Week 15 Flashcards
What is the MHRA is responsible for
The MHRA is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
What is CE marking
The CE mark indicates that the product meets minimum legal requirements of the relevant directive (in our case the MDR). This allows the product to be placed legally on the market in any European member state.
Outsourcing extra responsibility
You will be held professionally accountable for the safety and quality of the appliance.
•You take on the dental technician’s responsibilities of ensuring the appliance meets the requirements of the MDR.
•The GDC will hold you accountable for your decision.
•This is because you have chosen not to sub-contract or issue the prescription to a GDC registered dental technician who would otherwise be personally accountable.
•You will also be responsible for ensuring that the statement of manufacture, or if outside of the EU the name and address of the manufacturer are disclosed to the prescriber and patient.
what are Audits and inspections
are quality assurance processes, and ensure standards for patient treatment and upheld. These official reviews may be done internally or by an external company or regulatory body.
what are the legal requirements under the MDR
Under the MDR it is a legal requirement that dentists who commission, and laboratories who manufacture dental appliances for use in the UK must comply with it and failure to do so is deemed a criminal offence
What do the management system do
shall be internally audited to verify that manufacturing process activities and system activities comply with planned arrangements.
The internal auditing system shall be documented
and records shall be maintained to verify that internal auditing has been carried out. As a minimum the system shall be audited internally once per year.
custom-made device’
means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.” (MDR)
What do the MDR states that the laboratory has a duty to:
Keep laboratory tickets for a minimum of 5 years
•Ensure all appliancesare supplied to patients with completed paperwork clearly informing ‘ of the statement and offer them a copy. You should record whether or not they choose to take a copy of it. If the patient does not choose to take a copy of the statement, you will need to keep the statement for the lifetime of the device in case it is requested at a later date. The patient can request this at any time during the lifetime of the appliance.
Records & Retention
This recommends 15 years as the minimum retention period for adult dental clinical records and that children’s records should be retained until the 25th birthday or 26th if the patient was 17 when treatment ended
What must you do when using social media
a) Maintain and protect patients’ information by not publishing any information which could
identify them on social media without their explicit consent; b) Maintain appropriate boundaries in the relationships you have with patients and other members
of the dental team;
c) Comply with any internet and social media policy set out by your employer.
Under the GDCs Scope of Practice what is a Dental Technician Defined as?
Dental technicians are registered dental professionals who make dental devices to a prescription from a dentist or clinical dental technician. They also repair dentures direct to members of the public.
As a dental technician, what 11 things could you undertake if you are trained, competent and indemnified?
review cases coming into the laboratory to decide how they should be progressed
• work with the dentist or clinical dental technician on treatment planning and outline design
• give appropriate patient advice
• design, plan and make a range of custom-made dental devices according to a prescription
• modify dental devices including dentures, orthodontic appliances, crowns and bridges according to a prescription
• carry out shade taking
• carry out infection prevention and control procedures to prevent physical, chemical and microbiological contamination in the laboratory
• keep full and accurate laboratory records
• verify and take responsibility for the quality and safety of devices leaving a laboratory
• make appropriate referrals to other healthcare professionals
• Dental technicians can see patients direct to repair dentures.
What 9 additional skills could dental technicians develop?
Working with a dentist in the clinic, assisting with treatment by helping to fit attachments at chairside.
Working with a dentist or a clinical dental technician in the clinic, assisting with treatment by:
• taking impressions
• recording facebows
• carrying out intra-oral and extra-oral tracing
• carrying out implant frame assessments
• recording occlusal registrations
• tracing cephalographs
• carrying out intra-oral scanning for CAD/CAM
• taking intra and extra-oral photographs.
Dental technicians do not work independently in the clinic to do what 5 things?
perform clinical procedures related to providing removable dental appliances
• carry out independent clinical examinations
• identify abnormal oral mucosa and related underlying structures
• fit removable appliances
• Dental technicians do not provide treatment for or give advice to patients in the ways that are described under the sections for dental hygienists, dental therapists, orthodontic therapists or dentists.
