FACT SHEET FOR HEALTHCARE PERSONNEL Coronavirus...STERRAD 100S, NX, and 100NX Sterilization Systems,...

Coronavirus Disease 2019 (COVID-19)

FACT SHEET FOR HEALTHCARE PERSONNEL ASP STERRAD Sterilization System for Decontaminating Compatible N95 Respirators April 11, 2020

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088

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You have been given a N95 or N95-equivalent respirator (“compatible N95 respirator”) that has been decontaminated using a sterilization system for single-user reuse by healthcare personnel in a healthcare setting to help prevent exposure to pathogenic biologic airborne particulates during the COVID-19 pandemic. This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators. These compatible N95 respirators have been decontaminated using one of three Advanced Sterilization Products STERRAD Sterilization Systems, using the STERRAD Sterilization Cycles for N95 respirator decontamination: STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle (hereafter referred to as “decontaminated N95 respirators” and “ASP STERRAD Sterilization System” throughout this Fact Sheet). Decontaminated N95 respirators that have been decontaminated using an ASP STERRAD Sterilization System are authorized for single-user reuse by healthcare personnel in a healthcare setting during the COVID-19 pandemic.

Whether or not you use a respirator, always follow infection control measures: wash hands, cover coughs and sneezes, stay home if you may be sick.

What are the symptoms of COVID-19? Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days.

Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which may pose risks for public health. Please check the CDC webpage for the most up to date information.

What do I need to know about the emergency use of decontaminated N95 respirators?

• The ASP STERRAD Sterilization System has been

authorized for emergency use to decontaminate compatible N95 respirators for single-user reuse by healthcare personnel during the COVID-19 pandemic to prevent exposure to pathogenic airborne particulates. o Compatible N95 or N95-equivalent respirators

are those that are compatible with vaporized hydrogen peroxide (VH2O2) gas sterilization and can safely and effectively be processed two times after initial use without detrimentally impacting mask form, fit, or function.

o Cellulose-based materials are incompatible with the ASP STERRAD’s hydrogen peroxide-based sterilization system.

• Preparing compatible N95 respirators for decontamination: ü Place compatible N95 respirators after use into a

compatible sterilization pouch identified for use in vaporized hydrogen peroxide, such as a Tyvek® pouch with STERRAD Chemical Indicator

ü Write name and/or other identifier using a permanent marker so the respirator may be returned after successful decontamination

ü Place a tick mark on respirator each time a respirator is prepared for decontamination

ü Post-decontamination, open the pouches and allow the decontaminated N95 respirators to aerate for one hour prior to usage

ü Discard if decontaminated more than 2 times or if visibly soiled or damaged

• Use of decontaminated N95 respirators: ü Decontaminated N95 respirators are not sterile ü Inspect respirators after each use prior to

submission for decontamination ü If decontaminated N95 respirators are soiled or

damaged, they should be discarded




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ü Cellulose-based materials are incompatible with the STERRAD Sterilization System

ü Report problems with decontaminated N95 respirators to your healthcare facility

It is strongly recommended to maintain chain of custody on the respirator to minimize the risk of cross-contamination • Monitor healthcare personnel for signs and

symptoms of potential infection with SARS-CoV-2 or other respiratory infection for up to and including 14 days after last contact with the SARS-CoV-2 virus and related material, and promptly report such information to Advanced Sterilization Products.

• Report damage or discoloration observed

upon receipt of the decontaminated, compatible N95 respirators, and potential exposure of healthcare personnel from breaks in or other damage to or degradation of the decontaminated compatible N95 respirators.

Use appropriate personal protective equipment (PPE) when caring for individuals suspected of having COVID- 19 as outlined in the CDC webpages, including Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID- 19 in Healthcare Settings, Infection Control, and FAQ about PPE.

Current information on COVID-19 for healthcare personnel is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section). What are the known and potential benefits and risks of using decontaminated N95 respirators?

