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Student Compliance with the Medical Devices Directive

Research output: Chapter in Book/Report/Conference proceedingConference paper

Krishantini Mahendra, Barry Francis Arthur Quinn

Original languageEnglish
Title of host publication5th National Students' Research Day Yeditepe University Istanbul, Turkey
Place of PublicationIstanbul, Turkey
Publication statusPublished - Apr 2018

King's Authors


BACKGROUND: In an effort to strengthen transparency for consumers and address concerns about safety of materials, the European Commission has amended regulations on medical devices (MEDDEV) to ensure patients receive statements containing essential information and a unique identifier for all medical devices. These legislative changes apply to removable dentures (partial and complete), which are classified as long-term, non-active, invasive medical devices based on MEDDEV-2.4/1.

AIMS: Dental laboratories supply a ‘patient statement’ upon completion of final denture construction. This statement contains information regarding the laboratory at which the denture was constructed, a list of devices supplied to the patient (e.g. special trays, bite blocks, completed dentures) and their respective product codes. To ensure compliance with MEDDEV guidelines, all patient statements must be handed to the patient. The aim of this audit is to assess student compliance with guidelines on providing information about medical devices to patients.

METHODS: Institutional approval (King’s College London Dental Institute) was granted to conduct an audit. The Electronic Patient Records (SALUD), where removable prostheses had been provided by Dental Students (n=68), BDS Years 3-5, were randomly selected. Clinical notes documented during the final fit stage for the prosthesis were assessed for any mention of patient statement being handed to the patient/escort.

RESULTS: The mean across the entire cohort (n=68) was calculated. The expected compliance rate is 100% however, overall 5.88% of students recorded that patient statements were handed to patients. The highest percentage was noted among Year 3 students (9.09%), followed by Year 4 (5.17%) and Year 5 (0.00%).

CONCLUSION: At present, the majority of students are not recording that they are complying with the MEDDEV guidelines. Following identification of barriers to compliance, changes will be recommended and a re-audit is scheduled.

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