U.S. regulators have ordered a Pennsylvania company to recall its scope-washing machines used at more than 1,000 hospitals and clinics.
The Food and Drug Administration said Friday that it ordered the recall because Custom Ultrasonics had continued to violate federal law and those lapses could result in an increased risk of infection for patients.
The agency said an estimated 2,800 automated endoscope reprocessors made by Custom Ultrasonics are used by hospitals and outpatient clinics in the U.S.
A representative of Custom Ultrasonics couldn’t be reached for comment.
These sophisticated washing machines play a central role at many U.S. hospitals, which rely on them to disinfect endoscopes quickly to keep turnaround times short at busy medical facilities.
In investigating recent superbug outbreaks, health officials have focused much of their attention so far on a design flaw in a gastrointestinal device known as a duodenoscope.
Those scopes can be difficult to clean even when following the manufacturers’ instructions. Dangerous bacteria can become trapped inside the scope and then get passed to the next patient.
The FDA said several health care facilities with confirmed or possible duodenoscope-associated infections used the System 83 Plus unit made by Custom.
Custom machines can cost $30,000 to $50,000 and typically take about 30 minutes to wash scopes with disinfectant following some manual cleaning.
In a recent inspection in April, the FDA said it found numerous violations at a Custom facility. Regulators said the company couldn’t validate that its equipment can adequately wash and disinfect endoscopes.
The FDA also cited Custom for not reporting report adverse events in a timely manner.
The FDA recommends that health-care facilities move away from Custom Ultrasonics’ scope-washing machines “as soon as possible.” The company has seven business days to provide the FDA its plan for how to handle the recall.