Date: 1997-03-20

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

Contact
MDB Enquiries

---

March 20, 1997. No. 109

TO: Hospital and nursing home administrators and home care providers.

To the attention of: nursing, CCU/ICU, biomedical engineering, maintenance, occupational health and safety, materiel management, housekeeping and laundry staff.

SUBJECT: Incidents Involving Patient Lifts

Since 1981, Health Canada has received reports of 11 deaths and over 50 injuries related to the malfunction, failure, or misuse of patient lifts in Canada. In the United States, there have been over 41 deaths and 443 injuries reported to the US Food and Drug Administration since 1985.

In 1996 alone, Health Canada received reports of seven incidents resulting in injury involving the malfunction or misuse of six different brands of mobile floor patient lifts. The injuries included one death, one skull fracture, and five cases of less serious injuries involving mostly minor bruising. Four of the incidents involved the release of the sling from the lift or the failure of the sling itself. In three of those four incidents, an unbalanced load caused by an improperly positioned patient leaning to one side or moving around was confirmed or suspected as the cause.

Further investigations of these incidents revealed the following scenarios for the various brands (see figure 1):

• the patient fell to the floor when straps attached to the hygiene sling (see figure 2) released or the sling ripped at the strap.
  
  
• the patient was dropped from the lift when the gravity-activated locking clip which holds the sling onto the bar apparently failed. The clip may open when the load becomes unbalanced, allowing the strap to slip out of the bar.
  
  
• the sling slipped out of the spreader bar during use; the patient was reported to be moving while in the lift.
  
  
• the toileting sling used was too large for the patient, and the patient's arms were not placed outside the sling as indicated in the sling's instructions. The patient fell through the opening of the sling, hitting her head on the floor.
  
  
• the patient fell when a leg from the base of the lift separated from the rest of the lift after a split pin holding the leg pivot broke.
  
  
• a failure of the lift's hydraulic mechanism used to raise and lower the patient resulted in a sudden drop of the jib.
  
  

In view of these incidents, Health Canada recommends that hospitals, nursing homes and home care providers take the following safety measures (see figure 1):

1. Ensure staff are adequately trained and receive regular reviews on the safe use of patient lifts, following the manufacturer's directions.
   
   
2. Examine before each use, all lift support systems to ensure that they are structurally sound. Examine components including slings and chairs for any signs of wear. For example, examine slings for frayed material or weak stitching, and check straps, chains and hooks used to attach the sling to the lift. If wear is noticed, replace the component immediately. Also examine all hooks to ensure that they will not unhook during use, even if the load is unstable. Note that holding or supporting the patient while in the sling or chair may allow straps or hooks to disengage.
   
   Also check that the lift can be propelled in a normal manner, making sure that the castors are in good condition and are free in their movements. Check that all external fittings are secure and that all screws and nuts are tight. Ensure that all safety labels are firmly attached and in good readable condition.
   
   
3. Follow the manufacturer's maintenance instructions at the required intervals and as required by the health facility's maintenance procedures for that device.
   
   
4. Follow the manufacturer's cleaning instructions for slings and chairs. Strong bleaches or other disinfecting agents may weaken fabrics and cleaning products may also weaken the base of permanently mounted lifting devices.
   
   
5. Use slings and other lift accessories that are either original equipment or compatible with the brand and model of lift being used. Ensure that the accessory is suitable for the application and is of the appropriate size and strength for the weight of the patient. Also make sure not to exceed the overall maximum rated load for the lift.
   
   
6. When using a sling (see figures 2 and 3 for examples of these), ensure that the patient's limbs are properly placed as per the manufacturer's instructions in order to help secure the patient.
   
   
7. Ensure that any belts and/or restraining devices used to secure the patient are sufficiently tight.
   
   
8. Never leave the patient unattended in a lift.
   
   
9. Instruct the patient to remain motionless while being lifted to reduce the chance of lift instability.
   
   
10. Ensure that the base of the lift is kept as wide open as possible to maintain its overall stability. If the width of the base must be reduced in order to go through a doorway, ensure it is re-opened afterwards. Note that some lifts may become unstable if they are pushed and pulled by the jib or mast; always use the device's handles designed for this purpose.
    
    
11. Do not move the lift with a patient in it over a threshold. In such a case, move the patient in a wheelchair or stretcher.
    
    
12. Take care when moving an unloaded lift over raised thresholds or unevenness in the floor so as not to damage its base or tip it.
    
    
13. Do not use the lift to transport the patient for long distances. If moving the patient over short distances, ensure that the patient is kept in the lowest position possible to help maintain the lift's stability.
    
    

Health Canada has contacted the manufacturers involved in the above reports in order to discuss corrective actions. Health Canada is also participating on a Canadian Standards Association (CSA) committee drafting a standard to improve the safety of lifts and their use.

Inquiries concerning these incidents and reports of similar problems should be addressed to the Director, Drugs and Medical Devices Directorate, Health Canada, Tunney's Pasture, Address Locator 0301H1, Ottawa, Ontario, K1A 0L2. Telephone: (613) 957-4786, Fax: (613) 957-7318. Medical device problems may also be reported through the toll free Medical Devices Hotline at 1-800-267-9675.

The Health Canada and Medical Devices Internet websites are at:
http://www.hc-sc.gc.ca/dhp-mps/index-eng.php and
http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php

Figure 1

Figure 2

Figure 3

Dr. J.Z. Losos
A/Assistant Deputy Minister

---

Addendum
Medical Device Alert 109
Incidents involving patient lifts, March 20, 1997

January 2001

This addendum provides an update on developments related to several issues mentioned in Medical Devices Alert 109.

1. Transporting patients over long distances

The Alert states, in recommendation 13: "Do not use the lift to transport the patient over long distances. If moving the patient over short distances, ensure that the patient is kept in the lowest position possible to help maintain the lift's stability."

Some users in health care facilities have asked for clarification regarding what is meant by "long distances". This recommendation was meant to address hazards when transporting a patient from one room to another via a hallway or elevator.

In lifts of older design, the combined centre of gravity of the lift and patient was high, and the lift's wheel base was fairly narrow. Either of these conditions could lead to instability. It has been brought to our attention that some lifts are now designed to transport patients safely over long distances. Therefore, recommendation 13 should not be taken to discourage long distance transport with all mobile lifts. Such a decision should be taken carefully by the health care staff, bearing in mind the factors mentioned above that can lead to instability.

2. CSA standard on patient lifts

The Alert also mentions that Health Canada was participating on a committee of the Canadian Standards Association (CSA) that was drafting a standard to improve the safety of lifts and their use. This standard, CSA Z323.5-98 "Mechanical/Electromechanical Lifting Devices for Persons" was published in 1998 and is available from CSA International by calling 416-747-4044, or 800-463-6727, or going to CSA's on-line store at
http://www.csa-intl.org/onlinestore/welcome.asp.

The cost is $70.00. Payment may be made by cheque, money order or credit card.

Please note that this standard is NOT a regulation; it is a voluntary standard. However, should a patient lift become the subject of an investigation by Health Canada, the Department would take into consideration the requirements of this standard when evaluating the lift's safety and effectiveness as required by the Medical Devices Regulations.

3. ISO standard on patient lifts

In 1998, the International Organization for Standardization (ISO) also published its standard, ISO 10535, "Hoists for the Transfer of Disabled Persons - Requirements and Test Methods". It is currently being revised, and once this process is complete, CSA will review its own standard to determine whether it can be harmonized with the revised ISO standard.