We have been getting many calls from our practitioner members concerned that their use of the bioSCENAR® may be illegal.
Our written advice from the Assistant Director of the Devices Vigilance and Monitoring Medical Devices branch of the Therapeutic Goods Administration dated 24th August 2017. In it she clearly states:
“Devices purchased prior to the cancellation may still be used unless they were recalled. If a device had been recalled it should not be used. There have been no recalls for this device.” The cancellation occurred in January 2017. Therefore, if you purchased your device before that date, you are legally able to use your device.
From January 2017, “the device can no longer be lawfully supplied or advertised by a sponsor, distributor or retailer; users of the device will also be unable to advertise that they use this particular device.”
To summarise, if you purchased a bioSCENAR before January 2017, you can continue to use it but you can’t advertise that you use this particular device.
The Association has been in direct contact with RITM OKB in Russia. They described the circumstances of the withdrawal, which was not entirely under their control, and have assured me they are in the process of restoring TGA registration for this device. RITM OKB are continuing to invest in improvements and changes to their devices and expect that with the Bio’s re-listing, there may be more enhancements to it. The process may take some time.
RITM OKB have created an open door policy towards any RITM SCENAR user member of our association. If you have any queries or questions that you wish to address directly with them you are invited to contact Marina Gdalevich in Russia. We have her contact details here, if you would like them.