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  6. Medical Device Shortages During the COVID-19 Public Health Emergency
  1. Coronavirus (COVID-19) and Medical Devices

Medical Device Shortages During the COVID-19 Public Health Emergency

The FDA publishes this device shortages list to provide transparency to the American public, particularly those who use or purchase medical devices. The list fulfills a statutory obligation under section 506J of the FD&C Act and reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves. The presence of a device type on this list does not necessarily indicate that patient care has been affected.

During the COVID-19 public health emergency, the FDA has taken many actions to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. These actions include issuing Emergency Use Authorizations (EUAs) and guidance documents to provide recommendations and help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 public health emergency.

For healthcare providers and other stakeholders seeking information on acquiring assets from the Strategic National Stockpile (SNS), please refer to the request SNS assets web page. Contact Regional Emergency Coordinators (RECs) for assistance to request personal protective equipment (PPE), ventilators, medical countermeasures, and federal medical station needs. For additional resources, please see Supplies of Medical Devices for COVID-19: Frequently Asked Questions.

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Device Shortage List

Categories of devices in the device shortage list1 are:

  • Personal Protective Equipment
  • Testing Supplies and Equipment
  • Ventilation-Related Products
Category Product Code (Description) Availability and Estimated Shortage Duration2 Additional Information Reason for Interruption (per 506J) Date Posted (YYYY/MM/DD)3
Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies JRC (Micro pipette)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/12/23

2021/03/18 Reverified

Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies LXG (Equipment, laboratory, general purposes, labeled or promoted specifically for medical use, pipette tips only)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/12/23

2021/03/18 Reverified

Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies PPM (General purpose reagents for in vitro diagnostic tests, including pipette tips4)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Specimen Collection, Swab KXG (Absorbent tipped applicator)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Transport Media Device JSM (Transport culture medium)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Transport Media Device LIO (Microbiological specimen collection and transport device)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Transport Media Device QBD (Microbial nucleic acid storage and stabilization device)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies JJH (Clinical sample concentrator)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies NSU (Instrumentation for clinical multiplex test system)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies OOI (Real time nucleic acid amplification system)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.
To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see COVID-19 Testing Supplies FAQ). Demand increase for the device

2020/08/14

2021/03/18 Reverified

Ventilation-Related Products - Ventilators CBK (Continuous ventilator, facility use)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to support mitigations including alternatives (see Ventilators and Ventilator Accessories for COVID-19 FAQ).

While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain.

Demand increase for the device

2020/08/14

2021/02/09
Reverified

Ventilation-Related Products - Ventilators BZD (Non-continuous ventilator)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Ventilators and Ventilator Accessories for COVID-19 FAQ).

While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain.

Demand increase for the device

2020/08/14

2021/02/09 Reverified

Ventilation-Related Products - Ventilators NOU (Continuous ventilator, home use)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Ventilators and Ventilator Accessories for COVID-19 FAQ).

While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain.

Demand increase for the device

2020/08/14

2021/02/09 Reverified

Personal Protective Equipment - Gloves LYY (Latex, non-powdered patient examination glove)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Medical Gloves for COVID-19 FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Gloves LYZ (Vinyl patient examination glove)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Medical Gloves for COVID-19 FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Gloves LZA (Polymer, non-powdered patient examination glove, includes nitrile gloves)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Medical Gloves for COVID-19 FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Gloves LZC (Specialty, non-powdered patient examination glove, includes nitrile gloves)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Medical Gloves for COVID-19 FAQ).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Gowns and Surgical Apparel FME (Examination gown)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Gowns and Surgical Apparel FYA (Surgical gown)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Gowns and Surgical Apparel OEA (Non-surgical isolation gown, Level 2 only)
  • Limited supply available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers).

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Surgical Apparel FXX (Surgical mask)
  • Limited Supply Available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Face Masks, Including Surgical Masks, and Respirators for COVID-19).

While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain.

Demand increase for the device

2020/08/14

2021/03/18 Reverified

Personal Protective Equipment - Surgical Apparel MSH (Surgical respirator)
  • Limited Supply Available.
  • Estimated for duration of the COVID-19 Public Health Emergency.

To mitigate ongoing shortages, the U.S. government continues to take actions, including providing information about alternatives (see Face Masks, Including Surgical Masks, and Respirators for COVID-19).

While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain.

Demand increase for the device

2020/08/14

2021/03/18 Reverified

1. The FDA has determined, pursuant to section 506J(g)(3)(C) of the FD&C Act (titled "Public Health Exception"), that disclosure of the manufacturer's name of the devices determined to be in shortage during the COVID-19 public health emergency  will adversely affect the public health by increasing the potential for hoarding or other disruptions in device availability to patients.

