Medical Device Manual Cleaning: Everything You Need to Know

Medical Device manual cleaning

If someone had told me 16 years ago that I’d still be manually cleaning items as part of my job, I’d have been quite surprised. It wasn’t so much about the cleaning itself, but more about the fact that, even back then, I knew I wanted to be a scientist. My career began with early-morning shifts cleaning and polishing silver cutlery before starting my restaurant shift. Surely, I have moved a long way from there and did became a scientist, but that experience made me appreciate how important this behind-the-scenes work was, even though it went unnoticed by customers, as it played a crucial role in the overall service.
Recent months have brought back memories of those early days. Our lab team had to pull together to meet a tight deadline for a study validating reprocessing instructions for critical medical devices. As I scrubbed each device, I couldn’t help but reflect on how this seemingly minor task was essential for the success of the study.

Medical Device safe reuse

The Instructions for Use (IFU) of medical devices are vital. They ensure not only the correct use of the device but also that each reusable device is safe for the next patient. Safety is key. But what does “safe to reuse” mean? According to ISO 17664, manufacturers must provide comprehensive information on cleaning, disinfection, and sterilisation processes in their IFUs. Each step must be validated to support the manufacturer’s claims.
Sterilisation and disinfection, while seemingly straightforward, involve microbial efficacy claims. Manufacturers must demonstrate that their sterilization methods—such as steam, ethylene oxide, low-temperature sterilization, or gamma radiation—meet minimum requirements for sterility. Similarly, disinfection must achieve a specified reduction in microbial concentration. For automated thermal disinfection using a Washer Disinfector (WD), this means reaching a required temperature for a set duration (e.g., 1 minute at 90°C) to ensure adequate disinfection.

What defines a “cleaned” medical device?

According to the BS EN ISO 15883 series and ANSI/AAMI ST98, a device is considered clean when residue protein and other analytes (like haemoglobin, TOC, carbohydrates, ATP) fall below action levels specified in the standard. These standards primarily focus on automated cleaning processes using WDs.

The question then arises: What about manual cleaning?

Guidance is limited due to its variability and dependence on the device. ISO 17664 states that any claims in the IFU must be validated, including manual cleaning processes. While manual cleaning may replace automated cleaning in some cases, both should meet the same residual criteria.

Pre-manual cleaning, which often precedes an automated cleaning process, is crucial in most sterile service departments (SSD). This step typically involves rinsing with tap water, manual brushing with or without detergents, and sometimes sonication. The specifics can vary based on the device’s materials and intended use, and water quality ranges from tap water for initial rinsing to purified or RO water for final rinses.

Why is Medical Device manual cleaning important?

I recall a technician from one of the largest SSD departments in the UK telling me that pre-manual cleaning could be as significant, if not more so, than the automated process. This makes sense because manual cleaning can remove visible debris and dried stains, reach high-risk areas like lumens and hinges, and allow the reprocessing technician to dedicate more time to the devices that may need it, compared to automated cycles. Surely, there is a potential risk for human error, and therefore successful validation of the procedure should be carried out to ensure the risks are minimised (using worst-case scenario, such as lower times, lower detergent concentrations etc).

Effective manual cleaning involves specific instructions and procedures. Tools typically include various sizes of nylon brushes for removing dried soil, followed by a sonic bath to dislodge residues with high-frequency sound waves, and a final rinse with purified water. The amount of time and detergent used depends on the device and whether the step is pre-cleaning or an alternative to automated washing.

Developing the correct cleaning instructions can be daunting. At Test Labs, we have extensive expertise in reprocessing validation, both manual and automated, to assist with medical device IFU validation.

Contact Us:

020 3813 0969 info@testlabsuk.com

Explore how we can support your medical device journey to the market

Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

Learn more

Medical Device Cleaning Validation

We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.

Learn more

Medical Device Material Compatibility Testing

We analyse test item materials at both sample and product level to assess process compatibility.

Learn more

Written by Enrico Allegra September 13th 2024

As a Clinical Microbiologist, Enrico has been working in the regulatory world of pre-clinical safety assessment for over a decade. He graduated with a Bachelor of Science degree in Immunology with medical Microbiology followed by a master’s degree in clinical microbiology Queen Mary University of London in 2013.

As part of his MSc’s project, he collaborated with the Barts Health NHS Trust to develop a diagnostic PCR cycle to detect Pneumocystis jirovecii in samples from immunocompromised patients. This helped reduce the turnaround time from several days to less than 12 hours.
During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients. Over the last few years, he has been actively involved the scientific community publishing various peer-reviewed papers for the introduction of novelty assays of safety assessments. He positively contributed pioneering new alternative to in vivo testing for cytotoxicity using insect models alongside cell culture testing. He is a certified biosafety officer acting as the Technical Lead at Test Labs for any UKAS ISO 17025 testing.

During his career he has worked as a Study Director conducting pre-clinical testing under GLP requirements working for a large CRO company. In this role he was able to gain expert knowledge for product testing to meet the requirements for regulatory submission to various authorising bodies, such as FDA, EPA, MHRA. He was heavily involved in method transfer and development, with a keen interest in bringing innovative testing procedures to meet client needs. As a result, Enrico used all his previous knowledge and expertise to help setting up the new Medical Device testing facility for Test Labs.

As part of his new role Enrico has helped the company achieving various new accreditations for Medical Device testing including the reprocessing validation for Class Ir Medical Devices under the scope of ISO 17025. Guiding the analytical team for reprocessing testing he has gained invaluable knowledge in customising testing regimes to accommodate reprocessing of reusable Medical Devices with emphasis on process optimisation and safety aspect.

Here at Test Labs, he acts as the Head of Laboratory overseeing the operation of Medical Device testing spanning from microbiology, chemistry and product testing. Guided by a deep understanding of product development and regulatory standards, he strives for excellence in both clinical evaluations and technical assessments.