Consultation Draft Code of Practice and Safety Guide Radiation Protection in Dentistry

Transcription

1 Consultation Draft Code of Practice and Safety Guide SUBMISSION TO THE AUSTRALIAN RADIATION PROTECTION AND NUCLEAR SAFETY AGENCY BY AUSTRALIAN DENTAL ASSOCIATION VICTORIAN BRANCH INC. SEPTEMBER 2005

2 12 Mr Alan Melbourne Manager - Standards Development and Committee Support Section ARPANSA, 619 Lower Plenty Road, Yallambie VIC 3085 Dear Mr Melbourne ADAVB Submission re Consultation Draft Code of Practice and Safety Guide July 2005 The Australian Dental Association Victorian Branch Inc. (ADAVB) is pleased to respond to the Consultation Draft of the Code of Practice and Safety Guide on (2005). The ADAVB represents over 90% of private practitioner dentists and about 60% of public sector dentists in Victoria. It is the peak body for the dental profession in this State with most other dental organisations and societies recognised as affiliates. We have therefore appreciated the opportunity for our representatives to contribute to the development and refinement of the Consultation Draft. In order to assess the views of a wider cross section of members, comments were invited from the membership, and this submission now incorporates their feedback. Branch representatives would be happy to amplify the remarks offered herein if this would be of assistance to ARPANSA. Yours sincerely, Garry Pearson Chief Executive Officer AUSTRALIAN DENTAL ASSOCIATION VICTORIAN BRANCH INC. 49 MATHOURA ROAD (P.O.BOX 434) TOORAK 3142 TEL: (03) FAX: (03) adavbinfo@adavb.com.au Reg d Assoc. No.A E

3 Preamble The draft code is, overall, a very suitable document. However, there are some items where some clarification or alteration may make it more workable for the average dental practice. We recognise that the proposed Code is in two parts. The Code of Practice contains only the mandatory requirements (the must items). The Safety Guide contains recommendations which are such that if practitioners do not comply with the recommendations they would need to have a convincingly arguable reason for not doing so. Some of the features of the code are briefly noted below and followed by a discussion of areas of concern, from the point of view of a practitioner who must use the Code and Safety Guide as a reference document. The Responsible Person, who has overall responsibility for implementing the Code, need not be a dentist. In corporate or community practices this responsibility may belong to a senior person who has knowledge and control in the organisation, department or practice. This could free some dentists from the administrative, record keeping and training of staff duties in respect of radiography. The Responsible Person will appoint a Radiation Safety Officer (RSO) who will have sufficient knowledge and training and seniority to carry out RSO duties, which remain very similar to those which applied prior to Personal monitoring of all staff involved in radiography is to be continued, and records of dosages received during present and past employment must be kept. This remains a most welcome OHS measure. The proposed maintenance of radiographic records generally aligns with the medico-legal advice on general dental records.(7 years for adults, and until a child is 18 plus 7 years) The draft specifies that radiographs must not be taken prior to the taking of a medical history and preliminary examination. Whilst academically correct, this could be unnecessarily restrictive in some emergency situations. Equipment compliance with AS/NZS will present an issue for those owning the estimated 5% (or more) of machines which do not comply e.g. 55 KV machines. The code envisages that a mandatory quality assurance system must be set up to allow the rate of depletion of developing solutions to be monitored continually. While the draft does not specify the routine use of lead aprons and thyroid collars there is mention in the Safety Guide of the need for such protection for pregnant women, and children, particularly where the primary beam may be directed toward thyroid or gonads. The draft envisages increasing the use of digital radiography and suitable sections of the code and safety guide have been included. We suggest that it will be important for the Code and Safety Guide to specify the basic or minimum requirements. They should not impose restrictions on the use of new methods. It is important to allow for the development of new methods as these are what make the world improve. A number of clinical guidelines used in medicine do not allow this freedom of use of new techniques and place the clinician in a position of being subject to prosecution even though the technique offers improved outcomes. Page 2

