Guidance for Non-Medical Device Manufacturers to Produce Isolation Gowns
Introduction
Throughout the ongoing COVID-19 crisis, significant attention has been focused on the shortage of face masks for health care providers and responders. However, other types of personal protective equipment (PPE) have also run low as the health care industry strains to care for the increased number of COVID-19 patients. One type of PPE that is critically important is gowns. Like masks, health care entities have identified a shortage in usable gowns and sought aid from the community in sourcing gowns. [i] Manufacturers who want to help fill this gap will need to take certain steps to ensure they do not leave themselves open to potential liability. There are several guidance documents and statutes that potential manufacturers can look to when deciding whether to start manufacturing gowns. Additionally, potential gown manufacturers can leverage insurance and contract coverages to protect themselves from potential liability arising out of gown manufacturing. [ii]
Manufacturing Guidance from the FDA
In addition to producing guidance documents about the manufacture and importation of face masks, the FDA has issued guidance documents regarding the manufacture and distribution of gowns during the COVID-19 crisis. These documents outline different types of gowns and how those gowns will be regulated, depending on various factors. The FDA’s most recent guidance, issued March 30, 2020, sets forth the requirements manufacturers must meet in order to avoid regulatory enforcement by the FDA in manufacturing gowns. [iii] Gowns are generally defined as medical devices that fall within the regulatory enforcement of the FDA “when they are intended for a medical purpose, including for use by health care professionals.” [iv] However, given the shortage in gowns, the FDA does not intend to object to individual distribution and use of other types of PPE when “FDA-cleared gowns” are not available. [v]
If manufacturers intend to produce gowns “not intended for a medical purpose,” meaning not “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease,” the FDA will not require the manufacturer to complete premarket notification prior to production. Additionally, all other requirements of the Food, Drug, and Cosmetics Act (FDC&A) will likewise not apply. In order to avoid a “medical purpose” classification, manufacturers must clearly label that the gowns are not intended for use by a health care professional or in a health care facility or environment; and identify that the gowns do not include any drugs, biologics, or anti-microbial/anti-viral agents.
If a manufacturer does seek to produce gowns intended for use by health care providers or within a health care setting, the gowns are defined by the FDA as medical devices that fall squarely within two different regulatory categories. For the duration of the COVID-19 crisis, the FDA has relaxed its regulations and requirements regarding these types of gowns intended for medical use.
The first category is comprised of “non-surgical gowns,” which are currently designated as class I medical devices under current FDA regulations. The FDA will deem that a gown falls within this first category if it is labeled “as a gown other than a surgical gown (e.g., isolation gown),” that is not described as a surgical gown in any labeling, and is identified in labeling that the gown provides “only minimal or low barrier protection” (as governed by the ANSI/AAMI PB70 [vi]). [vii] These gowns are intended to “protect the wearer from the transfer of microorganisms and bodily fluids in low- or minimal-risk patient isolation situations and . . . are not intended for use during surgical procedures, invasive procedures, or when there is a medium or high risk of contamination.” [viii] Although class I medical devices are not subject to premarket notification, those devices are subject to the FDA’s general controls. Compliance with these general controls will be relaxed during the COVID-19 crisis for “non-surgical gowns.” To ensure gowns fall within this category of non-surgical gowns, the manufacturer must: (1) label the gown noting it is not a “surgical gown” and include a list of all body-contacting materials in the gown; (2) include recommendations to reduce the risk of use, such as against “use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected, use in a clinical setting where [ANSI/AAMI PB70] Level 3 or 4 protection is warranted, and use in the presence of high intensity heat source or flammable gas;” and, (3) ensure that “the labeling does not include uses for antimicrobial or antiviral protection . . . or uses for infection prevention or reduction.” [ix]
The second category is identified as “surgical gowns,” or gowns that are intended to be used in environments or procedures where “moderate-to-high barrier protection” is warranted. The FDA considers these “surgical gowns” class II medical devices. These gowns “are intended for use in health care settings requiring moderate or high liquid barrier protection levels (e.g., ANSI/AAMI PB70 barrier protection Level 3 or 4) and . . . are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, bodily fluids, and particulate material in moderate- or high-risk situations.” [x] The FDA has also relaxed its premarket notification requirements that manufacturers must meet before distributing class II gowns, as well as relaxed the enforcement of other general controls. [xi] For these types of gowns, manufacturers must ensure that the materials used for the gowns: (1) “meet[] liquid barrier protection at Level 3 or higher, consistent with ANSI/AAMI PB70 for the critical zone areas;” (2) “meet[] the Class I or Class II flammability standard per 16 CFR Part 1610;” and (3) have “been demonstrated to be sterile if intended for use in surgical settings.” [xii] If the materials meet these standards, FDA also requires manufacturers to include detailed labeling in the distribution of surgical gowns. [xiii]
Potential Liabilities
Producing any sort of consumer good bears risk, but production of PPE bears even greater risk. Aside from possible liability posed by manufacturer error, like product defect, there are several liabilities which could fall to the manufacturer. For example, users and consumers can misuse a product or, sometime in a product’s journey through the supply chain, that product’s integrity can be compromised. For PPE, as discussed above, there is a heightened landscape of liability and regulatory thresholds. In addition, producing medical devices to the satisfaction of FDA requirements creates an even greater risk for liability and regulatory enforcement issues.
