When storms hit a populated area, like Hurricane Sandy did in late 2012, we usually think of devastation like what’s pictured above. We can imagine that it’s hard for emergency vehicles to get through, and that there’s chaos at hospitals across the affected areas.
But did you ever stop to think about how flooding and/or fire can affect the actual tools of the medical industry? Think of how many sterilized products go into just a simple, routine blood test, or even a throat swab. Now think about how you would perform these procedures when you’re entire storage facility has been flooded with rank stormwater, causing all of your hypodermic needles, gauze and other implements to be completely useless.
In fact, today the U.S. Food and Drug Administration has publicly asked for input from both the medical industry and the public on how extreme weather and natural disasters affect the production and supply of medical devices. Once collated, the FDA will use the information to identify steps that the agency, manufacturers and the public can take to prepare for these events. And whether you believe that global warming exists or not, you have to admit that these severe storms and natural disasters are happening more and more frequently, so this is a problem that we’re happy to see the FDA addressing.
According to the FDA’s press release today, extreme weather and natural disasters “can interrupt the manufacturing and distribution of medical devices and affect their safety, quality and availability. For example, flooding and fire can damage facilities where sterile products are stored; electricity outages or lack of access to filtered water can stop or slow down medical device production; or large storms can disrupt the shipping and distribution of medical devices or the materials and components used to make them.” These aren’t things that we, all the way out here in California, realized was happening during a storm like Sandy.
On April 11, 2013, the FDA will collect input during a meeting of the Device Good Manufacturing Practice Advisory Committee and also through a public docket announced today in the Federal Register. The docket will stay open until May 10, 2013 for public comment.
This advisory panel meeting will focus on how the medical device manufacturing-chain processes and marketed medical device safety and quality are impacted by extreme weather, and through the public docket, the agency is calling for comments on the effects of extreme weather on the following:
- 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.
If you work in a hospital, doctor’s office, assisted-living facility or any other location where sterile and/or electronic medical devices are used and have had hands-on, work-related experience with an extreme weather event, we encourage you to comment on this docket—not just for your patients’ safety, but for the safety of victims across the world. The panel meeting and the call for comments are part of an ongoing effort on the part of the FDA and the federal government to improve disaster preparedness efforts.
During and after extreme weather and natural disasters, the FDA offers the following recommendations for medical devices.
- Keep your device and supplies clean, dry and secure.
- If you have a life-sustaining device that requires electricity, discuss with your physician 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.
If you have medical equipment at your home or office and need assistance in putting a comprehensive plan together in case of extreme weather, natural disasters or accidental fire or flooding, please call us immediately. We can help you be prepared for the worst, should it ever happen. Call now for an appointment; our experienced technicians are standing by: (877) 732-8471