Reprocessing Single-Use Devices in accordance with EU Medical Device Regulations (EU MDR 2017/745)

Single-Use Devices (SUDs) are indispensable in the healthcare sector, providing essential tools for medical procedures. While SUDs are originally designed for one-time use, the practice of reprocessing these devices has become increasingly important, driven by cost- effectiveness and environmental concerns. However, reprocessing SUDs entails a comprehensive set of considerations that must be meticulously addressed to ensure both patient safety and regulatory compliance.

The process of establishing an effective reprocessing cycle involves three pivotal steps:

1. Conducting Pre-Requisite Checks

2. Assessing the Suitability of SUDs for Reprocessing

3. Establishing the Reprocessing Cycle

Conducting Pre-requisite checks for Single-Use Devices

The first and most crucial step in reprocessing SUDs is conducting pre-requisite checks to determine if a device can undergo reprocessing. The reprocessor must verify the following:

• CE Mark: Ensure that the SUD is CE marked, indicating compliance with European regulations.

• Market Status: Confirm that the SUD has not been withdrawn from the market, and its certificate of conformity has not been suspended, withdrawn, or restricted.

• Safety Restrictions: Check if any safety restrictions have been placed on the use of the SUD, as indicated in field safety notices.

• Property Analysis: Perform a comprehensive analysis of the SUD's properties, considering factors such as design, material characteristics, and functionality. This step is critical for understanding the risks associated with reprocessing.

• Manufacturer Changes: Identify any changes made by the manufacturer to components, materials, intended purpose, or specifications of the SUD. Assess the impact of these changes on reprocessing.

Assessing Suitability of SUD for Reprocessing of Single-Use Devices

Once pre-requisite checks are completed, the reprocessor should assess the suitability of the SUD for reprocessing. This assessment involves evaluating whether the reprocessed SUD will maintain safety and performance equivalent to the original device. Factors to consider include:

The characteristics of single-use devices concerning construction, material properties and planned application have to be taken into account within the risk management procedures of the reprocessor. The characteristics such as:

• Technical specifications and geometrical properties.

• Material composition and leachable materials.

• Microbiological contamination, prions and transmissible spongiform encephalopathy agents, and potential risks.

• Endotoxins, pyrogenic reactions, allergic reactions, and toxic reactions.

The Person Responsible for Reprocessing plays a critical role in determining suitability, ensuring that all risks are adequately addressed.

Certain SUDs are unsuitable for reprocessing due to potential hazards or specific technical characteristics. These include:

• Devices emitting radiation.

• Devices used for administering cytostatic or radiopharmaceutical medicines.

• Devices incorporating medicinal substances.

• Devices for invasive procedures on the central nervous system.

• Devices posing a risk of transmitting spongiform encephalopathies.

• Implantable devices.

• Devices for which serious incidents have occurred after reprocessing and the cause of the incident is related to the reprocessing or it cannot be excluded that the cause of the incident is related to the reprocessing,

• Devices with batteries which cannot be changed or present a risk of malfunctioning after reprocessing,

• Devices with internal data storage necessary for the use of the device and which cannot be changed or presents a risk of malfunctioning after reprocessing,

• Devices with cutting or scraping blades, drills or components wearing off that are no longer suitable after the first use and cannot be changed or sharpened before the next medical procedure.

Establishing the Reprocessing cycle for a Single-Use Device (SUD)

Establishing a reprocessing cycle is a pivotal step in the process. It involves the identification of appropriate procedures for cleaning, sterilization, thermal disinfection, chemical disinfection, drying, and transporting followed by procedures for inspection, maintenance, and repair. The main purpose of these procedures is to validate the method and performance of the reprocessed device.

The reprocessing cycle must adhere to several critical principles:

• It must not change the SUD's original intended purpose.

• It should include a monitoring process to detect manufacturer-initiated changes that may impact reprocessing.

• Procedures for each reprocessing step must be established and validated.

• Validation ensures that the reprocessed device's performance and safety remain equivalent to the original device after each cycle.

