Devine Guidance

FDA & Duodenoscopes – The Panel

By Dr. Christopher Joseph Devine
May 26, 2015


• Categories: 05-Quality/Regulatory, Devine Guidance, RC - Medtech Regulatory Resource Center

It appears that as Dr. D was working on last week’s blog on the dangers associated with duodenoscopes and superbug infections, the FDA was convening a panel to further explore the same issues. Being a naturally inquisitive person, the doctor would like to know how safe is really safe when it comes to reprocessing these complex instruments? Now the “erudite” (look-it-up) scholars selected by FDA for this panel brought with them a plethora of knowledge pertaining to not only the medical device in question but the application of said device and the reprocessing. Dr. D has taken the liberty of reprinting the questions posed to the panel by FDA and the panelists’ responses. Enjoy!

The panel was asked to ponder the following six FDA discussion questions, while providing their insight into the actual procedure, patient risk due to duodenoscope reprocessing, and recommendations for improving patient safety.

1. Based on the methodology and criteria for acceptance of cleaning, high-level disinfection, and sterilization validation testing for both manual and automated processes, the panel concluded that duodenoscopes and AERs [automated endoscope reprocessors] do not provide a reasonable assurance of safety and effectiveness. The panel believes that manual cleaning is a critical component in the process, [and] thus needs to continue. Majority of the panel also believes it is necessary to reclassify duodenoscopes based on the Spaulding Classification from semi-critical to critical, and support the move from high level disinfection towards sterilization. Although, some panelists maintained that high level disinfection is adequate, if done properly.

   The panel unanimously agreed that ERCP [Endoscopic Retrograde Cholangiopancreatography] is an important procedure and the use of duodenoscopes during this procedure is safe and should continue from a public health perspective. The benefits of the procedure for the population outweigh the potential risks associated with the use of duodenoscopes.

2. The panel discussed the role of pre-market human factors testing in reprocessing instructions and concluded human factors testing is important and therefore, should be a part of the pre-market assessment. The panel supported a guide of best practices and competency assessments for ensuring user adherence with manufacturer’s reprocessing instructions.
3. The panel discussed cleaning agents and brushes differing from the duodenoscope manufacturer’s instructions and concluded that brushes or other cleaning agents should meet the manufacturer’s specifications. The panel also agreed it is necessary to receive data from the manufacturer on the efficacy of brushes or other cleaning agents as well as the need for development and validation of cleaning verification assays.
4. The panel discussed CDC’s interim guidance for surveillance for bacterial contamination of duodenoscopes after reprocessing and concluded the guidance is not sufficient in the current form to be implemented by healthcare facilities as a best practice. The panel believes more data and validation testing is needed before a surveillance program should be implemented by healthcare facilities. Despite its limitations, the panel agreed the guidance provides a well-documented outline for healthcare facilities.
5. The panel’s recommended approach for ensuring patient safety for ERCP is to discuss the informed consent with patients and to provide information on the risk of infection from the procedure and to disclose if the health facility has had an issue with infections. Patient selection is also critical for ensuring patient safety. Patients should also be informed of the effects of foregoing the procedure and provided alternatives to the procedure.
6. The panel discussed temporizing measures the FDA should consider when the FDA has a medical device concern but not enough information to determine the most appropriate action towards a resolution. The panel urged the FDA to provide early communication of the facts to the public. The panel also stated the FDA should work with professional societies in an effort to disseminate a consistent message to healthcare providers.

In Summary

It is Dr. D’s opinion that the panel provided some meaningful insight into the risks associated with the reprocessing of duodenoscopes. The panel agreed that as currently being performed, the reprocessing does not “provide a reasonable assurance of safety and effectiveness.” Conversely, some of the panelists actually believe the current method for cleaning scopes (post-procedurally) is adequate. However, the panel was unanimous when discussing the overall need for ERCP, and the benefits of the procedure to the general populous outweighing the potential risk to individual patients associated with the use of duodenoscopes. Tell that to the individuals who have lost loved ones to a superbug infection (post-procedure).

Additionally, the panel stated that they would like to see duodenoscopes reclassified as semi-critical to critical on the Spaulding Scale. The Spaulding Scale was developed by Dr. E. H. Spaulding and places medical devices into one of three categories: (a) Critical; (b) Semi-critical; and (c) Noncritical. The scale drives the level of disinfection/sterilization for medical devices.

Furthermore, the panel identified the CDC’s recent guidance associated with the bacterial contamination of duodenoscopes (post-reprocessing) as deficient. In fact, the panel concluded that “the guidance is not sufficient in the current form to be implemented by healthcare facilities as a best practice.”

Finally, the panel urged the agency to become more proactive in their communication process in the interest of improving public awareness and the promotion of public health and safety. It is Dr. D’s opinion that the FDA does a reasonable job when it comes to informing the public about potential problem devices. When the FDA becomes aware of problem devices, they are proactive in pursuing immediate action to protect the health of the public. Unfortunately, the medical device industry and healthcare as a whole is far from utopian so it is inevitable that bad things will occasionally happen.

Takeaways

For this week’s guidance there are no takeaways. Dr. D thinks the panel provided some valuable insight into the reprocessing of duodenoscopes. However, it is the doctor’s humble opinion that trading the potential health risk to a few patients versus the collective good of all patients is never acceptable, especially when these post-operative “superbug” infections can be prevented. Premised on everything that has been published on the topic of duodenoscope reprocessing, it appears that the effectiveness of the reprocessing is not effective. In fact, even the panel of experts has voiced their concerns over the effectiveness, or lack of in duodenoscope reprocessing. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.

References

1. Brief summary of the gastroenterology and urology devices panel meeting May 14-15, 2015. Accessed May 26, 2015. Retrieved from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM447407.pdf
2. Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon.
4. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.