Annex B
Dental appliances consultation analysis table

Key:
C – CDT                                    DO – defence organi...
Question 1:   Having        191     151     40     Yes
              read the      (99%)   3xC     2xC
              Stand...
- Impossible to guarantee quality of the appliance. A dental surgeon using a non UK
technician cannot know the quality of ...
believing the dentist makes the dental appliances. If standards are to work with all parties
responsible for work the labo...
Question 2:   Do you        188     125     63     If no, what would you add?
              think that    (98%)   2xC     ...
Qualification / Registration

- Indication of what a suitably qualified dental technician, in a non – UK context, is neede...
the source of the dental appliance offered to them. x 4 (2T, 2EO)

- Patients should know where appliance is made. x 1 (1T...
x 1 (1T)

- All labs should have a quality system in place. x 1 (1T)

- If the dentist cannot design the prosthesis he sho...
Respondents   Question 3                                         Yes                                            No
       ...
- Whilst I agree that these standards are necessary & “tick all the boxes” they mean nothing unless they are actively poli...
Footnote 2 on p5 is incorrect. "CE marking ...all the Essential Requirements of the MDD". It should say that CE marking re...
were to be manufactured and whether formal consent should be obtained. x 1 (1PA)

Concerns re. specific appliances

- Ther...
- Would like to know what protection the Technician gets from this. Very concerned that as it stands technicians are at th...
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Dental appliances consultation analysis table.doc

  1. 1. Annex B Dental appliances consultation analysis table Key: C – CDT DO – defence organisation D – Dentist EO – educational organisation H - Hygienist HO – Health/social care organisation N- Nurse RB – Regulatory body OT – Orthodontic therapist PA – Professional association S - Specialist OO – other organisation T – Technician P – member of public/patient Th- Therapist PG – Patient Group Th* = Hygienist & Therapist (duly Z - other qualified) Question Respondent Yes No Comment Respondent 192 types 5xC 5xD 6xS 159xT 4xEO 3xHO 7xPA 1xOO 2xZ (100%) Page 7
  2. 2. Question 1: Having 191 151 40 Yes read the (99%) 3xC 2xC Standards 5xD 34xT - Document provides a very sound start to this extremely important area of guidance on , do you 6xS 1xEO the commissioning and manufacturing of dental appliances. x 1 (T) agree that 124xT 1xPA these 3xEO 2xZ - It is much needed so that registrants can be in no doubt as to why they should use a Standards 3xHO GDC registered dental technician and ensuring transparency of who is competent to fill a gap 6xPA manufacture dental devices/appliances x 1 (T) in patient 1xOO protection - The first section on contracting with a GDC registered dental technician is very clear and in relation sets out the benefits for the prescribing registrants in choosing to use a GDC registered to the dental technician to carry out the manufacture of dental appliances for their patients. x 1 commissi (PA) oning and manufact - We agree in principle. There is a danger that these standards could restrict the standard uring of of care provided by practitioners. In this rapidly changing global world orthodontic dental appliances or crown/bridges may or may not fit the standards and practitioners may have appliance difficulty in making judgments as to their responsibilities. x 1 (T) s? - Important to stress to practitioners that a high quality supplier should be able to provide evidence that their product is satisfactory. We are also aware that there are international standards that apply to Dental Appliances and these should be applied to those used in the UK. x 1 (PA) ------------------------------------------------------------------------------------------------------------------------ If no, why? Concerns about work from outside of the EU - Does not protect patients from Dental Professionals using dental appliances manufactured outside the EU. Inadequate monitoring, the GDC should suggest a third party audit for non EU dental appliances to ensure they comply with MDD regulations. x 1 (T) - Standard of materials used outside the EU, lack of manufacturing control and requirements to comply with national government standards. x 7 (5T, 1C, 1D) Page 8
