Oct. 20, 2015

Michael L. Kochman, MD, who is the chair of the AGA Center for GI Innovation and Technology, provides takeaways from FDA’s October dudodenoscope announcement.

By Michael L. Kochman, MD, AGAF, FASGE
Chair, AGA Center for GI Innovation and Technology

The recent announcement by FDA that orders Fujifilm, Hoya (Pentax), and Olympus to conduct post-market surveillance studies on the reprocessing of duodenoscopes has wide implications. AGA applauds the effort to ‘Get to Zero’ device transmitted infections. FDA, physicians who use duodenoscopes and patients all have aligned interests with the ultimate safety of the procedure. Over the past year it has become clear that bacterial transmission and infections have occurred despite the best efforts of all involved.

These infections are unusual in that their mode of transmission is device related patient-to-patient transmission and not due to the breach of the technical performance of the associated physician directed procedure. There are multiple potential steps which have been investigated and in many instances it appears that no gross violations of reprocessing protocols were made, though FDA has identified difficulties with following the instructions as written.

Having said that, there are identified potential concerns with the companies’ devices and instructions and the validation of the reprocessing protocols as has been documented in the lay press and elsewhere. There were a series of meetings held by the GI Societies and FDA this spring. During a meeting called by the AGA Center for GI Innovation and Technology, it became clear that the ‘soil’ with which validation of reprocessing efficacy needs to be performed might not truly be representative of in vivo ‘soil’ with no clear standards for validating reprocessing with biofilm formation.

The complexity of the reprocessing protocols and the variations that need to be understood and implemented at the local level where the reprocessing core is responsible for a variety of flexible devices is quite high. A single endoscopic unit may have multiple different types of flexible endoscopes including upper endoscopes, colonoscopes, enteroscopes, and endoscopic ultrasound endoscopes, in addition to the duodenoscopes. Each of these flexible devices has specific cleaning instructions; a unit may have not only a variety of devices and of varying generations, but devices may also be from multiple different manufacturers.

The FDA call for data acquisition concerning the current instructions and practices will help to inform future policy and decisions. The AGA Center for GI Innovation and Technology has taken the lead in addressing this issue and remains committed to providing patients with the safest endoscopic environment possible. We agree with FDA that, despite the identified risks with the current duodenoscopes and reprocessing protocols, the overall health of the public is benefitted by the continued availability of the duodenoscopes and the procedures that utilize them.

The fundamental issues that FDA has requested the companies to address include a review of the reprocessing materials, hard data on the actual duodenoscope contamination after following the approved protocols and steps needed to decontaminate a colonized device.

The issues that FDA directed the companies to answer, and the tight timeline, are strong indications that there will be additional changes forthcoming to help us further protect our patients from device transmitted infections; whether due to the design of the devices, the reprocessing complexity of the devices, or non-adherence to the reprocessing protocols due to human factors.

Dr. Kochman recently coauthored a commentary on duodenoscope infections in Annals of Internal Medicine. In addition to serving as chair of the AGA Center for GI Innovation and Technology, he is Wilmott Family Professor of Medicine, Center for Endoscopic Innovation, Research and Training Gastroenterology Division University of Pennsylvania Health System.