Medical Device Safety

In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an established sterilization method for medical devices.
The Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical device sterilization processes.
Commenting yesterday on the Environmental Protection Agency’s proposed standards for ethylene oxide use to sterilize medical devices, AHA encouraged the agency to give commercial sterilization facilities sufficient time to comply with any final standards to protect access to safe and sterile…
The Environmental Protection Agency May 30 announced its intent to finalize by March 1, 2024, new rules governing emissions from ethylene oxide, the gas widely used in medical sterilization facilities.
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations.
The FDA revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require updates to product labeling regarding serial testing, and designated the recall of 60,500 filters used in breathing systems a Class I recall.
Exela Pharma Sciences this week recalled 49 lots of sodium bicarbonate injection because the vial may break while preparing the product for administration, causing glass to fly.
Philips Respironics has recalled more than 17 million masks used with Bilevel Positive Airway Pressure and Continuous Positive Airway Pressure machines because the masks contain magnets that could cause serious injury to people with implanted metallic medical devices or other objects, the Food and…
The FDA announced a Class 1 recall of devices used to access blood vessels through a patient’s bone because the devices may malfunction, and recommended customers quarantine the devices.
The Environmental Protection Agency released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby.