Recently FDA released a notice for request on comments regarding “Extreme Weather Effects on Medical Device Safety and Quality.” After all, it wasn’t long ago many felt the devastating effects of Hurricane Sandy. FDA Commissioner, Margaret Hamburg, M.D., noted that while many of us think of these major disasters in terms of property damage, FDA has a wider field of view. “At FDA we also have to focus on the effects of natural disasters on the safety of the products we regulate and those consumers and patients depend on – everything from fresh produce to canned foods to medicines and high-tech medical devices.”
The press-release on Federal Register notes that “extreme weather events and natural disasters can interfere with the manufacturing, shipping, storage, or use of marketed devices, which may lead to concerns with their safety or effectiveness.” The question at hand- How can FDA help minimize the impact of these events to protect the public?
To help guide those wishing to comment on FDA’s request for input, FDA lists three scenario topics relating to medical devices and extreme weather:
- Marketed Devices Already in Use for Patient Care
- New/Unused Devices, Components, or Accessories
- Damage to Medical Device Manufacturing Sites
FDA plans to use the information to help industry prepare and anticipate challenges that may occur as the result of extreme weather. In addition to the three scenario questions, FDA would also like to gain thought leader’s experiences regarding the following questions:
- In past EW situations, how was communication handled between the manufacturer facility and patients/users about the safe use of products during EW events? How did you provide/receive information about device failures? Do you have any suggestions for complaint handling during these situations?
- How can manufacturer’s best prevent or minimize temporary shortages of medical devices when EW may damage existing inventory or impact just-in-time production of critical components?
- Are there additional steps FDA can take to help industry anticipate, mitigate, or better tolerate the effects of EW? Are there steps that standards development or other professional organizations can take to support industry to optimally prepare for EW events?
So, whether FDA ensures patient safety through the rigorous review of submissions- or by FDA anticipating the impacts of extreme weather and disasters, keeping people save remains the #1 goal.
Do you have any experiences in this area? What are your suggestions to help keep patients save and minimize the effects on the medical device industry? Please share your experiences and recommendations below.
Photo Credit: Eimdal