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Compliance In Focus
Posted by John Lehmann on Wed, May 8, 2013

FDA Asks for Medical Device Industry Feedback

FDA Asks for Medical Device Industry FeedbackThere are only four days left for the medical device industry to provide comment, as requested by the FDA, on the topic of extreme weather conditions and medical device safety and quality. Hurricanes, floods, earthquakes, and tornados can pose potential interference with the manufacturing, shipping, storage, or use of marketed devices which is a cause for concern for the safety and effectiveness of devices.

The Device Good Manufacturing Practice Advisory Committee met April 11, 2013 to discuss the use current regulation and policy to address risks and vulnerabilities of extreme weather conditions to the manufacturing chain for medical devices. The FDA is opening up discussion by requesting industry feedback and comments the three following scenarios:

  • Device already in current use in patient care that can be damaged due to extreme weather, such as a ventilator.
  • Devices that can be damaged while in storage or during shipping, as in surgical gloves.
  • Damage to manufacturing facility or equipment, which would then result in limited quantity or quality of devices until repairs can be made.

Additionally, FDA is asking for information on the following questions of the medical device industry:

  • Have you experienced extreme weather conditions effecting medical device safety or effectiveness and how did you respond to periods of electrical or network outages?
  • At times during extreme weather conditions, how was communication handled regarding the medical devices affected?
  • How can products be monitored during transport and storage during or following an event of extreme weather?
  • What can manufacturers to do to prevent disruption in the care, storage, or manufacturing of a device during an extreme weather event?

Comments are due to back to the agency by May 10, 2013. The FDA has not set a further timeline for expected review of industry feedback or when policy can be expected to be released. However, it is promising that the agency is looking for expert input in consideration of how to move forward in preparation when extreme weather conditions.

Have you as a patient, family member of a patient, or a professional involved in the industry been affected by extreme weather conditions that disrupted health care? Do you know if other countries have similar policies that the FDA could use as a starting block for new policies or guidelines? Please comment here.

Photo Credit: Fairy Heart

 

Product Accountability in Clinical Trials

Topics: Weather, FDA, Medical Device Industry

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