An endoscope is a is a lighted optical instrument that can be introduced into the body to provide a view of its internal parts.  The endoscope is usually introduced into the body through a natural opening such as a mouth or anus.  The endoscope may be used for diagnostic or treatment purposes and often has multiple “channels”.

Investigation of outbreaks: The danger of improperly sterilized endoscopes

Infections are generally considered a known risk and complication of endoscopy procedures. However, recently these concerns have been brought into the public light because of several high publicity cases.

The investigation of some of these outbreaks revealed that the endoscopes, sometimes called duodenoscopes, may contain bacteria which remain even after conventional sterilization.  Because the endoscopes are reusable, the infections can be passed from patient to patient. The doctor assumes the device is sterile, but now they know that they may not be able to have confidence that the scopes they are using are actually sterile. Unfortunately, neither the FDA or the manufacturers of the endoscopes have offered much advise to doctors or to the public.

Response from the FDA and other organizations

In February 2015, the Food and Drug Administration (FDA)  issued a bulletin warning of the risk of  infection due to the complexity of the endoscope device, which contains many small working parts with hidden, often difficult to reach crevices.

The FDA concluded that the design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes may impede effective cleaning. So, this means that the devices themselves may be considered defective in their design if they are unable to be cleaned properly even when healthcare facilities follow the manufacturer’s instructions.

The Association for the Advancement of Medical Instrumentation (ANSI/AAMI) has concluded  that endoscopes can be removed of all harmful bacteria if the manufacturers’ cleaning instructions are followed, the person performing the disinfection is competent, the environment in which the disinfection is performed is free of contaminants and the manner in which the endoscope is stored does not expose it to contaminants.

The Society of Gastroenterology Nurses and Associates (SGNA) has also promulgated Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2016) 

[PDF].

How facilities can ensure education and compliance

All facilities should have standards for high level disinfection of endoscopes. It is also incumbent upon facilities to train their staff on the standards and to oversee the staff to ensure compliance with the protocols.  In addition, data should be kept in order to assess the protocol to ensure that it is effective to prevent endoscope acquired infections.

Interestingly, one group performed a study [PDF] using remote video technology to observe and assess staff to determine whether they completely followed the manufacturer’s recommendations for cleaning the devices. In this one study, there was less than a 50% compliance rate with the manufacturer’s recommended cleaning instructions.

“Standards Booster Pak”™

A “booster pak” has been developed to assist with education and compliance.  A “Standards Booster Pak”™ is a searchable  document available to hospitals who are accredited by the  Joint Commission (JCAHO). The “Standards Booster Pak”™ contains evidence-based guidelines on for how to perform high level disinfection and sterilization in order to minimize the potential risk of infection transmission to patients.

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The hope is that member organizations will use this information to observe deviations from the outlined standards and implement changes in order to avoid harming patients by infecting them through the use of a contaminated endoscope.

It is incumbent that all healthcare workers comply strictly with each manufacturer’s specific guidelines for proper cleaning and disinfection of the instruments. Unfortunately, each device manufacturer may have different instructions and this may lead to numerous procedures that need to be maintained for each device.

However, there can be no room for error.  

Use of an improperly sterilized endoscope on a patient can lead to serious and even fatal infections.

Did you or a loved one develop a severe infection after having an endoscopic procedure?

The Van Wey Law team is interested to hear from you.  Our team is comprised of experienced medical malpractice attorneys who are committed to helping people who have been seriously or fatally injured by the negligence of healthcare providers.

For a free evaluation of your case, call us at 855-403-3207 or CONTACT US and complete our quick case submission form.