In December, FDA issued a draft guidance for the medical device industry and FDA staff on Design Considerations for Devices Intended for Home Use [3] to address growing concerns about medical devices being misused in a home setting.
The draft guidance document is a step in the right direction. A key idea of the guidance is that the home is not the only place that these devices will be used, and that significant design brain cells should be spent on imagining and planning for multiple use environments.
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| Devices such as the One Touch are likely to already be following the FDA's steps for home device development. |
The draft considers the risks for over-the-counter and prescription devices, the use environment, the device or system, human factors, and labeling. It provides recommendations for design and development, as well as postmarket considerations.
The document essentially operates to provide known standards and recommended practices in a single, unifying guidance for home use. As such, the nitty gritty of the guidance should be largely intuitive if you follow or plan to follow 21 CFR 820.30, AAMI HE 74, AAMI HE 75, ISO 14971, IEC 62366, and IEC 62304, to name a few.
The guidance is not dogma, nor is it intended to be. “It would actually be impossible for a manufacturer to follow all of the recommendations contained within the guidance,” says Steve Wilcox, principal of Design Science. “Some of them directly contradict each other.” Instead, says Wilcox, companies should seek to review the guidance and use the applicable practices for their own development. There aren’t hard and fast requirements, says Wilcox. “Manufacturers should not think they have to conform to everything.”
In some cases, the contradictions worry experts. For example, FDA's new guidance does not consider nursing homes to be home use environments. This is a departure from one of the source documents of the guidance, IEC 60601-1-11, which addresses medical electrical equipment in home settings. The IEC standard considers nursing homes to be home healthcare environments.
“It doesn't make sense for [FDA] to rely on the standard, and then go so off book from the scope of the standard,” Leo Eisner, president of Eisner Safety Consultant explains.
Eisner isn’t sure why FDA would make this change, but he thinks that it could cause problems for manufacturers. Essentially, he says, any departure from a known standard should be accompanied with a thorough explanation, because it causes confusion for both FDA and IEC reviewers. “It could set a manufacturer back if FDA's interpretation of product specs is different from the standards committee interpretation, because the Safety Agency may certify a Home Use Device for the Nursing Home Environment whereas the FDA's draft guidance doesn't allow for this.”
Eisner is currently drafting his comments to FDA on the discrepancy. A source from FDA confirmed that the Agency plans to update the guidance in its final version to better reflect recognition of IEC 60601-1-11. FDA recognizes a nursing home to be a clinical facility, but the nuance is in the enhanced definition of home use. Specifically, the device is designed and intended for use in a clinical facility, it is not be considered a home use device. However, if it is designed and intended for use in both a clinical facility and a non-clinical facility, it is considered a home use device.
On the whole, the home use guidance is a valuable resource for manufacturers. The 23-page document seeks to clarify options for manufacturers, and aid them in identifying and overcoming the myriad challenges of designing for a home use device. FDA acknowledges that there is more work to do.
The guidance is part of a larger initiative to provide resources to manufacturers to encourage the safe use of home medical devices. Key areas of this Initiative are as follows:
- Issue a draft guidance document for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home.
- Develop a labeling repository for medical devices that have been approved or cleared for home use (FDA will hold a labeling workshop April 29-30).
- Increase public awareness of the use of medical devices outside a clinical setting.
—Heather Thompson [4]