Validation of the Reprocessing of Medical Devices

For operators, the validation of medical device reprocessing is a key requirement for employee protection, patient safety, and regulatory compliance. SMP supports you in this process with accredited testing laboratory expertise and many years of experience - ensuring reliable, quality-assured validation and revalidation of your medical device processing processes.

Reprocessed instruments and medical devices are used directly on patients. Errors in cleaning, disinfection, or (if applicable) sterilization increase the risk of infection and can lead to malfunctions. The KRINKO/BfArM recommendation on the reprocessing of medical devices, the Medical Device Operator Ordinance, and standards such as the DIN EN ISO 15883 series and DIN EN ISO 17665 therefore require the use of suitable, validated processing procedures.

For you, this means specifically:

• Verifiably effective cleaning, disinfection, and, where applicable, sterilization processes
• Traceable documentation
• Stable, consistent processes in washer disinfectors, sterilizers, sealing devices, storage processes, and manual procedures
• Reduced liability risk and effective protection of your brand

SMP offers validation services ProVal - validating your reprocessing processes at your facility.

SMP supports the entire reprocessing validation process.

Validation of Automated Cleaning and Disinfection Processes

Washer disinfectors (WDs) are the backbone of many reprocessing units. SMP validates your WD processes based on the guidelines issued by the DGKH, DGSV, and AKI for the validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices (MHP_ZS-Supplement-ENG-2017_E-Paper.pdf, 2017). This includes:

• Process validation of cleaning and thermal disinfection
• Use of standardized test specimens with defined test contamination
• Verification of cleaning efficacy on real-use and soiled medical devices
• Verification of the temperature profile in different process steps
• Evaluation of relevant load configuration and loading patterns
• Preparation of a traceable validation report

This provides you with a clear determination of whether your WD processes consistently achieve sufficient cleaning performance, cleaning effectiveness, and thermal disinfection, and whether the process chemicals used are sufficiently rinsed away.

Validation of Manual Cleaning and Disinfection Procedures

Manual reprocessing of medical devices is particularly widespread in medical practices and smaller facilities. SMP translates the DGKH, DGSV, and AKI guideline on the validation of manual cleaning and manual chemical disinfection of medical devices (2013) into practical test protocols:

• Analysis of your work instructions for the manual reprocessing of medical devices
• Simulation of the manual process steps using test specimens
• Verification of cleaning efficacy on real-use and soiled medical devices
• Evaluation of cleaning detergents, contact times, and concentrations

This transforms a theoretical guideline into a practical, validated process that proves its worth in everyday use.

Validation of steam sterilization

In addition to cleaning and disinfection, sterilization must also function reliably if required based on the risk classification. SMP performs:

• Validation of processes and optional additional microbiological testing in accordance with DIN EN ISO 17665
• Validation of low-temperature sterilization processes
• Tests with worst case loading
• Verification of drying performance

and documents the results in accordance with standards and guidelines. Requalifications ensure long-term process stability.

The validation of medical device reprocessing operates within the complex interplay of legal requirements, guidelines, and standards. SMP closely aligns all test protocols with these requirements:

SMP combines many years of specialization with technological innovation:

• More than two decades of expertise in the cleaning, disinfection, and sterilization validation of medical devices
• An accredited testing laboratory in accordance with DIN EN ISO/IEC 17025 and an established quality management system in accordance with ISO 9001
• As part of the Miele Group, SMP operates independently while drawing on a modern technical infrastructure
• Independent validation service provider for cross-manufacturer process validation
• In-depth technical expertise
• Meaningful and practical documentation
• Straightforward validation service, including subcontracting 

Are you planning to purchase a new instrument washer-disinfector, expand your instrument inventory, or do you need to recertify existing equipment? SMP is here to support you from the very beginning:

1. A brief initial consultation on the scope of application, equipment, and objectives
2. A proposal with a clearly defined scope of services, timeline, and required information
3. Validation carried out in accordance with relevant guidelines and standards
4. Discussion of results with your quality and hygiene managers
5. Provision of a comprehensive report upon completion of all laboratory tests

Operators of reprocessing units should take a look at our information for ProVal - validating your reprocessing processes | SMP GmbH

Contact SMP to plan and consistently implement the validation of medical device reprocessing together with experienced experts.

When must WD processes be validated?

A washer-disinfector (WD) must be validated after commissioning, after significant changes (e.g., software updates, modifications, or changes to the process chemistry), and regularly as part of requalification. This requirement is based on the KRINKO/BfArM recommendation, DIN EN ISO 15883-1 and relevant DGSV guidelines, which mandate the use of appropriate, validated reprocessing procedures.

What is the validation of processing procedures?

The validation of processing procedures is the documented evidence that a cleaning, disinfection, or sterilization process reliably delivers a reproducible, hygienically sound result under defined conditions. In practice, this means: The validation of medical device reprocessing demonstrates that this specific process, in this specific configuration (device, program, load configuration, chemicals, water quality), produces instruments free of relevant residual contamination. Guidelines from the DGSV, DGKH, and AKI define the framework for this process validation.

Who is responsible for the reprocessing of medical devices?

The operator of the (that is, the hospital, medical or dental practice, or the reprocessing facility) is responsible for the reprocessing of medical devices. The operator bears overall responsibility for ensuring that validated procedures are followed, appropriate equipment is used, personnel with the necessary knowledge and expertise in medical device reprocessing are assigned, and the results are documented. Within the organization, operational responsibility is typically assumed by the head of the reprocessing unit or the person responsible for hygiene. SMP supports operators with meaningful test results and test reports.

What hygiene requirements apply to the reprocessing of medical devices?

In Germany, the hygiene requirements for the reprocessing of medical devices are primarily derived from the KRINKO/BfArM recommendation, the Medical Device Operator Ordinance, and relevant standards. These include the classification of products into non-critical, semi-critical, and critical categories; the preferred use of automated processes for higher risk classes; validated cleaning and disinfection processes; appropriate training and technical expertise of staff; and traceable documentation. The validation of medical device reprocessing serves as formal proof that the hygiene requirements for the procedures used are met.

How does SMP support medical practices in the reprocessing of medical devices?

Medical and dental practices face specific organizational and hygienic challenges when reprocessing medical devices. Reprocessing often takes place alongside ongoing practice operations and must nevertheless be carried out reliably, reproducibly, and in compliance with regulations.

SMP supports practices with practical validation services designed to ensure efficient workflows and minimal operational disruptions.

These include, among other things:

• Validation of existing cleaning, disinfection, and sterilization processes during a joint on-site visit
• Conducting tests with minimal disruption to practice operations
• Validation based on current regulatory requirements and relevant guidelines
• Practical advice and best practices drawn from the experience of numerous facilities
• Direct technical support and clarification of individual questions during the visit
• Support in increasing process reliability and reducing hygiene risks

This is how SMP helps medical and dental practices establish safe and traceable reprocessing procedures as a permanent part of their daily practice operations.