Legal and Legislative Services Branch 28 January 2016 NSW Ministry of Health Locked Bag 961 NORTH SYDNEY 2059 Email: legalmail@doh.health.nsw.gov.au RE: Discussion Paper - Cosmetic Surgery and The Private Health Facilities Act 2007: The Regulation of Facilities Carrying Out Cosmetic Surgery To whom it may concern The Australian and New Zealand College of Anaesthetists (ANZCA) would like to take this opportunity to participate in the review of the cosmetic surgery industry in NSW by providing comment on the discussion paper Cosmetic Surgery and The Private Health Facilities Act 2007: The Regulation of Facilities Carrying out Cosmetic Surgery. The issues raised in the discussion paper indicate a clear understanding by the Ministry of the risks of performing anything more than minor cosmetic procedures in an unregulated environment. ANZCA, including the Faculty of Pain Medicine (FPM), is committed to high standards of clinical practice in the fields of anaesthesia and pain medicine. As the education and training body responsible for the postgraduate training programs of anaesthesia and pain medicine for Australia, New Zealand and parts of Asia, we believe in ongoing continuous improvement and strive to ensure our programs represent best practice and contribute to a high quality health system. The College s mission is to ensure that all Australians have access to high quality and safe anaesthesia and perioperative care. ANZCA is aware that there is increasing demand for cosmetic procedures and that they are generally performed outside the public health system. The broad concerns around provision of care to patients undergoing cosmetic procedures are as follows: Patient assessment Cosmetic procedures are entirely elective and usually initiated and requested by the consumer without referral from a GP who would have knowledge of a patient s general health. Screening and medical assessment needs to form part of the management of any patient undergoing a surgical procedure in any facility. Risk of anaesthesia In addition to surgical risks and complications, informed consent must also include provision of information regarding the risks of local anaesthesia, sedation and general anaesthesia when administered. No procedure is risk free and even provision of local anaesthesia alone can have potentially life-threatening complications in healthy individuals.
Regulation of facilities Regardless of the regulation and licensing of the facility, patient safety is paramount. Licensing ensures that certain standards are met including: provision of appropriately qualified staff, adequate numbers of staff, provision of appropriate equipment (including resuscitation equipment), incident/adverse event management and reporting, audit, infection control policies, drug handling compliance, emergency access (including mechanisms for transfer of patients to another healthcare facility if required) and compliance with the Building Code of Australia. Any patient having more than a minor procedure should have the right to care in a facility that meets these basic requirements. Classification of facilities as anaesthesia class or surgical class ensures compliance with a number of ANZCA Professional Standards as has been detailed in the discussion paper. ANZCA response to discussion paper questions for consideration In answering the questions posed by the discussion paper, ANZCA is mindful of the importance of ensuring that low risk cosmetic surgical procedures that can be safely carried out in a medical practitioner s rooms are not inadvertently captured by regulations. It is not our intention to stifle current safe practice or innovation. Discussion paper questions and ANZCA responses 1. Is the current regulation of facilities carrying out cosmetic surgery appropriate? ANZCA strongly believes that the current regulation of facilities carrying out cosmetic surgery is not appropriate. As there is no requirement for unlicensed facilities to undertake audit or report to authorities, the recent serious incidents that have been identified almost certainly represent a small proportion of actual adverse events. Regulation should aim to be effective in reducing the incidence of serious problems as well as ensuring that when problems arise facilities are equipped to deal with them. 2. Should a new class of cosmetic surgery be included in the Private Health Facilities Act and Regulation, requiring cosmetic surgery to only be undertaken in a licensed private health facility (or a public hospital)? ANZCA agrees that cosmetic procedures requiring intravenous sedation, general anaesthesia, epidural or spinal anaesthesia or major regional anaesthesia (which includes administration of large doses of local anaesthetic approaching maximal recommended) should be performed in a licensed facility. The Minister would need to be reassured that all major cosmetic procedures are actually performed in licensed facilities regardless of the way the class is defined. ANZCA recognises that a new cosmetic surgery class may allow easier regulation by authorities. We would support the development of such a class to the extent that it allows for more accessible surveillance of evolving cosmetic surgical practices. In general terms however, ANZCA believes that patients are best served by undergoing care for such procedures in surgical class facilities. Determining that defined cosmetic procedures be performed in a surgical class facility would ensure compliance with minimum standards and regulations. However, if such procedures were subsumed into the surgical class they would need to undergo regular scrutiny and updating. Page 2 of 5
