Bring An Equalizer to the Fight. Choose a Firm That Was Created to Advocate for Victims.

FDA Orders Duodenoscope Makers to Study Device Cleaning Protocols

The U.S. Food and Drug Administration (FDA) recently ordered the three leading manufacturers of duodenoscopes to complete post-market surveillance studies regarding how the devices are cleaned. The agency is seeking to determine how well new reprocessing instructions are working in the “real world” and whether additional measures are needed to lower the risk of infection.

“These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections,” the FDA said in a statement.

Duodenoscopes must undergo a multi-step cleaning and disinfection procedure called reprocessing so the medical devices can be reused between patients. If the complex procedure is not performed properly, the medical devices can transmit infections, including those that are resistant to antibiotics.

As previously discussed on our San Diego Injury Blog, the inability to thoroughly sterilize the specialty endoscopes was linked to a drug-resistant “superbug” that claimed the lives of three California patients earlier this year. All of the infected patients underwent endoscopy procedures at UCLA’s Ronald Reagan Medical Center. An internal investigation linked the outbreak of Carbapenem-resistant Enterobacteriaceae (CRE) to a contaminated duodenoscope. In total, nearly 180 patients were potentially exposed.

The FDA previously issued warning letters to the three manufacturers. The letters highlight a range of violations committed by the medical device makers, including the failure to report infections tied to the scopes. In its most recent order, the FDA directed the manufacturers to determine:

  • Are user materials, such as user manuals, brochures and quick reference guides included in the manufacturers’ duodenoscope labeling and instructions for use, sufficient to ensure user adherence to the manufacturers’ reprocessing instructions?
  • After use of the manufacturer’s validated reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms?
  • For devices that remain contaminated after use of the manufacturers’ labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?

The manufacturers must submit plans for the studies to the FDA within 30 days.

If you or someone you care about has suffered serious harm due to a contaminated or otherwise defective medical device, don’t hesitate to contact a San Diego product liability lawyer at the Law Offices of Robert Vaage for a free consultation.