Medical Device Deficiency


Ever since the COVID pandemic, there has been a significant change in the way medical staff use medical devices. Medical devices are considered a rudimentary component in Healthcare systems. The benefits these technologies provide only increase, as they are essential to the diagnosis, prevention, treatment, and rehabilitation of illness in an effective way. A few of the medical devices that have been identified on the shortage list are dialysis-related products, personal protective equipment, testing supplies, as well as ventilation-related products, according to the Food and Drug Administration. This article addresses the strain on the American healthcare system, which is only anticipated to increase following the recent unsteady production of medical devices.


Learning from Medical Device Shortages

The recent pandemic has highlighted the importance of medical devices in our healthcare system and public health. COVID-19 has exposed the national supply chain to the dependence of other countries. The Food and Drug Administration (FDA) and the Center for Devices and Radiological Health (CDRH) played huge roles during these dire times in mitigating this public health emergency (PHE). Once the FDA and CDRH were granted the new statutory authority under the CARES Act, they rapidly worked to diminish and prevent device shortages during public health emergencies. The CARES Act was enacted in March 2020, which gave the FDA device shortage authority over medical device manufacturers. The new authority required that the manufacturer provide information to the FDA on product availability and potential supply chain disruptions throughout or proceeding a PHE. CDRH assists in comprehending and monitoring the web of supply chains that feed medical supply industries. The CDRH worked with manufacturers to prevent potential shortages. For example, the CDRH provided assistance during the 2021 Texas winter storm with testing and diagnostics manufacturers to ease shortages of resins. These efforts helped stop shortages and disruptions in COVID-19 diagnostic test availability.


Prevention of Future Shortages

Before the CARES Act, reaching out to the manufacturer to request supply chain information was difficult to attain, with most companies never responding to the FDA’s requests. However, this was evidently due to the information solicited being optional. The authority that the CDRH has under the CARES Act is critical for proactivity as new supply chain issues compound. Despite the worst of the pandemic being over, new supply chain issues will continue to arise and threaten public health in years to come since shortages of medical supplies affect shortages of essential materials for a wide range of medical devices. However, with new authority and policies, there have been collaborations between CDRH and manufacturers to plan for expedited marketing submissions. Additionally, it helps increase device availability for products most needed for the COVID-19 response, as well as vaccine administration. The enhanced collaborative effort would allow for better health protection for American patients and healthcare workers in the future. These authorities are beneficial for patients, businesses, and overall public health.


Medical Device Jobs & the Following

There is a wide variety of medical device jobs that take part in the overall industry. The seven categories include surgical instruments, stents catheters, orthopedics, blood transfusion, IV equipment, syringes, hypodermic needles, and dental instruments. The medical device industry is growing rapidly, and today’s market is full of electronic devices that are able to provide people with instantaneous health data and analytics. Although, this puts increasing pressure on the medical devices industry to maintain high levels of technological invention and develop cost-efficient healthcare for the masses.


Ultimately, there are many unprecedented factors that increase demand for some medical devices as well as significant disruptions to global medical manufacturers and their supply chain operations. Although, after analyzing the shortage situation and further solutions to this ongoing conundrum, none of these solutions are going to take place in the near future as you cannot stockpile everything.


Thank you for reading!

- Evonna Chisom

 

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