The Food and Drug Administration (“FDA”) is seeking comments on a draft guidance entitled “Design Considerations for Devices Intended for Home Use.” The draft guidance urges manufacturers to “design out” product risks and consider usability and training for medical devices intended for use in a home environment. The deadline for submitting comments on the document is March 13, 2013.
The FDA says medical devices designed for use only in professional settings and by professional users are being used more frequently in home environments. Examples of these devices include infusion pumps, cold packs, oxygen supplies, CPAP machines, wheelchairs and walkers. The document lists risks associated with using these devices in the home, such as improper use, user error and problems with products interacting with the environment.
In the new draft guidance, the FDA tells manufacturers that if a product is intended to be used in the home environment, then it must be designed and labeled for easy and safe use in that setting. Key actions that the agency says manufacturers should take include:
- Addressing human factors related to lay users – formal training, education, cognitive skills, physical strength, how it will be used, etc.;
- Addressing environmental considerations, including the physical locations of where the device will be used and whether the environment is sterile;
- Designing devices that require little, if any, calibration;
- Ensuring wireless technology is compatible with other wireless uses in the home;
- Writing software that is user-friendly and easy to update;
- Designing cleaning procedures that can be followed using home supplies; and
- Effective training of both health care professionals and home users, followed by testing to ensure comprehension.
This draft guidance is part of the FDA’s Home Use Devices Initiative. The agency relied on input from the National Association for Home Care, the National Home Infusion Association and the National Family Caregivers Association in drafting the guidance. A copy of the draft guidance is available here.
If you have any questions about this topic, would like additional information about medical devices or home health care or need help preparing and submitting comments, please contact Todd Selby at 317-977-1440 or tselby@wp.hallrender.com, Mark Dahlby at 414-721-0902 or mdahlby@wp.hallrender.com, Kendra Conover at 317-977-1456 or kconover@wp.hallrender.com or your regular Hall Render attorney.
