December 5, 2013 —A hospital in Maine (USA) confirmed today a medical error — namely, that it had been improper cleaning cystoscopes after their use during certain urological procedures.
This incident reported by the Bangor Daily News (12-05-2013) can be read by clicking here.
In response, the hospital notified 76 patients of this reprocessing error and the increased risk of healthcare-associated infections (HAIs) that it posed.
These affected patients underwent cystoscopy between September 9, 2011, and October 25, 2013, a period of almost two years. Hospital staff discovered this on October 31, 2013, almost 5 weeks ago.
According to the hospital in Maine (USA), this reprocessing lapse was confirmed during routine surveillance of infection-control practices.
But that this error was not detected for more than two years certainly suggests that a routine audit of this hospital’s cystoscope-reprocessing procedures was not performed annually or more often as recommended by Lawrence F Muscarella, PhD, this article’s author.
The hospital is offering the 76 affected patients follow-up services, which are likely to include free blood tests to evaluate whether any were infected with a blood-borne pathogen, such as HIV and the hepatitis C virus (although the transmission via these improperly reprocessed cystoscopes of other potentially infectious agents, such as Pseudomonas, Serratia and such potentially antibiotic-resistance bacteria as “MRSA” and Klebsiella should not necessarily be ruled out).
For example, Wendelboe et al. (2007) implicated an improperly reprocessed cystoscope as the likely source of several cases of P. aeruginosa infection following cystoscopy.(1)
A trained physician may perform cystoscopy to examine the interior lining of a patient’s bladder and urethra.
The proper reprocessing of cystoscopes — like that of colonoscopes, flexible laryngoscopes, and other type of flexible endoscopes — is crucial to the prevention of transmission of the hepatitis C virus and other infectious agents including P. aeruginosa. — Lawrence F Muscarella PhD
While the 76 patients at this hospital in Maine who were reportedly exposed to a contaminated cystoscope may not necessarily exhibit signs of infection (for a number of reasons), there remains the possibility of their becoming colonized with bacteria (i.e. the transmission of bacteria to a patient who does not show signs of associated infection).
Sidebar: Click here to read Dr. Muscarella’s related article “Factors Affecting the Risk of Infection Associated with an Endoscope Reprocessing Error,” which discusses instrument reprocessing, medical device design, the regulation of medical devices by the FDA, the risk of disease transmission, patient disclosure, and the importance to patient safety of a robust quality assurance program.
Cystoscopes are remarkably similar in design, device classification, and clinical use to flexible laryngoscopes.
Therefore, the step-by-step reprocessing instructions of the former type of semi-critical instrument — which Dr. Muscarella published and which is available on the Internet by clicking here — can be adopted by the healthcare facility to the reprocessing of cystoscopes. Contact the cystoscope’s manufacturer with any questions.
This hospital in Maine is to be commended for its demonstrated commitment to transparency and the adoption of necessary and effective corrective actions that will prevent this breach’s recurrence. — Lawrence F Muscarella PhD
According to a spokesperson of this hospital in Maine: “We want to be very transparent about what happened. We have an obligation to our patients and to our community to be very transparent and proactive.”
This hospital reports that is currently implementing mandatory staff retraining, among other corrective actions, to prevent this reprocessing error’s recurrence.
Summary of the Incident
The identified breach was a hospital’s inadvertently failure to perform a requisite cleaning step, required by both the cystoscope’s manufacturer and published guidelines, prior to the instrument’s high-level disinfection.
Published guidelines, along with a number of published reports, indicate that this hospital’s reprocessing error poses an increased risk of infection, thereby warranting patient notification and the employment of corrective actions.
The likely root causes of this Maine hospital’s improper reprocessing of cystoscopes seemingly include, possibly among others:
- inadequate training of reprocessing staff;
- staff being unaware that the improper reprocessing of cystoscopes can be associated with serious patient harm; and
- performing audits less often than once a year.