Potential benefits include: • May help prevent exposure to airborne pathogens,

and therefore risk of infection or illness • Extends the usability of compatible N95 respirators

by allowing for decontamination and single-user reuse

• Availability of N95 respirators are critical to healthcare workers in the diagnosis and treatment of patients with COVID-19

Potential risks include: • Failure of filtration efficiency • Reduced breathability • Strap failure and ineffective face-fit • Reused respirators may not have been effectively

decontaminated of SARS- CoV-2 or other pathogens

Overview of the ASP STERRAD Sterilization Systems The ASP STERRAD Sterilization Systems, specifically the STERRAD 100S, NX, and 100NX Sterilization Systems, must be operated in the STERRAD 100S, NX Standard, and 100NX Express Cycles, respectively, to decontaminate compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 and other pathogenic microorganisms so that the respirators can be reused by HCP. N95 or N95-equivalent respirators containing cellulose-based materials are not compatible with the ASP STERRAD Sterilization Systems. The STERRAD Sterilization System decontaminates utilizing hydrogen peroxide vapor. The vaporized hydrogen peroxide is introduced to allow perfusion of the hydrogen peroxide throughout the chamber, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The ASP STERRAD Sterilization System enables single-user reuse of compatible N95 respirators that would otherwise be disposed of after a single use. However, respirators that are visibly soiled must be discarded and not reused or decontaminated. What is an EUA? The United States FDA has made the emergency use of the ASP STERRAD Sterilization System to decontaminate compatible N95 respirators available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the




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emergency use of medical devices, including alternative products used as medical devices, due to insufficient supply during the COVID-19 pandemic. The ASP STERRAD Sterilization System for decontamination of compatible N95 respirators has been made available under an EUA, and has not undergone the same type of review as an FDA-approved or cleared device. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe the ASP STERRAD Sterilization System may be effective at preventing exposure to pathogenic airborne particulates when there are insufficient supplies of respirators during the COVID-19 pandemic by decontaminating, for a maximum of 2 decontamination cycles per respirator, compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms. The EUA for the ASP STERRAD Sterilization System for decontamination of compatible N95 respirators is in effect for the duration of the COVID-19 declaration justifying emergency use of medical devices, unless terminated or revoked (after which the products may no longer be used).

Where can I go for updates and more information? CDC webpages: General: https://www.cdc.gov/COVID19 Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html Infection Prevention and Control Recommendations in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html FAQ on Personal Protective Equipment: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html FDA webpages: General: www.fda.gov/novelcoronavirus EUAs: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Advanced Sterilization Products (ASP) Inc. | April 11, 2020

Instructions for Healthcare Facilities: Decontamination of Compatible N95 Respirators in STERRAD® Sterilization Systems

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the emergency use of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems for use (hereafter referred to as the “STERRAD Sterilizers”) in decontaminating compatible N95 respirators (“compatible N95 respirators”) for single-user reuse by healthcare personnel in healthcare facilities. The STERRAD Sterilizer cycles to be used in decontamination of compatible N95 respirators are: STERRAD 100S Cycle, STERRAD NX Standard Cycle, and STERRAD 100NX Express Cycle. Healthcare personnel should follow these instructions, as well as procedures at their healthcare facility, to prepare compatible N95 respirators for decontamination in a STERRAD Sterilizer; please refer to the STERRAD Sterilizer User’s Guide for complete instructions for use.

• Due to incompatibility, the STERRAD Sterilization Systems are not authorized for use with respirators containing cellulose-based or paper materials.

• Compatible N95 respirators that are visibly soiled (e.g., blood, dried sputum, makeup, soil, bodily fluids) or damaged must be discarded and not reused or decontaminated.

• Compatible N95 respirators should be discarded after 2 decontamination cycles. • Any compatible N95 respirator whose traceability was lost or number of decontamination cycles not

able to be identified should be discarded. • Decontaminated compatible N95 respirators are not sterile.

Materials Needed: - Compatible sterilization pouch identified for use in vaporized hydrogen peroxide, such as Tyvek® Pouch with

STERRAD Chemical Indicator - Type 1 chemical indicator for vaporized hydrogen peroxide, such as ASP STERRAD Chemical Indicator Strips,

SEALSURE® Chemical Indicator Tape - VELOCITY Biological Indicator/Process Challenge Device or CYCLESURE Biological Indicator Compatible N95 Respirator Marking: The healthcare facility should ensure that the chain of custody is maintained to minimize risk of cross-contamination. Prior to collection by the healthcare facility personnel, the healthcare personnel should label their own individual compatible N95 respirator with their name and/or identifier, and number of decontamination cycles (as shown below) with a permanent marker. The healthcare personnel should pouch the compatible N95 respirator in a sterilization pouch, label the pouch with the decontamination cycle count, and seal it. The compatible N95 respirator in the sterilization pouch should be placed at a designated collection station. See the “Instructions for Healthcare Personnel” for details.


