The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs

Growth in Home-Use Devices Reveals Gaps in Training, Safety Controls

Jan. 24, 2014

Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. That’s the conclusion of a new report by the Association for the Advancement of Medical Instrumentation.

“The regulations, care processes and payments for device use in the home are built on a very old model that never anticipated the kind of home care being provided today,” the report says. “These challenges, along with inadequate safety testing, make it difficult to ensure that medical devices used in nonclinical settings are safe.”

The report, which draws on discussions at last fall’s AAMI/FDA summit on healthcare technology in nonclinical settings, examines major issues in home use of devices and identifies five “clarion themes” for follow-up.

The key regulatory challenge, according to the report, is to “standardize and simplify.” What is needed is a universal regulatory framework for devices used outside the clinical setting that incorporates healthcare, medical devices, IT, telecommunications and transportation. The FDA should work with other organizations to develop a certification process for devices that are safe for home use, the report adds.

Also needed is a deeper understanding of the variety of use environments. This requires more research and analysis of home-use environments and best and worst practices, AAMI says. The FDA’s MedWatch should also be primed for information on adverse events, challenges and near misses involving home-use devices. Responsibility for reporting problems should be shared by manufacturers, distributors, providers and payers, the report says.

The report also urges AdvaMed to work with the Centers for Medicare & Medicaid Services, private payers and others to create improved homecare delivery models for patients with varying needs, the report suggests. Training on home-use equipment should also be improved. Currently, many patients and caregivers are trained by the person who delivers the device, one summit participant pointed out.

To this end, manufacturers should design training instructions for lay users, with a worst-case scenario in mind, get input on training design from a diverse group of home users and test training with users before release, the report says.

Training should also cover maintenance, accessories and consumables; alarms and emergency contacts; the potential for utility failures; and a toll-free number. Manufacturers should take a multimedia approach to training and consider cultural, social and economic differences in their plans, the report says.

Industry should “adopt a systems approach encompassing people, workflows, therapies, technologies and payment to redesign the full spectrum of healthcare in nonclinical settings,” the report adds. Priorities include the development of biological sensors and other systems that communicate wirelessly and creation of a medical equipment management plan that covers all aspects of use, including recalls. Manufacturers should focus on developing smart durable medical equipment with signaling and sensing capabilities, the report says.

Finally, companies should strive to make home-use devices more user-friendly. This may mean conducting human factor assessments with intended users early in the design process. Adhering to standards on human factors engineering and usability engineering and standardizing device interface instructions for use formats could also help to achieve this goal, AAMI says.

When designing your products, it’s always good to think ahead about what kinds of needs it might serve in the future as well. Meanwhile, Investigations Operations Manual 2013 will help you design and validate your products to the FDA’s specifications. Order your copy here.