Contents
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 disposable surgical/isolation gowns.
Existing Solutions
Acquiring existing gown products is favorable given the extensive regulatory requirements needed for approval and use in the operating room. Current Disposable Gown Manufacturers/Vendors include the following:
Market Analysis
With the surge in COVID-19 cases, manufacturers of reusable gowns are not able to meet the current demand. After contacting current 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.
Furthermore, upon contacting companies abroad, multiple disposable surgical gown manufacturers in China stated that their production has been halted or slowed due to measures enforced by the government. They were unable to provide a timeline of when their manufacturing will return to normal levels.
Alternative Solutions
Given the complexity of manufacturing disposable gowns as well as the extensive regulatory requirements associated with these gowns, acquiring disposable gowns from an existing supply chain is preferrable. We do not recommend attempting to produce disposable gowns without using a material pre-approved for use in these gowns.
Furthermore, it may be beneficial to consider acquiring reusable surgical gowns (See reusable gowns section).
Concept Screening
- All medical gowns must meet ANSI/AAMI standards (AAMI PB70, ASTM F2407)
- Level 1 for minimal risk activities like basic care, or for visitors
- Level 2 for low risk activities like blood draw, suturing
- Level 3 for moderate risk use in the ED, trauma, arterial blood draw
- Level 4 for high risk, when infectious diseases are suspected
- Surgical gowns are considered Class II medical devices requiring 510(k) premarket notification, available in Levels 1-4
- Surgical isolation gowns provide barrier coverage in more areas, and are intended for use when risk of contamination is medium to high
- ASTM F2407 describes standards for tensile strength, tear resistance, seam strength, lint generation, and breathability
- Level 3 and 4 gowns are preferred due to COVID risk
- Additional documentation requirements for gowns sold as sterile
- FDA Sterility Information for Gowns
For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. This information may include:
- Sterilization method that will be used.
- A description of the method that will be used to validate the sterilization cycle, but not the validation data itself (for established sterilization methods).
- Reference to a standard method (e.g., AAMI Radiation Standard) usually is sufficient for established sterilization methods with FDA-recognized standards.
- The sterility assurance level (SAL) for the device which the firm intends to meet. An SAL of 10-6 is required for surgical drapes and surgical gowns which are to be used during surgical procedures.
- A description of the packaging’s ability to maintain the device’s sterility.
- If sterilization involves ethylene oxide (EtO), the maximum levels of residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol which remain on the device. The levels should be consistent with the draft Federal Register Notice on EtO limits.
Strategic Development
- Existing gown products and manufacturers are preferred due to regulatory requirements and extensive testing that are needed for approval and use
- Suppliers of disposable surgical gowns are prioritizing existing customers already using these gowns
- Clinical
- Regulatory
- R&D
- Quality Mgmt – if pursuing local manufacturers, then sterilization protocol would need to be tested as well in accordance with quality management guidelines
- Distribution
- (IP) — disclaimers
Prior to considering reusable gowns as an option, it is important for healthcare facilities to first:
- Understand their current isolation gown inventory and supply chain.
- Understand their isolation gown utilization rate.
- 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.
- Understand additional possible inventory that could be acquired from local healthcare coalitions as well as federal, state, and local public health partners.
- Understand key differences between reusable versus disposable gowns (current inventory, supply chains, costs, sterilization requirements, etc.).
- Investigate the feasibility of the healthcare facility to conduct sterilization of reusable gowns.
Once decision is made to secure disposable gowns, we recommend the following steps:
- 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.
- 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.
- We do not recommend manufacturing disposable gowns without pre-approved materials due to regulatory requirements.
- 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.
- Depending on the feasibility of acquiring and implementing disposable gowns at your institution, it may be beneficial to consider acquiring reusable gowns.