There are countless lessons learned since the pandemic began in early 2020. One of those learnings include the importance of medical devices — to both healthcare systems as well as public health in general.
Not only did shortages of personal protective equipment (PPE) cause a frenzy, but so did other essential devices such as ventilators, testing supplies, and tools necessary to conduct vaccines.
The coronavirus pandemic showed tremendous vulnerability in our supply chain, both nationally and abroad. It also exposed just how much the United States relies on devices and raw materials imported from other countries, including China.
When the supply of life-saving devices are compromised, patients pay the price and suffer from these shortages. For these reasons, a variety of systems and processes have been put into place at a federal level in order to avoid these breakdowns again in the future.
The CARES Act
In March of 2020, a law was signed known as the CARES Act, which amended the Federal Food, Drug & Cosmetic Act (FD&C Act) by adding a section to the statue, known as 506J.
For the first time, Section 506J brought forth statutory authority to the Food & Drug Administration (FDA) with the power to assist in mitigating or preventing 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 requires manufacturers of particular devices to inform the FDA during a declared public health emergency, “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.”
The FDA is now required to create and maintain a current list of medical devices deemed to be in short supply that are approved or cleared for sale in the United States, and make that list publicly-available. The FDA has also been mandated to provide a list of medical devices which have been indefinitely discontinued according to the manufacturers.
Supply Chain Issues
It is no secret that the U.S. healthcare system has been infested with supply chain disruptions in recent decades. This reality has cost many healthcare organizations millions upon millions of dollars on an annual basis. In addition to financial hemorrhaging, other implications include compromised clinical research efforts and most importantly, threatened the safety and lives of patients.
In a report, he National Academies of Sciences, Engineering, and Medicine challenged the Committee on Security of America’s Medical Supply Chain to address various issues as it relates to supply chain issues of medical products. In addition to identifying the root causes of shortages, their task is to also pinpoint opportunities of improving processes during non-pandemic times, as well as during public health emergencies.
The report also challenges the Office of the Assistant Secretary for Preparedness and Response to establish a means to upgrade how the Strategic National Stockpile is managed. There is a call to summon stakeholder groups in order to strengthen allocation and delivery of medical products during shortages as well.
Discontinuation of Devices
The 506J section list mentioned above, from the FD&C Act, will continually be refreshed as the FDA receives updated information regarding discontinuation of devices.
Here are the medical device categories that comprise the discontinuance list:
- General ICU/Hospital Products
- Infusion Pumps and Related Accessories
- Personal Protective Equipment
- Sterilization Products
- Testing Supplies & Equipment
- Ventilation-Related Product – Oxygen Conserver
- Vital Sign Monitoring
For current information related to the pandemic and how it is impacting healthcare systems, please visit our Auxo Medical blog.