The safety communication notes that patients being monitored via GE’s Healthcare Clinical Information Central Stations and Telemetry Services could be at risk.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
Stakeholders warn that more EtO facility closures could have a catastrophic result.
The agency continues to monitor the safety of the grafts manufactured by Endologix, while the company defends its safety.
Six medical societies sent a letter to the agency over concern that limiting EtO sterilization will also limit the availability of certain devices to patients.
All of the issues that ECRI calls out on its list are preventable, so device manufacturers and healthcare providers should take serious note.
Each year, more than 250,000 Americans die from the common and deadly condition.
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.