  3. 3. - Impossible to guarantee quality of the appliance. A dental surgeon using a non UK technician cannot know the quality of the product. x 2 (1T, 1D) - Unless dental labs outside the EU are regulated and monitored as labs in the EU are the risk to patients will remain high and create an unfair playing field. x 6 (6T) - Not possible for a DCP to take responsibility for items constructed outside the EU. They cannot be responsible for something beyond their control so should not be allowed to fit these appliances. x 1 (1Z) - Inability to trace or guarantee work from labs outside the EU. If GDC do not take steps to ensure patient protection in this area, it will be a major failing on their part. x 1 (1T) Concerns about work from outside of the UK - To ensure patient protection manufacture and construction of any dental appliance must be completed within the UK by a GDC registered dental technician and not get sent abroad. Otherwise the standards will never be employed and/or policed. x 9 (8T, 1C) No gap in patient protection in relation to the commissioning and manufacturing of dental appliances - Patients are already protected by MHRA regulations and consumer protection regulations, which these cross into. x 7 (6T,1Z) - Historically the dentist was ultimately responsible for the appliance fitted. The standards merely moves some responsibility onto UK based dental technicians, while still holding the dentist responsible for a foreign manufacturer's output as was previously the case in the UK. So, if there was a gap, it's still there x 1 (1T) - While we agree that there might be a gap theoretically, we are not convinced that it is strictly necessary for the Council to issue these standards. x 1 (1PA) Level of detail in guidance - encouraging communication throughout process - The GDC should emphasise throughout the document, and other guidance documents issued by the GDC, the importance of providing the “declaration of conformity” to the patient as it contains all the vital information. x 1 (1T) - Patient is not informed about the products the lab provides in enough detail, often Page 9
  4. 4. believing the dentist makes the dental appliances. If standards are to work with all parties responsible for work the laboratories should be recognised alongside dentists not below them. x 1 (1T) - Complex area where the patient will not necessarily know the difference between what’s right or wrong with an appliance and no way of measuring and easily stating where problems are. x 1 (1T) - The standards will not work unless the patient receives full disclosure and consultation regarding place of manufacture; including all sub-contracted parts. x 4 (2T, 1C, 1EO) - Guidance needed for dentists, for example on: commissioning prescriptions - made clearer with more precise instructions; private crown or bridge work - charging patient for private work but on the lab ticket only asking for a NHS crown or bridge. Paying the lab NHS price and fitting NHS crowns. x 1 (1T) - The GDC proposal arbitrarily apportion personal responsibilities and it is no good being able to identify exactly where the buck stops if the regulations do not lay down in plain English what the rules of the game are. None of the existing standards will bring us any nearer to measuring the fit or performance of a fixed or removable dental prosthesis. x 1 (1T). - More communication with patient and dental technician would help improve quality of products made. Transparency of pricing and materials would be very helpful to improve quality. x 1 (1T) - If technicians to be accountable and to take legal responsibility for a device patients billed separately for it so that there is certainty over who made the device and that a surgery has not duplicated invoicing to cover the odd import. x 1 (1T) - Guidance too vague – approved qualifications/standards/minimum requirements/equivalent authority should be given. GDP and lab need to communicate more in order to be clear where responsibility stops and starts and reasoning for source of materials/manufacture given in writing and with cooling off period x 3 (3T) Page 10
  5. 5. Question 2: Do you 188 125 63 If no, what would you add? think that (98%) 2xC 1xC the 5xD 1xS - Standards extended to cover all DCP groups who may be involved in commissioning Standards 5xS 54xT appliances, eg. dental nurses. x 1 (1T) cover 103xT 2xEO every 2xEO 3xPA - Does not consider protection gained through benchmarking of brand values. x 1 (1T) area 3xHO 1xOO required 4xPA 1xZ Training to ensure 1xZ patient - CPD for all individuals involved in commissioning appliances should reflect this. x 1 (1T) protection in relation - Standards do not cover training for technicians and dentists. x 1 (1T) to the commissi - Specific guidelines needed for supervisors, teachers, or technicians working with final oning year dental and dental technician students. x 3 (3T) and/or Prescribing concerns manufact uring of - Protection for a technician from being asked to carry out work that is unprofessional and dental unsound. x 1 (1T) appliance s by - Technician given the right to refuse work if inadequate prescription form dentist. x 1 (1T) dentists, CDTs and - Dental material manufacture and/or representative should also be accountable. x 1 (1T) dental technician - Need to avoid clinician having no responsibility to ensure standard of appliance x 3 (3T) s? - Requirement for verbal instruction to be recorded and counter signed. x 1 (1T) - Dentists should not just be responsible for the clarity, accuracy & appropriateness of a written prescription but also the accuracy of the impressions. x 4 (4T) - Emphasis needs placing on the accountability of the dentist to accurately prescribe the standard/type of restoration required from the manufacturing source. IE: metals. Materials as identified in the price listings supplied. x 3 (3T) - Clarification of responsibility if appliance adjusted by clinician when fitted, where then does responsibility lie. x 1 (1T) Page 11
