The Food and Drug Administration’s (FDA's) device center launched an initiative to promote at-home medical device development with a focus on health equity in at-home care.
It spent $1.2 million on the initial partnership, a spokesperson for the agency told Fierce Healthcare.
Lessons from the Home as a Health Care Hub could inform future regulation in the space and technology used in hospital-at-home programs.
The agency says the hub will help medical device developers, policymakers and providers develop and understand at-home medical technologies. The press release, attributed to Director of the Center for Devices and Radiological Health (CDRH) Jeff Shuren, M.D., said few at-home care options have optimally navigated the home environment.
“While many care options are currently attempting to use the home as a virtual clinical site, very few have considered the structural and critical elements of the home that will be required to absorb this transference of care. Moreover, devices intended for use in the home tend to be designed to operate in isolation rather than as part of an integrated, holistic environment,” the press release says.
FDA has paid nearly $1.2 million to Dallas-based architectural firm HKS Inc. to build a virtual reality model of a home. FDA says the VR model will help developers and policymakers better understand the structural elements of a home that could impact use of an at-home medical device. The press release says the first models will be focused on rural and low-income populations.
FDA has been considering how to ensure the safety of these devices since 2010, when the agency released a white paper on the topic. Though the FDA's lessons are nearly a decade and a half in the making, Krista Drobac, executive director of Moving Health Home, said the FDA is likely trying to further understand the extent of the use of at-home medical devices and software, which have rapidly evolved in recent years.
Some of the more recently evolved technologies include devices and software used for providing acute-level hospital care in the home. Many hospitals started offering these services during the COVID-19 public health emergency to free up overcrowded hospital beds. A source said the FDA has had trouble understanding the indications for use of at least one major software solution used for hospital at home. The new hub might help change that.
The launch of the initiative builds on information gathering FDA engaged in last year, a spokesperson for the agency told Fierce Healthcare: a request for public comment on at-home medical devices and a Patient Engagement Advisory Committee meeting.
In May 2023, FDA published a statement on its website saying that the agency’s authority to regulate medical devices alone would not fully ensure that at-home medical devices were safe. It also said that it had been receiving an increasing number of reports on bad outcomes from the use of at-home medical devices.
“CDRH regulates medical devices; however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home,” the CDRH’s website says. “CDRH wants to decrease the number of problems that occur in the home environment; but the issues are complex.”
In June, the FDA put out a request for public comment on medical devices intended for at-home use. A key issue raised in the public comments was how the FDA could support the development of such technologies. Stakeholders also asked about design attributes, equity and evidence generation.
At its September 2023 meeting, the FDA’s Patient Engagement Advisory Committee discussed accessibility of home healthcare and put out a lengthy report on its discussion, nearly half of which was dedicated to at-home medical devices.
The report notes the potential issues with home use medical devices like the need for intuitive design, safe use, automation bias, training of nonmedical device users, disability, less control over a home environment such as power losses, children and climate.
“Many of these challenges could likely be addressed through device design and more readable instructions and labels, and CDRH is placing a strong emphasis on encouraging and supporting innovators and manufacturers in this regard," the report authors wrote.
The report points to devices that would be particularly suited to home use including devices for pediatric seizures, maternal health, assistive technology for physical and cognitive impairment, in vitro diagnostics and chronic disease management.
FDA will be using diabetes as its test case for the hub due its disproportionate impact on minority populations.