May 15, 2013
ALTSA: ALF #2013-008
SAFETY RISK OF MEDICAL DEVICES
Dear Assisted Living Facility Administrator:
We recently heard about a death involving bed rails of an in-home personal care client. The purpose of this letter is to remind you about the safety risks associated with the use of medical devices. This letter replaces a letter sent out to assisted living providers in 2009 (BH#2009-016).
Not all medical devices are potentially dangerous for residents. However, some examples of medical devices with known safety risks when used include transfer poles, Posey or lap belts, and side bedrails. Potential risks of medical devices may include strangling, suffocating, bodily injury, skin bruising, cuts, scrapes, agitation, feeling isolated or unnecessarily restricted.
If you are using or considering the use of a medical device for a resident, review the following carefully:
- The resident assessment will include the resident's strengths and any needs for which a medical device might be considered. NOTE: The assessment identifies the resident's needs. Do not use the assessment to justify the use of the device.
- Ensure the resident's negotiated service agreement includes both the resident's needs and provides alternative interventions that support the needs of the resident and how best to keep the resident safe. Less restrictive alternatives are safer and should be implemented before using any medical device.
- Residents and/or family members must be provided with enough information about the significance and level of the safety risk of using the medical device to enable them to make an informed decision about whether or not to use the device.
It is always important to evaluate the safety of each resident and recognize the risks of using medical devices. For more information, the Federal Food and Drug Administration brochure, A Guide to Bed Safety, is available on the Department's ALF Professionals page under the heading "Side Rail Safety." If you have any questions, please contact your RCS Field Manager.
Sincerely,
Joyce Pashley Stockwell, Director
Residential Care Services