4 Areas of possible concern for dentists The Responsible Person, in consultation with the regulatory authority, must ensure that appropriate radiation safety assessments are made by an appropriately qualified person for the following circumstances: (d) where changes are to be made in the immediate environs that may result in an increase of occupancy; (e) where an increase in workload in the department or practice is anticipated; or. With regard to (d) the changes to occupancy levels is a regulatory requirement in local government property development regulations, and appears to be an unnecessary imposition on dental practices. The increase in workload mentioned in (e) would seem to relate to large hospital organizations rather than the average dental practice. We therefore suggest that it should not appear in the general dental guidelines but rather those related to public institutions Radiation dose records must show: (a) doses assessed during the present period of employment; and (b) doses assessed as a result of any previous employment in which ionizing radiations were used. We are not aware of any requirement on an employer to pass dosage received by an employee to a subsequent employer. If (b) relates only to any previous period of employment with the same employer it should say so. It would be helpful to make this an employee obligation to disclose the dosage received to their new employer. The situation needs to be clarified as privacy issues are involved. Perhaps consideration could be given the radiation monitoring service maintaining a central record of radiation exposure in a similar manner to employees have portable superannuation. 2.5 REFERRALS FOR RADIOGRAPHIC EXAMINATION In cases where patients are referred for radiographic examination, clinical notes must be provided. These notes must contain both the reason for the radiological examination as well as an adequate history. If any radiographs were taken in relation to the condition prior to the referral, these or the reports must also be included where relevant. This potentially places a significant imposition on the dentist that may not be able to be complied with due to the unknown exposure of a patient at other practices and even with other clinicians within a group practice. We agree however that if a referral to a radiologist is made, then it should be accompanied by a referral letter indicating the patient details, the nature of the film and any special instructions (such as the use of radiographic guides). Page 3

5 Dentists referring patients for radiographs, whether OPG, cephalometric or tomography in relation to implants, often comment that the reports, if any, provided with the films are significantly less helpful than the films. This is often because the dentist is highly skilled and experienced in interpretation in his/her own field. In this circumstance it seems administrative overkill to mandatorily require previous films or reports to be sent with the referral. The insertion of Item 2.5 was apparently prompted by the failure of some practitioners to adequately inform radiologists of the precise films required. Our recommendation would be to rephrase the last sentence in 2.5 as below. If any radiographs were taken in relation to the condition prior to the referral, these or the reports must also be included where they are both relevant and helpful in patient care Radiology must not be used as a substitute for a clinical investigation, and therefore radiography must not be undertaken until a medical history has been taken and a preliminary clinical examination has been performed. It would be rare in general dental practice to encounter a case where a medical history and preliminary examination could not be obtained prior to taking a radiograph, but we suggest that to expedite emergency treatment, Oral & Maxillofacial surgeons may sometimes order films urgently where trauma and altered states of consciousness are involved. It is therefore suggested that should read, Radiology must not be used as a substitute for a clinical investigation, and therefore radiography must not be undertaken until a medical history has been taken and a preliminary clinical examination has been performed, unless an emergency situation dictates otherwise, or duplicated consultations should be avoided e.g. requiring an OPG where a patient has problems with an erupting wisdom tooth Dental X-ray equipment which is in use at the time of introduction of this code, and which does not comply with the relevant requirements of AS/NZS , must be modified to comply with the requirements, except where otherwise approved by the regulatory authority, or phased out of use on a time scale approved by the regulatory authority. Note that it may not be practical to modify some old equipment. ARPANSA has estimated that 5% of X-ray machines used to expose intraoral films will not comply with AS/NZS Such an estimate may be conservative as is the estimate of $7000 to replace a noncomplying machine. A significant number of dentists will need to modify or replace X-ray machines, although the ADAVB is not in a position to accurately determine the actual number. Information was requested from the DHS Radiation Safety Program Unit, on the number of machines that they estimate would be non-complying in Victoria, or alternatively the number of machines operating at less than 60KV. A reply received by is attached to the end of these comments (see Attachment 2 on page 10). Page 4

6 Briefly, the Radiation Safety Program Unit indicates that approximately 10% of present dental intra-oral x-ray machines in Victoria operate at less than 60 KV, and would be non-compliant on that ground alone. The issues of reproducibility, linearity, timers, and KV accuracy may also render higher KV machines non-compliant, but the data on these issues seems not to be available. It is estimated that up to 10% of Victorian intra-oral X-ray machines will need replacement or modification to comply with the proposed code. In the interests of not imposing significant costs on both public and private dentistry over a very short time span, effort should be directed at ensuring that a generous phase-in time is agreed with the relevant authority. This would also prevent a bottleneck in the provision of service personnel at the time of introduction of the new code Equipment designed for intra-oral radiography must not be used for any other type of radiographic examination. Radiography of the mandible, including temporo-mandibular joints, must be conducted only on general purpose medical X-ray equipment or on special purpose equipment designed for such examinations and authorized as required by the regulatory authority. This section will prevent dentists taking lateral mandible films, using an intensifying screen cassette, with their usual machine. While this may have been largely superceded by the use of OPG machines, some dentists will be forced to refer these cases to a radiology practice, buy an orthopantomographic machine or cease using lateral mandibular views. As an OPG film potentially contains more information this may be desirable but is likely to be a source of complaint from some members Hand and wrist radiography (which may be required for bone age determination) must only be performed on medical X-ray equipment or on special purpose equipment designed for such examinations, and operated by appropriately trained and licensed persons. We understand that most orthodontists rarely use bone age determination films. In general those requiring such films refer to a radiologist An appropriate quality assurance program on film processing must be implemented to ensure that radiographs are of adequate diagnostic quality. This item has the potential to be the main source of contention as it will require extra staff time, materials (film) and extra documentation. The estimate in the impact statement of 12 hours/annum at $25 p/h (15 mins/week) seems optimistic. The impact statement also asserts that 50% of practices take digital images and would not therefore be processing film. This may or may not be correct. Page 5

