January 12, 2005

To: Hospital Chief of Medical Staff, Nursing homes and Long term care centres.

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.

The French Health Products Agency, Agence francaise de sécurité sanitaire des produits de santé (AFSSAPS) and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) have both reported incidents in which patients were trapped under variable height hospital beds with electric foot switch controls^1,2,3. In France, there were 24 incidents, six of which have resulted in patient deaths, while in the UK there was one reported incident which also led to patient death. The incidents are reported to have been more frequent at night, and to have occurred most frequently in geriatric and long term care facilities. In most cases, the patients involved were disoriented, weak or agitated.

These foot-operated electric switches may be located either on the floor near the side of the bed, or in the bed frame itself, slightly above the floor. Unintentional activation of the foot switch usually occurs when patients fall to the floor and apply weight to the foot switch with some part of their body. The bed then lowers and traps or crushes the patient. The patients are not coherent enough to realize they are causing the bed movement, and they are not agile enough to move out from under the bed before they are trapped. Several incidents also occurred when health care staff were cleaning or moving the bed.

The AFSSAPS concluded that the only way to prevent such incidents is to disable the foot switches, and it has recommended that manufacturers or user institutions do so. The AFSSAPS indicates that manufacturers have also agreed not to market in France any new electric beds with a foot switch that presents a risk of entrapment.

In the UK, the MHRA has provided a list of factors to consider where electric beds are used and also indicates that while lock out controls and covers or guards on foot pedals can reduce the risk of the foot switches being accidentally operated, users may want to consider removal of the foot switches if the risk posed by them is considered too great.

No similar incidents have been reported in Canada. At least one hospital bed with electric foot switches, the VersaCare^TM4 made by Hill-Rom, is known to be sold in Canada. The VersaCare^TM bed has safety features intended to prevent accidental activation of the foot switch and entrapment under the bed. VersaCare^TM beds were not reported to have been involved in the incidents in France. Older Borg-Warner beds that may still be in use in Canada may also have had foot switches but there is no evidence these were involved in the reported incidents in France; additionally their foot switches may have been located at the foot of the bed rather than along the side of the bed where they would be more accessible to the patient.

There are design features that could contribute to the reduction of the risk of accidental activation and health care facilities should consider all of these factors when assessing the safety of the beds. Examples of safeguards that may minimize the risk of accidental activation include, but are not limited to:

• optical sensors that detect the presence of an object under the mattress deck;
• a timer that deactivates the foot switch after a period of inactivity;
• a cover over the pedal to prevent accidental contact.

Should your facility have beds with electric foot switches, Health Canada recommends the following:

• immediately assess the need for the feature and evaluate any design considerations that might minimize its risk. Discuss any safety features with the manufacturer.
  
  
• if a decision is made to deactivate this function, do so only by following a procedure specified by the manufacturer. If this procedure is not included in the user or service manual for the bed, contact the manufacturer for instructions.
  
  
• if the manufacturer is no longer in business, the safest approach is to deactivate the foot switches.
  
  
• leave the bed in its lowest position when the patient is unattended. This is also a wise precaution to minimize injuries resulting from patient falls out of the bed.
  
  
• immobilize or lock out the bed's height adjustment when cleaning.
  
  
• lock out all electrical functions when moving a bed that has a battery.

Additionally, Health Canada advises health care facilities not to purchase beds with electric foot switches that control the bed height unless these switches have safeguards to prevent accidental activation.

The identification, characterization, and management of medical device-related adverse
incidents are dependent on the active participation of health care professionals in adverse
incident reporting programmes. Any occurrences of accidental activation of the variable height or other serious and/or unexpected adverse incidents with patients using beds with electric foot switches should be reported to Health Canada at the following address:

References:

1: http://agmed.sante.gouv.fr/htm/alertes/filalert/dm030205.pdf

2: http://afssaps.sante.fr/htm/alertes/filalert/dm040402.pdf

3: http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings/
FD9423476F5FCA8E80256EE8004D86B9?OPEN

4: http://www.hill-rom.com/canada/offering/products/beds_versacare.html#