The White House is reportedly in discussions with US auto companies to aid in the coronavirus (COVID-19) relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make hand sanitizer. With the demand for medical devices to combat COVID-19 set to exponentially increase in the United States, and with the risk that non-US countries may cease exportation of critical-need medical devices to the US market to meet their own citizens’ needs, highly skilled and advanced US manufacturers may be able to help meet the demand by converting manufacturing operations to support the US relief effort.
This could include:
- Manufacturing finished medical devices on a contract basis
- Manufacturing components and materials that are used to build finished medical devices
Regulatory Considerations
While medical device manufacturing is highly regulated by the US Food and Drug Administration (FDA), medical device manufacturing concepts are not significantly different from producing other complex products (e.g., automobiles, airplanes, and their components).
Manufacturing finished medical devices generally requires compliance with FDA’s Quality System Regulation (QSR).[1] The foundation of the QSR is ISO 9001, a voluntary consensus standard to which many non-medical product manufacturers already adhere. Both the QSR and ISO 9001 require the following:
- Management oversight
- Control of production processes
- Control of suppliers
- Control of nonconforming products
- In-process and final acceptance inspections and testing
- Document control
- Employee training
- Corrective and preventive action
Most finished medical device contract manufacturers do not require FDA pre-approval before manufacturing and distributing product; the contract manufacturer of a finished medical device, however, must register its facility with FDA.
Manufacturing components and materials that are used in finished medical devices does not require compliance with the QSR, and there is no FDA registration requirement for component manufacturing facilities. However, finished device manufacturers may impose QSR-like requirements on component manufacturers through a quality agreement, particularly for critical components.
FDA Enforcement Discretion for Ventilators and Anesthesia Gas Machines
FDA is offering enforcement discretion to help build the supply of critical-need medical devices. On March 22, FDA issued guidance indicating that it will not object to changes made to ventilators and anesthesia gas machines during the COVID-19 public health emergency that could otherwise trigger a premarket notification so long as the modifications do not create an “undue risk.”
It is likely that design changes may need to be made (e.g., different part and component suppliers) to produce ventilators and anesthesia gas machines at non-traditional medical device production facilities. Not having to submit premarket notifications to FDA can help significantly reduce the regulatory burden on companies thinking about transitioning their production capabilities, and thus speed up the timeline to market.
Key Steps for Transitioning Operations to Support the COVID-19 Relief Effort
For companies thinking about converting manufacturing or distribution operations to focus on medical devices or device components, below is list of action items to consider:
- Partner with a medical device manufacturer that is in need of expanding its production capacity
- Obtain access to the production processes used by the medical device manufacturer through agreements
- Enter into a quality agreement with the medical device manufacturer
- Make sure to document an established quality management system
- Qualify manufacturing processes using equipment within your facility that can demonstrate the ability to produce products to specification
- Build relationships with qualified suppliers that can provide the components and materials needed to produce the medical device
- Choose a skilled workforce that can be quickly trained on production processes
FDA Outreach and Connecting with the Medical Device Manufacturing Community
Also in the March 22 FDA guidance discussed above, FDA told manufacturers that have not previously been engaged in medical device manufacturing, but with capabilities to increase supply of ventilators and anesthesia gas machines, to email them at CDRH-COVID19-Ventilators@fda.hhs.gov. The email should describe the manufacturer’s proposed approach for producing ventilators and anesthesia gas machines.
In addition to FDA outreach, private entities are helping connect the medical device manufacturing community with nontraditional medical device manufacturers. For example. General Motors reported that its partnership with Ventec Life Systems (a Seattle-based manufacturer of ventilators) to produce ventilators was facilitated by StopTheSpread.org.
