Seeking Solutions for Scarce Resources: Options to Boost Medical Supplies and Devices to Battle COVID-19

The lack of medical supplies and equipment necessary to treat patients and to protect individuals and health care workers from becoming infected with and spreading COVID-19 has been a constant refrain during this pandemic. The overall supply of these essential items, ranging from ventilators to personal protective equipment (“PPE”) to prevent the spread of the virus, is critically low, resulting in the government, individuals and hospital supply chains seeking both short- and long‑term solutions.

Short‑Term Solutions

Working with State and Federal Agencies on PPE Rationing

Navigating how providers should request assistance from state and federal agencies can be confusing. Providers should ensure their supply chain leaders are coordinating with local and state emergency operations response agencies to help ensure these needs are met in an organized and comprehensive manner. The federal government maintains the Strategic National Stockpile (the “stockpile”) of pharmaceuticals and medical supplies that can be used during a public health crisis. However, only state health officials can access the stockpile, not individual providers, so hospitals and health systems will still need to work with the applicable state agencies. Further, the stockpile does not hold enough supplies to address the overwhelming need, and the Trump Administration advised state leaders last week to pursue their own supply chains to access the needed supplies.

Conserving PPE

Given many providers participate in group purchasing organizations (“GPOs”) and use strategic sources services GPOs offer, providers have an opportunity to discuss potential short‑term solutions regarding rationing supplies among different entities given that the GPOs also support many other similarly situated entities.

Additionally, the FDA and CDC have also provided guidelines on surgical mask and gown conservation. This guidance includes advising that, in a crisis situation, the same gown may be used while treating multiple patients with the same diagnosis in a confined area, use of surgical masks beyond the designated shelf-life if the mask still appears to be in good condition and extended use of a single mask in cohorted patient areas. Reuse of masks while caring for multiple patients when the transmission risk is low may be necessary. The CDC and FDA have proposed these steps in an attempt to conserve the limited supplies of PPE necessary for health care workers treating patients.

While telemedicine has been an emerging area in the health care space, now more than ever, providers are turning to telehealth visits to not only limit continued exposure, but to reduce the usage of PPE since providers are not coming into direct physical contact with patients and do not need to utilize the limited quantities of PPE.

Requesting and Accepting Donations of PPE

In the face of these critical shortages, many providers are receiving donated medical supplies from a variety of sources. From television medical shows to individuals with extra supplies sitting in the back of their closets, many are offering donation of these items to hospitals in need. The World Health Organization previously provided guidance on acceptance of donated medical equipment – generally as it relates to items donated to developing countries – and this guidance focuses on ensuring that the quality of the donated equipment is consistent with what a hospital or health care facility would purchase from manufacturers. The FDA has also issued an Emergency Use Authorization permitting the use of any NIOSH-approved N95 respirator in health care environments, even if those respirators were not tested or labeled for health care settings. This allows health care providers to use NIOSH N95 respirators that are labeled for other settings, such as those used in the construction industry.

When accepting donated supplies and equipment, health care facilities should consider what type of supplies will be accepted, whether supplies must be new/unopened, etc. Further, providers should implement a process for ensuring that supplies are brought into the facility in a manner that maintains necessary sterility or, alternatively, that supplies requiring sterilization are sterilized after receipt.

On March 25, 2020, the FDA provided further guidance to address use of face masks and respirators during the COVID-19 emergency that addresses how it will view the various PPE conservation strategies and the potential usage of donated and community-made masks. Per this additional direction, the FDA intends to use its enforcement discretion regarding additional mask and respirator usage beyond approved usages. Additionally, the FDA does not intend to object to use of non-FDA cleared items when no other options are available.

Long‑Term Solutions

Increasing Production

On Wednesday, March 18, 2020, President Trump announced that he would invoke the Defense Production Act of 1950 (the “Act”), if needed, in a “worst case scenario,” to mobilize the nation’s manufacturers to increase vital medical supplies and equipment in short supply, including N95 masks and ventilators. On the same date, Trump formalized that statement by signing the “Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of Covid-19.” The Executive Order (“EO”) can be found here.

