In a safety communication issued in September 2015, the FDA’s analysis of Medical Device Reports (MDRs) between 2010–2015 identified failure to meticulously follow manufacturer reprocessing instructions as a recurring theme. However, discrepancies between instructions from the respective manufacturers of the device and disinfection equipment can complicate reprocessing procedures. The following is excerpted from Larry Muscarella, PhD’s article, Recommendations for resolving inconsistencies in the reprocessing instructions of bronchoscopies and automated reprocessors.

In discussing the extent of the reprocessing problem, Muscarella states, “Indeed, user confusion about which set of reprocessing kits to follow and use—those provided and recommended by the AER’s manufacturers, or the endoscope’s manufacturer—has been linked to a number of bacterial outbreaks, with associated patient morbidity and mortality.

“An example of such a discrepancy would be a significant conflict between the endoscopes’ reprocessing instructions and those of the automated endoscope reprocessor, or AER, with each manufacturer recommending the use of its own unique and disparate set of reprocessing adaptors, fittings, and caps, termed ‘reprocessing accessories.’”

There are many publications that state the problem of these discrepancies…

“But, whereas each of these safety publications underscores the importance of the AER and endoscope manufacturer’s reprocessing instructions being consistent, the specific advice they provide hospitals about how to resolve identified discrepancies is limited…”

How can you overcome reprocessing discrepancies in your institution? Click here to receive Dr. Muscarella’s article, which includes his advice on how to address bronchoscope cross-contamination.


Founder of LFM Healthcare Solutions LLC, Lawrence F. Muscarella, PhD, has researched and authored more than 200 articles on the topics of disinfection, sterilization, instrument reprocessing, risk management, infection control and prevention, modes of disease transmission, and factors that pose an increased risk of healthcare-acquired infections (HAIs), with a focus in the fields of gastrointestinal endoscopy and critical care.

His articles have been published in such peer-reviewed medical journals as: The Journal of Hospital Infection, The American Journal of Infection Control, Gastrointestinal Endoscopy, Chest, Infection Control and Hospital Epidemiology, Endoscopy, and the World Journal of Clinical Infections Diseases.