FDA in an alert on Wednesday warned health care providers and facilities against using certain reusable endoscopes that do not have connectors with backflow prevention features, citing an increased risk of cross-contamination, Megan Brooks reports for Medscape.
Details of FDA's warning
FDA in the alert said the agency has not received the appropriate data to demonstrate the safety of endoscope connectors that are "labeled for use with multiple patients over the course of 24 hours without reprocessing." FDA said these connectors—called 24-hour multi-patient use endoscope connectors—in some cases do not include a backflow prevention feature, which when used can lower the risk of contamination.
In particular, FDA said the ERBEFLO port connector, a 24-hour multi-patient use endoscope connector manufactured by Erbe USA, does not have a backflow prevention feature. FDA said an assessment of the connector found that the device's design and recommended instruction did not adequately lower the risks of cross-contamination for endoscopy patients. According to FDA, without the backflow prevention feature, the connector "can become contaminated with blood, stool, or other fluids from previous patients that travel back through the endoscope channels into the connector and tubing."
FDA in the alert recommended that health care providers and facilities use connectors with features to prevent a patient's fluids from flowing backward into the endoscope to reduce the risks of cross-contamination. FDA said such connectors can be reusable connectors that are reprocessed or single-use connectors that are discarded after every patient. According to FDA, connectors with backflow prevention are widely available in the U.S. market (Brooks, Medscape, 4/18; FDA alert, 4/18).
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