FDA guidance on bed-safety regulations expected soon
The Food and Drug Administration hopes to make hospital and nursing home beds safer with its soon-to-be released recommendations for dimensions of bed systems used by patients in nursing homes, hospitals and home care settings. Though not specifically mandating new bed styles or the discarding of existing bed systems, many expect the government's guidance to spark new manufacturing processes and, eventually, new rounds of buying.
"The purpose of this guidance is to provide manufacturers of hospital equipment with recommendations on how to make beds safer for certain patients," said Mary Lou Pijar, general health scientist, FDA's Center for Devices and Radiological Health. "It's our hope they will use this guidance to assess current bed designs as well as designs they may have for new beds."
Developed through a partnership between the FDA and the Hospital Bed Safety Workgroup (HBSW), which includes representatives from the medical bed manufacturers industry, national healthcare organizations, patient advocacy groups and other federal agencies, these dimensional guidelines will provide bed manufacturers with criteria to enhance bed safety, according to Pijar.
Legacy of harm
Since its inception in 1999, the HBSW has strived to develop measures and programs to improve bed safety for patients who are most vulnerable to side-rail entrapment.
Between January 1985 and January 2004, as many as 575 entrapments were reported to the FDA, as required by the Medical Device Reporting Act. Of these cases, 358 resulted in deaths. In addition, the FDA said it suspects information regarding entrapment incidents is severely underreported.
While the FDA guidance will focus on recommendations primarily for bed manufacturers, Pijar said the dimensional guidance will be useful to nursing home providers and hospitals in assessing and identifying possible risks involved with "legacy," or existing beds and equipment.
Often a bed system purchased by the facility may be considered appropriate for frail, elderly patients at risk for entrapment, but over time, as equipment such as the mattress and side rails are changed or added, patient safety is at risk, according to Beryl Goldman, a licensed nursing home administrator and director for Outreach, The Kendal Corp., a not-for-profit.
Kendal, through its affiliate Untie the Elderly, an educational and training program for providers of long-term care to the elderly, offers workshops, training manuals and videos dedicated to eliminating physical and chemical restraints in nursing facilities.
In addition, early last year the HBSW released "Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long-term Care Facilities and Home Care Settings," a document that does not necessarily advocate the removal of all side rails but promotes better assessment, as well as more caregiver and patient education on so-called safety rails, bed rails or bed side rails. The guidelines, can be found at www.ute.kendal.org. The new dimensional guidelines from the FDA will primarily offer recommendations for entire bed systems for bed manufacturers.
Will this mean beds will be required to look drastically different in the future?
"I don't think so," said FDA's Pijar. "The intention is anything but to disrupt the entire hospital bed community."
The American Association of Homes and Services for the Aging has been a member of the bed-safety workgroup since its inception. "We continue to support the efforts of this group to improve resident/patient safety and offer both providers and manufacturers more and better tools for education, assessment and design," said Evvie Munley, AAHSA senior health policy analyst.
More trouble in nursing homes?
The FDA's dimensional guidelines will fit hand in glove with forthcoming HBSW recommendations and tools for assessment at the facility level, according to Goldman. For example, once the FDA guidelines are released, the workgroup plans to offer a cone/cylinder that can be used in making in-house equipment assessments.
Goldman predicted that long-term care facilities may uncover more trouble spots than hospitals because nursing homes tend to keep their beds longer, make more modifications to bed systems and have a larger frail, elderly patient population.
Adapting to the FDA recommendations does not, however, mean an across-the-board increase