7 Item 5.1 in the Safety Guide describes a method of exposing a batch of test films, greater in number than the number of days the developer solution is expected to last. This will require the purchase of a step wedge to expose test films (approx $100). Another method is possible without using a step wedge but it will be expensive in terms of dentist s time as four times as many exposures would be required (e.g. Instead of exposures about may be required). As only licensed personnel can operate the x-ray unit in Victoria, the test exposures could only be taken by dentists, or other licensed persons. These test films are to be made with a standardized technique prior to a new batch of developing solutions being prepared, at which time one master film will be developed. Each day one of the batch of exposed test films will be developed before any patient films are processed, and compared to the master film. By this method any deterioration in the film optical quality will be noted, and the old solutions discarded. The QA process of test films, and newly mixed solutions will be restarted. It is suggested that while a QA control of rate of deterioration of developing solutions is desirable the described method is wasteful of time and resources. It should be possible to devise a system in which a baseline rate of replacement for developing solutions is discovered for each practice by means of the method described, but then spot checks could be used when approaching the expected use by date. The complete QA process as described in the Draft could be repeated at six monthly or longer intervals as long as the results did not show any divergent rates of deterioration in the quality of films. This would be a process similar to the commissioning and retesting at specified intervals of dental bench top autoclaves. We understand the reason that ongoing daily test films are suggested in the Safety Guide is a concern that contamination of the developer can result in fogging of film well before the developer would normally be depleted. We suggest that this is essentially a training issue, and that rather than being addressed by daily ongoing testing, refresher training should be undertaken where any problem with fogging is found. This will usually focus on instruction in film alignment and positioning to ensure that films taken are of diagnostic quality. The provision for practices with low X-ray usage to reduce the frequency of testing once the working life of the developer has been established, to once every two to three days is acknowledged.- We would also suggest that a simple logbook be kept to record the process as the DPBV, who will no doubt adopt the Code, seems to work on the principle that if it isn t recorded it hasn t been done. Elaborate records seem to be unnecessary, as the films themselves are a record of their quality. Most dental practices are very small, and film development is done by hand so that even the slightest deterioration in image quality would be immediately evident. This means that formal quality assurance protocols are not indicated in the way they might be for a large public institution. Page 6

8 6.3 EXPOSURE TO THE PRIMARY X-RAY BEAM Under no circumstances must the operator or any member of the dentist s staff be exposed to the primary beam during a radiographic exposure or during testing of the equipment. 6.4 HOLDING OF IMAGE RECEPTOR AND STANDARDISATION OF TECHNIQUE BY USING IMAGE RECEPTOR HOLDERS The image receptor must not be held in position by the operator or any member of the dentist s staff either by hand or with forceps. 6.5 HOLDING OF X-RAY UNIT No person must hold any part of the X-ray tube head during a radiographic exposure. 6.6 HOLDING OF PATIENTS Neither the operator nor and any member of the dentist s staff must hold patients during radiographic examinations. If parents or other persons are called to assist, they must be provided with protective aprons and be positioned so as to avoid being exposed to the primary X-ray beam. One person must not regularly perform these duties. 6.7 POSITION OF OPERATOR DURING EXPOSURE With respect to the use of distance as a means of reducing radiation dose, the operator must stand outside the primary beam and either: (a) at least 2 metres away from both the X-ray tube head and the patient; (b) behind structural shielding of an adequate area and thickness; (c) behind a protective screen; or (d) wearing a protective apron Where a protective screen is provided, the exposure control must be arranged so that it can only be operated from within the protected area The operator must be able to observe the patient during dental radiographic procedures. Please refer to Attachment 1 (page 9), in which the Paediatric Dental Study Club argues for exceptional circumstances, particularly involving treatment of children, to be taken into account in allowing some flexibility in application of the procedures to minimise exposure to ionizing radiation. Page 7

