FDA to Examine Effects of Extreme Weather
On Medical Devices
Over the past year, the United States has seen its share of extreme weather, from blizzards to superstorm Sandy. And, as seen, these extreme weather events can cause logistical nightmares. But what kind of impact can they have on medical devices?
To help ensure the quality and safety of medical devices throughout the supply chain during extreme weather events, the U.S. Food and Drug Administration (FDA) is seeking stakeholder input so that regulators, manufacturers, and the public can better prepare for these situations. In addition to a request for comment filed in the Feb. 21 Federal Register, the agency has announced an April 11 meeting of the Device Good Manufacturing Practice Advisory Committee to discuss this issue.
Specifically, the FDA wants comments on three potential scenarios related to device safety and extreme weather situations:
- Medical devices, including ventilators, infusion pumps, and dialysis machines, damaged while in use for ongoing patient care
- New or unused devices, components, or accessories damaged before use, while in storage, or during shipping
- Damage to manufacturing facilities or equipment
The agency also wants interested parties to address several questions related to extreme weather, including whether stakeholders have experienced any of the above scenarios; how manufacturers can minimize temporary shortages when existing inventory may be damaged; how companies have handled communications during inclement weather; and how the FDA can help industry better tolerate extreme weather.
“In protecting public health, it is important that the FDA and industry be prepared for extreme weather,” says Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, in a prepared statement. “Anticipating and planning for the challenges of extreme weather can help the FDA and medical device manufacturers minimize potentially dangerous effects on the safety, effectiveness, and availability of medical devices.”
The agency is accepting comments on these issues until May 10. To read the Federal Register announcement, please click here (PDF).
Posted: February 26, 2013