Standards on commissioning and manufacturing dental appliances

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Standards on commissioning and manufacturing dental appliances

  1. 1. GDC Consultation Standards on commissioning and manufacturing dental appliances Deadline for response is 5.00pm on Friday 15 August 2008 Please reply to: Stephanie Lenn Dental Appliances Consultation General Dental Council 2nd Floor, 44 Baker St London W1U 7BE Email: daconsultation@gdc-uk.org General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  2. 2. Introduction The General Dental Council (GDC) is the organisation which regulates dental professionals in the United Kingdom. As part of this role, we: • register qualified professionals; • set standards of dental practice and conduct; • assure the quality of dental education; • ensure professionals keep up-to-date; • help patients with complaints about a dental professional; • are working to strengthen patient protection. The statutory registration of all dental professionals is a fundamental development in the regulation of dentistry in the UK. From the end of July this year, all dental technicians must be registered with the GDC, as the transitional period will be completed. Clinical Dental Technicians (CDTs) have been required to be registered with the GDC since July 2006. All GDC registrants involved in prescribing, manufacturing and fitting dental appliances have a role to play in protecting patients from harm and in providing a safe and effective standard of care. The purpose of these Standards is to ensure that dentists, dental technicians and CDTs understand and are responsible for the decisions they make in commissioning or manufacturing dental appliances. The accountability principle The draft standards are based on the idea that every time a dental appliance is supplied or fitted to a dental patient in the United Kingdom, a GDC registered professional (a dentist, CDT or dental technician) is accountable to the public (through the GDC’s regulatory procedures) for the safety and quality of the appliance, wherever in the world the appliance was actually manufactured. Our draft standards spell out the responsibilities registrants take on when commissioning work from a registered dental technician or registered CDT in the UK and the extra responsibilities they carry if they choose to commission work from overseas. By choosing to use a registered dental technician or registered CDT in the UK, dentists do not need to check that the manufacturing process is in order – the UK registered dental technician or CDT is directly accountable as a GDC registrant. Our draft standards also cover dental technicians who choose to sub-contract to 2 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  3. 3. overseas laboratories – the UK registered technician should be responsible to the GDC for the safety and quality of the appliance. The Medicines and Healthcare Regulatory Agency (MHRA) is responsible for regulating dental appliances in the UK. All dental laboratories are required to be registered with the MHRA by law. Equivalent regulators exist in the European Union. Our draft standards supplement the requirements of the MHRA and are intended to ensure that there are no gaps in patient protection in relation to the commissioning and manufacturing of dental appliances either in the UK or overseas. We are keen to hear from dentists, CDTs, dental technicians and other GDC registrants, as well as professional associations, patients and patient groups who could all be affected by these Standards. 3 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  4. 4. The consultation We would be very grateful for your responses to our questions list on page 11. If you need more space please continue on a separate sheet. Please note that all responses will be considered to be public unless you state that you wish your response to be kept confidential. This document is also available in the consultation section of our website at www.gdc-uk.org You can respond by email to daconsultation@gdc-uk.org or by post. If you use post, please send your response to: Stephanie Lenn Standards Policy Officer General Dental Council 2nd Floor 44 Baker Street London W1U 7BE This consultation will close at 5:00 p.m. on Friday 15 August 2008. We cannot guarantee that any responses received after this date will be considered. If you require further information in relation to the consultation, please contact Stephanie Lenn on the above email address. For any complaints about the way the consultation exercise has been carried out please contact our Stakeholder Relations Manager on 020 7009 2796. 4 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  5. 5. STANDARDS ON COMMISSIONING AND MANUFACTURING DENTAL APPLIANCES Issued by the General Dental Council under Sections 26B and 36M of the Dentists Act 1984. All GDC registrants involved in prescribing, manufacturing and fitting dental appliances have a role to play in protecting patients from harm and in providing a safe and effective standard of care. This document describes the standards of practice which dentists, clinical dental technicians and dental technicians must meet in order to protect patients. These standards complement the overriding principles set out in Standards for Dental Professionals. Registrants who make dental appliances If you make a dental appliance, you must understand and comply with your legal responsibilities as “manufacturer” under the Medical Devices Directive. These are legal requirements rather than GDC rules and the GDC expects you to fulfil these responsibilities and will hold you accountable for doing so. The Medical Devices Directive requirements include, amongst other items: 1. registration of the manufacturer with the Medicines and Healthcare Products Regulatory Agency (MHRA) 1 2. use of CE2 marked materials 3. defined manufacturing process 4. calibration and maintenance of equipment 5. cleanliness and infection control 6. packaging and labelling. Registrants who arrange for dental appliances to be made by a GDC-registered dental technician If you prescribe a dental appliance to be made by a GDC-registered dental technician, you are professionally responsible for • the prescription you issue (clarity, accuracy, appropriateness) • issuing the prescription only to a UK-registered dental technician • checking that the “manufacturer” (which may be an individual technician or a company) is registered with the Medicines and Healthcare Products Regulatory 1 Previously known as the Medical Devices Agency. 