Providers across the country have recently experienced surveys with an emphasis on the risks of enabler bars (assistive devices). These devices are being cited as restraints (F221) or potential/actual accidents (F323) due to the risk of entrapment. It is important to know that the regulations related to restraints and assist devices has not changed. Surveyors have been educated on the risks associated with these devices and instructed on how to determine if facilities are utilizing them appropriately.
Surveyors are citing assist devices on beds when they do not have:
- A physician’s order
- Proof of medical symptoms being treated
- Proof the device is the least restrictive and/or the rationale as to why it is the least restrictive if no other device was trialed
- Attempts at reduction and/or rationale why reduction has not been attempted
- Risk/benefit analysis including the specific risks related to the resident’s condition
- Informed consent signed by the resident or legal representative
- Documented entrapment zone measurements including measurements of the resident body parts per FDA recommendations ( www.FDA.org )
- A care plan addressing use and risk reduction interventions
All devices attaching to the bed should be measured for entrapment zones. Only devices meeting FDA guidelines should be used and only devices intended for use in a facility (i.e. do not use equipment intended for use at home). Do not allow the use of devices that slide under the mattress; these devices tend to shift during use and measuring entrapment zones will not be accurate.
Any devices attaching to the bed – side rails of all sizes, halo bars, enabler bars, etc. – present risk for entrapment that can result in death or maiming. The rate of loss and injury associated with devices attaching to beds remains relatively unchanged since 1999 when the FDA established the Hospital Bed Safety recommendations. This injury rate is due to the prevalence of use, not measuring entrapment zones, family/resident requests in absence of verified evaluation, equipment modification not in accordance with manufacturer guidelines, families bringing in rails that slide under the mattress, etc. Plaintiff attorneys are well versed in side rail requirements for Skilled Nursing Facilities and Assisted Living Facilities and claims are often filed by family members even if they provided the device or demanded its placement.
Side Rails and Restraints Recommendations
Ensure a physician’s order is in place specific to the assistive device/restraint. The order should contain the type of device, the medical symptoms being treated, when the device should be used, when the device should be removed/not in use. Safety is not a medical symptom and should not be used to justify use. The facility must be able to justify that the resident’s condition supports the use of the specific device.
- Ensure PT/OT assesses the assist device/restraint and documentation supports that less restrictive devices have been trialed and why it was not successful. If the device recommended is not the least restrictive, documentation should reflect the rationale for its use. There is no specific regulatory language defining duration of trials; be realistic and have a process that is consistently used.
- Ensure a risk benefit analysis is conducted/documented for any assistive device/restraint in use including side rails and enabler bars.
- Informed consent should identify all risks associated with the use of these devices up to and including the risk of death AND that no device on a bed is “safe”.
Ensure side rail entrapment zones are measured per the FDA’s guidelines.
- Review/download these guidelines for measuring entrapment zones: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072662.htm
- Use this site for references and suggestion: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/default.htm
– Do not adapt equipment unless specified per the manufacturer’s guidelines. This includes “portable rails” designed to slide under the mattress. Permanently affixing these devices to the bed frame is not recommended by the manufacturer.
– If an enabler bar, or other assistive device, is used on one side of the bed, use mattress clips or similar product to reduce risk of the mattress sliding to the side with no device, leaving entrapment zones between the assistive device and mattress.
Do not use assistive devices/restraints not intended for use in a Skilled Nursing Facilities or Assisted Living Facilities (i.e. do not use devices marketed for home use).
Educate residents and family members on the risks/dangers and benefits as needed.
Evolucent continues to promote quality of care in the least restrictive environment for all residents. If you should need additional assistance regarding assist devices/side rails please contact your Evolucent Risk Manager at 734.996.2700 or go to healthcapusa.com for additional resources.