Medical devices Flashcards
Define medical device
Any instrument, apparatus, appliance, material or other article intended by the manufacturer to be used for human beings for the purpose fo:
- Diagnosis
- Prevention
- Monitoring and treatment
- Alleviation of or compensation for an injury of handicap
Ho does the medical devices directive affect us?
The European commission states: A custom-made dental device for thes ingle use os a patient remains subject to regulation of medical device for: 1. quality, 2 .traceability of materials 3. certification conformity
Does the medical devices directive only effect dentists?
No also dental technicians
Are all dental devices subject to the medical devices directive?
no
Give examples of devices not subject to the medical devices directive
- .Fillings
- Temp fillings an chair side amp crowns
- Splinting
- Mss produced devices which are adaptable
Describe the difference in the number of dentate adults in 1968 and 2009
in 1986 63% of the population was dentate
In 2009 94% of the population was dentate
How many adults were found to wear dentures in the 2009 dental health survey?
One in 5 (19%) were found to wear a denture
Out of al the dentate adults how many of then had artificial crowns in 2009?
37%
Out of al the dentate adults how many of then had a bridge in 2009?
7%
Out of al the dentate adults how many of then had a dental planar in 2009?
1%
What can dental nurses do in regards to prescription and manufacturing?
Can with additional training:
1. Pour, cast and trim study models
Can with additional training under the prescription of another registrant:
1. Construct special trays and occlusal record rims
2. Repair acrylic components of removable appliances
3. Construct mouth guards and bleaching trays
What can orthodontic therapists do in regards to prescription and manufacturing?
May under the prescrption of a dentist:
1. Insert passive removable orthodontic appliance
2. Insert removable appliances activated by the dentist
3. Remove fixed appliances, orthodontic adhesives and cements
4 Fit orthodontic headgear and faces aasjuste day a dentist
5 Identify select prepare and place auxiliaries, brackets, bands
6. Prepare inert adjust and remove arch wires previously activated by a dentist
What can dental hygienist do in regards to prescription and manufacturing?
- Re-cement a crown with a temporary cement
May with additional training under the prescription of a dentist: - Carry out tooth whitening
What can dental therapists do in regards to prescription and manufacturing?
Carry out the same duties as a hygienist and also lace pre form crowns on primary teeth
Who are the dental technicians
They are registered dental professional who make dental devices to a prescription from a dentist or clinical dental technician
What can dental technicians do in regards to prescription and manufacturing?
With additional training:
1. Help with the fit of attachments chaiside
With additional training work with the dentist to:
1. Take impressions
2. Record facebows
3. Conduct intra oral scanning
4. Take intra and extra oral photography
Who are the clinical dental technicians?
They are registered dental professionals who can prescribe and provide complete dentures direct to the public
What can clinical dental technicians do in regards to prescription and manufacturing?
Under the prescription of a dentist:
- Perform technicals and clinical procedures related to providing there removal dental appliances
- Provide and fit other removal appliances
- Provide sports mouth guards
Talk though how you would write a prescription for a fixed prothesis
Take a GREEN prescription
Ensure all the fields are completed
You must have the tutor sign the prescription
Talk though how you would write a prescription for a removable prothesis
Take a BLUE prescription
Ensure al fields are complete
You must have the tutors signature
As a prescriber what do you need to comply with?
- Medical deices drective2. Ensure patient is aware they can request the statement of manufacture
- Make statement available yo patient if requested
- Record whether they have accepted the statement
What should th statement of manufacture include?
1, Name and addressor manufacture
- Data allowing identification of the device
- A statement saying it is a custom made dental appliance
- Name of practitioner who prescribed the appliance and name of practice
- Specific characteristics of the production
