HME Draws FDA Interest; Conference Set in Houston

HOUSTON–With the aim of promoting the safe use of medical
equipment in the home, the U.S. Food and Drug Administration is
partnering with the University of Houston to sponsor a conference
for HME stakeholders Sept. 17-18.

“Home Healthcare Technology: How Safe is Your Medical Device
When Used at Home” will feature two days of speakers and
discussions on topics ranging from respiratory therapy and infusion
devices to screening devices used in the home. The conference will
also address the need for updating HME that does not require FDA
regulation (walkers, wheelchairs, hospital beds, etc.).

The conference was sparked by increasing reports of adverse
effects from medical devices used in the home, according to the
FDA’s Center for Devices and Radiological Health, which is mandated
to regulate medical devices. Conference officials noted “the
challenge lies in safely operating medical devices in the home that
were initially approved for use in a clinical setting by health
care professionals.”

That is, in fact, a key concern about Medicare’s plan to pass
ownership of oxygen concentrators from HME providers to patients
after a 36-month rental period. The industry is seeking repeal of
the provision, which is part of the Deficit Reduction Act, through
passage of H.R. 621, the Home Oxygen Patient Protection Act.

“CDRH wants to decrease the number of problems that occur in the
home environment,” the agency said in announcing the conference.
“To be successful, the government agencies involved in home care
need to collaborate with relevant stakeholders: manufacturers,
distributors, health care professionals, health care organizations,
accrediting bodies and human factors experts.”

The agency wants to bring all the parties together to “identify
the problems with a safe migration into the home, identify barriers
to change and discuss meaningful technology and other actions that
will promote the safe use of devices in this environment.”

Another catalyst for the conference is the anticipated growth in
home health care.

“As the U.S. population ages, home health care will grow by
leaps and bounds,” said Isaac D. Montoya, clinical professor in the
UH College of Pharmacy and the conference moderator. “Home health
care and the medical devices needed to sustain it provide a welcome
respite for patients and their care providers who want to benefit
from safe medical treatment in a home environment. As this
phenomenon continues to grow, however, the FDA, industry and home
care interest groups may need to better collaborate to assure the
safety of products for home use.”

The conference will be held at the Hilton UH Hotel and
Conference Center. For information, go to http://www.uh.edu/pharmacy/hht/.

For information on the Home Oxygen Patient Protection Act,
click here.