Patients are leaving hospitals quicker these days, continuing treatment and recovery ? often with the aid of medical devices ? at home. As a result, the government and home care industry together must work toward providing a safe environment for the use of medical devices in the home.
The U.S. Food and Drug Administration and the University of Houston are addressing this issue at an FDA conference ? ?Home Health Care Technology: Promoting the Safe Migration of Medical Devices into the Home? ? cosponsored by UH Sept. 17-18 at the Hilton UH Hotel and Conference Center.
Anyone wishing to attend should register at http://www.uh.edu/pharmacy/hht/. The fee is $99 for the two-day event, featuring a variety of presentations, panels and breakout sessions. Continuing Education Units are expected to be offered and are currently under consideration.
Both prescription and over-the-counter medical devices are regulated by the FDA?s Center for Devices and Radiological Health (CDRH). Much of 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.
?As the U.S. population ages, home health care will grow by leaps and bounds. The technology, entertainment, communication and finance sectors are combining their efforts to create products that allow elders to continue living in their homes,? 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.?
Another area examined will be ?vulnerable populations,? such as the very young and the elderly, as well as those patients with complex birth defects, chronic diseases and terminal illnesses. Included in these various subgroups are disabled children with multi-symptom diseases (i.e. cerebral palsy) who require a multidisciplinary approach; elderly people with problems such as poor vision, hearing loss, physical weakness and cognitive impairments that limit their independence and ability to properly use devices; patients from different ethnic backgrounds who may have communication problems or cultural blocks to understanding device technology; and the chronically ill from rural areas, low-income families or foster care with few outreach services and transportation options.
?Attendees will be able to talk directly with government officials, affording participants an opportunity to influence government policy,? said Mary Brady, CDRH Home Healthcare Committee and conference chair. ?This conference is a unique opportunity and should not be missed.?
Additional topics to be covered include respiratory therapy for patients with disorders such as sleep apnea and chronic lung problems; risk management in the home of issues that address human error (i.e. misuse of equipment) and environmental (i.e. electromagnetic interference) factors; the need for updating durable medical equipment (i.e. walkers, wheel chairs, hospital beds) that do not require FDA regulation; creating a device-labeling repository that would provide easy online access to device instructions; and the evolution of over-the-counter devices such as cholesterol meters and continuous glucose monitors that were once ?for professional use only? and now approved for home consumer use. Accreditation, reimbursement, nursing practices, infusion therapy and governmental roles also will be discussed.
The conference is designed to benefit institutional officials, medical personnel with an interest in home health care and patient advocates, as well as graduate and undergraduate students. Home health care technology experts will give presentations in multiple plenary and general sessions that will follow a technology, governmental or clinical track for specific device groups.