Bucks firm subject to FDA manufacturing shutdown

Federal regulators in 2012 halted manufacturing and sales at a Pennsylvania company that made the scope-washing machines used at three California hospitals with recent "superbug" outbreaks.

The washers - known as automated endoscope reprocessors - were produced by Custom Ultrasonics, based in Ivyland, Bucks County.

The company's machines remain in use at more than 1,000 U.S. hospitals and clinics to clean reusable medical instruments.

The Food and Drug Administration in September 2012 ordered Custom to cease operations, and the company is still barred from manufacturing or shipping products. It continues to service its washers in the field.

"It's very disturbing if a hospital using this equipment might not know about all of its potential problems," said Lisa McGiffert, director of Consumers Union's Safe Patient Project. "These are real safety concerns and the public should know."

The 2012 FDA order stemmed in part from Custom Ultrasonics' failure at the time to obtain government clearance for its System 83 unit, featuring a significant upgrade to the machine's operating system.

Inspection reports obtained by the Los Angeles Times show that FDA officials had concerns about computer-related problems that could interrupt the cleaning cycle and possibly compromise patient safety.

Custom "failed to fully identify the health risk to the patient population if current products in distribution with potentially nonconforming computer hardware components should fail," an FDA investigator wrote in January 2012.

During a more recent inspection, in November 2014, FDA officials said management "has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization."

The full details are not available on the FDA website. The Times obtained documents through a Freedom of Information Act request.

Federal lawmakers and the families of infected patients have criticized the FDA for failing to alert the public sooner about the well-documented dangers of tainted duodenoscopes spreading deadly bacteria among patients.

"Presently, Custom Ultrasonics is prohibited from manufacturing, packing, labeling, or distributing any devices until the firm receives written notification from FDA that it appears to be in compliance" with regulations, said FDA spokeswoman Jennifer Corbett Dooren.

Custom said that it stands by the quality of its products and that customers are aware of its regulatory troubles.

Robert Blanchard, Custom's director of sales and product management, said the company is working with the FDA to resume manufacturing.