FDA sets meeting to review endoscope infection problems

WASHINGTON (AP) – Federal health officials will meet in May to review problems with the design and cleaning of specialized medical instruments linked to at least two recent “superbug” outbreaks.

The Food and Drug Administration has set a two-day meeting for mid-May to gather expert opinion on improving the safety of the specialized endoscopes, which are used on about 500,000 U.S. patients each year.

The meeting’s announcement comes amid escalating criticism of the FDA’s oversight of the hard-to-clean devices, which have been linked to sometimes fatal outbreaks of antibiotic-resistant bacteria at several hospitals in recent years. Last week 10 members of Congress asked the FDA to answer questions about the devices, including how the agency reviews manufacturers’ cleaning instructions.

In the last month, two Los Angeles hospitals have reported superbug infections in patients despite following manufacturer’s guidelines. The scopes’ complex design – to help physicians drain fluids in the body – also makes them extremely difficult to clean. Bodily fluids and other particles can stay in the device’s crevices even after cleaning and disinfection.

Previously the FDA recommended hospitals follow manufacturers’ instructions for disinfecting the devices, which typically involves the use of germ-killing disinfectants and manual or machine-assisted processing. But after the first of the two recent outbreaks, the FDA acknowledged that those instructions may not fully disinfect the devices.

In the first case, seven patients at Ronald Reagan UCLA Medical Center contracted an antibiotic-resistant strain of bacteria after undergoing endoscopic procedures with a device made by Olympus Corp. Two patients died from the infection. Last week officials at another Los Angeles Hospital, Cedars-Sinai Medical Center, reported that four patients were infected with the same superbug after being treated with the same Olympus scope. The specialized device, known as a duodenoscope, is a flexible fiber-optic tube that is inserted down the throat, through the stomach and small intestine to treat conditions in the pancreas and bile ducts.

Industry experts say that FDA guidelines do not require makers of reusable medical instruments to provide scientific evidence that their cleaning instructions fully disinfect the devices.

Some hospitals have adopted extra cleaning procedures, including sterilizing scopes with toxic ethylene oxide gas. Other steps include quarantining the devices for several days after each use to test for dangerous bacteria. Those techniques are becoming more common in Europe, Australia and elsewhere, but they are also more expensive than the current U.S. practices. Experts say adopting those techniques would require U.S. hospitals to purchase larger inventories of scopes that can be cycled in and out of use. One duodenoscope can cost about $40,000.

FDA officials have previously said that contamination problems have been reported with devices made by all three U.S. manufacturers of the devices: Olympus, Pentax Medical and Fujifilm.

Despite these problems, regulators said pulling the products off the market would cause a shortage and interfere with routine hospital care.