The US Food and Drug Administration (FDA) has issued new guidance requiring manufacturers of new reusable medical devices to more thoroughly test and label their devices to ensure patients are not inadvertently exposed to dangerous pathogens.
The guidance follows an outbreak of drug-resistant bacteria linked to the use of a reusable device known as endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope. The device—a flexible, lighted tube commonly used in surgical procedures to inject contrast dye or to obtain tissue samples—contains a small, movable "elevator" mechanism used to make the device more agile.
However, the same elevator mechanism also made the device considerably more difficult to clean, leading to several patients being infected with carbapenem-resistant enterobacteriaceae (CRE), a hardy and potentially deadly bacterium.
In the wake of the outbreak, FDA issued new warnings to healthcare professionals that "microscopic crevices" within duodenoscopes could harbor "residual body fluids and organic debris," leading to subsequent infections in patients exposed to the devices.
FDA has not ordered the devices to be taken off the market, and has noted that the majority of devices are used without incident and to the benefit of patients.
However, FDA's latest guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, seems to be aimed at ensuring future medical devices do not suffer the same fate as the duodenoscope.
"In recent years, there has been an evolution towards more complex, reusable medical device designs that are more difficult to reprocess," FDA says. Accordingly, the regulator says that each medical device must bear adequate information on its labeling to ensure the device is not only used safely, but also reprocessed properly.
"A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections," FDA explained in an accompanying press statement. "The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions."
Those criteria are:
- Labeling should reflect the intended use of the device.
- Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
- Reprocessing instructions should indicate the appropriate microbicidal process for the device.
- Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
- Reprocessing instructions should be comprehensive.
- Reprocessing instructions should be understandable.
The cleaning process will need to be validated as part of each company's quality system and medical device submissions to FDA (i.e. required for FDA to approve or clear a device), as will the microbicidal process (sterilization or disinfection) used to prepare the device for the next patient.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
FDA Press Announcement