Medical Device Shortages

FDA Update

As the Medical Device Shortage List Grows, the FDA Alerts Patients and Health Care Providers of Alternatives and Temporary Strategies

Here are two recent reportable shortages of medical equipment.

(1)        REUSE TRACHEOSTOMY TUBES OR SWITCH TO APPROPRIATE ALTERNATIVES DURING SHORTAGE – FDA SAFETY COMMUNICATION

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited. It is commonly used in pediatric patients because the tube is made from a flexible silicone material, which makes them easier to insert in pediatric patients.

The FDA added tracheostomy tubes to the medical device shortage list (see product code JOH – Tube Tracheostomy and Tube Cuff and product code BTO-Tube, Tracheostomy (w/wo Connector)). The medical device shortage list shows the types of devices the FDA has determined to be in shortage. The FDA will continue to update the list as needed.

The FDA will keep the public informed if significant new information becomes available. In addition, the FDA is working with manufacturers, Durable Medical Equipment (DME) suppliers, and HHS’s Administration for Strategic Preparedness and Response (ASPR) to help manufacturers obtain the needed raw materials and to help expedite supply of tracheostomy tubes that meet the FDA’s standards for safety and effectiveness.

Recommendations for Patients and Caregivers:

• Follow the manufacturer’s instructions for cleaning, sanitizing, and reusing tracheostomy tubes for the maximum number of times allowed.
  • For example, Bivona tracheostomy tubes may be cleaned, sanitized, and reused as described in A Handbook for the Home Care of Your Child with a TracheostomyExternal Link Disclaimer for single-patient use, as stated in the indications for use, up to:
    • 5 times for pediatric sizes
    • 10 times for adult sizes
• Work with your health care provider and durable medical equipment (DME) supplier to determine if appropriate alternatives, such as other FDA-cleared tracheostomy tubes that may use different raw materials, are available.

Recommendations for Health Care Providers:

• Review the Recommendations for Patients and Caregivers.
  • Discuss these recommendations with patients who use the affected devices and their caregivers.
  • Consider using these recommended conservation strategies in health care settings as well as encouraging their use in home settings.
• Contact your distributor or the manufacturer directly to inquire about current inventory, including if appropriate alternatives, such as other FDA-cleared tracheostomy tubes that may use different raw materials, are available.

(2)        CONSIDER ALTERNATIVES FOR MRI-GUIDED BREAST BIOPSY GRID PLATES DUE TO SHORTAGE

The U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers recommending providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy due to the shortage of Philips Invivo MRI breast biopsy grid plates or other Philips Invivo MRI coil disposables.

Imaging facilities notified the FDA of this shortage in July 2022, and the FDA has been working with Philips to identify potential contributing factors and mitigation strategies. The shortage is estimated to continue through the end of 2022. On October 31, 2022, the FDA added certain product codes associated with MRI breast biopsy grid plates to the medical device shortage list. The device shortage list reflects the types of devices the FDA determined to be in shortage. The FDA will continue to update the list as needed.

Recommendations for Health Care Providers:

• Discuss options with patients if MRI breast biopsy grid plates or other MRI coil disposables are not available at their facility.
• Continue to schedule procedures if you have available supplies.

If supplies are unavailable, if possible, recommend an appointment at a facility where the procedure can be performed. The American College of Radiology maintains a list of Breast MRI facilities where biopsies may be performed.

• Contact Philips for questions or assistance with shipment delays and shortages of breast biopsy grid plates using the Philips “Contact Us” form.

Reporting Problems to the FDA:

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

For more information on medical device shortages and FDA strategies and alternatives, please email us at: [email protected] and ref: Medical Device Shortages and FDA Strategies and Alternatives.