  6. 6. Qualification / Registration - Indication of what a suitably qualified dental technician, in a non – UK context, is needed. x 12 (12T) (9T, 1C, 1EO, 1PA) - Should require a check qualifications meet min criteria for dental technician, person’s competency in area of manufacture and CPD compliance – wherever work done and throughout process if work referred on. x 5 (4T, 1C) - Standards should require that appliances are made by a GDC registered dental technician. x 2 (2T) - Manufacture of dental appliances should be restricted to GDC registered labs. x 1 (1T) - Only dental technicians should be allowed to construct dental appliances and cast up impressions. x 1 (1T) - Should be a legal requirement for every dentist to ensure the lab they use is fully registered. x 2 (2T) - All individuals involved in the manufacture of Dental Appliances should be registered with the GDC at different levels. Full registration - dental technicians; junior registration - model technicians/CAD CAM operators etc. x 1 (1T) Level of detail in guidance - encouraging communication throughout process - Costs of manufacture and evidence of the level of workmanship should be more transparent to the patient. x 3 (3T) - The patient should be clearly informed and advised about the options regarding their treatment plan so that they are aware of the standards of work available to them and where it is being manufactured. With medical treatment patients are required to sign a consent form that confirms they have understood this and this should be considered for dentistry also. x 4 (3T, 1S) - Guidance is required as to how patients are clearly informed before treatment begins, on Page 12
  7. 7. the source of the dental appliance offered to them. x 4 (2T, 2EO) - Patients should know where appliance is made. x 1 (1T) - Sending work overseas to unregistered workers should be publicised more. So the patient can decide what they want. x 1 (1T) - The patient given a copy of document showing - dentist prescription, laboratory details, material and process used. x 1 (1T) - The public/patient need to be made aware of these requirements. x 2 (2T) Concerns about work from outside of the UK and EU - Needs to be tighter with regards to commissioning work from outside the E.U. x 14 (13T, 1D) - Should require dentists to obtain written consent from patients to having their appliances manufactured by a dental technician who not based in the UK and not registered with the GDC. x 2 (2T) - Prevent as much as possible (if not all) outsourcing of work to non regulated countries. x 5 (5T) - No commissioning of appliances outside of the UK allowed, only registered technicians should be used. x 11 (9T, 1D, 1Z) - Special permission should be obtained to send work abroad. x 1 (1T) Procedure - Clearer emphasis on penalties on non compliance with the rules and regulations required. x 4 (2T, 1D, 1C) - Explanation of how standards to be enforced. x 4 (4T) - Standards should require materials to be sourced from known regulated manufacturers. Page 13
  8. 8. x 1 (1T) - All labs should have a quality system in place. x 1 (1T) - If the dentist cannot design the prosthesis he should not prescribe or fit the prosthesis for his or her patient. x 1 (1T) - Fixed pricing required to ensure uniform standards, equipment or materials. x 1 (1T) - Regular auditing of laboratories to ensure quality standards. x 6 (6T) - Provision for maxillofacial prosthesis’s to design, take impression and fit prosthesis. Both intra and extra orally at the referral of a medical or dental professional. x 1 (1T) - Need for a database recording all devices and their prescription to which professionals could refer. x 1 (1T) - Need for the MDD Register of dental laboratories in the UK to be published or available on MHRA website for open viewing. EU member countries should also publish their equivalents. x 1 (1T) - Assistance or templates for various recording documents would allow an easy approach to recording. Service time for equipment product batch number. x 1 (1T) Page 14
