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.
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
As medical devices using software and wireless communication become more ubiquitous, hackers are becoming more advanced in their methods.
How to improve medical device security and the importance of security updates.