FDA issues tougher recommendations on reusable medical devices

FDA issues tougher recommendations on reusable medical devices

The FDA has issued stricter recommendations on reusable medical devices in order to prevent the spread of antibiotic resistant infections. These kind of infections occurred at Los Angeles hospitals.

According to the FDA, it has announced new recommendations for cleaning reusable medical devices like the duodenoscopes at the center of the ‘superbug’ infections. And the companies, which manufacture the scopes and other devices, will have to provide proof that the devices can be cleaned properly, prior to getting FDA approval.

According to the agency, manufacturers could conduct validation testing in order to prove that their cleaning and disinfection or sterilization instructions will help reduce microbial contamination properly.

According to Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, "This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them".

Dr. Maisel said that with this, patients will be assured regarding safety and effectiveness of the devices used on them.

It was reported by Ronald Reagan UCLA Medical Center last month that seven patients were infected with the superbug carbapenem-resistant Enterobacteriaceae, or CRE. They got infected after they underwent endoscopic procedures using flexible tubes called duodenoscopes.

Two patients later died whereas another 179 patients were thought to be exposed to CRE, which can cause death of almost half of those infected. Four cases were reported by Cedars-Sinai Medical Center earlier this month. However, one death was not the result of the infection. All the infected patients underwent procedures with duodenoscopes made by Olympus Corp.