The Curious FDA Reversal over Allegedly Flawed Endoscope Washers

Washington, DCThe curious about-face by the US Food and Drug Administration (FDA) over its position on an allegedly flawed endoscope cleaning machine has roots in a back-and-forth relationship between the federal regulator and Custom Ultrasonics Inc. (Custom) dating back to 1991. The history between the two parties, together with recent links to hospital infections, is of interest to anyone bringing an Endoscope lawsuit.

Endoscopes and duodenoscopes are intricate devices used in hundreds of thousands of procedures every year. In order to ensure sterilization and to mitigate transference of any infection from patient to the next, the reusable devices are cleaned and sterilized using automated systems, one of which is at the center of the current controversy. As our Heidi Turner documents, the FDA was definitive when it recently ordered Custom Ultrasonics to pull 2,800 System 83 Plus automated endoscope washing machines from the market.

Six months later the machines are still in use, and the FDA appears to have backed down from what was a blunt and direct order to pull the machines out of service. No one appears to know what motivated the FDA to change course.

According to an exhaustive report by Bloomberg News carried in the Sunday Telegram (Massachusetts 5/29/16), FDA inspections of Custom Ultrasonics as far back as 1991 uncovered “significant violations” of federal regulations governing good manufacturing practices and the timely reporting of issues and problems that could affect patient safety. An endoscopic infection lawsuit filed in 2006 by federal prosecutors in Philadelphia denoted additional violations stemming from FDA inspections conducted the year the surgical infection lawsuit was filed - in 2006 - as well as 2005, 1995 and 1992.

The endoscope negligence lawsuit noted that 13 patients tested positive for hepatitis C following treatment with endoscopes washed by the System 83 Plus washing machine manufactured by Custom Ultrasonics. Prosecutors noted that Custom learned of the infections in 2004, but waited two years to alert the FDA, or so it is alleged. Such reports are required by law to be reported within 30 days.

A consent decree put into place in January 2007 saw Custom Ultrasonics not having to admit any wrongdoing. The consent decree also - initially - barred Custom from manufacturing or vending the troubled automated washers. However, it wasn’t long before the FDA allowed Custom to resume operations on a limited basis after Custom was found to be in compliance with the consent decree.

That goodwill all went south in 2012, when the FDA mandated a recall of the System 83 Plus automated washers due to “recurring violations” of both the law and a consent decree that remains in force to this day. A further inspection only strengthened the FDA’s resolve, with Custom ordered to pay damages under the consent decree.

It gets worse.

According to the Bloomberg report, the FDA found that Custom had failed to validate several aspects of the troubled System 83 Plus system - compatibility with disinfectants, water filtration, and that it fully cleans duodenoscopes, the same issues raised in the most recent recall.

Two letters went out. The first, dated November 12 of last year, instructed Custom in no uncertain terms to recall the machines as fixing them wasn’t an option. The FDA, in this communiqué, referenced Custom’s “lengthy regulatory history” and noted that Custom would be required to recall every last one of its automated washing machines at its own expense, and to help facilitate a “transition from the System 83 Plus as soon as possible.”

A subsequent communication from the FDA to Custom Ultrasonics, dated January 29 of this year, noted the manufacturer’s insufficient response to the regulator’s letter of November 12, 2015. Custom Ultrasonics, in its response, had only offered to repair the units, rather than recall the devices according to the FDA’s November order.

The FDA made it clear, according to Bloomberg: “FDA orders Custom Ultrasonics to immediately recall all System 83 Plus devices by removing them from use.” The text used was reported to be in bold font, lest there be any misunderstanding of the FDA’s directive.

But then, curiously, the FDA backed off.

That turnabout by the FDA is something Mark Duro, director of sterile processing operations at New England Baptist Hospital in Boston, has never seen.

“In the 20 years that I’ve been in the business, I’ve never seen a recall get changed like that,” Duro said, adding that he remembers when the FDA determined in 2009 that a similar machine wasn’t cleared for use because it didn’t work as advertised. That time, the agency didn’t back down. “We were forced to buy new devices,” Duro said.

The FDA’s current position is that it is working with Custom Ultrasonics to ensure the machines “are validated in a timely manner.” In the meantime, it is allowing for the machines to continue to be used to clean most endoscopes, but not duodenoscopes. The reversal, according to an FDA spokesperson, was “based on information provided by the company.”

There was no further elaboration.