FDA Cares: Tips to Prepare Your Medical Device Facility from Scary Summer Storms
Batten down the hatches; it’s just about hurricane season again. But take your eyes off The Weather Channel for a minute and think about chiming in with your best tips and strategies for protecting your medical device and its manufacturing facility from nasty weather. The FDA is going the preventive medicine route by asking industry to comment on how to best deal with extreme weather.
The FDA will collect input during a meeting of the Device Good Manufacturing Practice Advisory Committee April 11. It’s also posting a public docket that will be open until May 10.
The advisory panel meeting will focus on the impact of extreme weather on the medical device manufacturing chain processes and marketed medical device safety and quality.
This isn’t about heavy rain. FDA is looking for ideas on how to deal with big storms in at least three situations, including:
- devices in use for patient care;
- new or unused devices, components or accessories in storage or in the process of being shipped; and
- damage to medical device manufacturing sites.
To get you started, FDA has already compiled these tips:
- Keep your device and supplies clean, dry and secure.
- If you have a life-sustaining device that requires electricity, discuss with your physician.
- Know what you should do in the event of a loss of power, water, or phone service—before severe weather happens. Notify your local public health authority to request evacuation prior to adverse weather events.
- Always use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use (to minimize the risk of fire).
- If your device appears to be damaged or if you need a back-up device, contact your distributor or device manufacturer.
- Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power in your home at the main breaker.
- Maintain your device in a well-lit area so you can assess your device’s performance (e.g., refilling your insulin pump, checking your glucose meter).
- Always make sure your device is clean before you use it (e.g., syringes, mechanical devices).
- Store the backup equipment for your device (such as spare batteries and accessories) in the same location as the rest of your emergency gear.
- Keep backup batteries for your cellular phone. If there’s a problem with your medical device during an emergency, your phone might be your lifeline to let someone know that your device is not working, and more importantly, that you need help.
Sure, a lot of it is obvious, but it’s also obvious to remind people to floss and brush regularly. Mom was right: Good advice is usually worth repeating.