Making Medical Devices Safer at Home

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Understanding the Instructions

Working on Providing Resources

Tips for Consumers

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 These efforts include issuing a draft guidance document for manufacturers on the design and testing of devices intended for home use, and the development of clearer instructions for use.
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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.
Usability is a critical factor in the design of medical devices. It refers to the extent to which people can use their medical device safely and effectively to accomplish specific tasks. The ECRI Institute (formerly the Emergency Care Research Institute), an organization that evaluates medical products and processes, has found that poor usability is among the top 10 health technology hazards of 2012.
Examples include users having difficulty with the start/stop button on an infusion pump or the inability to hear different types of alarms in other rooms in a house.
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Working on Providing Resources

In April 2010, the FDA launched the Medical Devices Home Use Initiative. The agency has been working since then to develop information and resources for manufacturers, health care professionals, patients (home care recipients), consumers and caregivers. These efforts include:

Issuing a draft guidance document for manufacturers that describes factors to consider when designing, testing, and developing home use devices, focusing on the realities of how people use their devices at home. FDA is asking device makers to consider factors such as the user's likely physical condition, emotional issues like anxiety, necessary training, and the home environment that might have children and pets. This document also addresses the development of user-friendly instructions, including how to handle the device in an emergency.

Designing Visual Learning Guides, using mostly pictures. The first two guides will be produced over the next two years, and will focus on containers for the disposal of sharps, (needles, syringes, and lancets) and patient lifts (used to move disabled or injured people).

Exploring the feasibility of making device labeling available on the Internet.

The agency has also created a list of recommended practices regarding the use of patient lifts. These devices are increasingly used in the home to transfer patients from one place to another, such as from bed to bath. These recommendations are designed to reduce risks associated with the use of these devices, such as falls.
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