3. If so, is the following definition appropriate: Cosmetic surgery is any surgical procedure (other than a dental procedure) that is intended to alter or modify a person s appearance or body, and a. that involves the administration of a general, epidural, spinal or major regional anaesthetic (including Biers Block) or sedation resulting in more than conscious sedation; or b. that involves one of the following procedures (however named): breast augmentation/reduction, mastopexy or mastopexy augmentation, buttock augmentation/reduction/lift, pectoral implants, penis augmentation, abdominoplasty (tummy tuck,) liposuction, belt lipectomy, large volume fat transfer, brachioplasty (arm lift), rhinoplasty, facelift, neck lift, facial implants, lower eyelid blepharoplasty or canthoplasty. ANZCA does not wish to define cosmetic surgery or the procedures which may be classed as cosmetic. There are also potential problems should a list of procedures form part of a definition as a number of procedures, for example rhinoplasty, are performed by a range of specialists (ENT surgeons, plastic surgeons and cosmetic surgeons). However, ANZCA believes that any procedure which requires intravenous sedation or analgesia or anything other than small doses of local anaesthetic should be performed in a facility that is adequately staffed and equipped to deal with the complications that can arise from excessive sedation or local anaesthetic or from the surgery itself. Using anaesthesia and sedation levels as criteria for licensing The term conscious sedation has been used in the NSW Private Health Facilities Act and Regulation to define categories of facilities for licensing but this approach has pitfalls. It has led to the use of excessive doses of local anaesthetic in order to avoid deeper sedation (and hence licensing). Conscious sedation forms part of the sedation spectrum and as such, there is no definite transition point. Individual patient sensitivities imply unpredictability of response to sedative drugs and the avoidance of transition from conscious sedation to deeper sedation cannot be guaranteed. The term major regional anaesthetic should be considered to include injection of large volumes of local anaesthetic to cover a large surgical area and doses of local anaesthetic that approach maximal recommended (e.g. lignocaine 5mg/kg). Both breast augmentation and abdominal liposuction require large volumes of local anaesthetic to cover a large surgical area and would constitute major regional anaesthesia. Whilst the practice of tumescent anaesthesia for liposuction involves the removal of the dilute solution of local anaesthetic via suction, when liposuction of large areas is undertaken doses of local anaesthetic far exceeding maximal recommended are used. Such procedures should only take place in facilities capable of handling serious adverse events in terms of both staffing and equipment. In these facilities the ANZCA professional document, Guidelines for the Management of Major Regional Anaesthesia (PS03) should apply. PS03 specifically states that it is not intended to include superficial nerve blocks or low volume local anaesthetic procedures and thus will not be expected to apply to simple procedures in a medical practitioner s rooms. It would be unusual for general practitioners to use intravenous sedation or large doses of local anaesthetic in the practice of removing skin lesions, biopsy, suturing wounds etc. Similarly, minor office based procedures performed by surgeons should not require intravenous sedation or intravenous analgesia. In this regard, ANZCA does not believe a recommendation of limiting use of intravenous sedatives or analgesics to licensed facilities would restrict such safe and acceptable practice. Page 3 of 5
Recommendations In summary, we believe that the requirement for licensing should be determined by both the surgical procedure (as determined by expert surgical opinion) and the use of anaesthesia or sedation. Furthermore, ANZCA recommends that the licensing criteria for describing the types of anaesthesia/sedation used should be expanded to include any one of the following: a. Epidural/spinal/major regional anaesthesia or local anaesthetic doses approaching maximal recommended b. Intravenous sedation or analgesia c. General anaesthesia or deeper levels of sedation (beyond conscious sedation) by any route. ANZCA recommends that the above change to wording of the legislation should apply regardless of whether a separate facility category is created for cosmetic surgery. ANZCA would be pleased to advise of appropriate recommended doses of local anaesthetic agents or medications used for sedation. 