The Food and Drug Administration has ordered a U.S. company to recall thousands of its endoscope washing machines used in various hospitals and other medical facilities in the country.
According to the government agency, the order was made due to a violation by the company that can increase the risk of infection cases among patients, the Associated Press reported.
The FDA's investigation on Custom Ultrasonics, a company based in Pennsylvania that manufactures endoscope reprocessing devices, began in April of this year. During the agency's inspections, they discovered that the company has violated a federal law.
The agency's officials noted that Custom Ultrasonics cannot guarantee if the devices, which are designed to disinfect the endoscopes used on patients, can thoroughly clean the medical instruments. This violation can lead to the spread of bacteria and diseases among patients through the non-disinfected endoscopes.
As a result, the FDA ordered Custom Utrasonics to recall around 2,800 units of its sophisticated washing machines in over 1,000 clinics and hospitals in the U.S.
"We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations," William Maisel, the deputy director for science of FDA's Center for Devices and Radiological Health said in a press statement.
"The FDA's recall order stemmed from the company's continued violations of federal law and the consent decree and is necessary to protect the public health," he continued.
The action by the FDA against Custom Ultrasonics came three years after the agency filed a manufacturing cease order for the company in 2012 due to the health risks associated with its products.
As reported by the Los Angeles Times, despite the order, Custom Ultrasonics was still able to continue operating after securing clearance from the U.S. government.
This then caused consumer advocates and other health groups to criticize the FDA for its lack of swift action in reprimanding companies that produce unsafe medical devices. In addition, critics noted that details of the FDA's 2012 report on Custom Ultrasonics were not released to the public.
"The failure of the FDA to act more promptly, based on their own words, could have resulted in deaths and injuries," Lawrence Muscarella, a consultant for hospital safety and former employee of Custom Ultrasonics said according to Los Angeles Times.
"This is very concerning from a public health standpoint," he added. "It has taken three years to recall a product. That's unacceptable."
According to Muscarella, he left Custom Ultrasonics due to the product safety issues associated with the company.
