Devine Guidance

Reprocessing Warning

By Dr. Christopher Joseph Devine
February 25, 2015


• Categories: Devine Guidance

The doctor is pretty sure that many of you that subscribe to and receive the FDA’s Medical Device Safety and Recalls information; received the communication warning about the reprocessing of “duodenoscopes” (also known as a specialty endoscope). As a result of potential reprocessing issues, there have been multiple patient deaths reported. The deaths have been attributed to the exposure to multidrug-resistant bacterial infections, including two highly-publicized events at UCLA.

Now Dr. D has never been a big fan of reprocessing medical devices, especially devices clearly marketed as single-use. However, the re-sterilization of many surgical devices is considered routine. In fact, many of the surgical instruments and a variety of scopes employed in minimally invasive procedures and placed into commerce in the United States and abroad, are routinely reprocessed without ill effects to the patient or user.

However, FDA has found it necessary to warn users and the public about the potential risk associated with the reprocessing of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes. Heck, Dr. D can barely pronounce it so reprocessing must be a challenge. When it comes to raising the proverbial red flag to alert industry of potential threats to patient and user health, the FDA can never be accused of being “histrionic” (look-it-up) in their rhetoric as their job is to clearly and quickly inform the public of potential dangers associated with a product (in this case a process and a device).

Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

“The FDA is issuing a safety communication to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of duodenoscopes, used during a procedure known as Endoscopic Retrograde Cholangiopancreatography (ERCP) may impede effective reprocessing. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. The FDA’s safety communication contains recommendations for health care professionals, reprocessing facilities and patients, to help reduce the risk of infection.”

Facts from FDA

In the case of the duodenoscopes, the agency felt compelled to educate the users, patients, manufacturers, and re-processors about the challenges associated with the cleaning of such a complex instrument. According to FDA, it appears that even when a manufacturer’s instructions for reprocessing are followed to the letter, there is a potential for adverse events driven by multidrug-resistant bacterial infections in patients. The FDA believes that “meticulously cleaning” duodenoscopes prior to a “high-level disinfection process” should reduce risk associated with spreading infections. Not wanting to state the obvious but obliged to do so, if the current reprocessing instructions authored by the manufacturers are not working; then Dr. D sees to potential issues: (a) the instructions are deficient; or (b) the organizations tasked with reprocessing the scopes are not following the manufacturer’s instructions.

According to FDA, over 500K ERCP procedures, using the special scopes, are performed each year in the United States alone. The procedure is commonly employed for the drainage of fluids from pancreatic and biliary ducts blocked by cancerous tumors, and gallstones. The complex design associated with duodenoscopes, especially small crevices associated with the elevator mechanism, makes cleaning and the subsequent disinfecting of these devices challenging. In fact, residual body fluids and other organic material may be left behind after the cleaning and disinfecting process has been completed. This residual organic material (serious yuck factor my dear readers) may contain microbial contamination. The end result is that the next patient could be exposed to this bio-contamination resulting in serious and potential fatal infections.

Now Dr. D has always been a big fan of the agency as they do a fabulous job in keeping patients and users safe. However, the doctor believes the FDA’s actions associated with this issue have fallen short. As previously stated, if the recommended manufacturers cleaning procedures are not effective; it is either a problem with the cleaning procedure or a problem with the execution of the cleaning procedure. Heck, it could be both. Regardless, it is Dr. D’s humble opinion; the reprocessing of these scopes should stop until the issues have been resolved. The red-flag warning should be lowered and in its place a stop sign installed. Instead, the agency has decided to pursue the following course of action and rely on guidance activity while the investigation continues (reprinted from FDA).

Recommendations for facilities and staff that reprocess ERCP Duodenoscopes:

• Follow closely all manufacturer instructions for cleaning and processing.
  • The FDA recommends adherence to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals, as described in the Additional Resources section, below. In addition, it is important to follow specific reprocessing instructions in the manufacturer’s labeling for each device.
  • Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection. Deviations from the manufacturer’s instructions for reprocessing may contribute to contamination. The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.
• Report problems with reprocessing the device to the manufacturer and to the FDA.
• Follow these additional general best practices:
  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.
  • Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
  • Refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 consensus document for evidence-based recommendations for endoscope reprocessing.”

  Recommendations for Health Care Providers

  • ​“Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
  • Consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.
  • Submit a report to the manufacturer and to the FDA via MedWatch, as described below, if you suspect that problems with reprocessing a duodenoscope have led to patient infections.”

  Recommendations for Patients

  • “Discuss the benefits and risks of procedures using duodenoscopes with your physician. For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed.
  • Ask your doctor what to expect following the procedure and when to seek medical attention. Following ERCP, many patients may experience mild symptoms such as a sore throat or mild abdominal discomfort. Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools).”

  Takeaways

  For this week, Dr. D will leave no takeaways. The salient purpose of this week’s guidance was to bring a serious issue associated with device reprocessing to the attention of the readers. As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.

  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. Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013).
  3. Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
  4. FDA’s safety alerts page. (2015, February). FDA.gov Website. Retrieved February 21, 2015, from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htmsource=govdelivery&utm_medium=email&utm_source=govdelivery.