Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining US and EU clearance. Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully navigate this process can do so confidently and efficiently if they are armed with knowledge, education, and guidance. To this end, Nelson Laboratories, Inc. recently published Successful Medical Device Cleaning Validations: What You Need to Know, a white paper available for download on QMED.com. This comprehensive overview of medical device cleaning and reprocessing validation highlights what medical device manufacturers need to know, where to start, and with whom to partner.
The following is an excerpt from Nelson Laboratories’ Successful Medical Device Cleaning Validations white paper, providing medical device manufacturers a check-a-box list of questions to help qualify potential lab partners:
As medical device manufacturers search for a testing lab to validate their devices’ cleaning instructions, asking the following questions of potential lab partners can help them best qualify the lab partner:
• Does the lab perform validation tests routinely for medical device clients and is therefore very familiar with this industry and various product types?
• Are the testing lab’s representatives members of applicable standards committees?
• Is the lab willing and able to consult with medical device clients in the early stages of cleaning-instruction creation and revision, especially when the instructions appear too simple or overly complex?
• Does the lab work closely with both the FDA and clients to resolve discrepancies between validation test results and FDA requirements?
• Are the lab personnel experienced and familiar with the full breadth of medical device types and understanding of patient contact and soiling techniques?
If the answer to all of these questions is yes, then the testing lab under consideration is a good candidate for the manufacturer’s validation testing needs.
Medical device companies must do their part to ensure that their devices are cleaned, disinfected, and sterilized properly between patient uses in the healthcare setting. To that end, validated cleaning instructions for medical devices is critical for both obtaining FDA clearance and keeping patients safe. The cleaning process described in a device’s IFU must be easily understood and repeatable in the healthcare facility. An experienced, conscientious lab partner will help medical device manufacturers through each step of the validation process to ensure satisfactory results.
To learn more about performing medical device cleaning validations DOWNLOAD Successful Medical Device Cleaning Validations: What You Need to Know from QMED.com, or visit Nelson Laboratories at www.nelsonlabs.com.
Related Reusable Medical Device Articles:
- Article: FDA Trends For Reusable Medical Device Reprocessing Validations. Published in MDDI Magazine, March 2012.
- Article: Design Considerations For Medical Device Manufacturers. Published in Horizons, Spring 2012.
- Article: In Reprocessing Devices, Human Factors Matters. Published in MDDI Magazine, October 2012.