These shortcomings are not unique to this one medical facility. Because of this specific hospital’s transparency and demonstrated committed to patient safety, however, it it Dr. Muscarella’s opinion that the likelihood of this error’s recurrence at this hospital — but not necessarily at a medical facility that encounters a similar reprocessing breach, but considers the error insignificant and does not notify patients or employ corrective actions — is extremely low.
The following recommendations are provided by Dr. Muscarella to prevent this type of incident’s recurrence:
1A. Review the cystoscope manufacturer’s step-by-step reprocessing instructions provided in the device’s operator’s manual.
1B. Print these instructions, compare them to your facility’s current policies and procedures (“P&Ps”) for reprocessing cystoscopes, and make the necessary changes, additions, and improvements where it is noted that the P&Ps are incomplete and/or their quality could be enhanced. Do this step for all of the facility’s flexible endoscopes.
1C. Or, review the step-by-step reprocessing instructions that Dr. Muscarella published and are available on the Internet by clicking here. Adopt these instructions, primarily intended for flexible laryngoscopes, to the safe and proper reprocessing of flexible cystoscopes.
Click here to read Dr. Muscarella’s related article “The Reprocessing of Sheathed “ENT” Endoscopes and Cystoscopes.”
2. Routinely evaluate the practices of reprocessing staffers to ensure their thorough competency and knowledge of the reprocessing requirements of every type of flexible endoscope and cystoscope in inventory and that they are responsible for cleaning and high-level disinfecting.
3. Understand that improper reprocessing of a flexible endoscope, such as a cystoscope, has been documented to cause serious patient harm, with associated morbidity and mortality.
4. Perform periodic audits of your medical facility’s infection-control and endoscope-reprocessing practices at least once a year (or more often as required) to ensure quality, patient safety, and accreditation.
- Surveys and proactive surveillance are crucial to the detection of quality deviations, the prevention of infections, and to patient safety.
5A. Read Dr. Muscarella popular article “Factors Affecting the Risk of Infection Associated with an Endoscope Reprocessing Error” — click here — for guidance about whether a specific instrument-reprocessing breach warrants patient notification.
5B. For a better understanding of how to make a proper assessment of the risk of infection associated with a specific breach, refer to Table 3 (click this link) of Dr. Muscarella’s peer-reviewed article “Medical errors, infection-control breaches and the use of adulterated and mis-branded medical devices.”
Whenever in doubt, consider notifying affected patients of an infection-control breach. Doing so displays a commitment to transparency, to quality improvements, and assuredly puts into place the employment of important corrective actions — as well as provides a degree of accountability — that all but prevents the breach’s recurrence. Failure to notify patients of a potentially significant breach could bode its recurrence. — Lawrence F Muscarella, PhD (this blog’s author)
6. Consider having an expert perform an external audit of your endoscope reprocessing practices to ensure compliance with current guidelines. Contact Dr. Muscarella if you have any questions.
7. Click here to read Dr. Muscarella’s related article “Disinfection or Sterilization of a Contaminated Reusable Instrument?“ for guidance about whether to disinfect or sterilize a specific type of reusable instrument.
8. Review Dr. Muscarella’s related blog — click here – “Recommendations to Prevent Infections Associated with Improperly Reprocessed Reusable Medical Equipment.”
9. Consider employing an endoscope tracking system that associates each patient with the specific endoscope that were used during treatment.
- While such a system might not have assisted in this Maine hospital’s specific cystoscope-reprocessing breach, endoscope tracking can distinguish between those patients who underwent certain urological exams and are at an increased risk of infection, and those who are not.
1. Wendelboe et al. (2007). Outbreak of cystoscopy related infections with Pseudomonas aeruginosa: New Mexico, 2007. J Urol 2008 Aug;180(2):588-92.
Article by: Lawrence F Muscarella, PhD. Posted 12/5/2013; updated 3/28/2016, Rev A.