The US government is about to finalize a set of instructions intended to prevent medical devices that are responsible for the transmission of “superbugs”, leading to the potentially fatal outbreak involving pathogens among the patients.
The US Centers for Disease Control and Prevention (CDC) has developed a new protocol for those clinical devices that are reusable, known as duodenoscopes. The CDC health experts behind the study have found role of duodenoscope in transmitting the infections since 2013.
The duodenoscope- transmitted infections came back into limelight again during the latest outbreak, where duodenoscopes were found responsible for spreading antibiotic-resistant bacteria to seven patients at a hospital in University of California in Los Angeles, which has claimed lives of two infected people.
Even though the guidance by CDC would not be mandatory, the Food and Drug Administration (FDA) will hold the authority to ask a manufacturer for the inclusion of more stringent safety instructions for their clinical devices. If the medical products fall short of desired instructions, the FDA can even order redesigning the company.
Despite knowing the health hazards associated with the duodenoscopes since at least 2009, no significant step has been taken by the regulatory authority FDA so far.
The agency, however, came out this week warning the medical community about the threats of the medical devices and the superbugs transmission risk linked to them.
Endoscopy consultant Lawrence Muscarella said, “If the CDC, which does not have regulatory authority, is doing more to make duodenoscopes safe than the FDA, which does have that authority, it raises the question of who’s running the ship here.”
Muscarella is the research author of a 2014 study on the pathogen-transmission risk by these medical devices.
Leslie Wooldridge, spokeswoman for FDA, said, “The agency is actively engaged with the manufacturers of duodenoscopes and with the CDC to develop solutions to minimize patient risk linked with the devices.”
Though the protocols by CDC are not levied mandatorily on the device makers, but they carry considerable weight as hospitals that would be found ignoring the set standards for the medical devices could be vulnerable to lawsuits.
Meanwhile, the experts associated with the infectious-disease control have hailed the involvement by CDC in the sensitive issue like this. They have also highlighted the serious observations made by the CDC that has poised a larger question about the FDA.
