The Growing Use of Consumer-Grade Medical Devices: Advice for Physicians and Their Patients
August 7, 2019 | Evaluations & Guidance
More and more patients are interested in monitoring and maintaining their health by themselves, and they are investing in a wide range of consumer products to enable them to do so. At the same time, healthcare is shifting from the inpatient hospital environment to the home environment, largely due to the escalating costs of health services and hospital stays. Both patients and physicians are increasingly looking to consumer medical products to help provide some level of care in the home when a traditional medical device is inappropriate, too expensive, or inconvenient. There is also recognition that the data from consumer devices can be useful in clinical management. This article will help facilities assist their patients in selecting and using consumer products safely, appropriately, and with a proper understanding of both the benefits and limitations of the technologies.
On the web pages linked below, FDA defines three relevant (and overlapping) groups of devices that are used for healthcare applications:
Medical device: "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals." This group includes a wide range of products from bandages to CT scanners to pacemakers.
Home-use medical device: "A device intended for use in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a health care professional in order to be used safely and effectively." This includes devices intended for use in both professional healthcare facilities and homes; a physician prescription is usually required for the use of these devices. Some examples are durable medical equipment like...