9 Conclusions & Recommendations The draft Code of Practice and Safety Guide is generally a suitable revision of the previous 1987 Code but it is felt that new code will impact significantly on dentists in the following areas. 1. Up to 10% the intra-oral X-ray machines in use in Victoria will need to be replaced or modified. The agreement by authorities to an extended phase-in time would avoid the imposition of sudden unexpected and significant costs to both public and private dentistry, and undue pressure on the technical services required to complete the upgrades. 2. While the Quality Assurance process designed to prevent the use of depleted developer and fixer, and thus improve film quality, is desirable, the developing of a test film each and every day that radiographs are developed would seem to be unnecessary. Once a satisfactory time limit of solution use is established, daily checking over the last 3-4 days of the cycle would be all that is required to fix the exact time for solution replacement. 3. Rephrase Item so that in emergency and other situations, the taking of a radiograph prior to preliminary examination and obtaining a medical history would not constitute a breach of the code, and of the DPBV regulation after adoption of the code by DPBV. 4. Rephrase Item 2.5 as suggested in the comments on this item so that the sending of previously taken films with each referral is required only when both relevant and helpful in patient care. 5. Item (b) may conflict with privacy legislation, or the information may not always be accessible to a new employer. Placing the onus on the employee to disclose their dosage exposure to their new employer would more usefully address privacy concerns here. The maintenance of a central database on dosage exposure by the monitoring agency might be a preferable means of achieving the desired outcome. 6. Make some allowance for exceptional circumstances with regard to the treatment of children, and perhaps special needs patients, in the interpretation and application of procedures to minimise exposure to ionizing radiation Page 8

10 ATTACHMENT 1: Comments from the Paediatric Dental Study Club highlighting the need for recognition of exceptional circumstances Dear Mr Pearson, With regards to the Draft Code of Practice and Safety Guide for, the Victorian Paediatric Dental Study Group would like to submit feedback on these draft guidelines. Our concerns lie with sections 6.3, 6.4, 6.5, 6.6 and 6.7 and the absence of variation of these guidelines under exceptional circumstance. 6.3 Exposure to the primary x-ray beam. It is necessary, on occasion, for the practitioner to support a small infant/child undergoing radiographic examination to ensure the beam is accurately positioned. This may occur due to the inability of the parent/guardian to accurately support the child and film, and would only occur in cases where radiographic information is vital. An example of this is in the case of a child of a pregnant mother who has traumatized/intruded their anterior deciduous teeth and a radiograph is required to determine whether the teeth are in situ or not. 6.4 Holding of image receptor and standardization of technique by use of image receptor holders. The same issue applies as for section 6.3; in the case of a pre-cooperative child who cannot stabilize the film themselves. The film can either be held by the parent/guardian, or the operator. An example of a clinical scenario is as above. The decision of the health cost/benefit regarding x-ray exposure to the individual holding the film is made depending on the clinical situation as outlined in section Holding of x-ray unit. In exceptional cases, it is necessary for the tube to be stabilized with the film when imaging a pre- or uncooperative child as illustrated above. 6.6 Holding of patients. In exceptional cases, it is necessary for the patient to be stabilized with the x- ray tube and film when imaging a pre- or uncooperative child as illustrated above. 6.7 Position of operator during exposure. As described previously, there are clinical scenarios in paediatric dental practice where it is necessary for the operator, under their judgment, to expose themselves to the x-ray primary beam. Suitable protective apparati, such as lead aprons and thyroid shields would be employed for the patient, parent and operator where appropriate. I thank you for this opportunity to comment on these draft guidelines Yours sincerely David Manton MDSc On behalf of Prof Louise Brearley Messer, A/Prof Roger Hall, A/Prof Nicky Kilpatrick and Drs Hanny Calache, Karen Kan, Barbara Lerpiniere, Jamie Lucas, Chris Olsen, Margarita Silva and John Sheahan Page 9

11 ATTACHMENT 2: in response to query regarding machines operating at less than 60KV or otherwise not complying with AS/NZS , Dear Dr Highfield I refer to your regarding comment on the Code of Practice and Safety Guide for Radiation Protection in Dentistry, Consultation Draft July It is difficult to accurately estimate the number of dental X-ray machines that don t comply with AS/NZS :2000. Some of the older X-ray units may not comply with all aspects of the Standard. According to our data base, approximately 10% of dental X-ray units operate at less than 60kV. These are generally older units and most of these units would not meet all the criteria listed in the above Standard as Standards are constantly being improved and updated. However it is expected that such older equipment is gradually being phased out and replaced by newer equipment. Routine inspection tests carried out on these X-ray units some years ago, found that many of the older X- ray units failed one or more of the following compliance tests: reproducibility, linearity, timer and kv accuracy. In most instances, X-ray units can be repaired or adjusted so that they meet all the requirements of the Standard. However, it may not be possible to repair some of the older units, especially if the kv is inaccurate. If the unit is operating at less than the nominal kv and it can't be adjusted, the X-ray unit is then required to be replaced as it could lead to considerably higher radiation doses to the patient per exposure. Hope this information helps. Please contact Ingrid Cardillo on should you have any further queries. Regards Ingrid Cardillo Radiation Safety Program Ph (03) Fax: (03) Page 10