AAMI News September 2019

For Hurricane Season, FDA Offers Safety Tips for Medical Devices

HurricaneAt the peak of hurricane season, the Food and Drug Administration (FDA) has offered tips to safeguard medical devices before, during, and after hurricane and related disasters. This is a good time to check your disaster plan to make sure it covers all the bases.

If you manage devices used in homes, consider sharing these tips with users.

Hurricane season lasts for six months each year, from June 1 to Nov. 30, according to the National Weather Service (NWS). Hurricanes, which originate in the Atlantic Ocean, Caribbean Sea, Gulf of Mexico, and Central Pacific Ocean, “are among nature’s most powerful and destructive phenomena,” according to the NWS. “Over a typical two-year period, the U.S. coastline is struck by an average of three hurricanes, one of which is classified as a major hurricane (winds of 111 mph or greater).”

Hurricanes—and less powerful tropical depressions and tropical storms—pose hazards to life and property, according to NWS. Hurricanes can do damage in many ways: coastal and inland storm surges, flooding, high winds, tornadoes, and high surf and rip currents. “During natural disasters and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity,” according to the FDA.

The FDA’s tips cover general safety, power outages, water contamination, sterility, re-use of medical devices, and dealing with heat and humidity. The FDA also offers a warning about potential carbon monoxide problems while using generators, and special information about using blood glucose meters. The tips are applicable not just to hospitals and other healthcare facilities, but to medical devices used in homes.

From the FDA:

General Safety

  • Check 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 at the main breaker.
  • Maintain your device only in a well-lit area so you can assess your device’s performance (e.g., refilling your insulin pump, checking your glucose meter).
  • Check your device for pests before you use it (e.g., syringes, mechanical devices).

Power Outage

  • Read your user instructions or call your distributor or device manufacturer to find out if your device can be used with batteries or a generator.
  • Check for water before plugging in your device. Do not plug in a power cord if the cord or the device is wet.
  • When the power is restored, check to make sure the settings on your medical device have not changed (often medical devices reset to a default mode when power is interrupted).

Water Contamination

  • Use only bottled, boiled, or treated water until your supply is tested and found safe.
  • If you use bottled water, be sure it came from a safe source. If you do not know that the water came from a safe source, you should boil or treat it before you use it.
  • Boiling water, when practical, is the preferred way to kill harmful bacteria and parasites. Bringing water to a rolling boil for one minute will kill most organisms.

Sterility

  • When performing medical procedures, maintain a clean environment by using bleach, alcohol, or a disinfectant in the area you are working (e.g., catheter changes, dressing changes, suctioning).
  • Check sterile packaging to make sure it is dry and intact (e.g., sterile gauze). If the packaging is wet or damaged, do not use the product inside.
  • When you purchase supplies, always check the packaging to make sure it hasn’t been damaged.

Re-use of Medical Devices

  • Do not reuse a medical device intended for single use.
  • If you find that you need additional single use products, contact a healthcare provider or emergency response personnel.
  • If you need to reuse a device that is intended for multiple uses (e.g., infusion tubing, syringes), the device must be cleaned and disinfected or sterilized according to the device manufacturer’s instructions. Devices should not be boiled unless explicitly allowed on the product label or instructions for use.
  • If you have supplies that are intended for multiple use with your medical device, follow the appropriate procedures for cleaning and disinfecting.

Dealing with Heat and Humidity

  • Use a dry cloth to wipe off your device regularly (e.g., mechanical infusion pumps).
  • Keep your device out of direct sunlight.
  • Enclose your medical products in plastic containers to keep them dry (e.g., wound care supplies).
  • Do not use ice if there is a danger of water contamination; use dry ice or instant cold packs to keep your device cool (e.g., prefilled syringes).
  • Do not use disposable devices that are wet (e.g., wound dressings, disposable thermometers, tubing).

See the full list of FDA tips here.


Find out how healthcare technology management professionals responded to the Camp Fire blaze in Paradise, CA, in an AAMI video, available at www.aami.org/wildfire.