Compatible N95 Respirator Collection and Transportation: 1. The healthcare facility should create a collection station at the point of generation (i.e., hospital floor/unit).

Each station should have a tray or container provided by the healthcare facility to collect the pouches containing the compatible N95 respirators for decontamination with the following note: NOTE: Only compatible N95 respirators in compatible sterilization pouches should be placed at this collection station for decontamination. No other items will be decontaminated in the same decontamination cycle.

2. The healthcare personnel who are assigned to decontamination (i.e., those with training for collection/transport of such materials) should collect the sterilization pouches containing the compatible N95 respirators at the collection stations, and place them into the appropriate container for transportation, such as a closed case cart, to minimize risk of environmental contamination. The case cart should have a hospital-controlled tag or identifier that indicates the location in the hospital where the respirators were utilized.

3. The case cart should be transported to healthcare facility’s decontamination area. Use of the STERRAD Sterilization Systems: To decontaminate compatible N95 respirators in a STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle: 1. Place individually pouched compatible N95 respirators in a

STERRAD Sterilizer; each cycle can decontaminate 10 pouches per sterilizer load.

2. A specific orientation of the mask in the sterilization pouch or pouches in the sterilizer is not required.

3. Pouches should not overlap or cover other pouches. 4. A Type 1 indicator for vaporized hydrogen peroxide (for

example, a chemical indicator or chemical indicator tape) may be used to monitor the cycle. The indicators may be placed on the pouch, inside a pouch or within the chamber to provide an indicator that sterilant has been delivered. One indicator per cycle is recommended.

5. Follow STERRAD Sterilizer User’s Guide instructions on how to initiate a cycle and verify successful cycle completion.

6. Upon completion of the cycle, the compatible N95 respirators should be aerated in an opened pouch for 1 hour after which they are ready for use.

7. Compatible N95 Respirators may be decontaminated a maximum of 2 times. After the STERRAD Sterilization Systems Cycle is complete: 1. Following completion of the cycle in the STERRAD Sterilizer, the chemical indicator’s color should be compared

to the “PASS” reference color. If the colors matched or the color present is lighter, the compatible N95 respirators have been exposed to the vaporized hydrogen peroxide. If the indicator does not match the “PASS” criteria, the compatible N95 respirators should not be considered decontaminated and either re-run through the cycle in the STERRAD Sterilizer or discarded.

2. Utilize existing facility processes to decontaminate case carts and sterilize transport trays or container for reuse and delivery of decontaminated compatible N95 respirators back to patient areas.

3. Successfully decontaminated, compatible N95 respirators should be loaded back in sterilized trays or containers and placed in a closed case cart following the healthcare facility’s policy for identifying/labeling processed loads. ASP recommends that the healthcare facility follow similar protocol for identifying processed


loads to transport to the operating room for surgical cases. Documentation should include a clean copy of the location identifier to ensure return of the respirators to the original location in the facility for distribution to healthcare workers.

4. The healthcare facility should ensure that the chain of custody is maintained to minimize risk of cross-contamination. Upon return of the decontaminated, compatible N95 respirators to the appropriate individuals, the respirator should be checked for the following: a. Ensure that the name or other identifier and number of decontamination cycles is still legible. Any

compatible N95 respirator whose traceability was lost or number of decontamination cycles not able to be identified it should be discarded.

b. Any compatible N95 respirator that is visually damaged or soiled should be discarded. c. Any compatible N95 respirator that has exceeded 2 decontamination cycles should be discarded. d. Ensure that the compatible N95 respirator is returned to its previous user.

5. The healthcare facility should make available the “Fact Sheet for Healthcare Personnel: ASP STERRAD Sterilization Systems for Decontaminating Compatible N95 Respirators” upon return of the decontaminated, compatible N95 respirators.