4. Are there any other procedures, such as vaginoplasty or calf implants, that should be included in the definition so that such procedures should only be carried out in a licensed private health facility (or public hospital)? ANZCA defers to the opinion of the relevant surgical colleges and societies. However, it is important that a clause that allows for new procedures or new names for current procedures is incorporated e.g. including but not limited to 5. If the definition is not appropriate, how should the cosmetic surgery class be defined? See response to question 3 with regard to the use of anaesthesia and sedation. Otherwise, ANZCA defers to the opinion of the relevant surgical colleges and societies. 6. If a new class of cosmetic surgery is created under the Private Health Facility Regulation, should the standards currently applying to the anaesthesia and surgical class apply to the cosmetic surgery class (in addition to the standards set out in Schedule 1)? Yes. As discussed in the response to Question 2, the same standards should apply to ensure both the safety and quality of health care. Although Schedule I in the Private Health Facilities Regulation details the requirements for licensing it does not capture the need for adequate pre-operative assessment, risk stratification and provision of procedural consent whereby the patient is informed of risks. These issues do not strictly pertain to the domain of facility licensing but are an important part of patient care for cosmetic procedures. They are captured in Schedule 2 for the anaesthesia and surgical class facilities by reference to ANZCA s professional standards and so should also apply to cosmetic surgery. We are pleased to note that several ANZCA Professional Standards are referenced in the licensing standards for anaesthesia and surgical class facilities. These include: anaesthetic equipment as per Recommendations on Minimum Facilities for Safe Administration of Anaesthesia in Operating Suites and other Anaesthetising Locations (PS55), monitoring equipment as per Recommendations on Monitoring During Anaesthesia (PS18), recovery equipment and drugs as per Recommendations for the Post-Anaesthesia Recovery Room (PS04) and anaesthetic records as per Recommendations on the Recording of an Episode of Anaesthesia Care (PS06) published in 2006. Page 4 of 5
[NOTE: PS06 has been republished since 2006 and the titles of some of these publications have changed from Recommendations to Guidelines. A list of all current ANZCA professional documents can be found on our website.] 7. Should there be any amendment to these standards as they apply to the cosmetic surgery class? Yes. In our responses to questions 3 and 8, two further ANZCA publications (PS03 and PS09) have been referred to and ANZCA recommends their inclusion in any licensing standards for cosmetic surgery. 8. Should additional standards, for example compliance with the Agency for Clinical Innovation s Minimum Standards for Safe Procedural Sedation, be imposed on the cosmetic surgery class? The ACI document was developed in recognition of the fact that whilst some health services have well developed processes to align resources and patient need, there is no consistent framework for the delivery of safe procedural sedation across the NSW health system. It presents standards and a toolkit to support high quality care for patients receiving procedural sedation. It deals with pre-procedure assessment and risk stratification, appropriate staffing and equipment and post procedural care. It is a sound, well considered document. The ACI document does however differ in a number of details from the ANZCA Professional Standard pertaining to provision of sedation or analgesia for surgical procedures, Guidelines on Sedation and/or Analgesia for Diagnostic and Interventional Medical, Dental or Surgical Procedures (PS09). In particular, it allows the proceduralist to give sedation and suggests that the person monitoring the airway is not necessarily skilled in airway management. ANZCA believes that PS09 should be the imposed standard of care. It has been referenced by the AHPRA and should apply in all facilities in which sedation is carried out. Currently, in Australia, there is the potential for two standards of care for a given procedure depending upon whether it is performed in a licensed facility or one that is not licensed and not subject to regulatory control. It is crucial that any patient presenting for a particular surgical procedure is assured of a minimum standard of care. Again, ANZCA appreciates the opportunity to participate in this review of a growing sector of the healthcare industry and wishes to formally state its willingness to be engaged in further discussion. Should you require any further information, please contact Helen Topfer, Manager Safety and Quality, via email policy@anzca.edu.au or telephone +61 3 9093 4908. Yours sincerely Dr Genevieve Goulding President Dr Phillipa Hore Chair, Safety and Quality Committee Page 5 of 5