TGA Review of Electromagnetic Chairs for Urinary Incontinence
The TGA Medical Devices and Product Quality Division has undertaken a review of its regulation of electromagnetic chairs for urinary incontinence, following USANZ and RACS, with support from RANZCOG, raising this an item of concern at the TGA Womens Health Products Working Group.
The Division has now published a report on this topic. In summary, the report states:
- The TGA does regulate these devices under a lower class of nonimplanted medical device (class IIa)
- They are considered low risk and on this review the TGA has no safety concerns for this device type
- Many have entered the ARTG having met conformity from comparable overseas regulators (COR)
- It is appreciated by the TGA the clinical evidence base has been modest with some studies suggestive of a similar performance to pelvic floor muscle training
Regarding whether they should be used or supported by MBS rebates in Australia, the TGA does not assess whether a device is cost effective as part of inclusion in the ARTG, moreso evidence to support device safety, and establish benefits outweigh undesirable effects for its intended purpose.
The TGA remains interested in advertising to consumers, such as unsubstantiated claims of benefit. If USANZ members note inappropriate noncompliant advertising of electromagnetic chairs, they should report it to the TGA who will investigate.