Health Canada Endorsed Important Safety Information on Vail Enclosed BedsJul 20, 2005 | Health Canada To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of Surgery, Emergency Medecine, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and other involved professional staff and post this NOTICE in your institution.
Subject: Potential patient entrapment in Vail Enclosed Beds
Health Canada has recently become aware of safety concerns with all models (500, 1000 and 2000) of Vail enclosed beds sold by Vail Products based in Toledo, Ohio. There have been some entrapment incidents and deaths reported in the United States, but none in Canada. Due to actions taken by the US Food and Drug Administration (USFDA), Vail Products has decided to cease operations. Information regarding the USFDA’s action is described at:
New Window http://www.fda.gov/bbs/topics/NEWS/2005/NEW01196.html.
The actions by the USFDA affects all models of Vail enclosed beds, i.e. models 500, 1000 and 2000. There are reports of 30 entrapment incidents, including 8 deaths, with more than half involving children. Adverse events are often under-reported.
Health Canada has performed a safety evaluation of this bed and has concluded that provided you have a retrofit kit (an accessory attached to all sides, head and foot of the bed to improve safety) properly installed on the bed and follow recently released revised user instructions, the bed does not present an unreasonable risk. Any bed manufactured after July 25, 2002, would have had this improvement provided at time of manufacture.
For other beds, the company made the kit available to users. Vail’s records indicate that less than half the beds sold in Canada have had the kit installed. Revised labelling and instructions for use have been provided by Vail to all Canadian and US customers on June 17, 2005. Users who opt to continue using the beds are advised to follow these new instructions.
Health Canada advises customers that since they can no longer obtain the retrofit kits or revised user instructions from Vail, they should follow Health Canada’s recommendations in this document as well as the revised instructions for use (see item 11 under Safety Precautions below).
HEALTH CANADA RECOMMENDATIONS
If your bed is not equipped with the manufacturer’s retrofit kit, we advise you to use another bed system. Should you decide to continue using the bed without a retrofit kit installed, we urge you to pay particular attention to the safety precautions further below and seek medical advice on the continued use of the bed. These safety precautions should be followed whether you have the kit installed or not.
To determine if you have a retrofit kit, please refer to the pictures at the end of this letter. Note: model 500 beds were provided at time of manufacture with only the end rails. Shim bars for all model beds can be obtained by contacting Mr. Rick Vail at R.C. Medical at (419) 862-2883. Please note that even with the kit installed, this bed, like many medical beds, can present some risk of entrapment. There have been some reports in the U.S. of incidents, including deaths, with beds equipped with the kits, although many were associated with improper kit installation or improper use.
Health Canada recommends that you ensure that the retrofit kit, if shipped separately, was properly installed. There have been reports of improper assembly of the bed itself. Please verify that all assembly instructions were properly followed. R.C. Medical may provide some assistance with questions about installation.
1) Use these beds only for patients who are at least 114 cm (45 inches) tall and who weigh at least 21 kg (46 lbs).
2) Do not use these beds for the following types of patients: Those with burrowing tendencies; those with violent, aggressive, combative, or suicidal behaviour; those who have tubes or monitoring cables attached; or those who have excessive PICA eating disorder. (People with pica frequently crave and consume non-food items such as dirt, clay, paint chips, plaster, etc.)
3) Use only a Vail mattress or a mattress with the same technical specifications as the Vail mattress (size, construction, density), to reduce potential entrapment between the mattress and bed canopy.
4) Keep the bed’s Hi-Lo feature in the low position while the patient is unattended and ensure that when the bed is lowered, the canopy is taut; it should be pulled down if necessary to eliminate pockets that could lead to entrapment.
5) Leave the back rest section lowered when the patient is unattended, unless head elevation has been ordered by a physician. Be aware that a gap forms between the back rest of the mattress support platform and the canopy when the back section is raised.
6) Keep the bed’s knee function in the low position while the patient is unattended, unless knee elevation has been ordered by a physician. Be aware that a gap forms underneath the mattress support platform when the knee function is raised.
7) Always leave the side rails in the raised position, except when the patient is being attended to or moved from the bed.
8) Always leave the end rails in the raised position.
9) Always keep the canopy zippers fully closed and locked. Never leave a patient unattended while the cover is unzipped.
10) Ensure that the mattress is kept centred on the mattress support platform. When this platform is articulated, with the head or knee functions raised, the mattress may move lengthwise. As well, the patient’s movement, if substantial and forceful, may cause the mattress to move sideways. These movements may increase the gaps between the edges of the mattress and the canopy. Always ensure the mattress is centred on the platform, and visually check its position when repositioning the mattress support platform to a flat position.
11) Review the revised instructions for use and labelling, and note the contraindications for the bed. This new documentation contains additional safety precautions to those listed above. The new labelling and revised user manuals, which the company recently mailed out to all registered owners of the bed on June 17, can be downloaded from Health Canada’s web site at the following address:
Health Canada continues to monitor the situation and will provide further communication if appropriate. Should you have any incidents to report with this bed, please contact the Health Products and Food Branch Inspectorate at 1-800-267-9675.
Should you have any questions or concerns, you may contact Dr. Roland Rotter, Director of the Medical Device Bureau, Health Canada at telephone 613-957-4786.