09 Apr How COVID-19 Is Changing the Medical Device Industry
With a shortage of medical devices around the globe, such as respirators, ventilators, and face shields, the United States government has issued an executive order allowing other medical and health resources that meet the previous requirements to be of use during the COVID19 pandemic.
This executive order could mean a wide array of things to the immediate and future of regulations regarding the manufacturing of medical devices and similar products.
Here are a few things we know:
Addressing the Shortages
We can infer several things from the medical and governmental response to the COVID-19 Pandemic. Firstly, the attitude towards medical device production, innovation, and regulations may change as we know it today.
Because of the shortage of medical devices, needed for patients infected with the Coronavirus, many companies have received explicit permission from the federal government to lend their engineering & manufacturing skills to rapidly create mass quantities of masks, ventilators, respirators, etc. One example of this is that Ford has teamed up with 3M and GE to aid with the manufacturing of ventilators, air-purifying respirators, and face shields. Furthermore, the entire medical industry is putting their heads together to find creative secondary uses for medical devices and other personal protective equipment, “PPE”, that have already been approved by all regulations and standard compliance in order to expedite and improve the ways we are able to mitigate patient and provider risk and exposure to this novel Coronavirus. From a regulatory standpoint, this is considered an other than primary intended use or secondary intended use for this equipment.
In addition, we are seeing some medical companies, like Medtronic, spreading their knowledge and sharing their full design specifications, product manuals, and design documents for their portable ventilators. Soon, they will share the software code for this device, allowing multiple other companies to help produce and manufacture more much-needed ventilators during this time of crisis.
Will changes to regulations be permanent?
On March 18th, President Trump signed an Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19.
“Under the delegation of authority provided in this order, the Secretary of Health and Human Services may identify additional specific health and medical resources that meet the criteria of section 101(b).
Sec. 2. Priorities and Allocation of Medical Resources.
(a) Notwithstanding Executive Order 13603 of March 16, 2012 (National Defense Resource Preparedness), the authority of the President conferred by section 101 of the Act to require performance of contracts or orders (other than contracts of employment) to promote the national defense over performance of any other contracts or orders, to allocate materials, services, and facilities as deemed necessary or appropriate to promote the national defense, and to implement the Act in subchapter III of chapter 55 of title 50, United States Code, is delegated to the Secretary of Health and Human Services with respect to all health and medical resources needed to respond to the spread of COVID-19 within the United States.
(b) The Secretary of Health and Human Services may use the authority under section 101 of the Act to determine, in consultation with the Secretary of Commerce and the heads of other executive departments and agencies as appropriate, the proper nationwide priorities and allocation of all health and medical resources, including controlling the distribution of such materials (including applicable services) in the civilian market, for responding to the spread of COVID-19 within the United States.
(c) The Secretary of Health and Human Services shall issue such orders and adopt and revise appropriate rules and regulations as may be necessary to implement this order.”
Read the full order.
Even more recently, another government order has been issued in an effort to quickly supply hospitals with medical devices during this time. Secretary Azar made a statement regarding the FDA’s decision to decontaminate used N95 respirators needed for patients with COVID-19.
The government is also expanding the jurisdiction in which healthcare workers are able to perform certain duties. For example, an article states, “CMS (Centers for Medicare & Medicaid Services) is issuing waivers so that hospitals can use other practitioners, such as physician assistants and nurse practitioners, to the fullest extent possible, in accordance with a state’s emergency preparedness or pandemic plan. These clinicians can perform services such as order tests and medications that may have previously required a physician’s order where this is permitted under state law.” This course of action will expedite testing and other services that are crucial in this pandemic, all while still being in compliance with the law.
While it is uncertain if regulations and standards compliance will permanently change due to the pandemic, there is certainly room for all of us, as design agencies, medical device manufacturers, healthcare professionals, scientists, and engineers to find more and more innovative passageways to achieving life-saving equipment and treatment. Given the current design and manufacturing process for new medical devices and treatments is in the neighborhood of 3-7 years, we should all be motivated to collaborate on simultaneous solutions for how we can use FDA approved medical devices, vaccines, and medications in different ways in order to provide the resources we need to combat the coronavirus, on a global scale.
Treatments and COVID-19 Patient Care
Stopping the spread has become a way of life for most Americans, and many other countries around the world. While staying home and reducing contact with others is essential to slow the infection rate, it is also important that while people are out providing services or tasks deemed essential that they are doing everything in their power to disinfect every step of the way. People are being urged to follow social-distancing guidelines, keeping at least 6 feet away from other human beings they may encounter outside of their home. This social rule derives from 6 feet being the average distance respiratory droplets usually travel, before landing on other surfaces or people. Although it is a great tool to potentially slow down the spread of the virus, a 6 foot distance may not be enough to prevent infection. These safety measures should be practiced in addition to keeping good hygiene health, and staying at home when possible.
Other technologies could be put to use, for example: UltraViolet light is being used in medical and healthcare settings, eliminating almost all pathogens in an area and in turn, helping to prevent people from catching infections. While UV light is a great tool for public spaces to make use of, it does not replace regular cleaning and chemical disinfection. This technology should be used as an extra precaution to help reduce viral infections from contaminating groups of people, along with traditional deep cleaning practices.
Treatments for COVID-19 are being discovered, including medications and vaccines. In a mere 63 days, Barney Graham’s first dose of a vaccine was already sent to a small trial at the Kaiser Permanente Washington Health Research Institute. Additionally, COVID-19 patients who have fully recovered are being asked to donate plasma & blood. The American Red Cross states, “This convalescent plasma is being evaluated as treatment for patients seriously ill with COVID-19,” in an effort to create a treatment that utilizes these healed antibodies to attack the virus.
Vaccines for the virus are attempting to be expedited, beginning with vaccines previously created for treatment of other coronaviruses. Although it will take much longer than 2 months to test these treatments and vaccines and make it publicly available, there are ways scientists are speeding up the process, such as studying and mapping genomes. Companies currently coming together for vaccine clinical trial preparation will end up saving a great amount of time later when it comes time for the later phases of clinical trials.
You can find more information and updates on COVID-19 here.
Whether changes are visible or microscopic, these industries are facing unbelievable obstacles, and not just regulatory ones. Studious minds are learning the hard way that it is essential to develop flexible solutions, nimble processes, and pursue opportunities to use this crisis to our advantage to make things safe, efficient, and cost effective.
Our team at Realtime is always searching for new and innovative ways to find the most effective and efficient technology solutions, all while meeting and exceeding all compliance and regulatory requirements. Got questions about a design, or device regulations and standards? We’ve got our experts ready to talk. Contact Realtime at (972) 985 – 9100.
Resources available here, here, and here.