In 2013, the U.S. Food and Drug Administration (FDA) learned that high rates of postoperative infections were observed among patients who had undergone endoscopic retrograde cholangiopancreatography (ECRP).
In this procedure, a medical device called a duodenoscope is used to explore and photograph a patient’s upper digestive tract in order to diagnose problems with the pancreas and bile ducts.
Duodenoscopes are designed to be used multiple times in multiple patients. Like all medical devices designed for reuse, duodenoscopes undergo a process called medical device reprocessing to prepare them for use in another patient.
Upon investigation, the FDA found that the infections were caused by bacteria that remained in the devices even after reprocessing. They found that design flaws and complex reprocessing procedures contributed to the high infection rates.
The manufacturers of these devices have worked with the agency to redesign the devices and simplify the cleaning and sterilization procedures.
In this article we discuss important aspects related to the reprocessing of medical devices.
As defined by the FDA, reprocessing is the cleaning and then disinfecting or sterilizing of a medical device to reduce the risk of infection prior to its reuse, either in the same patient or a different one.
Those three processes–cleaning, sterilizing, and disinfecting–sound similar, but have important distinctions:
- Cleaning is a manual process of removing as much biological debris (such as blood and tissue) as possible from the device, using hand tools and cleaning agents such as soapy water.
- Disinfection reduces residual pathogens but may not eliminate them.
- Sterilization uses high temperatures or chemicals to kill any remaining pathogens and render the device sterile.
The choice between disinfection and sterilization depends on risk. Lower-risk devices can be disinfected, whereas high-risk devices that are implanted or used inside the body must be sterilized.
Reprocessing Single-Use vs. Reusable Devices
Reusable devices are, of course, designed for reprocessing, but an increasing number of “single-use” devices are being reprocessed as well. This practice is somewhat controversial, because most manufacturers do not design their single-use devices for reprocessing or provide reprocessing instructions.
It often falls to third party device reprocessors to determine the correct procedure for reprocessing single-use medical devices so that they meet the specifications (such as sterility) of the original equipment manufacturers (OEMs).
Despite the concern, there are many good reasons to reprocess single-use devices, such as cost savings and reducing medical waste, which often requires special handling for disposal.
Designing for Medical Device Reprocessing
Reusability presents an additional set of considerations for device designers and manufacturers, over and above the functionality and intended use of the device. Some of these considerations for reprocessed medical devices include:
- As the duodenoscope example shows, it’s important to design reusable medical devices so that they can be sufficiently cleaned. This means that any part of the device that can accumulate biological debris must be accessible or replaceable.
- Devices that require sterilization must be designed to withstand multiple cycles of the harsh sterilization environment, such as high-temperature steam or caustic chemicals.
- Procedures for reprocessing medical devices must be easy to follow by personnel at health care facilities or medical device reprocessors with minimal training.
The design and procedures for reprocessing must be included as part of the device’s 510(k) submissions or PMA for FDA approval of the device.
Reprocessing Medical Device Regulations
Although the FDA does not have specific regulatory requirements related to the reprocessing of reusable medical devices, the agency has published guidance for the industry.
These guidelines provide manufacturers, hospitals, clinics, reprocessors, and other entities with commonsense tools to reprocess and reuse medical devices safely, thereby protecting public health.
RBC Innovations and Medical Device Reprocessing
At RBC Medical Innovations, we are experts in designing and manufacturing medical devices for reprocessing and remanufacturing. From early planning stages to market release, we take all device uses into consideration when designing your device.
If you have an innovative idea for a new reusable medical device, contact us today to learn how we can help bring it to market faster, more affordably, and error-free.