Reusable Gowns

Need Exploration and Identification

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread globally, resulting in the ongoing 2019–20 coronavirus pandemic. As of April 14, 2020, more than 1.94 million cases have been reported across 210 countries and territories, resulting in over 123,000 deaths (https://coronavirus.jhu.edu/map.html). The pandemic has resulted in travel restrictions and nationwide lockdowns in several countries.  With the sudden surges in patient volume during the COVID-19 outbreak, closing of borders and restrictions on international shipping, and temporary shutdown of manufacturers for medical supplies, personal protective equipment (PPE), ventilators and associated consumables, as well as many other medical supplies have become a scarce resource. Many other essential products (toilet paper, cleaning products) have also become scarce as consumers have anticipated extended periods of quarantine at home.

Surge capacity refers to the ability to manage a sudden, unexpected increase in patient volume that would otherwise severely challenge or exceed the present capacity of a healthcare facility. With the sudden surges in patient volume during the COVID-19 outbreak, isolation gowns, a key form of personal protective equipment (PPE), have become a scarce resource. This document details strategies to optimize supplies of isolation gowns through the use of reusable gowns.

Existing Solutions

Acquiring existing gown products is favorable given the extensive regulatory requirements needed for approval and use.

• Current Reusable Gown Manufacturers:
  • Lac-mac
  • Medline
  • Novo Health Services
  • Standard Textile
• Current Reusable Gown Vendors:
  • Encompass
  • MedVet International
  • Oh Medical

Market Analysis 

With the surge in COVID-19 cases, manufacturers of reusable gowns are not able to meet the current demand. After contacting current reusable and disposable gown manufacturers and vendors, it is clear that there is limited inventory. If companies did have available stock, it was already allocated to their current customers.

Alternative Solutions

Given the complexity of manufacturing reusable gowns as well as the extensive regulatory requirements associated with these gowns, acquiring reusable gowns from an existing supply chain is preferrable. If it is possible to acquire pre-existing materials for gown manufacturing (i.e. pre-approved fabric materials), it may be possible to produce reusable gowns. We do not recommend attempting to produce reusable gowns without using a material pre-approved for use in these gowns.

Further, it may be beneficial to consider acquiring disposable isolation gowns if reusable gowns do not seem to be a viable option for your institution. (See disposable isolation gown document).

Concept Screening

The performance of gowns is tested using consensus standards. The American Society for Testing and Materials (ASTM) F2407 is an umbrella document that describes testing for surgical gowns. Qualities tested include:

• Tear resistance: ASTM D5587 (woven), ASTM D5587 (nonwoven), ASTM D1424
• Tensile strength: ASTM D5034, ASTM D1682
• Seam strength: ASTM D751 (stretch woven or knit)
• Lint generation: International Organization for Standardization (ISO) 9073 Part 10
• Water vapor transmission (breathability): ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75

All medical gowns must meet American National Standards Institute (ANSI) and Association of the Advancement of Medical Instrumentation (AAMI) standards. These standards classify a gown’s ability to act as a barrier to liquids or liquid borne pathogens into four levels. Below is a table summarizing the ANSI/AAMI PB70:2012 standards recognized by the FDA. Level 4 gowns are preferred for COVID-19 exposure.

Level	Description	Applicability
Level 1	Used for MINIMAL risk situations. Provides a slight barrier to small amounts of fluid penetration. Single test of water impacting the surface of the gown is conducted to assess barrier protection performance.	Basic care, standard hospital medical unit.
Level 2	Used for LOW risk situations. Provides a barrier to larger amounts of fluid penetration through splatter and some soaking. Two tests are conducted to assess barrier protection performance: Water impacting the surface of the gown. Pressurizing the material.	Blood draw from a vein, suturing, intensive care unit, pathology lab.
Level 3	Used in MODERATE risk situations. Provides a barrier to larger amounts of fluid penetration through splatter and soaking (more than Level 2). Two tests are conducted to test barrier protection performance: Water impacting the surface of the gown. Pressurizing the material.	Arterial blood draw, inserting an IV, emergency room, trauma.
Level 4	Used in HIGH risk situations. Prevents all fluid penetration for up to 1 hour. May prevent virus penetration for up to 1 hour. In addition to the other tests conducted for Levels 1-3, barrier level performance is tested with simulated blood containing a virus. If no virus is found at the end of the test, the gown passes.	Pathogen resistance, infectious diseases (non-airborne), large amounts of fluid exposure over long periods of time.

This table was adopted from the FDA website.

(https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns)

It is also important to note that reusable gowns will need to be reliably sterilized prior to reuse. Established sterilization methods with a long history of safe and effective use include:

• Dry heat
• Ethylene oxide
• Moist heat or steam
• Radiation (e.g. gamma, electron beam)

For more specific information regarding sterilization, please see the following document from the FDA: https://www.fda.gov/media/74445/download.

Strategic Development

Prior to considering reusable gowns as an option, it is important for healthcare facilities to first:

1. Understand their current isolation gown inventory and supply chain. 
2. Understand their isolation gown utilization rate.
3. Implement initial engineering and administrative control measures, including…
   • Minimizing the amount of healthcare personnel needed to safely care for patients.
   • Reducing face-to-face healthcare personnel encounters with patients when possible.
   • Maximizing the use of telemedicine.
   • Excluding visitors to patients.
   • Cohorting patients and healthcare personnel.
   • Reducing the number of patients going to the hospital or outpatient settings.
4. Understand additional possible inventory that could be acquired from local healthcare coalitions as well as federal, state, and local public health partners.
5. Understand key differences between reusable versus disposable gowns (current inventory, supply chains, costs, sterilization requirements, etc.).
6. Investigate the feasibility of the healthcare facility to conduct sterilization of reusable gowns.

Once decision is made to secure reusable gowns, we recommend the following steps:

1. Sourcing strategies for existing gown products are preferred due to regulatory requirements and extensive testing. Prior to acquiring gowns, it is important to assess the feasibility of gown sterilization (equipment and services) at your institution.
2. If inventory is minimal and existing gown products cannot be obtained, manufacturing gowns with existing and approved gown materials is an option. Again, it is important to consider sterilization requirements prior to pursuing this path.
3. We do not recommend manufacturing reusable gowns without pre-approved materials due to regulatory requirements. 
   1. Regulatory – If pursuing this option, one should observe the Quality System Regulation (21 CFR 820) (https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) also known as “Good Manufacturing Practices” both for the manufacturing as well as the sterilization protocols. 
4. Depending on the feasibility of acquiring and implementing reusable gowns at your institution, it may be beneficial to consider acquiring disposable gowns.