FDAnews
www.fdanews.com/articles/62513-at-home-medical-devices-raise-compliance-challenges

AT-HOME MEDICAL DEVICES RAISE COMPLIANCE CHALLENGES

September 14, 2006

Manufacturers of at-home medical devices should consider the unique human factors involved in using such devices, or face the risk of liability lawsuits.

Because of the high cost of healthcare and technology itself, at-home testing is a growing market, and a larger proportion of the overall device industry is being taken up by at-home devices, used for testing and diagnosis and care.

Pregnancy tests, ovulation tests, blood glucose monitoring systems and blood pressure machines are only the beginning of the shift to home healthcare devices.

While the FDA hasn't issued specific regulations addressing these devices, the agency in recent years issued guidance on how to appropriately design and label at-home medical devices to best account for human factors.

"Manufacturers must concern themselves with user interface, because there are always design issues that could lead to user error, and those risks are amplified when you're dealing with laymen working with the devices," said Dave Vogel, president of Intertech Engineering Associates, which consults with manufacturers on device design.

(http://www.fdanews.com/ddl/33_36/)