Commission Implementing Regulation (EU) 2020/1207Show full title

CHAPTER II U.K. ORGANISATION OF REPROCESSING AND RISK MANAGEMENT

Article 3 U.K. Contracting external reprocessors

1. If reprocessing is carried out by an external reprocessor, the health institution and the external reprocessor shall conclude a written contract.

2. The contract shall include the following elements:

(a) the attribution of tasks, obligations, and responsibilities of the two parties;

(b) the arrangements for transition from one external reprocessor to another and responsibilities of the external reprocessor that is a party to the contract;

(c) the requirements related to the qualification and expertise of the personnel participating in the reprocessing activities;

(d) the requirements for the reprocessing, collection of information related to the reprocessed devices and information exchange between the health institution and the external reprocessor;

(e) the requirement to ensure compatibility of the quality management systems (QMS) of the parties, as referred to in Article 21;

(f) the procedure for monitoring of the quality of the reprocessing performed by the external reprocessor via on-site audit(s).

Article 4 U.K. Staff, premises and equipment

1. Reprocessors shall ensure that the personnel involved in the reprocessing:

(a) is sufficient in number to ensure the quality of the reprocessing;

(b) has the relevant specific knowledge and sufficient professional training in view of the reprocessing steps applied;

(c) has clearly defined tasks and responsibilities laid down in writing.

2. Reprocessors shall designate one or more persons responsible for the reprocessing.

3. The person responsible for reprocessing shall comply with the following criteria:

(a) has sufficient experience and qualification in the domain of reprocessing;

(b) has received training on reporting incidents and on undertaking critical analysis in accordance with Article 23(8).

The person responsible for reprocessing shall be permanently and continuously available to the reprocessor during working hours of the reprocessor. The person responsible for reprocessing shall also be responsible for the elaboration and management of the technical documentation referred to in Article 9 and of the QMS referred to in Article 21.

4. The premises where the reprocessing is taking place and the equipment to be used shall be adapted to the type of single-use devices to be reprocessed, the steps of the reprocessing cycle and the number of reprocessing steps.

5. The surfaces of the premises, ambient air (temperature, humidity, viable and non-viable airborne particles), water and other gases and fluids shall be controlled and periodically monitored to verify that their microbiological and physical quality is adequate for reprocessing.

6. The equipment shall be subject periodically to generally acknowledged state-of-the-art maintenance, performance checks, and calibrations, according to the manufacturer’s instructions. The equipment shall be validated and, where applicable, periodically revalidated, in order to establish that it is suitable for the intended purpose.

7. The reprocessor shall describe in the technical documentation referred to in Article 9(1) the types of single-use devices for which the reprocessor has decided that it has the ability to conduct reprocessing and the justification for that decision. The reprocessor shall make publicly available the list of devices that it is able to reprocess.

8. If the reprocessor decides that it has no longer the ability to reprocess certain types of single-use devices it shall describe the reasons of that decision in the technical documentation referred to in Article 9(1). The list referred to in paragraph 7 of this Article shall be updated accordingly.

Article 5 U.K. Preliminary assessment of the suitability of a single-use device for reprocessing

1. Before deciding to start reprocessing a single-use device, or requesting an external reprocessor to do so, the health institution shall assess if the single-use device is suitable for reprocessing.

2. For the purposes of paragraph 1, the health institution shall analyse whether the safety and performance of the single-use device once reprocessed will be equivalent to the original single-use device.

3. When assessing the suitability of a single-use device for reprocessing the health institution, where applicable, shall:

(a) verify that the single-use device is CE marked;

(b) verify that the single-use device has not been withdrawn from the market and its certificate of conformity has not been suspended, withdrawn or subject to restrictions;

(c) verify if the use of the single-use device has been subject to restrictions for safety reasons as indicated in the field safety notices;

(d) conduct an analysis of the properties of the single-use device, taking into account all available documentation and information on the single-use device to ensure sufficient understanding and know-how on design, constructional properties, material characteristics, functional properties, and other risks factors related to the reprocessing of the single-use device, including its previous use.

Where applicable, when carrying out an assessment in accordance with the first subparagraph, the health institution shall consult an external reprocessor and rely on its operational support in accordance with the contract referred to in Article 3.

For the purpose of points (b) and (c), the health institution shall verify the information in the European Database on Medical Devices (EUDAMED). Until EUDAMED is fully functional, the health institution shall verify the information in accordance with the provisions on exchange of information referred to in Article 123(3)(d) of Regulation (EU) 2017/745.

Where the information cannot be obtained in accordance with the third subparagraph, the health institution shall verify the information on the website of the manufacturer or of its authorised representative.

For the purpose of point (d), the health institution shall review the information referred to in point (p) of Section 23.4 of Chapter III of Annex I to Regulation (EU) 2017/745 and all other relevant documentation and information in the public domain.

