Let’s be honest, if you’re in the scope management and reprocessing industry, how excited are you about the prospect of having an endoscopic procedure? Is the recent focus by regulatory agencies on the cleaning and disinfection of flexible endoscopes really a surprise? According to Dr. Martin Favero, PhD, Director of Scientific and Clinical Affairs for Advanced Sterilization Products “one of the worst offenders in this game of microbial hide-and-seek are endoscopes.” In a June 2002 article of Infection Control Today, Favero states;

“In 1978 the Centers for Disease Control and Prevention (CDC) convened a meeting with gastrointestinal physicians, endoscope manufacturers and CPs. The overwhelming consensus at that meeting was that industry should be designing endoscopes that either could be steam sterilized, which is impossible, or more realistically, endoscopes that could be easily cleaned compared to what was on the market. The reality is that very little has changed since then regarding endoscope design. They are still difficult to clean and let’s face it, this medical device is the one associated with the most hospital-acquired infections.” 1  

So, here we are in 2015, with the FDA releasing a Safety Alert regarding reprocessed flexible bronchoscopes and the risk of infection. The FDA’s recommendations are targeted on what healthcare facilities can do, rather than device manufacturers, to better ensure flexible bronchoscopes are in proper condition for use. The recommendations include:

  • Strict adherence to the manufacturers reprocessing instructions, stating it is critical to have the manufacturer’s instructions for use (IFU) readily available to the technician.
  • Immediate removal from service of any scope that fails a leak test, or shows visible signs of damage.
  • Adherence to the manufacturer’s recommendations for preventative maintenance and repair.
  • Implementation of a comprehensive reprocessing quality control program.
  • Proper storage of bronchoscopes in a manner that will minimize contamination or collection and/or retention of moisture per manufacturer’s guidelines.2

In addition to the FDA Safety Alert a recent article by Biomedical Instrumentation & Technology discussed the challenges facing sterile processing departments specifically endoscopes. Damien S. Berg, CRCST and consultant for University of Colorado, suggested “Some IFU’s, are just impossible to perform in the ‘real world,’ and others really don’t get to the root cause of why they can’t be cleaned”, referring to the fact that product design plays a big factor. Damien went on to say “You will need to develop your own cleaning protocol that not only meets the IFU, but exceeds it.”3 In other words, we should have enough confidence in our endoscope reprocessing procedures, that we would be willing to have it used on ourselves.

The good news is that technology today can offer some assistance to help facilities work toward ensuring the FDA’s recommendations along with the manufacturer’s IFU’s are followed. Some ways new software can help are:

  • One-click access for technicians to on-line, document management systems that provide manufacturer’s IFU’s.
  • Electronic instrument-level tracking to alert staff when equipment is due for maintenance.
  • Electronic data capture of leak test results and disinfection processes for every endoscope with data retrieval just a few clicks away.
  • Electronic data capture of technician processing productivity.
  • Ability for technicians to access facility-designed or manufacturer-provided instructional videos and images.

With over 15 million flexible endoscope procedures performed annually, and Central Sterile understanding that every patient is someone’s loved one, complimenting current reprocessing protocols with great technology solutions may end up being a savings rather than a cost.


Author: Jennifer Zola, RN, BSN


1Pyrek K.M. Nooks and Crannies: The Breeding Grounds for bacteria. Infection Control Today. June 2002, page 32


3Passut J. A Roundtable Discussion: The Many Challenges of Sterile Processing. Biomedical Instrumentation & Technology. July/August 2015, page 264-265.