FDA Recommends Healthcare Providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration (FDA) recommended (https://www.fda.gov/medical-devices/letters-health-care-providers/consider-alternatives-mri-guided-breast-biopsy-grid-plates-due-shortage-letter-health-care-providers?utm_medium=email&utm_source=govdelivery) that healthcare providers discuss alternative options for magnetic resonance imaging (MRI)–guided breast biopsy procedures with patients if a facility is unable to perform it because of a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.
FDA recommended that healthcare providers:
- Continue to schedule procedures if supplies are available.
- Discuss options with patients if MRI breast biopsy grid plates or other MRI coil disposables are not available.
- If supplies are unavailable, consider recommending an appointment at a facility where the procedure can be performed. The American College of Radiology maintains a list of breast MRI facilities (https://www.acraccreditation.org/accredited-facility-search) where biopsies may be performed.
- Contact Philips for questions or assistance with shipment delays and shortages of breast biopsy disposables using the company’s contact form (https://www.usa.philips.com/healthcare/resources/landing/mr-disposables-update#u59contactwidget=sales).
FDA reported that, on September 29, 2022, Philips informed customers of shipment delays and shortages of certain products (https://www.usa.philips.com/c-dam/b2bhc/master/landing-pages/disposable-products/list-of-disposable-products.pdf) in its portfolio of MRI coil disposables. The company instructed customers to contact Philips directly (https://www.usa.philips.com/healthcare/resources/landing/mr-disposables-update#u59contactwidget=sales) with questions or need for assistance.
FDA said it is working with Philips to resume deliveries and prioritize shipments to facilities in regions with no alternative imaging centers. Imaging facilities notified FDA of the shortage in July 2022, and FDA is working to identify contributing factors and mitigation strategies. FDA estimated that the shortage would continue through the end of 2022.
FDA added certain product codes associated with MRI breast biopsy grid plates to its medical device shortage list (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency#shortage). It is monitoring the shortage and will keep healthcare providers and consumers informed if new or additional information becomes available. If you are experiencing a medical device supply chain issues, contact FDA (https://www.fda.gov/medical-devices/medical-device-safety/contact-fda-about-medical-device-supply-chain-issue).
Healthcare professionals should report any adverse reactions or quality problems (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda) they suspect are associated with the devices to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.