“Home medical devices once were designed only to keep you alive but now they’re designed to keep you as independent as possible” according to Mary Brady, MSN, RN, Senior Policy Analyst at FDA’s Center for Devices and Radiological Health (CDRH).
The FDA has been concerned that consumers may sometimes be dependent upon medical devices that they may not know how to operate and they may not understand the safety risks. There have been serious and even fatal problems reported to FDA associated with medical devices used at home.
FDA is working on ways to help consumers safely operate and maintain home use devices such as blood glucose monitors, infusion pumps, and respirators. The FDA has issued a draft guidance document for manufacturers on the design and testing of devices intended for home use and has developed clearer instructions when the devices are used.
“Using a medical device at home is not as simple as it might sound” as Brady explained. “The device might not come with written instructions that tell a home user how to operate the device safely and how to let the user know if it is not working properly. Even if the device comes with instructions, the language used might be too technical.”
While more medical devices are being specifically designed for home use, there are some devices used at home that weren’t originally designed for use by the average person. “Devices are often designed for the healthcare professional to use in a clinical setting such as a medical office or a hospital” says Brady.
In addition, home use devices designed to be used in medical facilities and 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. The ECRI Institute an organization that evaluates medical products and processes has found that poor usability were among the top ten health technology hazards of 2012. Examples include users having difficulty with the start or stop button on an infusion pump or the inability to hear different types of alarms in other rooms in a house.
In 2010, the FDA launched their Medical Devices Home Use Initiative. So far, the FDA has:
· Issued a draft guidance document for manufacturers that describes factors to consider when designing, testing, and developing home use devices
· Asked device makers to consider the user’s physical condition, consider emotional issues, consider the training needed to use the device, and the home environment where the device will be used
· Requested that user-friendly instructions be included and also how to handle the device in an emergency
· Requested that Visual Learning Guides use mostly pictures. The first two guides will be produced over the next two years and will focus on the proper containers to be used to dispose of sharp objects
· Explored the feasibility of making device labeling available on the internet
· Created a list of recommended practices, regarding the use of patient lifts to reduce the risks associated when transferring patients from one place to another
Go to www.fda.gov/ForConsumers/ConsumerUpdates/ucm330943.htm for more information.