Reporting to ASP Healthcare facilities should report any discoloration or other signs of degradation with a decontaminated respirator to ASP, and the healthcare facility should discard the respirator. Healthcare facilities using the decontaminated, compatible N95 respirators should monitor healthcare personnel who use such respirators for the signs and symptoms of potential infection with SARS-CoV-2 or other respiratory infection and promptly report such information to ASP, so that ASP can provide a weekly report to FDA. Reports of adverse events should be reported up to and including 14 days after the last contact with suspected SARS-CoV-2 virus.

Customer Service: Phone: 888-783-7723 Fax: 949-266-5990 www.asp.com


Instructions for Healthcare Personnel: Preparation of Compatible N95 Respirators for Decontamination in STERRAD® Sterilization Systems

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the emergency use of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems (hereafter referred to as the “STERRAD Sterilizers”) for use in decontaminating compatible N95 or N95-equivalent respirators (hereafter referred to as “compatible N95 respirators”) for single-user reuse by healthcare personnel. The STERRAD Sterilizer cycles to be used in decontamination of compatible N95 respirators are: STERRAD 100S Cycle, STERRAD NX Standard Cycle, and STERRAD 100NX Express Cycle. Healthcare personnel should follow these instructions, as well as procedures at their healthcare facility, to prepare compatible N95 respirators for decontamination in a STERRAD Sterilizer.

Compatible N95 Respirator Marking and Collection: 1. ASP recommends maintaining chain of custody on the compatible N95 respirators to minimize the risk of cross-

contamination. Pouch your own individual compatible N95 respirator in a compatible sterilization pouch, such as a Tyvek pouch, at the end of use. You should label with your name and/or other identifier using a permanent marker. Labeling should be legibly written on the outside OR inside of each compatible N95 respirator, as shown below.

2. Place a tick mark on your compatible N95 respirator and compatible sterilization pouch each time to maintain the decontamination cycle count. NOTE: Your respirator and sterilization pouch may be decontaminated no more than 2 times.

• Due to incompatibility, the STERRAD Sterilization System is not authorized for use with respirators containing cellulose or paper materials.

• All compatible N95 respirators used in the STERRAD Sterilizers must be free of visible damage and soil/contamination (e.g. blood, dried sputum, makeup, soil, bodily fluids).

• Compatible N95 respirators that are visibly soiled or damaged must be discarded and not reused or decontaminated.

• Compatible N95 respirators should be discarded after 2 decontamination cycles.

• Any compatible N95 respirator whose traceability was lost or number of decontamination cycles not able to be identified should be discarded.

• Decontaminated compatible N95 respirators are not sterile.


3. Confirm that the labeling is legible, and that there is no visible damage or soil/contamination prior to pouching

the compatible N95 respirator.

4. Place your compatible N95 respirator in the sterilization pouch provided by your healthcare facility and seal it. Place the pouched, compatible N95 respirator at the healthcare facility’s designated collection station.

5. After receiving your decontaminated, compatible N95 respirator, please check the respirator to ensure you are

the appropriate individual. 6. If at any time the labeling is not legible or there is visible soil or damage, discard the respirator. Discard the

respirator and sterilization pouch after 2 decontamination cycles. NOTE: Only compatible N95 respirators in compatible sterilization pouches should be placed at this collection station for decontamination. No other items will be decontaminated in the same decontamination cycle.

April 11, 2020

Ms. Laurie Cartwright Director, Worldwide Regulatory Affairs Advanced Sterilization Products, Inc. 33 Technology Irvine, California 92618 Dear Ms. Cartwright: This letter is in response to your request that the U.S. Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of the Advanced Sterilization Products, Inc. (ASP) STERRAD 100S, NX, and 100NX Sterilization Systems1 (hereafter “ASP STERRAD Sterilization Systems”) for use in decontaminating compatible N95 or N95-equivalent2 respirators (“compatible N95 respirators”)3 for single-user4 reuse by healthcare personnel (HCP)5 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of N95 respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.6

1 This EUA includes the emergency use of the ASP STERRAD 100S, NX, and 100NX Sterilization Systems in the STERRAD 100S, NX Standard, and 100NX Express Cycles, respectively, for decontamination of compatible N95 respirators (as defined in footnote 3). Use of the ASP STERRAD Sterilization Systems on other types of personal protective equipment is not authorized and would require a request for a separate EUA or marketing authorization and data supporting such other use. 2 For purposes of this EUA, “N95-equivalent respirators” refers to respirators identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators and in Appendix A of the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, which are available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. 3 For purposes of this EUA, “compatible N95 respirators” means any N95 or N95-equivalent respirator that does not contain cellulose-based materials. Respirators containing cellulose-based materials are incompatible with the ASP STERRAD Sterilization Systems. 4 Single-user reuse means that the same HCP should use the mask following decontamination. 5 HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel). 6 The ASP STERRAD Sterilization Systems are FDA cleared for use in the sterilization of certain metal and non-metal medical devices, which do not include N95 respirators (see K023290, K162007, and K160903 for the most recent clearances).

