Top 4 Cleaning Validation Challenges In 2022 For Reusable Devices
What are cleaning validations?
Cleaning validations are protocols that ensure items, equipment, or areas are consistently cleaned to certain acceptance criteria. For reusable devices, cleaning validations prepare devices to undergo sterilization and ensure that tissues, proteins, lipids, bacteria, and cellular debris are removed from used devices to acceptable levels. Cleaning validations have internationally accepted standards that must be met. These cleaning standards can be verified using test soils that simulate contaminants that the reusable devices would collect during use. For example, cleaning validations specify how contaminants like blood, tissues, and feces are removed from reusable medical devices during reprocessing.
What is the importance of cleaning validations for reusable devices?
Medical devices are extremely diverse in their shape, size, and use. Reusable medical devices require cleaning, disinfection, and sterilization before they can be used again. Each of these processes (cleaning, disinfection, and sterilization) must be validated to ensure patient safety and prevent hospital-acquired infections due to inadequate cleaning (and subsequent inadequate sterilization) of reusable devices.
What are the top cleaning validation challenges?
#1: Incorrect Soil Selection
Many cleaning validations are undergone without using an appropriate soil that mimics device use. FDA has indicated that bacterial spore challenges and Hucker’s soil are inadequate to validate a cleaning protocol. Thus, cleaning validations must use soils containing contaminants such as proteins, carbohydrates, red blood cells, and lipids.
Artificial Test Soil (ATS 2015) is a popular standardized test soil containing various proteins, hemoglobin, carbohydrates, cellulose, lipids, and mucins. ATS is useful to simulate when fat tissues, joint capsules, stomach tissues, or respiratory tissues come in contact with a device. Coagulated blood is liquid blood that has undergone a clotting process to form a gel-like substance. This gel-like substance contains platelets and other proteins within the liquid blood. In a coagulated state, blood is especially “sticky.” Thus, coagulated blood helps simulate soil for instruments that contact whole blood during use. Other items such as microbes, saliva, urine, and defibrinated blood (which is good for devices that will contact primarily blood during use), may be added depending on device use.
#2: Lack Of Cleaning Verification vs. Revalidation Knowledge
Medical device businesses, particularly companies in the start-up or early phases of business growth, do not always know when modifications to products in a tray (such as adding a product) require cleaning process verification or a full cleaning process revalidation. In the case of product addition, revalidation is almost always required. However, what is the differences between cleaning verification and revalidation?
Cleaning verification is a one-time process for a specific device cleaning event that assesses the effectiveness of the cleaning process. In contrast, a cleaning validation or revalidation is a process for assessing the effectiveness and consistency of a cleaning process for certain products and equipment. Cleaning validations are not a one-time event.
#3: Unavailable Corrosion Testing
An increasing number of medical device companies want to be able to verify that their devices can be cleaned and re-sterilized a certain number of times without corrosion. Thus, reusable device businesses are looking for a way to validate cleaning and sterilization cycles for device corrosion. Corrosion testing with cleaning and sterilization validations is a specialty combination test that large contract testing facilities cannot always accommodate. Indeed, large contract testers have pre-set standard operating procedures. Thus, big contract testing facilities cannot easily problem solve testing adaptations for unique combination projects in a timely or cost-effective manner.
#4: Combination Device Issues
The final challenge is that many companies are struggling with finding companies to address cleaning validation criteria for combination devices. By a combination device, I am referring to a device with a combination of reusable parts, disposable parts, and parts that do not contact the patient at all. The FDA uses Spaulding classifications to determine the microbicidal methods needed for reusable device cleaning validations and sterilization validations. A combination device may have parts that fall under different Spaulding classifications (critical, semi-critical, and non-critical). Spaulding classifications are based on exposure risk to various contaminants. A reusable device is considered critical if it is introduced directly into the bloodstream or contacts an internal tissue or body space that is normally sterile during use. Examples of critical devices are surgical instruments, implantable devices, and arthroscopes. Semi-critical devices contact body areas with some microbial resistance. Intact mucous membranes or non-intact skin are examples of areas resistant to microbes. Examples of semi-critical devices are laryngoscope blades and gastrointestinal endoscopes. Reusable devices considered non-critical are items that touch but do not penetrate the skin. Non-critical devices are also medical devices that do not touch the patient but may become contaminated with microorganisms, blood, or bodily fluids during patient care. Examples of non-critical devices are room vital signs monitors and blood pressure cuffs.
Here are some things you can do right now to improve the speed and ease of your cleaning validation testing:
- Use soils that represent the device’s intended use instead of using a generic microbial blend. Use a mix of fats, microbes, carbohydrates, fresh blood, saliva, urine, and coagulated blood as fits the project. Otherwise, your cleaning validation will not represent a “worst-case” scenario and could be rejected by the FDA. Alternatively, if your device is not in contact with blood or fatty tissues during use, do not add these contaminants to your cleaning validation soil. Avoiding contaminants that will not be in contact with a product will make your cleaning validation process faster and simpler.
- For those in the start-up category or new to cleaning validation requirements, ensure your contract testing organization will give you feedback on your cleaning validation requests. It is never good for a company to simply run the tests you requested without knowing your device or intentions for product use. Feedback from your contract testing facility will avoid any issues with cleaning validation verification vs. revalidation.
- Ensure your contract testing organization has an available process for corrosion testing of your reusable devices following multiple cleaning & sterilization cycles.Assure that your contract testing agency can create signature testing processes for corrosion that meet standards, needs, and save clients time and money
- For those of you with tricky combination devices, contact your current contract testing organization and see if they offer specialized cleaning validation testing for combination devices at the price point and turnaround time you require.
Summary
Overall, reusable medical devices require cleaning, disinfection, and sterilization before being used again. Each process (cleaning, disinfection, and sterilization) must be validated to ensure patient safety and prevent hospital-acquired infections due to inadequate reusable device cleaning (and thus sterilization). Cleaning validations simulate “worst-case” contaminant conditions and verify that certain cleanliness levels can be met consistently following a set cleaning protocol. Indeed, a cleaning validation specifies how blood, tissues, and feces are removed from reusable medical devices during reprocessing. The primary challenges with reusable device cleaning validations are 1) incorrect test soil selection, 2) lack of cleaning verification vs. revalidation knowledge, 3) unavailability of corrosion testing with cleaning validations, and 4) issues with cleaning validations for combination devices. MycoScience specializes in overcoming these challenges and creating effective cleaning validations for their client’s reusable components and devices. Ensure you choose a contract testing organization that can support you with your unique cleaning validation needs.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling for parenteral products. MycoScience also offers testing services, including Preservative Efficacy Testing/Suitability Testing, Bioburden Testing, Microbial Aerosol Challenge Testing, Cytotoxicity Testing, Cleaning Validations, Accelerated Aging, Microbiology Testing, EO Residual Testing, Bacterial Endotoxin Testing, Package Integrity Testing, Sterilization Validations & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
Association for the Advancement of Medical Instrumentation Technical Information Report. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Arlington, VA, USA. AAMI; 2011. (AAMI TIR30-2011).
Michael J. Akers. Sterile Drug Products Formulation, Packaging, Manufacture, and Quality. Drugs and the Pharmaceutical Sciences. Informa Healthcare. 2010.
Steven G. Richter. Cleaning Validations of Medical Products. Chapter 10: The Medical Device Validation Handbook 2nd Edition. RAPS.
