When going in for a medical procedure, you probably want to be certain the doctor’s instruments are clean. Following a recent turnabout by the Food and Drug Administration, that certainty may be a little harder to come by.
Six months ago, the regulator said a machine tied by a Senate report to a deadly superbug outbreak should be taken off the market "as soon as possible" to protect public health. Twice. But the machine, which uses water, disinfectant, and sound waves to clean certain surgical instruments, remains in use for some of those instruments after FDA officials backed down. And no one is saying precisely why.
The FDA ordered a small Ivyland, Pennsylvania, company called Custom Ultrasonics Inc. to take its 2,800 System 83 Plus machines out of service. The automated washing machines are used across the United States to clean endoscopes, devices with a light and camera on one end for probing inside your body.
A specialized type of endoscope known as a duodenoscope, used to look in tiny crevices of the small intestine, has proven particularly hard to clean and was linked to antibiotic-resistant infections at hospitals over the last few years.
The use of Custom Ultrasonics equipment was one of several factors that "likely contributed" to dangerous infections spread by inadequately cleaned duodenoscopes, according to a report issued this year by Senate Democratic staff investigating the incidents.
Up to 350 patients may have been infected at dozens of hospitals since 2010, according to separate documents released in April by the House Committee on Oversight and Government Reform.
The exact number is difficult to ascertain because reporting of cases has been spotty, though more than a dozen patients who were infected subsequently died. Not all outbreaks occurred at hospitals using Custom Ultrasonics machines, and the company has previously denied in court filings that its machines are unsafe or contributed to patient injury or death.
In its November 2015 correspondence with the company demanding a recall, the FDA raised concerns about the device’s compatibility with disinfectants, whether it works with duodenoscopes, and whether it properly eliminates microorganisms from water.
In pulling back that recall demand, the regulator now says it’s working with the company to ensure that the machines "are validated in a timely manner," according to agency spokeswoman Deborah Kotz. "Validated" means the company has to prove the devices work as advertised.
In the meantime, the machines can still be used to clean instruments including most endoscopes – just not duodenoscopes, she said. The reversal was "based on information provided by the company," Kotz said, without elaborating.
Custom Ultrasonics said in a notice posted on its website that it will send hospitals a label to affix to the washers warning users not to use the machines to clean duodenoscopes.