Cleaning validation tests are integral to the development and approval of reusable medical devices. They play a key role in establishing proper reprocessing standards so that healthcare professionals can use these instruments to treat patients safely.
Because this is such a vital process to the safe use of reusable medical devices, it’s important for device manufacturers to understand what cleaning validation entails. Learn more about this process, its importance, the standards it uses, and more with this comprehensive list of questions to ask about cleaning validation.
What Is Cleaning Validation?
The goal of cleaning validation is to verify that a manufacturer’s cleaning instructions can effectively remove enough soil from a device to safely move to the next stage of processing. A validated cleaning process is also reproducible, meaning that healthcare facilities can follow the cleaning instructions to safely reprocess the device without damaging it or wearing it down past the point of intended use.
Cleaning is only one step of the reprocessing procedure. It falls after point-of-use processing, which occurs quickly after and in close proximity to the device’s point of use. Depending on the device and the contamination it faces during use, a thorough cleaning process might be the last stage of reprocessing before cycling the tool back into use. However, in many cases, disinfection or sterilization procedures follow the cleaning process.
Why Is Cleaning Validation Important?
Cleaning validation ensures healthcare facilities can properly reprocess reusable medical devices. By validating the efficacy of the cleaning process in a device’s instructions, manufacturers make sure their instructions for use are effective, responsible, and safe enough for real-world medical environments. This helps achieve any necessary regulatory goals and takes medical devices one step closer to market approval.
More importantly, it provides healthcare professionals and facilities with reusable medical devices that are safe for patient care. Validated cleaning processes prevent infections, support effective sterilization, and support efficient and responsible healthcare workflows.
What Regulatory Requirements Revolve Around Cleaning Validation?
Regulatory requirements vary depending on where a manufacturer is based, what market they’re targeting, and other factors. In many cases, device manufacturers must submit their cleaning validation data to the FDA or other International regulatory bodies for approval. However, some companies might also have to follow standards such as AAMI ST98 due to state requirements or other specific local regulations.
Understanding what regulatory bodies, you face for approval is key to performing relevant and successful validation tests. It is also important to work with a cleaning validation partner who understands and follows any standards and regulatory guidelines that are relevant to your regulatory pathway.
At HIGHPOWER, our validation processes follow methods and guidelines from standards such as AAMI TIR12 and AAMI ST98. We also follow methods from the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
What Is Manual vs. Mechanical Cleaning?
Depending on the device, reprocessing will entail either manual or mechanical cleaning methods. Savvy device manufactures will typically validate both methods to ensure their device can compete at the highest level. Manual cleaning refers to cleaning instruments by hand through wiping down, hand washing in a sink, or other methods. Mechanical cleaning refers to the use of cleaning equipment, such as medical device washers or washer-disinfectors.
Cleaning validation must consider the human factors involved in both manual and mechanical reprocessing. End user skill and comprehension affect the cleaning process. For example, how will an end user interpret the written cleaning process instructions? Does a typical user have the dexterity or perception to conduct a thorough cleaning according to those instructions? A cleaning process is only safe and effective if its intended users can perform it successfully and consistently.
Why Use Worst-Case Testing?
What happens if an end user doesn’t follow the cleaning process properly? Distractions and other limitations in a healthcare setting can hinder reprocessing and pose a risk to patients. That is why cleaning validation services must account for real-world conditions by conducting worst-case testing. Validating a cleaning process with unideal conditions minimizes the risk of infections and other health hazards occurring because of mistakes, distractions, and other problems that arise in a healthcare setting.
Worst-case testing uses the least rigorous implementation of an intended cleaning process and its parameters on devices that are as contaminated as possible with soils while remaining relevant to the intended clinical use of the instrument. If a cleaning process proves effective even in these adverse conditions, end users can trust it to remain effective in a hectic and intense real-world healthcare setting.
Questions To Ask Your Validation Partner
Working with an experienced cleaning validation partner means working with industry professionals who are well-versed in a wide range of testing methods and standards. Asking the right questions about cleaning validation and choosing the right cleaning validation partner helps set you up for success on the path to market approval. The more you know going into the process, the easier it is to select the right validation partner and find success with your testing processes.
What Standards and Compliances Do You Work With?
Cleaning validation does not fall under any specific FDA jurisdiction, but there are national and international standards that device manufacturers can follow to make the regulatory pathway easier. As we mentioned above, some state or local entities might require these standards to gain market approval. That’s why it’s important to choose a cleaning validation partner that follows the standards you need or prefer for your device.
Certifications and accreditations are also important to ask about. At HIGHPOWER, we operate within the ISO 17025 quality system and have achieved accreditation through an evaluation of technical competence by the American Association for Laboratory Accreditation. We also strive for GMP compliance within FDA 21 CFR Part 820, Quality System Regulation.
What Tests Are Available?
Different reusable medical devices require different cleaning procedures based on the device complexity and its use. This calls for different testing methods tailored to each device and its instructions for use. It’s important to ensure your validation can perform not just these different testing methods but also different scenarios, such as worst-case testing and simulated use testing. A cleaning validation partner needs to understand the importance of the detergent used in the cleaning validation study. Here is the US, a neutral pH detergent is preferred, whereas outside the US, a high Ph detergent is typically used.
HIGHPOWER Labs has the equipment and knowledge necessary to conduct validation tests with a variety of International and FDA-accepted cleaning analytes, including protein, hemoglobin, and TOC. We also conduct bioburden testing that meets the European Medical Devices Regulation (MDR) approval.
What Does Turnaround Time Look Like?
There is no set time frame for cleaning validation, as each device is assessed on its own merits and complexity. Turnaround times also depend on factors such as the type of testing, the number of samples available for testing, currently available employees and equipment, and current demands. Talking with your validation partner can give you a clearer estimate of the timeframe for your validation tests. HIGHPOWER Labs also offers expedited testing to streamline the process for urgent client situations.
Expert Cleaning Validation Services From HIGHPOWER
At HIGHPOWER Labs, we offer over 30 years of experience in various cleaning validation procedures. Learn more about our medical device cleaning standards when you partner with us for validation testing today.