FDA Releases Final Guidance on Designing Medical Devices for Home Use

Posted August 5, 2014

The U.S. Food and Drug Administration (FDA) has issued a hotly anticipated document that details considerations manufacturers should take into account when designing medical devices that will be used in homes.

The final guidance, part of the FDA’s Home Use Devices Initiative, covers a range of design-related topics, including environmental considerations such as temperature, storage, and travel and international use. It also includes sections on user considerations, human factors, and labeling.

A draft version of the document was issued Dec. 13, 2012 and prompted comments from many in the industry, including the trade association AdvaMed, UL (Underwriters Laboratories), and leading device and diagnostic companies Johnson & Johnson (J&J) and GE Healthcare.

“After we received comments back on the draft guidance, we found that industry concerns were similar, as we received several comments on the same section,” said Mary Weick-Brady, senior policy advisor at the Center for Devices and Radiological Health.  “Their questions, edits, and comments to the draft guidance were thoughtful, well documented with references, and beneficial to the final product.”

AdvaMed was among those that commented on what many had characterized as  vagueness with some of the terms used in the draft document. It asked the FDA to define a lay person as someone without specialized knowledge or training, separating the concept from “user.” The agency did adopt language along those lines. Other comments, including those submitted by J&J, asked for an expanded definition of home use device. The FDA expanded the definition to include examples of environments outside the healthcare facility in which these products may be used, such as offices, schools, and emergency shelters.

Other comments expressed concern about the use of the terms “childproofing” and “tampering” in the environmental considerations section.

“Stakeholders brought these terms to our attention,” said Brady.  “They strongly suggested we change ‘childproofing’ to ‘child resistant.’”

GE Healthcare was among those that suggested the use of childproofing could put too large of a burden on manufacturers. “The term ‘childproofing’ implies that the manufacturers are required to eliminate all hazards that may be associated with the potential access to the device by children. This standard is not achievable in practice.” The company suggested including language that device makers should consider the dangers posed to children during the design phase.

The draft version also included a provision saying, “Home-use devices should be resistant to tampering.” AdvaMed called for a change of wording, as it is “unlikely a device can be ‘resistant’ to all tampering.” The advocacy group also questioned how the agency intended to evaluate tamper resistance.

In response to industry concerns, Brady said the FDA removed the two subsections covering these topics and put in the following sentence into Section VI. User Considerations: “You should consider that children or adults might interact with the device in inappropriate ways.”

Human factors is a major consideration when designing home-use devices, as users and their caregivers don’t have advanced training to handle the devices. The draft document included a provision calling on industry to provide ways to verify that users are getting the retraining they need.

In its comments, J&J called this requirement “not practical,” pointing out that users often don’t respond to requests from companies. It also highlighted that making such requests to users, whose identities often aren’t known by the manufacturers, might run afoul of the Health Insurance Portability and Accountability Act.

While the final document emphasizes the importance of training, it doesn’t include a sentence calling for the verification of retraining.

AAMI has worked to bring the topic of home healthcare technology to the forefront.  Last fall, the association and the FDA hosted the two-day summit titled Summit on Healthcare Technology in Nonclinical Settings, whose findings are included in a report.  In addition, AAMI has a hot topics page devoted to the topic with a variety of free resources.