ReNewal Mask Decontamination

Caregiver safety is a priority, and we have a critical mask supply problem due to COVID-19. We need to

use the ReNewal mask reprocessing (AKA: decontanimation) process to make sure we do not run out of

masks in order to maximize the safety of the caregivers on the frontline of this crisis.

Please see below for information describing how this process is regulated and safe for caregivers.

HOW

All masks returned to PSJH meet strict regulatory requirements and standards. See pages 2-5 for

more details.

Decontamination – use of ethylene oxide (EtO) gas (standard way to decontaminate healthcare

items, including OR kit masks, multi-layered surgical masks, gowns, & drapes)

Post-decontamination testing

o Performance – thorough testing after decontamination, then labeled accordingly

o Residual EtO –tested to make sure there are no residual chemicals on the masks

WHO

There is a large team of experts working on this process.

Decontamination - Medline (a major PSJH equipment supplier), FDA-registered for reprocessing

single-use devices since 1997

Safety review & approval – PSJH Infectious Disease Clinical Decision team (ID CDT, local infection

preventionists and infectious disease physicians)

Implementation (collection & shipping) – Resource, Engineering & Hospitality (i.e., Supply

Chain). See pages 6-9 for collection and shipping instructions.

WHAT

Both masks and face shields can be reprocessed

Includes tie masks, earloop masks, N-95 respirators & face shields worn by healthcare workers

Does not include

o Masks worn by patients

o Masks that are soiled, (dripping) wet, or stained (including makeup)

o Damaged masks (holes, tears, or torn ear loops)

WHEN

Now. It is important that caregivers start putting the items listed above in the ReNewal collection boxes

and containers immediately so they can be decontaminated and returned to caregivers who need masks

and face shiels for protection when we run out of new items.

Every mask you collect has the potential to protect you and your colleagues.

Thank you for being a part this innovative and safe solution.

ReNewal™

Full Circle Reprocessing

1500 NE Hemlock Avenue

Redmond, OR 97756

(541) 923-3310

type of microorganisms (including spores, bacteria and viruses) are bacterial spores. Our EO cycles are

all validated to provide a minimum 12D Log Reduction to these highly resistant spores. Based on the

hierarchy of resistance, these cycles will deactivate a viable viral load. Medline also has EO and ethylene

chlorohydrin (ECH) residual data on file for the mask materials after exposure to an EO sterilization

process that was validated in accordance with the requirements of ISO 11135: 2014, Sterilization of

health care products - Ethylene oxide - Requirements for development, validation and routine control of

a sterilization process for medical devices.

The masks and shields will not be labeled or represented as sterile; therefore, this cycle is designed for

decontamination only. We already have validated unused masks through our EO process; however, we

will conduct performance testing on used masks after exposure to EO cycle(s) to prove they remain

effective and meet their cleared intended use. ReNewal will perform, at a minimum, the following tests

to confirm that the decontamination process does not adversely affect the performance of the mask.

• Fluid Resistance Per ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to

Penetration by Synthetic Blood

• BFE per ASTM F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE}

of Medical Face Mask Materials, Using a Biological Aerosol of Staphylcoccus aureus

Other tests may be conducted pending the specific design of the mask and its labeled intended use.

Claims on filtration and the level of mask protection will be based on testing results and clearly stated

on the device labeling to ensure safety and effectiveness. Medline ReNewal is confident that our process

for decontaminating face masks and shields will provide health care staff an additional source of reliable

PPE.

Please contact me if you require any further information.

President

Medline ReNewal

medline.com

Medline Industries, Inc. Three Lakes Drive, Northfield, IL U.S.A 60093

March 26, 2020

Dear Valued Medline Customer,

This letter is in response to your concern regarding the use of ethylene oxide to decontaminate personal protective equipment (PPE), such as N95 masks.

The United States Food and Drug Administration (FDA) which regulates, monitors and sets standards for the safety of medical drugs and devices in the United States has recognized that products that meet the requirements of the following standards are safe and effective for human use. The following standards apply specifically to ethylene oxide sterilization processing:

- ANSI/AAMI/ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices

- ANSI/AAMI/ISO 10993-7:2008(R)2012, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

Medline’s ethylene oxide sterilization program complies with the requirements outlined in the aforementioned standards.

Ethylene oxide sterilization can be divided into three phases: (1) preconditioning, (2) in-chamber processing (exposure to the sterilant gas), and (3) aeration. The third phase, “aeration” or “heated aeration” is where product, such as an N95 mask, is removed from the sterilization chamber and placed into a chamber or cabinet that is specifically designed for ethylene oxide and its reaction products to desorb from products until predetermined levels are reached.