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationhttps://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationhttps://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationhttps://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.7 Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared on March 24, 2020, that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak, pursuant to Section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.8 Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of the ASP STERRAD Sterilization Systems, as described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of the ASP STERRAD Sterilization Systems for decontaminating compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms during the COVID-19 pandemic meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that: 1. SARS-CoV-2, the virus that causes COVID-19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the ASP STERRAD Sterilization Systems may be effective at preventing exposure to pathogenic airborne particulates when there are insufficient supplies of N95 respirators during the COVID-19 pandemic by decontaminating, for a maximum of 2 decontamination cycles per respirator, compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, and that the known and potential benefits of the ASP STERRAD Sterilization Systems, when used to decontaminate compatible N95 respirators for single-user reuse by HCP to prevent exposure to pathogenic airborne particulates during N95 respirator shortages during the COVID-19 pandemic, outweigh the known and potential risks; and

7 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 7316 (February 7, 2020). 8 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 17335 (March 27, 2020).


3. There is no adequate, approved, and available alternative to the emergency use of the ASP STERRAD Sterilization Systems for decontaminating compatible N95 respirators for single-user reuse by HCP during N95 respirator shortages during the COVID-19 pandemic.9,10 II. Scope of Authorization I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the ASP STERRAD Sterilization Systems for use in decontaminating compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, for no more than 2 decontamination cycles per respirator, for single-user reuse by HCP to prevent exposure to pathogenic airborne particulates during the COVID-19 pandemic. Authorized ASP STERRAD Sterilization Systems

The ASP STERRAD Sterilization Systems, specifically the STERRAD 100S, NX, and 100NX Sterilization Systems, must be operated in the STERRAD 100S, NX Standard, and 100 NX Express Cycles (hereafter “STERRAD decontamination cycles”), respectively, to decontaminate compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 and other pathogenic microorganisms so that the respirators can be reused by HCP. N95 respirators containing cellulose-based materials are not compatible with the ASP STERRAD Sterilization Systems. Any visibly soiled or damaged masks should not be processed in the ASP STERRAD Sterilization Systems and should be immediately discarded. The ASP STERRAD Sterilization Systems are to be used with the cleared and commercially available STERRAD Cassettes, compatible sterilization pouches, such as Tyvek pouches with STERRAD Chemical Indicators, STERRAD Chemical Indicator Strips, SEALSURE Chemical Indicator Tape, and VELOCITY Biological Indicator/Process Challenge Devices. The ASP STERRAD Sterilization Systems are to be loaded with compatible N95 respirators that are individually pouched in Tyvek Pouches with STERRAD Chemical Indicator. The sterilizer may contain ten pouches per sterilizer load. A Chemical Indicator or chemical indicator tape identified for the ASP STERRAD Sterilization Systems may be placed in the chamber to verify sterilant exposure. The STERRAD decontamination cycles decontaminate utilizing hydrogen peroxide vapor. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures 9 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act. 10 There are not sufficient quantities of N95 respirators to meet the needs of the U.S. healthcare system. These disposable N95 respirators are an integral part of routine patient care. Due to shortages of N95 respirators, HCP may need to treat patients without personal protective equipment (PPE) or use a bandana or other less effective masks unless single-use N95 respirators can be decontaminated for reuse. Providing a method for decontaminating compatible N95 respirators reduces stress on the supply chain and helps meet the needs of the healthcare system. Providing HCP who are on the forefront of the COVID-19 response with N95 respirators is necessary in order to reduce the risk of illness in HCP and increase their availability to provide care to affected patients or those suspected of having COVID-19.