4. The decision of the health institution concerning the suitability of a single-use device for reprocessing shall be based on a written positive opinion provided by the person responsible for reprocessing. Single-use device shall not be reprocessed if the person responsible for reprocessing has provided a negative opinion on the suitability of the single-use device for reprocessing.

Article 6 U.K. Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device

1. Reprocessors shall not change the original intended purpose of the single-use device as indicated in its instructions for use.

2. Reprocessors shall establish a monitoring process to verify the following:

(a) that the single-use device is not withdrawn from the market;

(b) that the certificate of conformity of the single-use device has not been suspended, withdrawn or is not subject to restrictions;

(c) the use of the single-use device is not subject to restrictions for safety reasons based on the information referred to in Article 5(3), (b) and (c);

The reprocessors shall also identify any change made by the manufacturer to components, materials, intended purpose or specifications of the single-use device that may have an impact on the reprocessing. Reprocessors shall assess the significance of these changes for the appropriateness of reprocessing. If a change has a detrimental effect on the reprocessed single-use device, reprocessing shall be discontinued or the reprocessing process shall be modified to adapt to the change made to the single-use device.

Article 7 U.K. Determination of reprocessing cycle

1. Health institutions reprocessing single-use devices shall determine, when applicable together with external reprocessors, the reprocessing cycle for single-use device to be reprocessed.

2. The reprocessing cycle shall be determined based on the documentation and information collected in accordance with Article 5 and the results of a technical assessment including, when appropriate, physical, electrical, chemical, and biological and microbiological tests, and reverse engineering. The reprocessing cycle shall not change the intended purpose of the single-use device, shall take into account the scientific and technical knowledge, and, if applicable, the original method of sterilisation and the relevant standards.

3. The reprocessing cycle shall be established in writing and shall be validated by the health institution reprocessing single-use devices, when applicable, together with external reprocessor. The reprocessing cycle shall describe each step of the reprocessing. For each step, the relevant procedure shall be established and each step shall be validated. Validation of the reprocessing steps shall consist of installation and operational and performance qualification.

4. The validation shall ensure that the performance and safety of the single-use device remains equivalent to the original single-use device after every reprocessing cycle and up to the maximum allowed number of reprocessing cycles.

5. The reprocessing cycle shall be monitored through periodic routine tests and contamination controls, physical, electrical, chemical and biological monitoring and testing of process parameters and calibration.

6. The reprocessed single-use device shall be released after it is confirmed that cleaning, disinfection and sterilization steps and any testing, as appropriate, assure that the reprocessing cycle has been completed in compliance with the requirements applicable to such cycle.

Article 8 U.K. Maximum number of reprocessing cycles

1. Each reprocessing in accordance with Article 11 shall be counted as one reprocessing cycle. Each reprocessing cycle of a single-use device shall be counted to determine the maximum number of reprocessing cycles even if a single-use device was not reused on a patient following the reprocessing.

2. The health institution, together with the external reprocessor, when applicable, shall determine the maximum number of reprocessing cycles which can be applied to the reprocessed single-use device, during which the performance and safety of that single-use device remains equivalent to the original single-use device.

3. Once the maximum number of reprocessing cycles has been reached, the reprocessed single-use device shall be disposed of.

Article 9 U.K. Technical documentation

1. Reprocessors shall have a technical documentation on its reprocessing activities which shall include:

(a) the procedures for controlling and periodically monitoring premises and equipment referred to in Article 4(5) and (6);

(b) any decision concerning the ability or lack of ability to reprocess a type of single-use devices.

2. Reprocessors shall also have a technical documentation specific to each model of single-use device, manufactured by the same manufacturer, as identified by its device identifier in the Unique Device Identification system (‘UDI-DI’). The technical documentation shall include:

(a) the results of the determination of the reprocessing cycle and procedures referred to in Article 7;

(b) the actions to be undertaken in case one or more steps of the reprocessing cycle have not been performed.

3. The technical documentation specific to each model of single-use device manufactured by the same manufacturer, as identified by its UDI-DI that is kept by health institutions, shall also include:

(a) the results of the assessment of the suitability of the single-use device for reprocessing described in Article 5 and the data and information used for the assumption that the safety and performance of the reprocessed device will be equivalent to those of the original single-use device;

(b) the results of the monitoring process referred to in Article 6;

(c) the description of the system for tracking the single-use device from the first use until its last reuse;

(d) the description of the system for reporting serious incidents in accordance with Article 23;

(e) the description of the system to identify and to dispose of the single-use device if it fails to meet any aspect of functionality, performance or safety, prior or during reuse.

4. The technical documentation shall be kept for 10 years after the last reuse of a single-use device.