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 14 April 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.
Applications: Hospitals, other public facilities, work environment (considerations for different applications (Tom)
Cleaning products for the healthcare setting must also demonstrate efficacy against many other known pathogens, particularly those which might have become antibiotic-resistant. Home and other non-medical work environments are not as likely to be contaminated with these nosocomial (hospital-based) pathogens, which means that there is a much wider range of products that can be used for disinfection of surfaces potentially exposed to COVID-19 outside of the healthcare setting. Many common, commercially available products are suitable for use at home or in non-medical workplaces.
Super Sani-Cloth® Germicidal Disposable Wipes are very commonly used to clean all kinds of surfaces throughout the hospital, notably to clean the face shields to protect providers in the COVID response. We anticipate these types of products being critical for patient and provider safety during the crisis, as there is heightened concern for hygiene and disinfection of surfaces and concern for spread of this respiratory virus via fomites.
Existing Solutions
- current supply chains
- Current suppliers of Sani-Cloth wipes
- All Med
- American Medical Depot
- BP Gamma
- Boundtree
- Buffalo Hospital Supply
- Busse Hospital Disposables
- Cardinal Health
- Cardinal Health at Home
- Claflin
- Clock Medical Supply
- Concordance (Kreisers, Midwest Medical Supply, Seneca Medical)
- First Choice Medical Supply
- Thermofisher Scientific
- Geriatric Medical
- Grove Medical
- Hemasource
- Henry Schein
- McKesson Medical Surgical
- Medical Specialties
- Medline Industries
- Moore Medical
- Network Solutions
- NDC
- Optimal
- Owens & Minor
- Preferred Medical
- Quick Medical
- Staples
- Stockd
- Twin Med
- Unimed Corp
- Current supplier of other cleaning products, and other cleaning wipes products that can be provided by existing suppliers
- Check current inventory of products against List N
- Current suppliers of Sani-Cloth wipes
- Alternative Healthcare/Hospital Wipe Products on List N
- Opti-Cide 3® Wipes
- Clorox Healthcare® Bleach Germicidal Wipes
- Lonza Disinfectant Wipes Plus 2
- Oxivir 1 Wipes
- Avert Sporicidal Disinfectant Cleaner Wipes
- Peridoxrtu (Brand) One-step Germicidal Wipes
- Opti-cide Max Wipes
- Benefect Botanical Daily Cleaner Disinfectant Towelette
- Micro-kill Bleach Germicidal Bleach Wipes
- Caviwipes 1
- Caviwipes Bleach
- PJW-622
- Oxy-1 Wipes
- Accel TB Wipes
- Lysol® Disinfecting Wipes (All Scents)
- Clorox Disinfecting Wipes
- Clorox Commercial Solutions® Hydrogen Peroxide Cleaner Disinfectant Wipes
- Clorox Commercial Solutions® Clorox® Disinfecting Wipes
- Clorox Healthcare® VersaSure® Wipes
- Lonza Disinfectant Wipes
- Oxivir™ Wipes
- PURELL Professional Surface Disinfectant Wipes
- Peak Disinfectant Wipes
- Discide Ultra Disinfecting Towelettes
- Stepan Disinfectant Wipe
- Lonza Disinfectant Wipes Plus
- Nugen 2m Disinfectant Wipes
- Nugen Low Streak Disinfectant Wipes
- Caterpillar
- Sporicidin (Brand) Disinfectant Towelettes
- Super Sani-Cloth Germicidal Disposable Wipe
- Sani-Cloth Bleach Germicidal Disposable Wipe
- Sani-Cloth Prime Germicidal Disposable Wipe
- AF3 Germicidal Disposable Wipe
- Sani-cloth Germicidal Disposable Cloth
- Other suppliers of List N Wipe products
- Discide
- Thomas Scientific
- Patterson Dental
- New Line Medical
- CleanCide
- Wexford Innovations
- Oxy-1
- Diversey
- Contec
- Fisher Scientific
- VWR
- Discide
- Other suppliers of List N Non-wipe cleaning products
- Hillyard
- Civco
- Many- this list is non-exhaustive
- Consider existing relationships with suppliers and what products they can provide
Market Analysis
- Demand for household and healthcare disinfectant wipe products surged in response to concerns about the spread of the coronavirus. Essential businesses also depend on these products to decrease likelihood of disease transmission. Manufacturers of common household cleaning products were overwhelmed by consumers who were anticipating an extended period of quarantine.