2 A CE marking signifies that the item meets all the essential requirements of the relevant European Directive(s). 5 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  6. 6. Agency • receiving the appliance only from a registered dental technician • checking that the registered dental technician from whom you receive the appliance has issued an appropriate declaration that the appliance has been manufactured in accordance with the Medical Devices Directive requirements (a “declaration, or certificate, of conformity”). Because you are receiving the appliance from a registered dental technician who is personally accountable to the GDC for the manufacture of the appliance, you are entitled to rely on the certificate – we do not expect you to verify yourself that the manufacturing process has been in order. Registrants who arrange for dental appliances to be made in the UK by an unregistered dental technician If [after 31 July 2008] you prescribe a dental appliance to be made by a person in the UK who is not a registered dental technician you are liable to face a GDC fitness to practise inquiry. Equally, you are liable to face a GDC fitness to practise inquiry if you receive a dental appliance made in the UK by a person who is not a registered dental technician. The registration of dental technicians ensures that UK dental technicians • have extensive professional experience and/or an appropriate professional qualification • work to GDC standards of practice, conduct and competence • are accountable for their work and professional standards. [After 31 July 2008] procuring a dental appliance from an unregistered person in the UK is wholly unacceptable in professional standards terms, given that dental technicians are now registered and regulated. Dentist and clinical dental technician registrants who prescribe a dental appliance to be made3 outside the UK in a dental laboratory in the European Union When making the decision to use a dental laboratory or agent which sources dental appliances from the EU, outside the UK, your choice not to use a UK-registered dental 3 Either wholly or partially 6 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  7. 7. technician puts a particular responsibility on you. You will be held professionally accountable for the safety and quality of the appliance, on the basis that it is your choice not to issue the prescription to a registered dental technician who would otherwise be accountable him or herself. You take on the dental technician’s responsibilities and the GDC will hold you accountable for your decision. Further we expect you to have taken appropriate steps to discharge the extra responsibilities you choose to accept when you make this decision. The GDC considers that you have a positive obligation to demonstrate that you have discharged these additional responsibilities: • Ensure that the manufacturer is registered with the appropriate regulatory body equivalent to the Medicines and Healthcare Products Regulatory Agency. • Take appropriate reasonable steps to check that the person who manufactures the dental appliance is suitably qualified. • Ensure that you receive the necessary statement of conformity from the manufacturer confirming that the appliance has been manufactured in accordance with the minimum requirements of the Medical Devices Directive. • Before issuing the prescription, and again before fitting the appliance in a patient’s mouth, explain to the patient the choice you have made about where to have the appliance made, the extra responsibilities you have undertaken as a result, and the steps you have taken to discharge these responsibilities. This is an important part of the process of enabling the patient to make an informed choice and to give consent to the manufacture and fitting of the appliance. Give the patient a copy of the statement of conformity confirming that the appliance has been manufactured in accordance with the minimum requirements of the Medical Devices Directive. Dentist and clinical dental technician registrants who prescribe a dental appliance to be made outside the European Union When making the decision to use a dental laboratory or agent which sources dental appliances from outside of the EU, your choice not to use a UK-registered dental technician puts a particular responsibility on you. You will be held professionally accountable for the safety and quality of the appliance, on the basis that it is your choice not to issue the prescription to a registered dental technician who would otherwise be accountable him or herself. You take on the dental technician’s responsibilities and the GDC will hold you accountable for your decision. Further we expect you to have taken appropriate steps to discharge the extra responsibilities you choose to accept when you make this decision. 7 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  8. 8. The GDC considers that you have a positive obligation to demonstrate that you have discharged these additional responsibilities: • Ensure that all the materials used in the manufacturing of the dental appliance are CE marked and meet the minimum materials standards set out in the Medical Devices Directive. • Take appropriate reasonable steps to check that the person who manufactures the dental appliance is suitably qualified. • Ensure that you receive the necessary statement of conformity from the manufacturer’s authorised representative (who must be registered with the Medicines and Healthcare Products Regulatory Agency, or the equivalent regulatory authority in another EU state) confirming that the appliance has been manufactured in accordance with the minimum requirements of the Medical Devices Directive. • Before issuing the prescription, and again before fitting the appliance in a patient’s mouth, explain to the patient the choice you have made about where to have the appliance made, the extra responsibilities you have undertaken as a result, and the steps you have taken to discharge these responsibilities. This is an important part of the process of enabling the patient to make an informed choice and to give consent to the manufacture and fitting of the appliance. Give the patient a copy of the statement of conformity confirming that the appliance has been manufactured in accordance with the minimum