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Planning vital when using patient handling slings
Medical Devices Safety Update
Patient handling slings are a vital resource to make patient transfers safer for both staff and patients, but processes must be adhered to, in order to maintain skin integrity and prevent injury.
Patient handling sling use is the standard of care to transfer and transport dependent or immobile patients, (such as those with spinal cord injury), to and from their beds or wheelchairs. These mechanical lifting devices have been shown to prevent health worker injuries, e.g., back injuries, but no substantive literature demonstrates their safety with respect to skin integrity for at-risk patients.
Transferring individuals with patient handling slings can expose them to high interface pressures. Interface pressures are independent of the sling type or manufacturer, but appear to depend on anatomy, type of device and time spent in the device. Interface pressures are maximal while individuals are suspended in a sling. Therefore, the duration of suspension should be limited.
The anatomical areas exposed to high pressures while participants are utilising a sling or hoist device include the posterior upper and lower thighs, groin and knees when in seated slings and the tissues of the peri-sacral area, buttocks, and greater trochanters in supine slings.
Pressure area injuries
Pressure area injuries, such as pressure ulceration, are a serious, costly, and potentially life-long complication experienced by immobile individuals.
The National Pressure Ulcer Advisory Panel (pdf,473kb) defines a pressure ulcer (PU) as a "localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction". High pressure applied to an area of skin over a length of time will inevitably cause tissue damage in addition to tissue deformation. PUs are most commonly found over and around bony prominences, locations where interface pressures are the greatest. The majority of PUs are found in the gluteal and sacral regions, principally at the ischial tuberosities, sacrum and coccyx.
The use of patient handling slings needs to be undertaken in conjunction with consideration of interface pressures, regardless of time spent using the device. The care and handling of patients in these devices requires appropriate adherence to recommendations regarding the prevention of pressure area injuries.
Regardless of where the slings are being used, systems should be developed with consideration of local circumstances and the individual risks, roles and resources of each facility or private location.
Develop prevention plans
Pressure injury prevention plans based on best practice guidelines should be used as these can improve a patient's outcome. Effective pressure injury prevention plans rely on the assessment of risk, the identification of all potential risks, and the development of tailored prevention plans for at-risk patients.
Prevention plans are not static and should be reviewed and repeated whenever there is a change in the patient's condition or environment.
A pressure injury prevention plan should include, but is not limited to:
- implementing skin protection strategies
- considering the nutritional needs of a patient
- consideration of the need for constant low pressure redistribution support surfaces
- regular re-positioning
- appropriate input from allied health team members (for example, dieticians for nutritional advice and pharmacists for medicines review)
- patient education.
Currently, there is a lack of high-level evidence examining how allowing slings to remain under patients potentially affects pressure ulcer development. Clinicians and carers are therefore tasked with using this limited evidence and their clinical assessment to make this determination. Systematically each clinician or carer must review their patient care assessment against the physical features of the sling to be utilised. For example, design features such as prominent, thick seams or clips would clearly provide localised pressure points pose risk to PU formation. At all times, regard to potential interface pressures should be paramount considerations in the care of an immobile patient.
In consultation with the TGA, Arjo issued a Safety Alert for its slings made of 'All Day' material. The term 'All Day' refers to the material the sling is made from rather than an advised mode of use.
While the Arjo All Day Sling is intended to allow the patient to be seated on it for longer periods of time i.e. between patient transfers, the use of this sling between transfers does not supercede or replace facility protocols and appropriate clinical assessment of the patient.
While using the Arjo All Day Sling, as with any sling, a proper care plan must be established based on clinical best practice and care judgment which includes regular inspection of pressure points, turning schedules and repositioning intervals where appropriate for 'at risk' patients.
It is important that any part of the sling that creates a pressure point - hooks or clips etc - not be left under the patient.
There have not been any reports of Arjo All Day Sling causing or contributing to any pressure injury.
Arjo is working with the TGA to co-ordinate the distribution of updated Instructions for use (IFU). The words "All Day" have been removed and appropriate warnings have been added to the IFU. Arjo is required to confirm to the TGA that all customers have received the updated IFU.
- Pressure Injury Prevention Points
- Do Lift Slings Significantly Change the Efficacy of Therapeutic Support Surfaces? (pdf,473kb) A National Pressure Ulcer Advisory Panel White Paper
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS) or contact the TGA's Devices Post Market Monitoring Section on 1800 809 361.
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing email@example.com
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
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