FDA issues warning over ‘shared endoscopic equipment’

fda warning endoscopy
Male doctor conducts endoscopic examination.

The FDA has sent a letter to health care providers and facilities warning them of the dangers involved with using certain connectors during gastrointestinal endoscopy procedures. The letter discourages the multi-use of these connectors as they present an opportunity for dangerous cross-contamination.

Yes, the FDA is having to warn medical professionals to not reuse endoscopy procedure equipment between patients. Endoscope connectors are labeled as OK to use between patients over the course of a 24 hour period.

The FDA claims it can’t provide proof that cross contamination won’t happen.

Endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing are known as 24-hour multi-patient use endoscope connectors. To date, the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use.

Endoscope connectors are small accessories used to connect the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. To mitigate the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent patient fluids from flowing backwards into the endoscope (backflow prevention features). These connectors may be either single-use connectors that are discarded after each patient, or reusable connectors that are reprocessed according to their instructions for use prior to each patient.

Essentially, the connectors, manufactured by Erbe USA Inc, are potentially making false claims. Aside from that, the obvious “yuck” factor is resonating with all of us right about now. Was sharing endoscopic equipment between patients ever a sound idea?

Here’s the link to the letter posted on the FDA’s website yesterday.

 



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