Devices

FDA Warns Battelle About Decontamination System MDR Issues

FDA says Battelle Memorial Institute, Columbus, OH, failed to meet medical device reporting (MDR) requirements included in an emergency use authorization (EUA) for its Battelle Critical Care Contamination System. The system is used for decontaminating certain N95 respirators for reuse by healthcare personnel where there are insufficient supplies of filtering faceplate respirators due to the Covid-19 pandemic.

A 10/7 Warning Letter says the firm does not have in place required processes. Specific issues cited in the letter are:

the documents submitted by Battelle as its Medical Device Reporting 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;
the company procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting;
the procedure does not establish internal systems that provide for timely transmission of complete medical device reports; and
the procedure does not describe how the firm will address documentation and record-keeping requirements.

The letter says that based on requirements in the EUA issued to Battelle, the agency believes that these types of events are required to be reported — allergic reactions; evidence that a decontaminated respirator is unable to perform its essential function and its therapeutic effect is compromised; events related to odor due to hydrogen peroxide residuals or wearer contact with hydrogen peroxide residuals that required medical or surgical intervention; infection in respirator wearers, healthcare personnel, or respirator decontamination staff; and malfunctions of the hydrogen peroxide vapor generator used to decontaminate the respirators per the process authorized by the EUA.

Battelle was told to take immediate steps to correct the violations and to respond with a list of specific steps the firm will take to correct the violations and prevent their recurrence, with a timetable for implementing the steps.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome