Devices

Panel to Discuss Heater-Cooler Devices

The FDA Circulatory Devices Panel of the Medical Devices Advisory Committee will discuss at its 6/2-3 meeting concerns about the adequacy of cleaning and disinfection of heater-cooler devices (HCD) and how to best remediate the mode of nontuberculous mycobacteria (NTM) aerosolized transmission from the heater-cooler device to the sterile field and the patient’s open chest during cardiopulmonary bypass procedures. A briefing document released in advance of the meeting says that the agency believes “that it is appropriate to have an open and transparent dialog with all stakeholders to review and discuss available data regarding the benefits and risks associated with the use of HCDs during cardiothoracic surgeries and generate evidence-based recommendations on how to best care for patients undergoing these life-saving procedures.”

According to the agency, several strategies have already been implemented to mitigate the risk of HCD contamination with NTM and to reduce the potential for its airborne transmission by directing the device vents away from the patient and the sterile field. “FDA is presently working with each of the HCD manufacturers to develop more robust cleaning and disinfection test methods and validated instructions for use,” the briefing document says. “Questions, however, persist as to how clean is clean enough to enhance the safety margin of these devices, and what standards should be employed for microbial water contamination.”

Committee members are being asked to discuss:

the effectiveness of HCD cleaning and disinfection methods;
the amount and type of premarket Data and information needed to demonstrate validation of cleaning and disinfection of HCDs in support of labeling claims and technical instructions;
the appropriate risk mitigations to be implemented by manufacturers of HCDs and/or hospital facilities to ensure patient safety during surgical procedures where the devices are used; and
the appropriate guidelines and criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries.

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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