created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD decontamination cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The ASP STERRAD Sterilization Systems use a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. Following completion of the cycle, the chemical indicator’s color should be compared to the “PASS” reference color. If the colors matched or the color present is lighter, the compatible N95 respirators have been exposed to the vaporized hydrogen peroxide. If the indicator does not match the “PASS” criteria, the compatible N95 respirators should not be considered decontaminated and either re-run through the STERRAD decontamination cycle or discarded. Validation and performance studies conducted by the firm indicate compatible N95 respirators can be processed through the STERRAD decontamination cycle of the ASP STERRAD Sterilization Systems a maximum of 2 times. The respirator reuse limit is based upon the filtration performance evaluation of the respirators processed for 2 exposures in the STERRAD decontamination cycles of the ASP STERRAD Sterilization Systems. ASP must provide the following information pertaining to the emergency use of the ASP STERRAD Sterilization Systems before the decontamination process begins (i.e., before a healthcare facility begins preparing and collecting compatible N95 respirators for decontamination for use with ASP STERRAD Sterilization Systems—which the healthcare facility already owns, or the healthcare facility has notified ASP of its intent to purchase—consistent with the use outlined in the Scope of Authorization of this letter (Section II)), which are authorized to be made available to HCP and healthcare facilities:

• Instructions for Healthcare Personnel: Preparation of Compatible N95 Respirators for Decontamination in STERRAD Sterilization Systems (“Instructions for Healthcare Personnel”); and

• Instructions for Healthcare Facilities: Decontamination of Compatible N95 Respirators in STERRAD Sterilization Systems (“Instructions for Healthcare Facilities”).

In addition, following decontamination, compatible N95 respirators decontaminated by the authorized product must be accompanied by the following labeling, developed by ASP, upon return of the respirators to the appropriate single-user HCP:

• Fact Sheet for Healthcare Personnel: ASP STERRAD Sterilization Systems for Decontaminating Compatible N95 Respirators (“Fact Sheet”).

The Fact Sheet, Instructions for Healthcare Personnel, and Instructions for Healthcare Facilities are referred to as “authorized labeling.” The emergency use of the ASP STERRAD Sterilization Systems must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the


circumstances set forth in the Secretary of HHS’s determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), the authorized ASP STERRAD Sterilization Systems are authorized to be used for decontaminating compatible N95 respirators that are authorized to be used by HCP in healthcare settings under the terms and conditions of this EUA. Changes to the process, procedures, or labeling for the authorized product may be revised by ASP subject to review and concurrence of the Division of Infection Control and Plastic and Reconstructive Surgery Devices/OPEQ/CDRH and OCET/OCS/OC. I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the ASP STERRAD Sterilization Systems, when used and labeled consistently with the Scope of Authorization of this letter (Section II), outweigh the known and potential risks of such products. I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the ASP STERRAD Sterilization Systems may be effective at preventing HCP exposure to pathogenic airborne particulates during N95 respirator shortages during the COVID-19 pandemic by decontaminating compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 and other pathogenic microorganisms, when used consistently with the Scope of Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that ASP STERRAD Sterilization Systems, when used to decontaminate compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms (as described in the Scope of Authorization of this letter (Section II)), meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness. This EUA will cease to be effective when the HHS declaration that circumstances exist to justify the EUA is terminated under Section 564(b)(2) of the Act or when the EUA is revoked under Section 564(g) of the Act. III. Waiver of Certain FDA Requirements I am waiving the following requirements for the ASP STERRAD Sterilization Systems during the duration of this EUA:

• applicable current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the authorized ASP STERRAD Sterilization Systems used in accordance with this EUA; and

• labeling requirements under the FD&C Act and FDA regulations, including unique device identification requirements (see Subpart B of 21 CFR Part 801), except that the ASP STERRAD Sterilization Systems must comply with the authorized labeling requirements specified in this EUA (Section II).


IV. Conditions of Authorization Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this authorization: Advanced Sterilization Products, Inc. (“ASP”)

A) ASP will make available to all existing customers the authorized labeling for the ASP STERRAD Sterilization Systems through posting on the ASP website and notifying their distribution list of healthcare facilities. In this notification, ASP will instruct healthcare facilities to notify ASP if the healthcare facility intends to use the ASP STERRAD Sterilization Systems for the emergency use. ASP will send the appropriate authorized labeling to each healthcare facility who notifies ASP that the healthcare facility intends to use the ASP STERRAD Sterilization Systems for the emergency use, consistent with Section II of this letter.

