The Therapeutic Goods Administration (TGA) has issued a warning to all Australian state and territory health departments following concerns that a product called the All Day Sling is being routinely misused within the confines of nursing homes, residential homes, and hospitals around the country.
Despite its name, the ‘All Day Sling’ has only been approved to assist in the lifting and transferring of patients and is not supposed to be used for prolonged periods of time, but unfortunately, it appears that this is not always the case.
When used correctly, the sling is placed underneath patients in beds or wheelchairs and then attached to a lifting device which is used to transfer that patient, but there have been reports of patients being left in the sling for hours in between transfers and actually developing pressure sores from this process.
Pressure sores have suddenly become a hot topic in healthcare space, as new research from the University of New South Wales recently indicated that the common practice of repositioning people every two-hours does not prevent bedsores from happening and that disrupting people’s sleep to reposition them may actually be a form of abuse.
The All Day Sling is made by Arjo Australia, who is a global supplier of medical devices, and in a statement provided to HelloCare, Arjo Australia addressed some of the recent concerns over their product.
“We are investigating the issue, including its naming, in detail internally and with the TGA. Patient safety is crucial to Arjo and we continuously work to ensure that products are used in the intended manner,” said a spokesperson for Arjo Australia.
“We take all concerns related to patient safety seriously, and are investigating this issue both internally and with the TGA.”
“Arjo is investigating this issue in detail, and will always work to ensure that patient safety is prioritized. Once the investigation is complete, we will make any amendments deemed necessary.”
“The All Day Sling has not been removed from the market as it is an approved and safe Patient Handling product. However, we are investigating the issue in detail internally and with the TGA.”
A spokesperson from the TGA told HelloCare that they recently launched an ‘investigation’ into the device and that they are currently “seeking further information on the device from both the sponsor and manufacturer.”
“Following consultation with the TGA, Arjo Australia Pty Ltd issued a Safety Alert to its customers which reiterates that use of the All Day Sling does not supersede or replace existing protocols for prevention and management of pressure injuries. Following approval, the TGA provided a copy of the Safety Alert to State and Territory health departments on 14 May 2019.”
“Arjo Australia Pty Ltd has been reminded of its obligations under the Advertising Code including that advertising material must align with the Instructions for Use for the device,” said a TGA spokesperson.