When a medical device is designed , it ’ s critical that human factors and the end user be considered . As more patients receive medical care outside hospitals and nursing homes , the reality of modern care settings should influence the design of devices and other supplies we need to keep patients healthy .” — Marcus
Schabacker , MD , PhD
ECRI says that these problems can be avoided or risks that can be minimized through the careful management of technologies . Let ’ s review some of these top health tech hazards for 2024 .
Usability challenges with medical devices in the home
This is ECRI ’ s No . 1 issue on this year ’ s hazards list .
In 2010 , the Food and Drug Administration ( FDA ) launched the Medical Device Home Use Initiative to support the safe use of medical devices in the home . As part of that initiative , the FDA issued the document , “ Guidance for Industry and Food and Drug Administration Staff : Design Considerations for Devices Intended for Home Use ,” to encourage manufacturers to take into consideration a range of factors when designing , testing , and labeling home use devices to optimize their safe use in the home and other non-clinical settings . Included in this guidance are steps that manufacturers can take to design and test devices for use in the home , and to develop user-friendly instructions ( labeling ) for home care recipients , consumers , and caregivers . The guidance is intended to improve the design and quality of home use devices to reduce errors that may occur during use . It provides recommendations that consider the device user , the use environment , the device itself , and its labeling .
There are myriad key considerations related to medical devices used in homecare delivery , including :
●Patients should understand how the device works by reading the patient education information
●Homecare providers should also understand how the device functions
●There should be an understanding of what is needed to operate your device ( such as electricity , running water , telephone , or computer connections , etc .)
●The home should be suited for the device in terms of electrical wiring , any special space accommodations , etc .
●There should be an understanding of any alarms and / or error messages
●There should be informational access to the medical device supplier / manufacturer
●Report to any problems with the device to the consulting physician of the medical service supplier
●Operate the device according to the manufacturer › s instructions
●Understand how the medical device should be cleaned , batteries or filters replaced , etc . as regular maintenance
●Maintain appropriate supplies that may be associated with the medical device
●Report any serious injuries , deaths , or close calls to the FDA and the supplier
As the ECRI report ( 2024 ) explains , “ The trend toward providing healthcare in the
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february 2024 • www . healthcarehygienemagazine . com •