May 15, 2013
ALTSA: ICF/IID 2013-002
SAFETY RISK OF MEDICAL DEVICES
Dear ICF/IID Administrator/Superintendent:
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 ICF/IID superintendents in 2009 (ICFMR#2009-005).
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 are considering the use of a medical device for your resident, please 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.
- Assessment data must identify the extent to which the device would impact the resident's functional status.
- A device should not be used as a substitute for programs or therapy which may reduce dependency on the device.
- Residents must be taught to use and to make informed choices about the use of medical devices.
- The facility must ensure that the devices are in good repair and working order.
- Residents or their legal guardians must be informed of the risks associated with use of the medical device, including acceptable alternatives if available.
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 ICF/IID 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