THE Therapeutic Goods Administration (TGA) has launched a post-market review of continuous positive airway pressure (CPAP), Bi-Level PAP devices and ventilators on the Australian Register of Therapeutic Goods (ARTG).
The review followed the announcement of a recall of ventilators, CPAP and BiPAP devices supplied by Philips Electronics Australia (PD 06 Jul), after risks were identified relating to a polyester-base polyurethane foam used as soundproofing material.
As part of the review the review the TGA is asking sponsors of all ventilators, CPAP and BiPAP devices listed on the ARTG for more information about the type of soundproofing material used, the manufacturer's risk assessment, and whether the devices pose any unnecessary risk to the user's health during normal use.
The above article was sent to subscribers in Pharmacy Daily's issue from 16 Aug 21
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 16 Aug 21