B) ASP will make available to all new customers the authorized labeling for the ASP STERRAD Sterilization Systems, consistent with Section II of this letter. ASP will instruct new customers to notify ASP if the healthcare facility intends to use the ASP STERRAD Sterilization Systems for the emergency use.

C) All descriptive printed matter relating to the use of the ASP STERRAD Sterilization Systems shall be consistent with the authorized labeling. No descriptive printed matter relating to the use of the ASP STERRAD Sterilization Systems may represent or suggest that this product is safe or effective for the prevention or treatment of COVID-19.

D) ASP will have a process in place for reporting adverse events about ASP STERRAD Sterilization Systems and the decontaminated, compatible N95 respirators of which they become aware and send such reports to FDA, and will establish a process to collect information from healthcare facility customers regarding degradation of decontaminated, compatible N95 respirators and reports of infection or potential infection of users of the decontaminated, compatible N95 respirators and send such reports weekly (unless otherwise notified by FDA) to FDA.

E) ASP will ensure that any records associated with this EUA, including, but not limited to, records of healthcare facilities that have notified ASP that the facility is using the ASP STERRAD Sterilization Systems consistent with the Section II of this letter, are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

F) ASP is authorized to make available additional information relating to the emergency use of the product that is consistent with, and does not exceed, the terms of this letter of authorization.

Healthcare Facilities


G) Healthcare facilities must notify ASP when they intend to use ASP STERRAD Sterilization Systems for the emergency use, consistent with Section II of this letter.

H) Healthcare facilities using compatible N95 respirators that have undergone decontamination using the ASP STERRAD Sterilization Systems (“the decontaminated, compatible N95 respirators”) must make available to HCP who are or may be using the decontaminated, compatible N95 respirators the authorized Fact Sheet for Healthcare Personnel and authorized Instructions for Healthcare Personnel that is required to be provided by ASP.

I) Healthcare facilities using the decontaminated, compatible N95 respirators must monitor HCP who use such respirators for the signs and symptoms of potential infection with SARS-CoV-2 or other respiratory infection and promptly report such information to ASP, so that ASP can provide a report to FDA consistent with Section IV.D of this EUA. Reports of adverse events should be reported up to and including 14 days after the last contact with suspected SARS-CoV-2 virus.

J) Healthcare facilities using the decontaminated, compatible N95 respirators must inspect the decontaminated, compatible N95 respirators following the decontamination process using the ASP STERRAD Sterilization Systems. Any discoloration or other signs of degradation with a decontaminated respirator should promptly be reported to ASP, and the healthcare facility should discard the respirator.

K) Healthcare facilities must track the number of times a compatible N95 respirator is decontaminated, up to a maximum of 2 decontamination cycles per compatible N95 respirator. Healthcare facilities must ensure that the decontaminated, compatible N95 respirator is returned to its previous user. Healthcare facilities should maintain documentation for use of the ASP STERRAD Sterilization Systems consistent with current healthcare facility protocols.

Conditions Related to Advertising and Promotion

L) All advertising and promotional descriptive printed matter relating to the use of the ASP STERRAD Sterilization Systems shall be consistent with the authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.

M) No advertising or promotional descriptive printed matter relating to the use of the ASP STERRAD Sterilization Systems shall represent or suggest that such products are safe or effective for the prevention or treatment of patients who have COVID-19.

N) All advertising and promotional descriptive printed matter relating to the use of the ASP STERRAD Sterilization Systems clearly and conspicuously shall state that:

• the ASP STERRAD Sterilization Systems have neither been cleared or approved for the prevention of the COVID-19 infection;

• the ASP STERRAD Sterilization Systems have been authorized by FDA under an EUA;


• the ASP STERRAD Sterilization Systems are authorized only for the duration of the

declaration that circumstances exist justifying the authorization of the emergency use of the ASP STERRAD Sterilization Systems under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

V. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying this authorization is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

Sincerely,

____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration

Enclosures

STERRAD Letter of Auth FDA 04.11.20 FINAL.PDFConditions Related to Advertising and PromotionConditions Related to Advertising and Promotion

Date post:	06-Feb-2021
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