Can-or should-medical device products and their supply chains be developed with worst-case scenarios like natural disasters or extreme weather events in mind? The US Food and Drug Administration (FDA) isn't yet sure, and has called on industry and the public to weigh in on its efforts to mitigate the effects of natural and weather disasters.
The idea that some patients, particularly those beholden to a medical device to support or sustain their lives, could be at elevated risk during extreme weather events or natural disasters (EW/ND) is not new to FDA. It has regularly put out warnings to consumers specific to the care of devices, along with basic tips on how to keep those devices functional.
In general, FDA's advice falls into one of two categories: Keeping the device secure/clean/dry, and making sure that the device is able to obtain power if it is necessary for it to function.
The problem is that with so many different types of devices, it's difficult to inform patients about the risks specific to their particular devices. A diabetes patient who takes insulin must take very different care of his or her needles and supply of insulin than must a person dependent on a supply of oxygen.
Anticipating the Worst to Prevent Shortages
So beyond warnings, FDA is trying to see if it might be possible to build disaster planning into good manufacturing practice frameworks to encourage-or perhaps even demand-that medical device manufacturers proactively address the risks and vulnerabilities of their devices.
"Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of EW conditions," FDA explained. That includes things like supply shortages of devices, spot shortages in disaster areas, and long-term disruptions resulting from quality problems after a disaster event.
FDA's now due to hold a meeting of its Device Good Manufacturing Practice Advisory Committee on 11 April 2013 to discuss the idea, as well as three distinct scenarios.
- In the first, a life-supporting device like a ventilator, infusion pump or dialysis machine is caught up in an extreme weather event, such as a hurricane.
- In the second scenario, an area is recovering from an extreme weather event, which has damaged stockpiles of medical supplies such as surgical gloves and temperature-sensitive devices.
- In the third scenario, the extreme weather event has damaged a device manufacturing facility, "limiting the number or quality of devices that can be produced until repairs are made," or otherwise interrupting power and supplies to the facility.
In all three of these cases, FDA is interested in assessing not only the risks that are present, but also how manufacturers might plan to mitigate the negative effects of the situation.
Nine Questions for Industry
To that end, FDA said it has nine questions it wants feedback on from members of industry:
- Have you experienced any of the scenarios or any other effects of EW on the safety and effectiveness of medical devices?
- How did you respond to extended periods of electrical or network outages or other events related to EW?
- 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 should industry optimize the design, production, and use of medical devices during and after EW events?
- How could products be monitored during transport and storage in light of potential interruptions and environmental extremes from EW events?
- How can manufacturers best prevent or minimize temporary shortages of medical devices when EW may damage existing inventory or impact just-in-time production of critical components?
- In what ways have EW events impacted your manufacturing site? What were the lessons learned during the recovery process as you returned to production? What changes were made as a result of the EW event?
- 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?
Comments should be submitted to www.regulations.gov (Docket No. FDA-2013-N-0118) by 10 May 2013.