The FDA Office of Regulatory Affairs has enforcement power related to medical devices in addition to drugs, foods, biologics, etc. The FDA could take administrative action such as issuing Warning Letters, seizing products, filing civil complaints for monetary penalties, or sometimes criminally prosecuting. While the FDA has relaxed its standards during the Public Health Emergency to expand the availability of PPE for health care professionals, it is best to avoid running afoul of FDA regulations, if at all possible. Failing to adhere to some of the relaxed requirements, such as premarket notification, does not pose a large increase in risk for manufacturers. However, failing to use materials that meet the liquid barrier protection and flammability standards set forth by the FDA, compounded with failure to clearly label the gowns with the level of protection intended, could expose manufacturers to significant risk from both products liability and regulatory enforcement standpoints.
There is also the risk of liability from end-users and even the health care entity itself.
End-user liability could mean individual suits from health care workers, patients who interacted with those health care workers, and even the household members of those health care workers and patients. Suits could range from personal injury to wrongful death and if a number of health care workers and patients use the gown and then subsequently become ill, they could form a class.
There is also the risk of liability for breach of contract with the health care entity. By way of example, if the manufacturer is unable to produce the entity’s requested number of gowns, and the resulting shortage causes the entity to rely on crisis techniques or substitutions, any suit filed against the entity could result in a third-party claim against the manufacturer for breach of contract. The same formula could apply if there was an alleged defect in the gown’s manufacturing.
Actions to Limit Liability
There is no way to wholly avoid the potential for regulatory enforcement, a lawsuit from an end-user, or a lawsuit from the health care entity. There are, however, actions to take to limit liability as much as possible. First, there are steps a manufacturer could take related to production methods and compensation for the manufacturer’s services. Second, draft a fulsome and specifically tailored contractual agreement. Finally, draft a clear product label.
If at all possible, produce Level 1 or Level 2 gowns intended to have lower liquid barrier protections. The FDA classifies these Level 1 or Level 2 gowns to be used in “minimal risk” or “low risk” situations. Accordingly, these situations bear legal liability. Levels 3 and 4 are to be used in “moderate risk” and “high risk” situations. Additionally, if possible, produce Class I medical devices such as non-surgical gowns. Non-surgical gowns are not worn in situations where medium to high risk of contamination is present and the same liability rationale applies.
If the manufacturer can volunteer its services, state and federal volunteer protections would offer an additional shield. The Volunteer Protection Act, state emergency guidelines, and federal emergency orders can be invoked to waive manufacturer’s liabilities. In some states, Samaritan statutes will offer broad protection. If the manufacturer is required to purchase materials, determine whether billing only those costs maintains volunteer protections.
Next, ask the health care entity receiving the gowns to provide all materials (such as fabric, elastic, ribbon, and thread) as well as all instructions, templates, patterns, and samples for the construction of the gowns. Provide a prototype and ensure requested revisions and approvals are provided in writing. Take photographs of all prototypes. If the entity requests that the manufacturer provide its own material, seek out the assistance of a third-party lab to test the liquid barrier performance to ensure it meets ASTM/ANSI-AAMI and flammability standards.
Draft a strong agreement with the receiving health care entity. First and foremost, waive all warranties, express or implied. If the entity provided materials, instructions, and also approved a prototype, have the entity assume responsibility for determining any and all fitness for a particular purpose. Attach the instructions, photographs of the prototype, and written approvals as exhibits. Next, request that the entity extend insurance coverage to manufacturer. Finally, be sure to limit methods of remedy and draft strong indemnification language. The entity should agree to indemnify and immediately assume defense, especially if a manufacturer is volunteering its services. Extend indemnification to include individual employees, but where COVID-19 is highly communicable, be cautious in how far protections are extended. Extending protections too far, beyond an end-user’s household, could run afoul of equity and fairness. Take into consideration what level barrier resistance the manufacturer has agreed to produce and what situations those gowns would be used in. Include information regarding all of these considerations in the written agreement between the manufacturing entity and the health care entity.
Conclusion
As the COVID-19 crisis continues and the need for PPE continues to grow, manufacturers have an opportunity to aid in the Public Health Emergency by using their facilities to manufacture PPE. A prudent manufacturer will monitor both the FDA and the CDC for updates regarding production and use of PPE in this rapidly-changing environment. With clarity as to the type of gown being made, the materials and instructions for construction, and a strong written agreement with the health care entity, manufacturers should have a solid foundation of liability and regulatory enforcement protection in place.
For information on producing face masks or covers for masks, see this article discussing mask regulations, contractual measures, and volunteer protections.
[i] See Centers for Disease Control and Prevention, Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings (“Major distributors in the United States have reported shortages of PPE, including N95 respirators, facemasks, eye protection, gowns, and gloves.”) available here.
[ii] This article does not address potential immunity that manufacturers may seek under various federal and state statutes and declarations. For more information on potential immunity from liability manufacturers may seek under the PREP Act, see HHS Provides Liability Immunity for Coronavirus Countermeasures available here.
[iii] See U.S. Food & Drug Administration, Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff (March 2020) available here.
[iv] Id. at 3.
[v] Id. at 4.
[vi] ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. For the current edition of the FDA-recognized standards used in the guidance document, see the FDA Recognized Consensus Standards Database available here.
[vii] See U.S. Food & Drug Administration, Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff at 6 (March 2020) available here.
[viii] Id. at 6.
[ix] Id. at 9.
[x] Id. at 7.
[xi] Id. at 8.
[xii] Id. at 8.
[xiii] Id. at 9 (labeling requirements for surgical gowns).