FDA Warns Medical Device Manufacturers for Post-Market Surveillance Failures

The U.S. Food and Drug Administration (FDA) has warned the manufacturers of duodenoscopes of their obligation to conduct post-market surveillance studies to assess the effectiveness of post-use decontamination protocols.

Under the terms of an FDA order issued in 2015, the three companies, Olympus, Fujifilm and Pentax, are required to conduct post-market surveillance studies to determine whether healthcare facilities were able to properly clean and disinfect duodenoscopes after each use. The required studies involve the sampling of reprocessed duodenoscopes and conducting cultural assays to assess the extent of any contaminants. The results of such testing are intended to determine how well healthcare staff are following the reprocessing instructions, and to identify possible protocol modifications.

However, according to the FDA, Olympus has failed to initiate the required data collection process, and Fujifilm and Pentax have failed to provide sufficient data consistent with the FDA’s requirements.

In a press release issued in early March, the agency notified the device manufacturers that their failure to conduct mandated post-market studies could lead to further enforcement action by the FDA, including product seizures, injunctions and civil monetary penalties.

Read the complete text of the FDA’s press release.

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