HQ Team
October 31, 2022: The FDA has told healthcare providers to consider different MRI-guided breast biopsy procedure options due to a shortage of grid plates and coil disposables.
The regulator stated there was a scarcity of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.
If a facility cannot perform the biopsy because of the shortage, the FDA recommends that healthcare providers discuss options with patients.
The providers must continue to schedule procedures if they have available supplies. “If supplies are unavailable…recommend an appointment at a facility where the procedure” can take place.
Philips statement
On its website, Philips stated on September 29, 2022, that it informs customers of shipment delays and shortages of certain products in its portfolio of MRI coil disposables.
The FDA is aware of the shortage and has worked with Philips to resume deliveries and prioritize shipments to facilities in regions with no alternative imaging centres.
“Imaging facilities notified the FDA of this shortage in July 2022, and we have been working with Philips to identify potential contributing factors and mitigation strategies.”
The shortage may continue through the end of 2022.
Devices shortlist
On October 31, 2022, the FDA added specific product codes associated with MRI breast biopsy grid plates to the devices shortage list.
Device manufacturers and users must comply with the applicable Medical Device Reporting (MDR) regulations.
Healthcare personnel employed by facilities subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