requirements of the Medical Devices Directive. Dental technician registrants who sub-contract the manufacture of a dental appliance to a laboratory outside the European Union When making the decision to sub-contract the manufacture of a dental appliance to a laboratory or agent which sources dental appliances from outside of the EU, your choice to sub-contract to a non-registered dental technician puts a particular responsibility on you. You will be held professionally accountable for the safety and quality of the appliance, on the basis that it is your choice to sub-contract the work in this way. You take on the dental technician’s responsibilities and the GDC will hold you accountable for your decision. Further we expect you to have taken appropriate steps to discharge the extra responsibilities you choose to accept when you make this decision. The GDC considers that you have a positive obligation to demonstrate that you have discharged these additional responsibilities: • Ensure that all the materials used in the manufacturing of the dental appliance are CE marked and meet the minimum materials standards set out in the Medical Devices Directive. 8 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  9. 9. • Ensure that the person who manufactures the dental appliance is suitably qualified. In the absence of GDC registration, you must make sure you are satisfied that the manufacturer has the requisite knowledge and skill. • Ensure that you receive, and forward to the prescribing dentist or clinical dental technician, the necessary statement of conformity from the manufacturer’s authorised representative (who must be registered with the Medicines and Healthcare Products Regulatory Agency, or the equivalent regulatory authority in another EU state) confirming that the appliance has been manufactured in accordance with the minimum requirements of the Medical Devices Directive. • Before sub-contracting, and again before delivering the appliance to the prescriber, explain to them the choice you have made about where to have the appliance made, the extra responsibilities you have undertaken as a result, and the steps you have taken to discharge these responsibilities. This is an important part of the process of enabling the prescriber to give the patient the information they need to make an informed choice and to give consent to the manufacture and fitting of the appliance. Give the prescriber the statement of conformity confirming that the appliance has been manufactured in accordance with the minimum requirements of the Medical Devices Directive. Consultation Questions Who are you? Name: Address: Email: Do you want to receive the Summary Consultation Report? Yes No 9 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  10. 10. To help us to understand the context of your response, please indicate the perspective from which you are replying (please tick the box which applies to you below) Dental Professional: Clinical Dental Technician Dental Hygienist Dental Nurse Dental Technician Dental Therapist General Dental Practitioner Orthodontic Therapist Specialist Registered in more than one group (Please specify)……………………… Organisations On behalf of an organisation (Please specify)……………………… On behalf of an education provider (Please specify)……………………… On behalf of a regulatory body (Please specify)……………………… On behalf of a professional association (Please specify)……………………… Public and patients: Individual member of the public (Please specify)……………………… Representative of an organisation Other (Please specify)……………………… 1. Having read the Standards, do you agree that these Standards fill a gap in patient protection in relation to the commissioning and manufacturing of dental appliances? Yes No If no, why not? 10 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  11. 11. 2. Do you think that the Standards cover every area required to ensure patient protection in relation to the commissioning and/or manufacturing of dental appliances by dentists, CDTs and dental technicians? Yes No If no, what would you add? 3. Are there any practicalities regarding the implementation of the Standards that you feel that the GDC should consider prior to implementing them? Yes No If yes, what does the GDC need to consider to ensure that the Standards can be implemented practically? What we will do with your consultation response When you send your response we will provide you with an initial acknowledgement. Once the consultation has closed we will collate all the consultation responses we have received by the deadline and staff in the Standards team at the GDC will carry out a consultation analysis and produce a report for our Standards Committee and Council to consider. Please note that: • we cannot guarantee that consultation responses received after the stated 11 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org
  12. 12. deadline will be considered. • we do not put single responses (whether sent on behalf of organisations or individuals) before the Standards Committee or before Council on request, whether or not they are addressed to the Committee, its individual members, or members of Council, so please do not ask us to. It is important that, as a public body, our consultation process is transparent and fair to all our stakeholders, and so we will reflect the whole range of comments made in the responses we receive in the consultation report itself. • a consultation process is not a ‘vote’. We make decisions based on public protection, and not a simple count of the number of views expressed for or against a particular approach, although we will take that into consideration. On 3 September 2008 the Council will consider the recommendations from the consultation, and make a decision on what action to take. We will provide feedback to everyone who responded to the consultation on the Council’s decision and how the consultation influenced policy development. We will provide a consultation summary report to everyone who has requested it once our Council has considered and agreed the final Standards. It will also be published on the GDC website. The Standards will be approved by the Plain English Campaign and then published for all registrants. 12 General Dental Council 37 Wimpole Street London W1G 8DQ Tel: 020 7887 3800 Fax: 020 7224 3294 Minicom: 18001 020 7887 3800 (via TypeTalk) Email: information@gdc-uk.org

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