Investigators have learned that the FDA has been aware of problems with the machines since at least September 2012, but many of the machines are still being used around the nation.
Until now, much of the concern has focused on a complex mechanisms in duodenoscopes that are extremely difficult to sterilize. Much of the blame has fallen on scope-manufacturers for failing to provide good cleaning instructions.
The Times report suggests that the problems may extend to the scope-cleaning machines in use all over the nation.
In 2012, the FDA ordered Custom Ultrasonics to stop manufacturing and selling scope-cleaning machines, known as automated endoscope reprocessors. The agency was concerned about a software issue that could cause the machine to unexpectedly fail to sterilize the scope:
“[Custom Ultrasonics] failed to fully identify the health risk to the patient population if current products in distribution with potentially nonconforming computer hardware components should fail.”
The Times also reported that Custom recalled the machines in 2008 and 2013, but the FDA allowed them to remain in use. Custom Ultrasonics continues to provide service. Only recently has the FDA asked the company to provide data proving that the machines actually work.
Since 2012, hundreds of people have been exposed and dozens have died from antibiotic-resistant “superbug” infections transmitted on dirty scopes. The FDA has received at least 152 reports of possible disease-transmission on contaminated scopes between 1992 and March 2015.