  9. 9. Respondents Question 3 Yes No 84 104 188 Are there any practicalities regarding the 2xC, 1xD, 3xS, 67xT, 2xEO, 6xPA, 1xOO, 2xC, 4xD, 3xS, 89xT, 2xEO, 3xHO, 1xPA (98%) implementation of the Standards that you feel 2xZ that the GDC should consider prior to implementing them? Question 3 If yes, what does the GDC need to consider to ensure that the Standards can be implemented practically? Comments Consistency with current regulation - The word ‘Manufactured’ should replace ‘made’ as this is the more appropriate term, in line with the MHRA devices directive. It should be made clear that the word, ‘requisite’, applied to ‘knowledge and skill’ means ‘comparable’ to that expected from a qualified UK dental technician. x 1 (1PA) (7S/PA) - Requirements to report incidents in accordance with EC Medical Devices Directive 2.12 x 1 (1OO) - The guidelines make reference to ‘minimum requirements’ of the medical devices directive whereas the directive refers to ‘essential requirements’. The use of ‘minimum’ implies that there is some leeway in the Directive which is not the case. Devices need to comply with the directive. Equally it is not necessary to add an obligation to ensure that materials are both CE marked ‘and meet the minimum materials standards set out in the medical devices directive’ The CE mark by definition should ensure this. x 1 (1PA) - How the GDC and MHRA should work together to ensure the dental laboratory and the dental technician uphold their responsibilities to the MHRA and the GDC respectively. The MDD places the dental laboratory as the manufacturer and not the individual dental technician. How, therefore, will a case against a faulty appliance be dealt with? x 1 (1PA) - Compliance with EN ISO 13485 could be one way to demonstrate that a medical device met the requirements of the Directive. There is an NBMED consensus statement on the requirements of a declaration of conformity that could be considered as a reference to the standard. Widespread publication of the following link to the EC list of regulatory bodies equivalent to the MHRA http://ec.europa.eu/enterprise/medical_devices/ca/ca_vig.htm. x 1 (1OO) - It is utterly impossible to know whether such work complies with our regulations and the GDC know it. The CE mark means nothing outside the EU in many cases. This policy indicates that the GDC cares little for the patient and leaves the field wide open for unregulated appliances to be fitted to UK patients with no knowledge of any potential health risks. A simpler solution to this issue would be to make it incumbent on any technician or dentist to be able to prove beyond doubt that the appliance supplied/fitted complies with the MDD regulations. This could be done by an independent third party audit such as DAMAS. x 1 (1T) Page 15
  10. 10. - Whilst I agree that these standards are necessary & “tick all the boxes” they mean nothing unless they are actively policed. This can easily be done by actively encouraging dentists to use a DAMAS lab. DAMAS labs already maintain these standards. It is very easy for dentists to check these standards are being met as DAMAS labs are audited every year. x 1 (1T) - Guidance required on how best to meet the requirements for proof of: Suitably qualified; CE marked materials; other EU registration regulatory agencies; MDD & the MHRA. x 1 (1T) - The consultation brought up concerns relating to: • The difference in working practices of other regulatory bodies charged with enforcing the Medical Devices Directive throughout the EU • The lack of evidence of the Medicines and Healthcare products Regulatory Agency and the GDC working together to enforce the regulations, both sets of which have the common aim of protecting the patient. The fact that the issuing of the “declaration of conformity” is actually the responsibility of the company/business and not the individual registrant. x 1 (1PA) - As MHRA does not publish a list or register of registered manufacturers, nor issue a formal certificate, the prescriber must rely upon the manufacturer providing a copy of a confirmation letter. Presumably the GDC requires dentists to check that the manufacturer is registered with MHRA, as opposed to the individual technician, as they may not know which technician/s is/are involved in the manufacture? There may be some confusion in interpreting the three bullet points at the top of page 6 and difficulty for a dentist in ensuring that they are ‘receiving’ the appliance from the correct individual and that the declaration has been made by the correct individual. The point has been made to us that dentists are not required to check the credentials of pharmacists. Strictly legally, the responsibility is on the manufacturer to ensure registration and compliance with the law, not the prescriber and we do not feel that the responsibility for compliance by UK technicians with UK law, whether that is statutory registration or medical devices, should be passed on to the dentist. The regulation of technicians is a matter for the Council. x 1 (1PA) - Would like to take this opportunity of emphasising the concerns relating to the work of the MHRA and of encouraging the GDC to work more closely with this regulatory body. We believe that without sufficient integration of policies and procedures between these two regulatory bodies a large gap will be created in regulations that have been developed to help