The process of establishing a reprocessing cycle for SUD devices is complex and requires strict adherence to regulatory standards. The reprocessing cycle comprehensively encompasses various stages, including preliminary treatment at the point of use, safe transportation, preparations prior to cleaning, the cleaning process, thermal or chemical disinfection, drying, meticulous inspection, maintenance, repair, functional testing, packaging, labeling, instruction provision, sterilization, and storage. The critical steps involved in ensuring the safety and reliability of reprocessed single-use devices include –

• Establishing and Validating Methods: The journey of reprocessing a single-use device begins with thorough research and analysis. It's essential to understand the device's properties, materials, and intended use fully. This step may involve a technical assessment, including physical, electrical, chemical, and microbiological tests. The reprocessing cycle should align with scientific and technical knowledge and adhere to relevant standards. Validation of the reprocessing methods is a crucial aspect of this step. The process must ensure that the reprocessed device maintains performance and safety equivalent to the original single-use device throughout multiple reprocessing cycles.

• Documentation and Validation: All procedures involved in the reprocessing cycle must be documented in detail. This documentation serves as a foundation for validation, which involves installation, operational, and performance qualification. The objective is to ensure that every step of the reprocessing cycle meets rigorous quality and safety standards. Validation plays a pivotal role in guaranteeing that the reprocessed device remains as safe and effective as the original, even after multiple cycles of reprocessing.

• Monitoring and Routine Testing: The reprocessing cycle is an ongoing process, demanding continuous monitoring and routine testing. This includes physical, electrical, chemical, and biological assessments, as well as calibration checks. The goal is to detect any deviations from the established standards and address them promptly. Monitoring helps in maintaining the safety and reliability of the reprocessed devices and ensures that they consistently meet performance expectations.

• Determining Maximum Reprocessing Cycles: An important aspect of the reprocessing cycle is establishing the maximum number of reprocessing cycles that can be applied to a single-use device. This ensures that the device's performance and safety remain equivalent to the original single-use device. Once the device reaches the maximum number of reprocessing cycles, it must be disposed of appropriately to maintain patient safety.

Processing Step	​Parameters to be determined while establishing Reprocessing cycle
​Pre-treatment at the point of use	Description of pre-treatment techniques Checks to be undertaken Maximum allowed time period between use and cleaning
Transportation	​Support systems and containers for transportation Requirements for transportation
Preparation before cleaning	Requirements for disassembly of SUD Capping or opening of ports Leak testing Special soaking or brushing techniques and ultrasonic treatment
Cleaning	Techniques to be used, including rinsing Description of the accessories required for cleaning process Identification and concentration of chemicals required for cleaning Identification of water quality to be used Limits and monitoring of chemical residues remaining on the single-use device Limits on process parameters, including temperature, concentration of solution(s) and exposure time to be used
Thermal Disinfection	Limits on process parameters, including temperature and exposure time Description of the accessories required for the disinfection process Identification of water quality required Techniques to be used including rinsing volume and time with criteria or requirements for approval or rejection
Chemical disinfection	Identification and concentration of chemicals required for the disinfection process Contact time of the disinfectant Temperature(s) to be used Limits on temperature, concentration of solution(s), exposure time Description of the accessories required for the disinfection process Identification of water quality required Techniques to be used including rinsing volume and time Limits and monitoring of chemical residues remaining on the single-use device after disinfection Limits and monitoring of chemical residues from cleaning agents to ensure these residues do not interact adversely with the disinfectant Criteria and/or requirements for approval or rejection
Drying	Criteria and/or requirements for the maximum temperature and exposure time Specification of the drying agent
Inspection, maintenance, repair and functionality testing;	Method(s) and performance criteria for inspection Method(s) for adjustment, reparation and/or calibration Type, amount and method of application of lubricant Re-assembly of the single-use device Specification of parts that might need to be replaced Functionality testing and parameters to be considered for acceptance or rejection
Packaging	Material specification Compliance with the specific sterilization or disinfection method Limits on packaging process parameters, including sealing temperature Criteria for acceptance or rejection The packaging and the instructions for use of the reprocessed single-use device shall not bear the CE mark

Establishing a reprocessing cycle for single-use devices is a meticulous process that prioritizes patient safety and device reliability. It involves a series of critical steps, including method validation, continuous monitoring, and thorough documentation. By adhering to these steps and maintaining strict quality standards, healthcare institutions can confidently reprocess single-use devices while ensuring the safety and well-being of their patients.

Ready to navigate the intricacies of reprocessing single-use devices in compliance with EU MDR? Take the first step toward ensuring patient safety and regulatory compliance today! Contact Artixio today for expert insights and guidance!