How does reprocessing work?
Strunk: The Medical Device Reporting (MDR) regulation alongside the so-called "common specifications" itemize the requirements and process steps. It starts with customers preparing the devices. We instruct our customers on how to prepare the medical devices and provide the required documentation. We also make sure we return proprietary medical devices to the original healthcare facility. To do this, all medical device collection containers feature a customer-specific code. This enables us to identify and match the reprocessed medical devices to the respective customer. Before the medical device is released, it must undergo various process steps, including pre-cleaning, disinfection, technical and hygienic testing of each individual medical device and sterilization. This ensures that every device we reprocess is like a new product from a technical and hygienic perspective.
Process validation requires us to develop valid procedures to guarantee the reproducibility of any given results. We conduct a prior risk analysis and assessment for each product, which allows us to determine whether we can reprocess a medical device in accordance with the regulatory requirements. If we conclude uncontrollable risk factors pertaining to a device, we refuse reprocessing.
The "common specifications" mandate the documentation and reproducibility of the complete process chain. We must establish documented evidence for ten years. This greatly improves patient safety since we can track all steps. We also use a laser to label the devices with a code. If we identify a deviation, we can provide relevant information.
How do you guarantee patient safety along with the hygienic and functional safety of the medical devices?
Strunk: As it pertains to technical safety, we must define production-concurrent test measures based on the risk analysis and assessment results. This includes whether the surface and the shape of the product are undamaged. Thin devices can sometimes have a kink, which means we must dispose the device. We use applicable tools to detect material changes and test all relevant electrical parameters. We also check mechanical functions since some devices are controlled via Bowden cables, for example.
Many parametric approaches are used to address hygienic aspects. A process is established beforehand as part of the medical device validation. This process is monitored and once it has been adhered to, the batch is granted parametric release for cleaning. When it comes to products with internal lumens, we sample for so-called residual proteins by flushing a solution through the lumen channel, which frees any residual proteins. If we still detect proteins, we block the product or clean and check it again. Once we detect no residual proteins, we release the product for cleaning.
Sterilization works the same way. We send all devices to a third-party certified company for sterilization that checks whether the specified parameters are being met. It also uses a process challenge device containing a biological indicator strip to assess the performance of the sterilization process. If the sterilization was unsuccessful, the batch is blocked or re-sterilized where applicable.