protect the safety of the patient. x 1 (1PA) - There is confusion in the document about the role and scope of the Medical Device Directive (MDD). It is implied that the MDD sets minimum standards for the appliance itself, which is not true. The dental laboratory constructs a "custom-made medical device" and the MDD is concerned with the quality of the process of construction and the quality of the medical devices used in its construction. These devices, of course, include materials. On p5, it suggests that the materials used in the construction of a custom-made device shall be CE marked. This is not true; the materials shall be fit for the intended purpose. The prescriber of the appliance may use any materials, CE marked or not, as long as he is satisfied that their properties are appropriate for the custom-made device. Where the draft document says p9 the appliance shall meet the minimum requirements of the MDD or the minimum materials standards of the MDD, it implies that the MDD has far-ranging requirements; again this overstates the powers of the MDD. Page 16
  11. 11. Footnote 2 on p5 is incorrect. "CE marking ...all the Essential Requirements of the MDD". It should say that CE marking refers to the appropriate ER, as they apply to the device in question. The document should reference the CEN dental standards which are mandated by the EC to support the MDD. These are EN1639 Dentistry – Medical devices for dentistry - Instruments EN1640 Dentistry – Medical devices for dentistry - Equipment EN1641 Dentistry – Medical devices for dentistry - Materials EN1642 Dentistry – Medical devices for dentistry – Dental implants x 1 (1OO) Promotion/Implementation - The distribution of these guidance notes is also an issue and it may be that copies should be made available to laboratories to be able to raise awareness amongst their clients of their responsibilities of using overseas laboratories and the benefits of using laboratories employing UK registered dental technicians. x 1 (1PA) - We have concerns as to what happens during the transition phase of these standards. There will be patients who may be wearing appliances made with the standards. There will be patients who may be wearing appliances made with the standards that have been fitted with the practitioners in good faith, and it is necessary to incorporate appropriate wording in to the standards to cover this matter. x 1 (1PA) - Need to be able to link and communicate this information to all in the Dental Team so that there is no confusion or debate regarding the message, at some later date. - Engage with stake holders and educational providers of DCP training - Ensure that all registrants of the GDC are provided with an A5 summary sheet - Maintain the link to the Dental Technicians organisations - Publicise in the relevant vocational publications x 1 (1T) - Is it necessary for the patient to be given a copy of the certificate of conformity – it could be offered to the patient (although this may be unnecessary); and is it really necessary to explain twice to the patient where the appliance has been made and the precautions taken? x 2 (1PA, 1HO) - Dental technicians come and go – perhaps it would be better to register the business? It’s going to be difficult to keep track! x 1 (1T) - One of the main issues here is how much do the dental team know about the range, standards and quality of work that they can expect from a UK registered and qualified dental technician. In order to prepare an appropriate treatment plan, provide appropriate options and prescribe accordingly it is important to know what can be achieved by a qualified dental technician. x 1 (1PA) - The consultation brought up concerns relating to: • Consultation with patients on the options available to them with regard to the manufacture of the appliances, including where they Page 17
  12. 12. were to be manufactured and whether formal consent should be obtained. x 1 (1PA) Concerns re. specific appliances - There are two unique orthodontic appliances which are quite widely used by UK orthodontists which are only manufactured overseas. The Invisalign appliance use a succession of clear removable aligners individually constructed for each patient in the USA. It is not possible for these appliances to be constructed in the EU. The Incognito appliance is a custom made fixed and bonded gold lingual appliance which is individually constructed for each patient in Germany. It is not possible for these appliances to be constructed in the UK. x 1 (1PA) - The majority of laboratory manufactured dental appliances are permanent restorations to replace missing coronal dental tissue and/or missing teeth. Laboratory manufactured orthodontic appliances are different. They are temporary devices which may be: 1. active appliances intended to undertake specified tooth movements commonly with springs or screws. 2. functional appliances and bite planes utilising muscle activity to induce tooth movement. 