- There are a wide range of products with known efficacy against COVID-19.
- Sani-Cloth Wipes are manufactured by PDI in New York. They have ramped up production of surface disinfectants and wipes, but demand is still overwhelming the supply. They have deprioritized their non-essential product lines. They claim to have good availability of raw material to make wipes at this time, as they took steps to ensure that their supply chain would not be disrupted. (https://pdihc.com/manufacturing-through-covid-19-pandemic-meeting-customers-needs-one-wipe-at-a-time/)
Alternative Solutions
- Acquire available EPA-approved bulk liquid cleaners
- Develop disposable wipes from List N-approved bulk liquid cleaners
- Would require finding materials for the wipes, and packaging materials
- Consider reusable wipe options
- These wipes could not be sold or distributed unless they met regulatory requirements
- Develop disposable wipes from List N-approved bulk liquid cleaners
- Re-engineering
- List N describes the active ingredients in each approved product
- Reformulation of chemical cleaners or development of new formulations
- This would require rigorous testing for safety, efficacy, compatibility
- Would become necessary only if other options have been exhausted, given that regulatory processes are required to approve new products for use (https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-4-additional-considerations)
Concept Screening
- The EPA has approved a number of commercially available cleaners for use against SARS-CoV-2. These are summarized in List N: (https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2). List N can be exported from the EPA website as a CSV file which you can use to filter by use/setting, by active ingredient, by manufacturer, etc.
- Some of the active ingredients in EPA-approved products for COVID-19 use include:
- Chlorine dioxide
- Citric acid
- Ethanol
- Hydrochloric acid
- Hydrogen peroxide
- Phenolic
- Quaternary ammonium
- Sodium hypochlorite (bleach)
- The EPA’s list also describes the contact time needed to kill the virus for each of the products listed. “Contact time” refers to the amount of time the surface must be wet with the product before the virus is inactive. If the product dries or gets wiped away before the contact time has elapsed, users should rewet the surface with the cleaning product to ensure that the pathogen has been exposed to the cleaner for long enough to disinfect the surface.
- Each product will have specific instructions for best use, make sure to follow these instructions to ensure efficacy of disinfection.
- Super Sani-Cloth® Germicidal Disposable Wipes are preferred for use in the hospital because of known efficacy against common pathogens in the healthcare setting and good compatibility with a wide range of surface materials, but there are other products (wipes and bulk cleaners) that have known efficacy against COVID virus that have been approved for use by the EPA.
- Since the SARS-CoV-2 pathogen is not readily available for commercial testing use, the EPA is approving products for use against COVID-19 based on the following criteria:
- Demonstrate efficacy (e.g. effectiveness) against a harder-to-kill virus; or
- Demonstrate efficacy against another type of human coronavirus similar to SARS-CoV-2.
- Many of the other products on List N are commercial products available for purchase by the general public, which may make them harder to get in large quantities for healhcare use. Products that are not commonly used in the healthcare setting might not be effective at killing other nosocomial pathogens, which is important to consider when evaluating alternative products.
- Approval by Environmental Health and Safety departments of your institution will also be necessary
- Consideration of factors like contact time, toxicity, usability, compatibility with the products it is used on, compatibility with other cleaners
- Consideration of user preferences
Strategic Development:
- Exhaust existing supply of preferred disinfectant wipe product, as purchased through existing vendor relationships
- Prioritize your institution’s preferred products
- Check if any of the products you have on hand are on List N
- Look for other sources of preferred products
- Look for other healthcare/hospital-use List N EPA-approved wipes (see Alternative Healthcare/Hospital Wipe Products on List N)
- EPA-approval guarantees that products are meeting regulatory standards
- Discuss preferred product characteristics with Environmental Health and Safety
- Consider other non-wipe healthcare-use List N products, and how they can be deployed for surface disinfection
- Regulatory – Any repurposing of products in any form should follow the Quality System Regulation (21 CFR 820) if they are intended for commercial sale/distribution (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.