Partner with Accuratus to Validate Your Reusable Medical Device Reprocessing Procedures
Posted on: May 18, 2018
Accuratus Lab Services performs reusable medical device reprocessing validations by partnering with our customers to develop and validate an effective procedure. Manufacturers of reusable medical devices must provide validated instructions to reprocess their products to comply with regulations and to ensure they can be reprocessed in the healthcare setting (AAMI TIR 30).
We work with clients to understand their device and how it’s used to determine appropriate test methods, test soils and soiling methods. The client’s expertise regarding their device is crucial to an accurate validation test.
Accuratus follows FDA guidance, AAMI TIR 30, AAMI TIR 34, AAMI TIR 12, and ASTM and ISO methods to perform cleaning validations. Cleaning is quite possibly the most important step in reprocessing medical devices because it is the physical removal of organic soil. Without the thorough removal of soils, disinfection or sterilization processes may not be effective at rendering the device safe for reuse. Effective cleaning ultimately provides product safety for patient use.
Our cleaning validations include a soiling step to simulate, as best as possible in the lab, clinical use. We then dry the soil for a relevant time, for which we rely on our client’s expertise to help us determine the best drying conditions. After drying, cleaning is performed. A visual inspection is performed, followed by validated analytical methods to test for residual protein, hemoglobin or carbohydrates.
We partner with our clients to achieve an effective cleaning process. We do this by reviewing cleaning procedures before testing, being flexible to test to our client’s needs, and giving suggestions to improve the process as needed.