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WARNING LETTER

Battelle Memorial Institute MARCS-CMS 610928 —

Product:
Medical Devices
Recipient:
Recipient Name
Jeff Rose
Recipient Title
Vice President Government Relations and Public Policy
Battelle Memorial Institute

505 King Ave.
Columbus, OH 43201
United States

rosej1@battelle.org
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER

Dear Mr. Rose:

The Food and Drug Administration (FDA) authorized the Battelle Memorial Institute’s (Battelle’s) Critical Care Decontamination System (CCDS) under Emergency Use Authorization (EUA) EUA200210 on March 28, 2020.  FDA subsequently revised and reissued the EUA on March 29, 2020, and June 6, 2020.  CCDS is authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) Pandemic.

On August 7, 2020, FDA issued a letter notifying you it had come to our attention that you may not be complying with Conditions H and I of the June 6, 2020 EUA for the CCDS. This letter requested information about Battelle’s process for submitting reportable adverse events to FDA as well as the submission of MDRs for any reportable event of which you had been aware for more than 30 days. You responded on August 12, 2020 and stated that Battelle has a process in place to report adverse events and provided supporting documents. You also stated that Battelle had not identified a reportable adverse event through August 7, 2020.

Pursuant to Condition of Authorization H of the CCDS EUA, Battelle must have reporting and record collection processes in place in accordance with 21 CFR Part 803. FDA has reviewed the information you provided  and has determined that you are not in compliance with Condition H of the authorization because you do not have processes in place in accordance with 21 CFR Part 803 as follows:

1.  The documents provided titled “Intake and Reporting of Product Reports (Adverse Events and Product Problems),” Document Number CCDS-011, Revision 3.0, dated 7/22/2020 and “Product Report Intake Form,” Document Number CCDS-011-F1, Revision 2.0, dated 6/29/2020, which were referenced as your firm’s MDR procedure, do not establish internal systems that provide for timely and effective identification, communication and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:

a.    Your procedure does not include instructions for how Battelle will evaluate information about an event to make MDR reportability determinations in a timely manner. 

b.    Your procedure omits definitions for the terms “becomes aware,” “caused or contributed,” “malfunction,” and “serious injury,” which are terms found in 21 CFR 803.3. Additionally, your procedure omits the term “reasonably suggests” found in 21 CFR 803.20(c)(1). The exclusion of the definitions for these terms from the procedures results in the procedures being ineffective in so far as they may lead to an incorrect reportability decision when evaluating a complaint under 21 CFR 803.50(a).

2.  The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example:

a.    There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event.

3.  The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include:

a.    instructions for how to complete the Form FDA 3500A;

b.    the circumstances under which you must submit initial 30-day reports, supplemental or follow-up reports, or 5-day reports, and the requirements for such reports;

c.    a process for submitting MDRs electronically in accordance with 21 CFR 803.20(a)(3); and

d.    how you will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within the firm.

4.  The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b). Specifically, the procedure does not address the following:

a.    information that was evaluated to determine if an event was reportable; and

b.    documentation of your deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).

As communicated in our letter dated August 7, 2020, and based on the requirements in your EUA, FDA believes that the following types of events are required to be reported. This is not meant to be a complete list of reportable event types under 21 CFR Part 803 for your authorized product but is rather intended to identify helpful examples of reportable events that may be relevant to your authorized product:

  • allergic reactions;
  • evidence that a decontaminated respirator is unable to perform its essential function and its therapeutic effect is compromised. These events include shrunken or misshaped respirators, poor fit or seal including respirators that cannot form to the users face, metal nose bridge breakage or metal bridge split with or without air leakage, any changes in the materials including softening, shredding, peeling, or discoloration of the respirator, or breaking or loosening of straps;
  • events related to odor due to hydrogen peroxide residuals or wearer contact with hydrogen peroxide residuals that required medical or surgical intervention. This may include reports of burning or irritation of eyes, nose, or throat, burning, tingling, numbing of lips, and tongue or face, breathing difficulties, coughing, chest pain, itching sensation or any adverse skin reaction, or lightening of the skin;
  • infection in respirator wearers, healthcare personnel or respirator decontamination staff. This includes any trends in infections of users or decontamination staff; and
  • malfunctions of the hydrogen peroxide vapor generator used to decontaminate the respirators per the processes authorized in the EUA.

For more information regarding the electronic submission of MDRs, please refer to the FDA guidance document Questions and Answers about eMDR - Electronic Medical Device Reporting. In addition, please see the guidance document eMDR – Electronic Medical Device Reporting for details on how to set up an account for submitting these reports.  If you need to create a new account and are asked for a Registered Establishment Number (REN) or FDA Establishment Identifier (FEI), please enter 1523658, which is the FEI number FDA created for your firm as part of previous bioresearch monitoring inspection activity.

You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your product(s) or operations. It is your responsibility to ensure that your actions and the products you sell are in compliance with applicable legal requirements.

In addition to correcting the violations cited in this letter, please also review your reports for any reportable events that you have been aware of for more than 30 days and submit an MDR to FDA as soon as possible. Please note that manufacturers must submit MDRs electronically using FDA’s Electronic Medical Device Reporting (eMDR) system and the completion of Form FDA 3500A in electronic format to capture the information for each event. Electronic submission of these MDRs requires the creation of an account for submitting reports to the FDA-wide Electronic Submissions Gateway.

Within fifteen (15) calendar days from the date you receive this letter, please submit the specific steps your firm will take to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. If you believe that your actions and your product are not in violation of the conditions of the EUA or the Act, include your reasoning and any supporting information for our consideration.

If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities in your initial response. If corrections and/or corrective actions cannot be completed within fifteen calendar days, please state the reason for the delay and the time within which these activities will be completed. Given the nature of the intended use of the CCDS to decontaminate FFRs for multiple-user reuse by HCP during the COVID-19 pandemic, FDA expects that you will implement your corrections within 30 days. When responding, please also include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken.

Your response should reference “CMS# 610707” and be sent to:

Attention: Cynthia J. Chang, Ph.D.
Director
Division of Infection Control and Plastic Surgery Devices
Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Building 66, Room # 4646
Silver Spring, Maryland 20993-0002

If you have any questions concerning this letter, or would like to schedule a conference call to discuss this letter or your obligations under Condition H of your EUA, please contact Dr. Cynthia Chang at Cynthia.Chang@fda.hhs.gov.

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to your compliance with Condition H of the June 6, 2020, authorization letter and does not necessarily address other obligations your firm has under the law.

Sincerely,

/S/

Binita S. Ashar, MD, MBA, F.A.C.S.
Director
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

 
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