Making Medical Devices Safer at Home

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Patients and consumers are using medical devices more often at home—not just in health care facilities. Many medical devices are now portable, and this feature enables patients to live active lives outside of the confines of the hospital room or treatment center.
“(Home use) devices once were designed only to keep you alive. Now they’re designed to keep you as independent as possible,” according to Mary Brady, MSN, RN, a senior policy analyst at FDA’s Center for Devices and Radiological Health (CDRH).

However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.

There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn’t hear an alarm on his ventilator signaling that the tubing had become disconnected.

FDA is working on ways to help consumers safely operate and maintain home use devices, which include blood glucose monitors, infusion pumps (a device that delivers fluids, including nutrients and medications, into a patient’s body) and respirators. These efforts include issuing a draft guidance document for manufacturers on the design and testing of devices intended for home use, and the development of clearer instructions for use.


Understanding the Instructions

Using a medical device at home is not as simple as it might sound. Brady explains that the device might not come with the written instructions that inform a home user how to operate it safely and how to know if it’s not working properly. Even if the device comes with instructions, the language used in the instructions might be too technical.
“If you can’t understand the directions,” said Brady, “it’s hard to be independent.”

While more medical devices are being specifically designed for home use, some devices used at home weren’t originally designed for use by the average person. “Devices are often designed for the health care professional to use in a clinical setting such as a medical office or a hospital,” says Brady.

Also, home use devices designed to be used in medical facilities—not homes—might be adversely affected by things found in a home environment, such as pet hair, well water or temperature variations.

Other challenges include the user’s and the caregiver’s physical and emotional health. People taking medications that affect their alertness or memory might have trouble using or taking care of their devices. Similarly, the emotional impact of caring for a loved one might influence the caregiver’s ability to use complex, high-maintenance devices.

Tips for Consumers

  • Know how your device works; keep instructions close by.
  • Understand and properly respond to device alarms.
  • Have a back-up plan and supplies in the event of an emergency.
  • Keep emergency numbers available and update them as needed.
  • Educate your family and caregivers about your device.
  • Frequently ask your doctor and home health care team to review your condition and recommend any changes related to your equipment.