WHAT ABOUT TPPT?
Criteria Applicable to Third-Party Organised Procedure Trainings (TPPT)
Background
Chapter 2 of the MedTech Europe Code of Ethical Business Practice provides that Member Companies may support Third Party Organised Procedure Trainings either:
- via Educational Grants (in accordance with Chapter 4: Charitable Donations and Grants);
OR
- by providing financial support directly to individual Healthcare Professionals to cover the cost of attendance at Third Party Organised Procedure Training sessions.
Third-Party Organised Procedure Trainings qualify a type of Third-Party Organised Educational Events that are primarily intended to provide Healthcare Professionals with information and training on the safe and effective performance of one or more clinical procedures, in circumstances where the information and training concern:
- Specific therapeutic, diagnostic or rehabilitative procedures, namely clinical courses of action, methods or techniques (rather than the use of medical technologies); and
- Practical demonstrations and/or training for HCPs, where the majority of the training programme is delivered in a clinical environment.
As recommended by the MedTech Europe Code Committee, this exception is to be narrowly interpreted.
Cross-border and international Third-Party Organised Procedural Trainings must be submitted to the Conference Vetting System (CVS).
As from January 1st 2024, sponsoring members will need to ensure that the event complies with the requirements of a TPPT. The CVS assessment will no longer verify that the scientific programme follows the requirements of the TPPT. The assessment will focus on the CVS criteria, including the appropriate venue for TPPT (typically in a clinical environment or in places suitable for (or set up to) simulating medical procedures).
For avoidance of doubt, as provided in the MedTech Europe Code (Q&A 21) : Proctorships and Preceptorships taking place on Healthcare Organisations premises are not considered to be a Third-Party Organised Procedural Training or a Third-Party Organised Educational Event.
Checklist to qualify as TPPT
Programme: Unlike Third-Party Organised Educational Events, which are theoretical in nature, practical, hands-on activities comprise the majority of the programme of TPPT. Such trainings are often referred to as “courses”, rather than conferences or seminars. Examples may include courses aimed at acquiring or improving Healthcare Professionals’ skills in minimally invasive surgery; orthopaedic trauma surgery; or implantation of cardiac rhythm devices; etc.
The TPPT programme must be focused on acquiring specific medical skills relevant to certain medical procedures as opposed to products, or medical technologies. The programme must include practical sessions.
In order to be considered a TPPT, the practical sessions must in all cases represent more than 50% of the full programme and hands-on sessions must represent at least one-third of the full programme. These requirements must be clearly indicated in the TPPT programme.
The member companies, which are planning to support TPPT by providing financial support directly to individual Healthcare Professionals to cover the cost of attendance at Third Party Organised Procedure Training sessions, are required to ensure if fulfils this requirement of practical and hands-on sessions.
Will be considered practical sessions:
- Hands-on sessions in which all attendees to the TPPT participate actively: in these sessions attendees perform specific procedures on settings and environments appropriate for the practice of the relevant procedure. Examples of hands-on may include surgery simulations where the technologies relevant to the specialty are practiced on cadavers; skin models; synthetic bones; cath labs; etc.
To ensure participants can fully benefit from the active aspects of the hands-on sessions, no “station” (model, cadaver, table, etc.) should in principle gather more than four participants. For ethical considerations, whenever human cadavers are used, a “station” may be shared by up to eight participants.
- Streaming (e.g. video, 3D-rendering software, augmented reality) or demonstrations of live surgeries followed immediately by participation of attendees in related hands-on sessions. Such demonstrations would only qualify as practical sessions if they are followed by hands-on sessions, because they do not normally require active participation of the attendees.
Whenever the practical part of the TPPT programme entirely consists in participants merely watching a live surgery or the streaming of a surgery, it is not sufficient to qualify the course as a TPPT – due to the lack of active participation and hands-on sessions.
- Case study sessions where the trainees learn about procedure preparation, the tips and tricks, and complications handling of the procedure from specialty experts. Those sessions must be interactive and based on pictures, videos, animations, 3D rending software, augmented reality, etc.
Venue: The hands-on sessions for TPPT are typically organised in either a clinical environment or in places suitable for (or set up to) simulating medical procedures. This criterion will be assessed by the CVS team.
Examples of a clinical environment may include: hospitals or clinics, where medical treatment on patients may be delivered (Operating Room, Cath. Lab).
Examples of simulation settings may include conference or meeting rooms that are equipped with relevant simulation devices/systems or experimental laboratories suitable for training on cadavers, skin models, synthetic bones, live animals in accordance to applicable regulations and ethical rules, etc.
Stand-alone event: Third-Party Organised Procedure Trainings must be stand-alone. In case the majority of the training is not delivered in a clinical environment, or if the training is organised in connection, adjacent to, or at the same time as, a larger Third-Party Organised Educational Conference, that training will not qualify as a Third-Party Organised Procedure Training as defined in the MedTech Europe Code. Member companies which are planning to support TPPT must ensure this requirement is fulfilled.
Size: Given the essential practical and hands-on element of a TPPT, and given that the importance of the exception resides in the fact that Member Companies are informed about the identity of the HCPs participating in the course, the size of such trainings is usually relatively small. However, provided that the above criteria are met, size may not be a determining factor. Member companies which are planning to support TPPT must ensure this requirement is fulfilled.