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Joint Market Surveillance Actions on medical devices intended to be re-sterilized focusing on information in the Instruction for use and validation data necessary for the re-sterilisation by the user [COENJA2014] [676988] - Joint Actions
Project abstract

Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropriate checks on the characteristics of products placed in the European Market. This joint action (JA) includes further development and expanding the coordination between MS, joint inspections by the Competent Authorities (CAs) shall be part of the project.
This Joint Action of European CAs will improve the transparency in the medical device market regarding compliance of medical devices to be reprocessed. It shall be investigated if the instruction for use (IFU) of medical devices intended to be re-used and resterilized conforms and contains all necessary information for safe and adequate re-processing. This will also allow an actual overview of the market related to these products and detecting deficiencies regarding re-processing posing a serious hazard to safety.
The market surveillance JA also contains additional elements, besides review of the IFU and sections of the technical documentation, such as inspections of manufacturers and other relevant actors. The outcome may also result in joint enforcement actions by the respective MS to be coordinated if needed and adequate. Meetings shall support harmonizing the processes to achieve a uniform action and to discuss and publish the final report.

Summary of context, overal objectives, strategic, relevance and contribution of the action

Preliminary market surveillance activities of European Competent Authorities for medical devices on a national level have uncovered a lack of conformity and safety of re-processable medical devices placed on the European market. This ranges from highly insufficient information for the user to information for the user, reprocessing data which are not suitable for European and local standards, and reprocessing instructions for the specific products which are not based on validated processes. This also became evident during on-site visits and reports from hospitals where the instructions for use (IFU) of medical devices intended to be re-processed often did not show the required information necessary for safe and adequate cleaning, disinfection and re-sterilisation (re-processing).

It is evident that proper implementation of cleaning, disinfection and sterilization is essential for ensuring that medical and surgical instruments do not transmit infectious pathogens from patients and users to other patients (cross-infection). The CDC Guideline for Disinfection and Sterilization in Healthcare Facilities from 2008 summarized from multiple studies in many countries that a lack of compliance with established guidelines for disinfection and sterilization has led to numerous outbreaks of infectious diseases. These incidences show the importance of correct implementation of the re-processing procedures at the user's site according to the information given by the manufacturers of the devices.
Current published data reveal that approx. 4 million hospitalised patients in Europe are affected by healthcare associated infections (HAI) per year and approximately 37 000 of them die as the direct result of the infection. According to the Surveillance Report of the European Centre for Disease Prevention and Control the most frequent HAI types are urinary tract infections, pneumonia, surgical site infections, bloodstream infections and gastrointestinal infections – where the surgical site infections are the second most frequent healthcare-associated infection in European hospitals. There is a high risk of potential underreporting of incidents which also may be associated to poor re-processing instructions.

Another important justification for carrying out this project was to organise joint inspections to check at the site of the manufacturer whether the re-processing validation data fulfil the legal requirements.

Therefore two major goals were to be achieved by this project:
1) To evaluate the fulfilment of the legal requirement by manufacturers / authorised representatives (who are acting with regard to the manufacturer’s obligation under the Medical Devices Directive) in the field of re-processable medical devices regarding:
- Medical Device Directive 93/42/EEC Annex I, 13
- Compliance with harmonised standards EN 17664 & EN 14937
- Taking European and national standards and parameters for reprocessing and sterilizing into consideration
2) To improve, harmonize and intensify joint market surveillance activities between Member States.

Methods and means

According to the Medical device directive "Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer." In order to evaluate the fulfilment of this specific subset of the legal requirement by manufacturers and authorised representatives in the field of re-processable medical devices, the task was divided into following parts:

2.1. Identification of appropriate reusable medical devices
Due to the broad field of re-processable medical devices, criteria had to be specified to select the appropriate device types and to be able to evaluate the status in the market. To ensure the practical perspective is included the following representative Health Care professionals were asked for input by the Portuguese Competent Authority: Association of Gastroenterology and Endoscopy Nurses (APEEGAST), the Operating Room Nurses Association (AESOP) and the Sterilization Association (ANES).
Based on the outcome of the consultation of the above mentioned Health Care professionals and the input from the project partners suitable selection criteria and medical device types were defined.

Defined selection criteria:
a) Most often found devices in the hospital units - widely used
b) Intended to be invasive and/or for surgical use – commonly used in surgical procedures in different fields (e.g. cardiology, thoracic, orthopaedic, neurology, gastroenterology)
c) Challenging in cleaning, disinfecting or sterilising due to the structure of the device – e.g. surface, geometry or medical device composition
d) Steam sterilisable – because steam sterilisation is the most commonly used sterilisation process in the hospital

2.2. Identification of the corresponding economic operators (manufacturer, authorised representative, distributor) - Having defined the appropriate re-processable medical device types based on the above mentioned selection criteria, the related economic operators were identified. The search was limited to economic operators based in the territory of the participating member states (AT, BE, HR, IT, NO, IE, HU, SE, ES, PT, SK, UK) and some collaborating Member States (DE, NL and CH). It has to be noted that presently there is no centralized and complete database where all manufacturers placing products on the common market are listed. So this search had to be done on national databases in cooperation between all participating member states, and the results had to be pooled and aligned.

2.3. Tool to receive information from the market (checklist 1) - To get the necessary information from the economic operators for investigating if the instruction for use contains all required information necessary for safe re-processing, a questionnaire (in the following: “checklist 1”) and a cover letter were developed. Checklist 1 is based on the harmonized European standard EN ISO 17664. The checklist consists of 59 questions addressing the information considered necessary for safe re-processing.