2. Information on availability and estimated shortage duration is based on current FDA analysis and may change as the COVID-19 Public Health Emergency evolves.

3. FDA has provided clarification in the "date" column regarding changes in information on the device shortages list.

  • New: A device has newly been determined to be in shortage and added to the list
  • Revised: Change in information to device already on the list
  • Reverified: No change in the information

4. On December 23, 2020, the FDA updated the shortage list so that the description for product code PPM includes pipette tips, in addition to general purpose reagents and in vitro diagnostic tests.

Discontinuance List

As part of the list required pursuant to section 506J(g) of the FD&C Act, the FDA is providing a separate, publicly-available, up-to-date list of the devices for which the FDA has been informed by the manufacturer have been permanently discontinued. The FDA will update this list when it receives additional information regarding device discontinuances.

Categories of devices in the discontinuance list are:

  • Infusion Pumps and Related Accessories
  • Orthopedic
  • Personal Protective Equipment
  • Sterilization Products
  • Testing Supplies & Equipment
  • Ventilation-Related Product – Oxygen Conserver
  • Vital Sign Monitoring
Category Product Code Manufacturer Name Device Trade Name Reason for Discontinuance Date Posted (YYYY/MM/DD)
Sterilization Products KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories) Becton Dickinson and Company (ContainMed Inc.)

V. Mueller Horseshoe Retraction Kit Blades and Clamps Insert

V. Mueller Horseshoe Retraction Kit Frames and Post Insert

V. Mueller Universal Ring Retraction Set Blades and Rings Insert

V. Mueller Universal Ring Retraction Set and Posts Insert
Discontinuance of the manufacture of the device 2021/02/26
Ventilation-Related Product - Oxygen Conserver NFB (Oxygen Conserver) Inovo, Inc.

Single Lumen Conservers;
Accupulse;
Inovo, Inc. Accupulse Single Lumen Conserving Regulator

Dual Lumen Conservers;
Economizer;
Inovo, Inc. Economizer Conserving Regulator

Discontinuance of the manufacture of the device 2021/02/26
Vital Sign Monitoring DSJ (Alarm, Blood-Pressure) Philips Medical Systems

SureSigns VS4 NBP, SPO2

SureSigns VS4 U.S. Gov NBP, SPO2

SureSigns VS4 Government Bundle
Discontinuance of the manufacture of the device 2021/02/26
Orthopedic MOZ (Acid, Hyaluronic, Intraarticular) Teva Pharmaceuticals USA, Inc. Synojoynt (Sodium Hyaluronate 1% INJ 10mg/ml 3X2M)* Discontinuance of the manufacture of the device 2021/02/26
Personal Protective Equipment - Surgical Apparel FXX (Surgical mask) 3M Company 3M Triple Layer Molded Face Mask (2042F), 3M Triple Layer Molded Face Mask, Petite (2042FP) Discontinuance of the manufacture of the device 2021/01/22
Testing Supplies & Equipment - Laboratory Reagents and Testing Supplies NSU (Instrumentation for clinical multiplex test system) BioFire Diagnostics, LLC FilmArray Instrument (FLM1-ASY-0001) Discontinuance of the manufacture of the device (to be permanently discontinued on April 1, 2021) 2021/01/22
Vital Sign Monitoring MSX (Cardiac monitor, including cardiotachometer and rate alarm) Philips Medical Systems IntelliSpace Event Management Discontinuance of the manufacture of the device 2020/09/24
Infusion Pumps and Related Accessories

FRN (Infusion Pump)

MEA (Infusion Pump, Patient Controlled Analgesic))

Becton Dickinson and Company (CME America, LLC)

BodyGuard Infusion Pump System

BodyGuard Syringe Pump System, BodyGuard microsets

Shortage or discontinuance of a component or part;

Discontinuance of the manufacture of the device;

Facility closure

2020/08/14

* Note: This device is not included as part of the table of device types and corresponding product codes that identifies devices that FDA believes are critical to the public health during the COVID-19 PHE. This information was voluntarily provided by the manufacturer and has been posted to this list for transparency to assist stakeholders.

How the FDA Determines What Devices are in Shortage

For more information, see Supplies of Medical Devices for COVID-19: Frequently Asked Questions.

Information on Section 506J of the FD&C Act

On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the statute. Section 506J provides the FDA—for the first time—with authority intended to help prevent or mitigate medical device shortages "during, or in advance of, a public health emergency declared by the Secretary under section 319 of the PHS Act." The provision includes requirements for manufacturers of certain devices to notify the FDA "of a permanent discontinuance in the manufacture of the device" or "an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States" during a declared public health emergency.

One provision of this new statutory authority—section 506J(g) of the FD&C Act—requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued.

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