The aeration cabinet is a controlled environment that operates between 122 – 140°F. This room is specifically designed to be heated, because ethylene oxide readily dissipates at 51°F, so in an environment above 51°F, ethylene oxide can readily dissipate off of the product. The aeration cabinet is not only heated, but it also has a recirculation system that removes ethylene oxide and its reaction products and replenishes the environment with fresh air. In Medline’s aeration cabinet, there are forty-four (44) complete fresh air exchanges per hour, thereby creating an environment (heat + circulation) that effectively removes ethylene oxide and its reaction products.

The ISO standard for sterilization residuals (10993-7) defines the maximum allowable levels of ethylene oxide and/or its reaction products that can remain on a device after exposure to an ethylene oxide process. The standard only outlines three chemical compounds: (1) ethylene oxide, (2) ethylene chlorohydrin, and (3) ethylene glycol. The standard only defines maximum allowable levels for ethylene oxide and ethylene chlorohydrin. There are no established exposure limits for ethylene

medline.com

Medline Industries, Inc. Three Lakes Drive, Northfield, IL U.S.A 60093

glycol (EG) because, “risk assessment indicated that when EO residues are controlled, it is unlikely that biologically significant residues of EG would be present” (ISO 10993-7, C.1).

Ethylene oxide residuals will not result in occupational exposure while wearing an N95 mask. The diffusion rate of ethylene oxide at normal atmospheric conditions is so great that respiration exposure is not possible even under conservative assumptions.

In an article published by the Journal of Occupational and Environmental Hygiene1 the authors state that following decontamination in an ethylene oxide sterilization process diacetone alcohol, 2-hydroxyethyl acetate (HEA) and cyclohexanone were found in the straps of the samples, in trace amounts (≤ 3 times the s/n of the baseline). While the straps would not present a respiratory risk to the end user, we understand your concerns. Chemical compounds, or residues, like diacetone alcohol, HEA and cyclohexanone follow a similar diffusion model to ethylene oxide, where levels would be quickly diffused to non-detect, following a validated heated aeration process.

Medline is required to perform extensive studies to demonstrate the effectiveness of our sterilization process, including heated aeration, and then implement stringent controls to ensure our validated ethylene oxide processes perform in a repeatable and reproducible manner.

All records are reviewed to verify the appropriate sterilization (or decontamination) process was utilized and that all required parameters for sterilization were achieved. This includes review of parameters for the specified aeration period that was validated to assure that residual levels are met per the requirements of ISO 10993-7, before the product completes aeration. Upon confirmation that all sterilization acceptance criteria were met through record review against specifications, the product is released by quality assurance and is ready for shipment to our customers.

This process allows us to assure you that the products, when received at your facility, meet all regulatory requirements and standards for ethylene oxide residual levels and are deemed safe for handling and storage at your facility.

Please contact me directly if you require additional information.

Respectfully yours,

Kasie Mueller, CISS-EO, CISS-RAD Technical Services Manager Medline Technical Affairs - Sterilization KRMueller@medline.com

1 Salter, W.B., Kinney, K., Wallace, W.H., Lumley, A.E., Heimbuch, B.K., & Wander, J.D. (2010, June 17). Analysis of Residual Chemicals on Filtering Facepiece Respirators After Decontamination. Journal of Occupational and Environmental Hygiene., 7(8), 437-445. doi:10.1080/15459624.2010.484794

The U.S. is currently at an all-time shortage of personal protective equipment (PPE). Medline ReNewal quickly switched our business operations to be a resource to facilities constrained by PPE availability.

Medline ReNewal is now able to decontaminate through a validated Ethylene Oxide (EtO) cycle tie masks, earloop masks, N-95 respirators, and face shields that have been used by a healthcare worker or visitor only. These masks, respirators, and face shields are to be collected in the containers provided and then shipped in the pre-labeled shipping box to our Redmond, Oregon plant.

Items used on a patient are strictly prohibited from collection

ONLY collect product that has no visible soil or stains, and no damagesuch as holes, tears, or torn ear loops

Item number Description UOM

REPMASKEL Earloop Dust Cover Mask, Decontaminated EACH

REPMASKTIE Tie Dust Cover Mask, Decontaminated EACH

REPSHIELD Face Shield, Decontaminated EACH

REPN95I Conical-Style Dust Cover Respirator, Industrial,Decontaminated EACH

REPN95M Conical-Style Dust Cover Respirator, Medical, Decontaminated EACH