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.

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