3. space maintainers which passively allow natural spontaneous tooth movement to take place. 4. retention appliances which inhibit movement of teeth to pre-treatment positions following orthodontic treatment. All these types of appliance may be removable by the patient or may be temporally fixed in the mouth. Laboratory manufactured orthodontic appliances are not essentially very different from fixed appliances fitted directly to the patient by the orthodontist using manufactured components such as brackets, tubes, bands, wires, elastomerics, elastics and springs. There is good orthodontic laboratory provision of quality orthodontic appliances in the UK at economic prices and no incentive to use overseas laboratories. These orthodontic laboratory facilities are provided on a commercial basis and also through in-house Hospital Orthodontic Laboratories and also a number of practice owned laboratories. x 1 (1PA) Quality concerns - The most important feature of laboratory made orthodontic appliances, after appropriate considerations of patient safety and lack of toxicity, is that they are a tool used by the orthodontist to deliver treatment. The efficacy of a laboratory made appliance is very difficult to define. Everyone knows what a good appliance should be like but it is a very complex task to quantify this. Particular consideration should be given to the special circumstances around laboratory made orthodontic appliances both at home and overseas. x 1 (1PA) - Many UK Dental Labs produce inferior quality prostheses and restorations. The GDC needs to produce guidelines on what constitutes an acceptable standard of work. Today dental technology is highly sophisticated. Standards need to be upwardly revised. x 1 (1S) - To protect the whole profession we must 1) outlaw manufacture of cheap ill made appliances from abroad 2) educate the Government that dentistry in this country is so expensive because the dental surgeons skim too much money off the top. 3) educate the public of the problems of cheap overseas manufacture and in particular that the manufacture of said appliances are undertaken by a qualified registered experienced Dental Technician not the usual surgeon in their back room. x 1 (1T) Page 18
  13. 13. - Would like to know what protection the Technician gets from this. Very concerned that as it stands technicians are at the mercy of Dentists some of whom try to push technicians to produce work for them at a low price. This pressure seems to be causing the technician’s businesses to suffer and could be an issue of patient protection (i.e. if a dentist’s main concern is just getting work done as cheap as possible). x 1 (1T) Qualification / Registration - Registrants are permitted to take responsibility for checking that foreign manufacturers are suitably qualified (even though there is no foreign qualification that is acceptable to the GDC), but there is no freedom to do the same with an unregistered UK dental worker, rather the threat of a "fitness to practice inquiry". If it is "wholly unacceptable in professional standard terms" to "procure a dental appliance from an unregistered person in the UK" how can it ever be acceptable, in professional standard terms, to procure a dental appliance from a similarly unregistered foreign worker? Even though, in the certain knowledge of the prescriber, the unregistered UK worker may have extensive experience and work to a high standard of practice, conduct and competence. x 1 (1T) Concerns about work from outside of the UK - There is no physical way a clinician or technician can guarantee that work sent outside the UK can meet appropriate manufacturing or conformity guidelines. Until such times as this guarantee can be initiated (such as sampling or an approved overseas providers list), there has to be a blanket ban on non-EU labs, and EU based techs without a UK register able qualification. The MHRA guidelines are very clear on this. If this practice continues, the GDC is essentially allowing unqualified individuals to assess the quality of appliance materials; therefore creating its own set of rules outside EU legislation. x 1 (1T) - The consultation brought up concerns relating to: • The difference in qualifications and training in other countries and therefore the difficulties in establishing whether individuals are ‘suitably qualified’. x 1 (1PA) - It will be difficult for a dentist or CDT to ensure than any non-UK manufacturer is registered with the appropriate regulatory body in the country of origin or manufacture, but they have the choice of whether or not to source outside the UK. With regard to sourcing outside the EU, presumably the Council considers it sufficient for a prescriber to seek from the manufacturer a declaration that all materials used meet the MDD requirements, since it will not be possible for the prescriber to inspect the manufacturing process on all occasions. x 1 (1PA) Page 19

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