Defective endoscopes linked to spread of superbug

Patients in Tennessee undergoing exploratory surgical procedures trust in the medical community to use only those devices that are deemed safe. A recent spread of superbugs linked to some types of endoscopes (also known as duodenoscopes) have called attention to manufacturer practices as well as the timeliness of the U.S. Food and Drug Administration’s response to device defects.

While infections related to use of endoscopes were first reported in 2012, the FDA only issued a safety alert regarding the problem in 2015. The aim of this alert was to raise awareness of health issues posed by the design of endoscopes, which must be sterilized before reuse. However, even in cases where endoscopes were sterilized according to specifications, the transmission of multi-drug resistant infections (such as those caused by Carbapenem-Resistant Enterobacteriacea) still occurred.

Adverse event reports forwarded to the agency include 75 potentially defective medical devices affecting approximately 135 patients, although more cases may be unreported. While the FDA is urging medical professionals to fully inform patients of the risk of duodenoscopes and ensure that these devices undergo proper sterilization, the agency has not called for a full-scale recall. According to CNN, these actions have caused the FDA to come under fire from numerous government officials.

In addition to claims that the FDA acted too slowly regarding this issue, the current surveillance system for medical devices has also been criticized as being far too lenient and too reliant on manufacturer response. Many officials call for the creation of a new system to track medical devices that would be similar to the monitoring system in place for prescription drugs. The proposed system would make use of insurance claims, as opposed to relying solely on adverse event reports. Bar codes may also be used on devices, which would make for easier identification should a particular instrument cause harm. 

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