If you're developing a medical device that will be reprocessed, you've got a lot to consider.
|Alpa Patel, B.S. RM (NRCM)|
Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them?
"There have been many issues over the last 7 years, so there's increased scrutiny of cleaning validations," explained Alpa Patel, B.S. RM (NRCM) of Nelson Laboratories. "FDA published the 2015 guidance, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.' Yet a lot of uncertainties and inconsistencies remain regarding cleaning validation plans."
Patel will explore such issues in the presentation "Key Factors that Determine a Successful Reusable Device Cleaning Validation" on Wednesday, June 14 at MD&M East 2017.
Cleaning validations are inherently challenging because "reprocessing entails multiple steps and involves both manufacturers and healthcare facilities," she told Qmed. "When manufacturers design cleaning validations, they need to keep in mind the healthcare environment and FDA guidelines as they possess challenges to designing a successful validation.
"There's also the impact of repeated use and how to evaluate the impact that repeated use has on the ability to effectively reprocess a medical device," she continued. "There are still a lot of unknowns. There are many factors that play a role, and one wrong move can lead to a failure mode."
Other challenges arise when "manufacturers seek reprocessing consultations and testing just before product launch," she said, speaking of Nelson Laboratories' services. "Cleaning validation should be considered during the design phase of engineering--not at the end. It's not uncommon to see these types of validations submitted when manufacturers are in final preparations for a 510(k) submission."
It is common to see instructions for use (IFUs) as an afterthought when medical device manufacturers should actually be thinking about them from the start, she added. "There is the chance that during the validation, the instructions for use and the cleaning process wouldn't meet the acceptance criteria," she said. Such criteria are offered in AAMI Technical Information Report (TIR) 30, "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices," which specifics a benchmark.
"This benchmark, however, is not necessarily applicable for all devices. The benchmarks to evaluate the effectiveness of a cleaning validation specified in TIR 30 was designed from an endoscope study, and the thinking is that all other reusable devices could fall under the same acceptance criteria umbrella," she said. "The question now in everyone's mind: 'Is this benchmark specified in TIR 30 appropriate for all types of reusable medical devices?' The answers to this question are yet to be determined."
To offer some assistance, ASTM did recently publish the new standard, F3208 "Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices." Patel, who helped write this standard, believes that it will help resolve the confusion surrounding selecting the right test soils. "There are many more ASTM standards to come to address different steps performed for cleaning validations. However, the process will take a couple of years before every step is ironed out," she said.
In terms of future developments, Patel points to new acceptance criteria for chemical analysis for protein and hemoglobin that may be established in ISO documents.
|Image courtesy of Nelson Laboratories|
There is also a lot of movement in AAMI regarding addressing cleaning for reusable medical devices, she added. TIR 12, "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers," has formed a working group to classify devices into six categories according to the complexity and design of the reusable medical device in an Annex. "This will help manufacturers identify the appropriate IFU for cleaning procedures for their devices," Patel said. She would like to see standardized IFUs so that personnel working in the central processing areas in healthcare facilities have one type of IFU to refer to for a particular device. "Think of the confusion if every scissor manufacturer had a different IFU," she said.
As industry working groups continue to address these questions, Patel offers this best practice in the meantime: "Always test the cleaning validation on device prototypes. Think about cleaning validation studies with biocompatibility studies during the design phase," she said. "When you put off thinking about a cleaning validation at the end of product development, you often find difficulty achieving the final goal."
For more details, attend Patel's presentation as well as Nelson Labs booth #1933 at MD&M East.
Patel co-authored the whitepaper Successful Medical Device Cleaning Validations: What You Need to Know, which is a free download available through Nelson Laboratories's Web site.
Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to Qmed. Reach her at [email protected] and on Twitter at @daphneallen