IADR Abstract Archives
Investigating Dental Student / Laboratory Compliance With the Medical Devices Directive
Objectives: In the EU, the Medical Devices Directive (MEDDEV) mandates that patients receive statements containing essential information and a unique identifier for all medical devices. This applies to dental removable prostheses which are classified as long-term, non-active, invasive medical devices based on MEDDEV-2.4/1.
Dental laboratories should supply a ‘patient statement’ upon completion of the denture containing information regarding location of construction, a list of device(s) supplied to the patient (e.g. special trays, bite blocks, completed dentures) and their respective product codes. To ensure compliance, all patients should receive a statement.
The objectives of this study are to assess:
1) Student compliance in documenting provision of the statement
2) Whether the laboratories provide a fit for purpose statement.
Methods: Institutional approval (KCL) was granted to investigate MEDDEV compliance on the undergraduate clinic. A random day was chosen to collate all notes from the electronic patient records (Salud). Only notes where a prosthesis had been fitted and authorised by a staff member were included (n=68). Binary scoring was used as to whether or not the notes had included evidence of the patient statement being handed to the patient/escort. The laboratory statements were also reviewed to ensure that all MEDDEV requirements were fulfilled.
Results: Expected compliance rate is 100%. However, only 5.88% of students recorded that statements were handed to patients. The percentage compliant by year group was Year-3 (9.09%), Year-4 (5.17%) and Year-5 (0.00%).
None of the laboratories provided a fully compliant statement.
Conclusions: The majority of students are not complying with the MEDDEV guidelines and the laboratories are not providing a fit for purpose statement. This study has identified an educational need for EU/UK Dental Schools to ensure students, staff and laboratories understand the importance and role of the patient statement in enhancing transparency and safety in the provision of dental prostheses.
Dental laboratories should supply a ‘patient statement’ upon completion of the denture containing information regarding location of construction, a list of device(s) supplied to the patient (e.g. special trays, bite blocks, completed dentures) and their respective product codes. To ensure compliance, all patients should receive a statement.
The objectives of this study are to assess:
1) Student compliance in documenting provision of the statement
2) Whether the laboratories provide a fit for purpose statement.
Methods: Institutional approval (KCL) was granted to investigate MEDDEV compliance on the undergraduate clinic. A random day was chosen to collate all notes from the electronic patient records (Salud). Only notes where a prosthesis had been fitted and authorised by a staff member were included (n=68). Binary scoring was used as to whether or not the notes had included evidence of the patient statement being handed to the patient/escort. The laboratory statements were also reviewed to ensure that all MEDDEV requirements were fulfilled.
Results: Expected compliance rate is 100%. However, only 5.88% of students recorded that statements were handed to patients. The percentage compliant by year group was Year-3 (9.09%), Year-4 (5.17%) and Year-5 (0.00%).
None of the laboratories provided a fully compliant statement.
Conclusions: The majority of students are not complying with the MEDDEV guidelines and the laboratories are not providing a fit for purpose statement. This study has identified an educational need for EU/UK Dental Schools to ensure students, staff and laboratories understand the importance and role of the patient statement in enhancing transparency and safety in the provision of dental prostheses.