Medical device shortages continue to persist into 2023. While shortages of devices and drugs were creating challenges for the medical community even prior to the COVID-19 pandemic, the shortages have become more widespread and long-lasting. The shortage of supplies in hospitals and other care facilities has created difficult working conditions for caregivers who must adapt to new strategies of supply conservation. Hospital supply managers are struggling to find substitute supplies as demand grows with each new device shortage, leading them to compete with other facilities that are also trying to claim resources.
The massive disruption to the medical device supply chain is not expected to resolve any time in the near future, so you want to be aware of the current status of shortages and how to best source the supplies you need to limit the impact on your medical facility. The US Food And Drug Administration (FDA) has an updated device shortage list this month, and we’ve collected some of the critical information for you to review.
2023 Updates To The FDA Medical Device Shortage List
The FDA publishes a comprehensive list of medical device shortages. There are a few notable devices that your medical facility should be aware of on the list, as their ongoing shortages continue to impact caregiving, hospital budgeting and planning, and supply sourcing. Several of the devices on the FDA list are in short enough supply that the FDA has released conservation strategies to help hospitals extend their supplies where possible, and you will need to alert your staff to these recommendations.
Take note of the following medical devices on the FDA shortage list that have recently been added or have had their shortage status extended:
- Saline Vascular Access Flushes
- Blood Collection Tubing
- Automated External Defibrillators (AEDs)
- Micropipettes, pipette tips, and other testing supplies
- Tube Tracheostomy and Tube Cuff
- Tube, Tracheostomy (w/wo connector)
- Intra-aortic Balloon and Control System
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Transport Media Devices
- Ventilators (facility and home use)
Explanation Of Updated Medical Product Shortages
While some of the equipment on the shortages list are in low supply due to high demand, some are the result of a manufacturer discontinuance. If a manufacturer discontinues a piece of equipment, or can no longer produce or source a component of the equipment, then they may elect to end their production of the device. This can cause a significant disruption in the supply chain until the gap is filled by another manufacturer who takes up production. Let’s take a look at some of the causes for the current device shortages.
Saline vascular access flushes have been in shortage even prior to the COVID-19 pandemic due to a discontinuance of production of the equipment by a manufacturer that was then compounded with an increase in demand.
Blood collection tubing is in shortage due to high demand and a slower production rate to comply with requirements related to good manufacturing practices.
While the urgent demand for ventilators has diminished somewhat from the acute need during the height of the pandemic, there is still an increased need for them in hospitals and for medical equipment for COVID-19 at home. Additionally, compliance with good manufacturing practices and the shortage or discontinuance of components of ventilators have also led to their persistence on the shortage list.
Testing supplies such as micropipettes, pipette tips, and other specimen collection supplies are in shortage strictly due to high demand.
Medical Gloves Removed From FDA Shortage List For 2023
The COVID-19 pandemic decimated supplies of personal protective equipment around the world due to an unprecedented rise in demand among not only healthcare workers but also the general public. One of the biggest struggles for healthcare was the shortage of medical gloves. Fortunately, on December 12, 2022, the FDA updated the device shortage list to remove medical gloves from the list. Decreasing demand from the general public and an increase in supply manufacturing helped to resolve this shortage.
Isikel is one of the companies working to reduce current and future shortages of medical gloves by locally manufacturing and managing the supply chain of nitrile medical gloves. Nitrile gloves, saline flushes, and blood collection tubing are all available from Isikel.
Jason has over 20 years in the medical industry, ranging from pharmaceuticals, to supply chain, finance, operations, and clinical engineering. Jason began his career supporting every aspect of the pharmaceutical industry and grew into a decade long career at AdventHealth. Jason transitioned to supporting UTMB’s supply chain senior leadership team while working at Premier Inc. Before starting with Isikel, Jason supported the launch of an extremely large health system, with 18 hospitals, and 300+ outpatient locations, with 110k assets.