Every year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes being blamed for two Los Angeles patient deaths and an increase of Healthcare Acquired Infections (HAIs), Nelson Laboratories has compiled a suite of educational resources detailing important reusable medical endoscope processing and reprocessing considerations.
“All scopes require careful thought and consideration before validation testing and FDA submissions are conducted,” said Emily Mitzel, Nelson Laboratories Consulting Manager, specializing in reusable medical device validations. “The reprocessing instructions need to be accurate for different regions of the world and must be usable in a variety of different healthcare facilities’ reprocessing programs. Healthcare facilities need to ensure staff is properly trained on cleaning procedures and that technicians understand the importance of cleaning difficult locations multiple times when visual inspections are not adequate.” Effective reprocessing of endoscopes and other reusable medical devices will help minimize the prevalence of healthcare acquire infections.
Nelson Laboratories offers the following information and resources for reusable medical device manufacturers and healthcare facilities reprocessing reusable devices:
- Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015 – Learn more about how the FDA’s new guidance document (issued March 17, 2015) differs from their 2011 draft guidance.
- Healthcare Reprocessing of Medical Devices and Human Factors Debrief – Complex reusable medical device designs and other device enhancements that do not take human factor considerations into account may make it difficult, or even impossible, for hospitals to clean, disinfect, and sterilize reusable devices effectively.
- Validating Cleanliness Taking Human Factors Into Effect – Medical device manufacturers are expected to provide clearly understandable reprocessing instructions with their medical devices. Nelson Laboratories recommends validating reprocessing with a conservative approach to ensure a safety buffer is built in to account for human factors.
- Successful Medical Device Cleaning Validation: What You Need to Know – Validating cleaning instructions for reusable medical devices is an important milestone on the path to obtaining FDA clearance. Get the detailed information you need to know about medical device cleaning validations with this complimentary white paper.
- Functionality vs. Simulated-Use Testing in Device Reprocessing – The FDA has said that if a medical device is to last 100 cycles, it needs to be validated to 100 cycles. Likewise, endoscopes need to be tested for a buildup of soil. Testing for these two different conditions is very similar, but looks for very different results based on human factors.
- Standardization of Test Soils for Reusable Endoscopes – Scientists at Nelson Laboratories actively participate with the ASTM committee and writing the ASTM standard that is slated to standardize test soils for reusable medical device testing, making it easier and more cost effective to develop and validate cleaning instructions.
For additional information on requirements for processing and reprocessing of reusable endoscopes and other medical devices, manufacturers can contact Nelson Laboratories at [email protected], or 801-290-7502.
In addition to reusable device validation testing, Nelson Labs offers quarterly assessment or qualification tests to help healthcare facilities assess the human factors and cleanliness of their endoscope reprocessing facility. Nelson Laboratories’ Technical Consulting group is also available to provide manufacturers and healthcare facilities technical support at every phase of the product life cycle.