Home-Use Medical Devices: FDA Workshop

February 25, 2011

By Meredith DeZutter

A few weeks ago I attended a workshop convened by the FDA as they begin the process of drafting a document for the FDA titled “Medical Device Home Initiative.” The purpose of the workshop was for the FDA to gather industry opinion in helping them with future definition of Home Medical Devices. The workshop was well attended by human factors consultants as well as large medical device companies who are concerned about how future regulations will guide them.

Ximedica designed and manufactured the Zeo® Sleep Manager™ for at-home use.

The document under development will establish guidelines for manufacturers of home use devices, provide recommendations for labeling, and support home use. The FDA currently defines a home use device as “a medical device intended for users in a non-clinical or transitory environment, that is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a licensed health care provider in order to be used safely and effectively.”

The first part of the day was devoted to talks on key topics that will affect regulation and included information on: defining the users (the patients as well as their caregivers), key characteristics of the home environment, labeling concerns, and an overview of current technology and trends, with an emphasis on the use of wireless technologies.

The afternoon was devoted to break-out sessions where groups were formed to flush out the issues surrounding each category. Here is a summary of some key topics and insights:

  • Home medical devices may be too complex for the education level, emotional stability, cognitive and physical abilities, as well as the lifestyle of many patients and/or their caregivers. Additionally, many home use devices do not come with instructions written for a non-clinical person.
  • Home environments are unpredictable in their: level of cleanliness, size, presence of children and pets, temperature and humidity control, electromagnetic interference, and types of electrical outlets. They are also not typically prepared for power and water outages.
  • The FDA has not fully defined all the different types of home use devices, but it expects the definitions and formats to change and evolve as home health care becomes more prevalent. The current FDA definition includes everything from: equipment for specific diseases/conditions such as infusion pumps to things as basic as an iPhone app that provides nutrition guidance for an obese patient. This range shows that moving forward, technologies and equipment that we think of as purely in the consumer realm, like an iPhone, may require FDA approval if they are used by people in the home who have an episodic or chronic medical condition. This will mean that usability testing and proper human factors analysis that is required for current medical devices may also be required for consumer devices in the near future.

Moving forward, the FDA will be synthesizing the feedback from the workshop and continue to define what a home use device is (and likely have different classes of devices) and continue to refine guidelines. This is an area in which I have a great deal of interest, and will continue to post insights and information in this space in the future.