FDA Safety Communication: Duodenoscope Recall by Fujifilm ©
On July 21, 2017, Fujifilm
© issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes.
As was previously noted in the FDA's February 2015 Safety Communication, the complex design of duodenoscopes can potentially impede effective reprocessing. Reprocessing is a detailed, multi-step process to clean and disinfect or sterilize reusable devices. The FDA has been working with several duodenoscope manufacturers as they modify
and attempt to validate their cleaning and reprocessing instructions to further enhance the safety margin of their devices
and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.
The FDA recommendations include:
- Acknowledge Fujifilm's© Urgent Medical Device Correction and Removal and identify affected products in your facility.
- Indicate if you do NOT have any affected duodenoscopes or Operation Manuals.
- Upon receipt of the enclosed new operation manuals, remove and replace any older operation manuals from your facility, and destroy and dispose of properly.
- Be aware of the manual reprocessing procedures outlined in FDA's December 23, 2015 Safety Communication "FUJIFILM© Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes."
- Continue to use these validated instructions when reprocessing Fujifilm ED-530XT duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Fujifilm© ED-530XT duodenoscope.
To read the entire recall notice go to,
click here:
In last week’s
blog post we talked about the definition of an IFU and its impact on patient safety. As this week’s recall by Fujifilm
© clearly demonstrates, the lack of
validated cleaning IFUs for these duodenoscopes represents a very real patient hazard.
On August 12
th of 2015 the
FDA sent warning letters to three medical device manufacturers whose scopes had been blamed for spreading deadly CRE bacteria. This was the agency's regulatory response to the CRE outbreaks in Chicago, Los Angeles, Seattle, and elsewhere that occurred earlier in the year. The devices, made by three prominent medical device manufacturers were used in hundreds of thousands of procedures each year. In the warning letters the
FDA said that the companies failed to report problems with the scopes as required by law and in some cases
failed to ensure that the devices could be adequately cleaned.
"Over the last several decades, we have seen an increase in the number of failures or lapses in flexible endoscope reprocessing as well as patient infections reported," said Naomi Kuznets, PhD., vice president and senior director of the AAAHC Institute for Quality Improvement. "The costs of these failures include patient morbidity, mortality, pain and suffering, and decreased productivity, as well as legal, testing and treatment costs."
The documented patient harm caused by devices who’s IFUs had not been validated at facilities like Lutheran General in Park Ridge, IL, UCLA Medical Center and Virginia Mason in Seattle is just the tip of the iceberg. According to the
CDC, over 30,000 patients die annually from surgical infections. Many of these deadly infections are caused by contaminated instruments who’s cleaning IFUs have never been validated. Without independent laboratory
validation of a device’s cleaning IFUs, reprocessing personnel do not have the ability to provide clean, sterile, moisture-free instruments for every patient, regardless of how hard they try.
The ability to improve patient outcomes and reduce patient risk from contaminated devices lies within your control. You must insist that your reusable devices come with
validated cleaning IFUs.
