelligence and machine learning technologies have significant potential, but regulatory hurdles may stand in their way.
After prompting from the agency, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue expanders.
A timely step toward ensuring patient safety through data-driven product development.
The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.