Quality management system
1. Reprocessors shall establish, document, implement, and maintain a QMS for the reprocessing activities.
2. The QMS shall ensure that requirements set out in this Regulation and requirements applicable to reprocessing set out in Regulation (EU) 2017/745 are complied with.
3. The QMS shall cover the organisation of all steps of reprocessing and shall address at least the following aspects:
(a)
strategy for regulatory compliance;
(b)
procedures for each step of the reprocessing cycle;
(c)
description of the responsibilities, of the personnel involved in reprocessing (tasks, qualification, training and continuous training), and description of the premises;
(d)
establishment and maintenance of the technical documentation referred to in Article 9;
(e)
control of documents and communications concerning the reprocessing activities;
(f)
control of records concerning the reprocessing activities;
(g)
reporting of incidents and management of corrective and preventive actions and verification of their effectiveness;
(h)
risk management;
(i)
traceability system, including procedures for disposing or returning to the external reprocessor reprocessed single-use devices that do not belong to the health institution;
(j)
internal and external audits;
(k)
contract conditions with external entities participating in the reprocessing activities.
Annual audit
1. Reprocessors shall undertake at least one annual independent external audit of the reprocessing activities. The audit report shall be made available to the notified body competent for the certification of the reprocessor pursuant to Article 17(5) of Regulation (EU) 2017/745 and, upon request, to the competent authority of the Member State where the reprocessor is established.
2. The reprocessing processes and the QMS shall be revised, as needed, on the basis of the results of the independent external audit.
3. The audit report and the documentation related to the eventual follow up actions shall be kept for a period of five years.
Reporting of incidents
1. Health institutions using reprocessed single-use devices shall report all serious incidents involving reprocessed single-use devices, to the relevant competent authority. Those incidents shall be reported by the deadlines set in Article 87 of Regulation (EU) 2017/745.
2. The serious incident report shall contain the following information:
(a)
confirmation that the single-use device is reprocessed and by which entity;
(b)
specify the number of reprocessing cycles performed and the maximum number of reprocessing cycles allowed for the device concerned;
(c)
the description of the serious incident, including a description of the failure mode, description of how the devices was being used and the point in the procedure when the failure occurred, as well as the outcome for the patient;
(d)
include an analysis of the possible root causes for the serious incident, indicating any of the following:
—
the root cause is linked to the single-use device original design and manufacturing;
—
the root cause is linked to the reprocessing;
—
the root cause could not be clearly established;
(e)
include information regarding preventive and corrective measures to be implemented in the reprocessing process and the timeline to implement these measures or provide reasons as to why measures are not needed.
3. When the health institution sends the report referred to in paragraph 1 of this Article to the competent authority, the health institution shall send a copy of that report also to the manufacturer and, when applicable, the external reprocessor. Following receipt of the copy of the report, the manufacturer shall take any of the actions listed in Article 83(3) of Regulation (EU) 2017/745, where necessary.
4. Reprocessed single-use devices involved in a serious incident shall be set apart and shall not be used further. The health institution shall keep such single-use devices for five years and make it available to the competent authority upon request, unless otherwise instructed by the competent authority.
5. During investigation of the serious incident, devices of the same type subject to the same reprocessing cycle shall be set apart. If the investigation of the serious incident has shown reprocessing as the possible root cause for the serious incident, these reprocessed devices shall be disposed of.
6. The health institution shall request its staff and, where appropriate, invite its patients to report to a contact person within the health institution any serious incident involving reprocessed single-use devices.
7. The external reprocessor shall report to the health institution any failure occurring during reprocessing that could indicate that the reprocessing cycle is no longer adequate or that the safety and performance of single-use devices already released for use cannot be guaranteed anymore. If failure occurs, adequate corrective and preventive measures shall be taken immediately. The health institution shall inform the competent authority accordingly and the public list referred to in Article 4(7) shall be updated.
8. The health institution shall register and compile information about all incidents involving reprocessed devices and shall perform, at least annually, a critical analysis of those incidents. The critical analysis of all incidents, including the analysis of the trends of incidents, shall be transmitted to the manufacturer and, if applicable, to the external reprocessor. Upon request, the critical analysis of all incidents, including the analysis of the trends of incidents shall be transmitted to the relevant competent authority. The analysis shall be used by the health institution, and if applicable, by the external reprocessor, to improve the reprocessing cycle, to review and update the technical documentation and/or to decide to discontinue reprocessing certain types of single-use devices.
