The rapidly growing home health industry has raised new safety concerns about devices being used in the home setting and is leading FDA to reassess its regulatory oversight of such products, agency officials indicated at a meeting in Houston last week.
"Despite the fact that there is a lot of activity in this area and we've seen a lot of progress, I think we all want more devices that are designed and specifically tested for home use," Dan Schultz, director of CDRH said Sept. 17 at a meeting on home health care at the University of Houston.
"We want better and more consistent review criteria," he said.
CDRH's Home Health Care Committee hosted the Sept. 17-18 meeting in collaboration with the university to discuss with stakeholders the safety concerns that are surfacing as patients - and their devices - move out of the hospital and into the home (1"The Gray Sheet" June 11, 2007, p. 5).
Home-use devices range from simple equipment such as canes and wheelchairs to sophisticated items such as glucose meters, ambulatory infusion pumps and laptop-sized ventilators.
According to Patricia Patterson, president of Agilis Consulting Group, homecare medical devices are the fastest growing segment in the device industry; the market is expected to double in size by 2011.
Device Migration Into Home Creates New Concerns
Although manufacturers need FDA approval to market a device over-the-counter directly to a patient or specifically for home use, there are few restrictions on whether a physician can send a patient home with a device that is not specifically labeled for use in the home.
"Certainly that is something that has been done in the past, is still being done, and frankly for which there is no good regulatory answer," Schultz said.
From a manufacturer's perspective, "One of the biggest concerns ... is that legacy devices, old products that were used in the institution that may have been replaced by newer versions, are now migrating into the home because they're available," said Susan Morris, VP-government affairs for wound care technology firm Kinetic Concepts. "But they aren't products that we originally designed for use in the home." Morris was speaking at the meeting on behalf of AdvaMed.
Another worry is that patients are using devices for which the FDA-approved labeling and instructions for use are either missing or are not intended for a non-clinician user.
The home-use issue has become even more troubling, several noted at the meeting, due to provisions passed by Congress in the Deficit Reduction Act of 2005, which requires Medicare patients to purchase certain durable medical equipment after a limited rental period (2"The Gray Sheet" Jan. 2, 2006, p. 12).
EBay is a likely repository for all of the patient-owned equipment once it is no longer needed, suggested Ruth Ann Ellison, home health equipment provider Apria Healthcare's national director for accreditation, licensing and credentialing.
With patients potentially selling or giving the equipment they own directly to other patients, it will be increasingly difficult to ensure that the devices making it into homes are well-maintained or come with appropriate instructions, she said.
"That is a concern that as an industry we need to look at."
Human Factors And Supplier Control
KCI's Morris stressed that industry at least has the obligation to make sure that products meant to be used in the home are designed and marketed appropriately.
Products used in the home should be designed specifically for use by patients and non-clinician caregivers, she said. Human factors engineering, which relates to reducing the risk of user error, is an important consideration.
Manufacturers redesigning institutional products for home use should take out all functionality that is not necessary in the home setting, while adding appropriate new features such as patient alarms or therapy monitors to ensure patients adhere to prescribed protocol, she explained.
Further, Morris stressed the importance of manufacturers having tight control over the distribution of their products.
Few manufacturers of home health care devices sell their products directly to patients. Rather they rely on distributors and suppliers, which can create a certain disconnect from a device's end use.
KCI is an exception to the rule - it both manufactures and distributes its V.A.C. negative pressure wound therapy system and bed surfaces.
Morris noted that the complexity of the devices contributed to KCI's decision to become a supplier as well as a manufacturer "because of this intense burden of clinical research, training, education and support."
As for the majority of manufacturers who sell devices for home use through a third party, Robert Floro, director of homecare accreditation at the Joint Commission, noted that "progressive" firms are increasingly requiring distributors to meet certain training requirements to ensure their devices will be used in a safe and effective manner.
"I think that's their greatest sphere of influence and that's their greatest hammer," Floro said of manufacturers. "They can certainly elevate the culture of quality and safety within our industry by simply requiring their distributors to meet certain expectations."
FDA Signals Some Near-Term Responses
Meanwhile, in the next six months FDA hopes to invite manufacturers to participate in its new online labeling repository for home-use devices. The voluntary repository, which will initially focus on infusion pumps, will give consumers access to the most up-to-date instructions for specific models.
The agency is also preparing to launch a sub-network of its MedSun adverse event reporting program called HomeNet. Participating home health agencies will be encouraged to report to FDA adverse events, including close-calls, related to devices used in the home setting.
Schultz also said that it was possible that new regulations and even legislation might be necessary to deal with the some home health safety issues, but he was short on detail about what precisely that would entail.
- Chloe Taft
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