The EO specifies that the health and medical resources required to respond to the spread of COVID-19 including PPE and ventilators meet the criteria of the Act and that the Secretary of Health and Human Services (“Secretary of HHS”) may identify additional specific health and medical resources authorized by the Act. Further, the EO delegates authority to the Secretary of HHS to “require performance of contracts or orders . . . to promote the national defense over performance of any other contracts or orders, [and] to allocate materials, services, and facilities as deemed necessary or appropriate to promote the national defense. . .” Finally, the Secretary of HHS may determine in consultation with other executive departments and agencies nationwide priorities and the allocation of all health and medical resources, including controlling the distribution of resources and services in the civilian market in order to respond to the COVID-19 pandemic. In short, the EO gives the Secretary of HHS the authority to work with companies to cause them to produce equipment to fight the pandemic and to order companies to process and prioritize government orders for ventilators and PPE, if necessary. To date, the Trump Administration has resisted invoking the full power of the Act, taking the position that it has not been necessary to do so because companies are stepping up to increase the supply of equipment and supplies. On March 23, 2020, Senators Chris Murphy (D-CT) and Brian Schatz (D-HI) introduced the Medical Supply Chain Emergency Act to compel President Trump to implement the full powers of the Act and to federalize the manufacture and distribution of desperately needed medical supplies. The bill would require President Trump to identify private sector capacity to help secure 500,000,000 N95 respirators, 200,000 medical ventilators, 20,000,000 face shields, 500,000,000 pairs of gloves and 20,000,000 surgical gowns in addition to other necessary medical equipment.

In addition to the EO, on Wednesday, March 18, 2020, Defense Secretary Mark Esper announced that the Defense Department would make available up to 5,000,000 N95 masks and other PPE from U.S. strategic reserves. Further, Secretary Esper stated the Defense Department would distribute 2,000 ventilators, as needed. It will be up to the Department of Health and Human Services to prioritize where this additional equipment will go.

Finally, on March 24, 2020, the FDA issued instructions to manufacturers to engage with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S., ultimately increasing the overall supply of necessary products throughout the country.

Expanded Use of Existing Medical Devices and Supplies

On March 22, 2020, the FDA issued guidance (“Guidance”) to be effective for the duration of the public health emergency indicating the FDA’s intent to increase the availability and utility of existing ventilators and anesthesia gas machines by permitting certain device modifications. This Guidance will apply where the intended modifications would otherwise trigger the requirement for a new 501(k) premarket approval from the FDA. While clarifying the FDA prefers that medical devices be used within FDA-cleared guidelines, the Guidance states that the FDA will not object to changes to the FDA-cleared functionalities for these devices, as long as such modifications do not create significant risk. The Guidance offers examples of such modifications, including, but not limited to: use of medical devices outside of their cleared environment for use; expanded use of devices intended to treat sleep apnea to treat patients in respiratory distress; and software modifications that provide for remote monitoring of the patient using the device.

This Guidance has the potential to increase the number of medical devices that providers would have access to in order to treat a patient with COVID-19 and can be used to encourage manufacturers to expand functionalities of existing medical devices. Given that hospitals and health care facilities have immunity from liability for certain products used to treat, mitigate or prevent an epidemic or pandemic if certain criteria are met under the Public Readiness and Emergency Preparedness Act, the risks associated with patient claims as a result of use of modified devices are mitigated. Guidance from manufacturers regarding the best approach to modifying ventilators and similar devices, including information regarding how to operationalize the use of modified devices, will be important, given the lack of experience with such modifications.

Innovation Within the Health Care Sector

Another way the health care industry has attempted to combat the inevitable supply and device shortages is to turn to innovation. Companies with materials that can be used to make fabric face masks are donating material, and individuals across the country are offering to sew masks. Other organizations with access to 3D printers are stepping up to produce ventilator components, face masks and other PPE. These new products are still considered medical devices, and therefore it is important to consider current FDA guidance as such projects proceed. Providers should take measures to fully vet the risks and potential benefits associated with such innovation before proceeding.

Practical Takeaways

Supply chains are complicated, and it takes time to mobilize companies to shift resources and increase production. Expanding production of necessary supplies and equipment, allowing for expanded uses of already existing and manufactured devices and accepting donations into the hospital supply chain are ways in which health care facilities may be able to prepare for the coming tsunami of infected patients.

We recommend that providers continue to consider:

Leaning into their supply chain leadership to better understand what strategic sourcing options are available;
Revisiting standardization protocols around patient encounters and educating clinicians on how to best conserve the current resources;
Continuing to educate the community on when to seek medical attention at the hospital to reduce the number of non-emergent visits;
Establishing criteria for acceptable donations as well educating clinicians in what order such items should be used; and
Communicating with clinicians about the appropriate use of available PPE and potential conservation methods and alternative solutions.

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