By Sean Fenske, Editor-in-Chief
 
Medical devices are universally developed with a shared primary goal—to help diagnose, treat, or prevent disease among the patients requiring them. They may be used by different people, from care providers to physicians to the patients themselves, but all are primarily intended to help. Unfortunately, when a reusable device is improperly reprocessed after use, they can do more harm than good.
 
Due to some incidents that became very public through media coverage, regulators have taken a closer look at how cleaning and sterilization validations are handled for reusable devices. This has impacted not only devices being developed for future use, but also, devices that have already been in use for some time. As such, device companies are uncertain how they need to proceed to ensure their products remain compliant to the revised standards.
 
Fortunately, Alpa Patel, director of scientific improvement at Nelson Laboratories, has provided insights and clarification on a number of questions surrounding this issue. In the following Q&A, she offers some background on the situation and a pathway to action for device makers seeking to ensure compliance.
 
Sean Fenske: What changes are happening with regard to reusable medical devices and who is behind these changes?
 
Alpa Patel: Changes with reusable medical devices have been occurring for over a decade, however, within the last few years, there have been many standards that have been updated regarding cleaning, disinfection, and sterilization validations. Healthcare-acquired infections related to reusable medical devices have alerted the regulatory agencies advising the manufacturers and testing labs to conduct validations on reusable devices that simulate practices that occur during the use of these devices. The most focus was dedicated to update the requirements for cleaning validations as there was no clear information specified in standards regarding validation methods for cleaning. AAMI, ASTM, ISO, and MDR have brought into light the importance of regulation regarding processing validation for reusable medical devices. In August 2022, the first AAMI standard—AAMI ST98—on validating reusable medical devices for cleaning validations was published. This awareness on validations has alerted the regulatory industry globally and changes may affect the strategies conducted for the cleaning validation of new devices, the validation of legacy devices, and studies conducted before this time.
 
Fenske: Why are these changes being made? What are the driving factors?
 
Patel: Reusable medical devices historically have taken a back seat when it came to awareness of healthcare-acquired infections. However, when deaths related to flexible endoscopes made it the media in 2014, it triggered an investigation as to what the cause of the deaths was. Ultimately, they were linked to inefficiencies in reprocessing these complex devices. This tragedy caused the standards governing these tests to investigate if information published was enough to guide validation methods. From this point, we started to see a wave of standards and participation of regulatory agencies in these standards to not only update old standards but create new ones to clarify not only validation methods but good hospital practices.
 
Fenske: How will these changes affect medical device manufacturers and their products currently on the market?
 
Patel: The changes in the new standards now will affect how we perform reusable device validations, especially cleaning legacy products (products that have been out in the industry for decades) and devices that were validated before 2015. FDA published a guidance document on labelling and validation of reusable medical devices in 2015 after the outbreak. Although comprehensive instructions were provided by FDA on validation methods, there was information that could be interpreted differently by manufacturers and testing facilities that created inconsistencies to validations. Therefore, AAMI TIR30, which was specifically written on considerations for cleaning validations, was converted to a standard (AAMI ST98) with more clear, precise language. Now that we have a standard, regulatory is looking at design history files (DHF) to see if they have valid cleaning procedures and the instructions for use are complete for all devices. These include the assessment of master product (worst-case device) validations to products that are being adopted in as well.
 
Fenske: Will device manufacturers need to update the design history file with the new protocols associated with these changes?
 
Patel: Yes, they will have to address the impact of AAMI ST98 in their design history files and re-evaluate not only the worst-case design features for validations but legacy products and products validated before a certain period of time.
 
Fenske: Can you share best practices for how to best implement these changes and ensure compliance with the new rules?
 
Patel: The first thing would be to evaluate the design history files of the master products (worst-case devices) and their validation methods. If they were performed before 2015, you may want to conduct a re-validating of this device. Questions like:
 

• “Are product adoptions being conducted properly with regard to worst-case device assessments?”
• “Are the device validations used as worst-case devices for product adoptions and for product testing before 2015 still appropriate and compliant to current requirements?”
• “Are the validations complete for the market we are selling the products in?”

 
Fenske: Where are the blind spots with regard to these changes? What should device manufacturers be sure not to miss?
 
Patel: The blind spot here is re-evaluation of your DHF. We are seeing an upstream of cleaning validations due to audit findings on legacy products, products tested before 2015, and re-evaluation of worst-case instruments for validation to current standards.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Patel: Understanding validation methods used to evaluate reusable medical devices have been updated for the better; however, this leaves a lot of devices that are already out in the market in question and a lack of understanding of what to do next.
 
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