2.4. Assessing the compliance of the manufacturers’ re-processing instructions by the participating member states - The basis of a valid assessment performed by all twelve participants requires a harmonised approach. The participating Member States harmonised their knowledge in a multi-day training course about re-processing, organised for this project. To ensure a harmonised assessment regarding the compliance of the manufacturers’ re-processing instructions, open questions were collected and answered by all participants, using the team collaboration software, as well questions and their judgement were discussed and clarified during face to face meetings.

2.5. Overall analysis of the assessment results of the economic operators’ responses to achieve an European overview - For statistical analysis of the participants' assessment of the manufacturers’ responses the statistic program SAS 9.3 was used. For the compa

Work performed during the reporting period

- Kickoff-meeting with all particpants was held in Brussels on Nov.30th 2015.

Several meetings were held in order to align the respective member state work and to foster cooperation:

- alignment meeting with all participants
-- Generating Checklists and adapting to the specific need of this project, translation of the checklists into the national languages, drafting a common cover letter and translating it;
-- identify products to be investigated (market investigations and interviewing users)
-- identify manufacturers to be investigated (pooling of data from various memberstates)
- send out checklists

- training meeting: harmonise the necessary expertise related to re-processing of medical devices of all participants through organising a training course (including a training video)

- assess responses received from manufacturers
- harmonisation meeting: harmonise the assessment of the responses sent in by manufacturers (face2face harmonisation meetingwith all participants)

- statistical assessment of the assessment outcome
- generating reports, uploading/dissemination of the reports (e.g. CAMD, COEN-group, ADCO)
- final meeting for finalizing the reports and outcome

finally a lot of adminstrative work and coordination work had to be resolved

The main output achieved so far and their potential impact and use by target group (including benefits)

The participating member states market surveillance authorities achieved a better and sound picture of the actual status in the market. As the majority of reprocessable medical devices is currently classifed and placed on the market as class I devices, the level of pre-market surveillance is mostly not given. This includes the existence and technical and regulatory quality the IFUs. Most of them are currently incomplete, and mostly do not contain all relevant information necessary for safe and effective reprocessing. The assessment of the reprocessing instructions provided by the manufacturers show that the overall quality of this information is insufficient by a large margin regarding compliance to the MDD 93/42/EEC.
In general – when observed a significant difference between risk class I and other risk classes – the reprocessing instructions of risk class I devices tend to be less compliant. Notwithstanding these observations, this exercise also highlights an urgent need for significant improvements in the instructions for use of devices which have undergone assessment by a notified body.

The conformity assessment procedures (Art. 52(7))in the new legislation Medical Device Regulation (EU) 2017/745 (which is replacing the Medical Device Directive 93/42/EEC as from 26.05.2020) requires then the review of the validation and suitability of the reprocessing of such devices (review of manufacturer's obligation regarding product and process validation), which should improve the situation. This should be reviewed after the new framework is fully applied, to monitor the effectivity of the stronger requirement including certification procedures.

During the joint inspections it became evident that none of the inspected manufacturers/European authorised representatives could show reprocessing validation data being fully compliant to the legal requirements. It was also shown that the expertise as well as the awareness required for validating the process of pre-cleaning, cleaning, disinfecting and sterilizing is clearly lacking among manufacturers/authorised representatives. During the joint inspections and additional inspections on a national level it also became evident that many manufacturers rely on a relatively small number of 3rd party reprocessors, which may result in the propagation of non-state-of-the-art practices. Over-reliance on the expertise of the 3rd party could also account for lack of internal understanding on requirements relating to reprocessing.

Improvement of knowledge and expertise of Market Surveillance Authorities of all participating Member States has been achieved, as well the harmonisation of the procedures and interpretation has been supported.
Clear and better understanding on the needs and content of IFU to accompany medical devices has also been achieved.

Achieved outcomes compared to the expected outcomes

The Joint Action met all expectations and plans, all planned deliverables were achieved, no deviations and major discrepancies occured. One Member State, originally planning to participate had to be excluded for not being eligible, another one missed the registration deadline by one day and could not be signed in.

Dissemination and evaluation activities carried out so far and their major results

The project results were communicated on EU level on different Competent Authorities’ meetings (e.g. COEN, CAMD), on the project website and was communicated on national stakeholder meetings (e.g. Austrian Society for Sterile Supply (ÖGSV)).

Manufacturers are now becoming aware of the activities and started to improve, as the pressure to supply safer products increases as a result of additional inspections aside of the project in some member states.

Improvement of knowledge, expertise and harmonised understanding of Market Surveillance Authorities regarding reprocessing of all participating Member States has been achieved, an internally accessable link to a videa of the complete training will ensure that the knowledge will be expanded to authority members who were not present at the face2face training in June 2016.

Clear and better understanding on the needs and content of IFU accompanying reprocessable medical devices has been achieved (alignment and harmonisation meeting) - the manufacturers affected had to work with the checklist and therefore do a thorough review of their technical documentation and understanding of reprocessing inclduing the information to be stated in the IFU, as well the market surveillance authorities achieved a common understanding and interpreation of the legal requirements regarding reprocessing and resterilasation

As a result of the project a clear picture of the actual status in the market has been achieved, the data derived during the project underpinned the new requirement in the MDR Art.52, requiring the involvment of a Notified Body for the conformity assessment of reprocessable devices in all risk classes.
As well the results have been presented at meetings of Authorities on market surveillance. as well to national interest group for supply for sterile good and reprocessing

Parts of the Layman report shall be sent in the close future to hospitals and reprocessing units to generate additional awareness regarding the reprocessablity, the IFU and their processes