Introduction of New Health Technology · Web viewApproval will be sought prior to the introduction...
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CHHS18/104 Canberra Hospital and Health Services Operational Policy Introduction of New Health Technology Contents Contents..................................................... 1 Policy Statement............................................. 2 Purpose...................................................... 2 Scope........................................................ 2 Roles & Responsibilities.....................................3 Related Policies, Procedures, Guidelines and Legislation.....3 Definition of Terms..........................................4 Search Terms................................................. 5 Doc Number Version Issued Review Date Area Responsible Page CHHS18/104 1 16/03/2018 01/04/2021 Chief Medical Administrato r 1 of 7 Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
Transcript of Introduction of New Health Technology · Web viewApproval will be sought prior to the introduction...
CHHS18/104
Canberra Hospital and Health Services Operational Policy Introduction of New Health TechnologyContents
Contents....................................................................................................................................1
Policy Statement.......................................................................................................................2
Purpose.....................................................................................................................................2
Scope........................................................................................................................................ 2
Roles & Responsibilities............................................................................................................3
Related Policies, Procedures, Guidelines and Legislation.........................................................3
Definition of Terms...................................................................................................................4
Search Terms............................................................................................................................ 5
Doc Number Version Issued Review Date Area Responsible PageCHHS18/104 1 16/03/2018 01/04/2021 Chief Medical
Administrator1 of 5
Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
CHHS18/104
Policy Statement
Approval will be sought prior to the introduction of a new health technology into ACT Health through the submission of an approved application form to the Health Technology Management Committee (HTMC).
The HTMC will seek advice from the Health Policy Advisory Committee on Technology (HealthPACT) or the Medical Services Advisory Committee (MSAC) on the assessment and introduction of the proposed health technology. If the health technology has yet to be assessed by HealthPACT or MSAC, HTMC will request an assessment. On receipt of advice from HealthPACT or MSAC, HTMC will evaluate the health technology for use in ACT Health.
The HTMC recommends health technologies to the Director General (DG), ACT Health for approval that are safe, efficient, effective, and represent value to ACT Health.
Purpose
The purpose of this policy is to establish a systematic and transparent approach to the introduction of new health technologies into ACT Health.
Scope
The policy applies to all health technology not yet evaluated by the HTMC for introduction into ACT Health.
The HTMC advises the DG on the role, safety, efficacy, effectiveness, and resourcing implications of proposed health technologies that have been assessed and recommended for use in Australia by HealthACT or MSAC. This includes: Procedures that have not been performed by ACT Health; Medical devices new to ACT Health, including software; Any variation to an existing procedure or treatment where a new medical device is
introduced; Any circumstance where a manufacturer or third party provides a new medical
device for a trial at no cost to the organisation, loan or donation; and Medical devices designed for the therapy of individual patients.
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Roles & Responsibilities
Director-General, ACT Health:The DG is responsible for the health technologies that are introduced into ACT Health including: Approval of the investment and disinvestment of health technologies; and Ensuring that approved health technology is managed appropriately, and associated
risks are managed within levels acceptable to the ACT Health.
Chief Finance OfficerThe Chief Finance Officer is responsible for: Ensuring that resources are approved, allocated and funded for the effective, safe
application, use, maintenance, sustainment and disposal of health technology owned by ACT Health.
Health Technology Management Committee (HTMC):The HTMC reports to the DG and is responsible for: Liaising with HealthPACT and MSAC on the assessment of safety, efficacy, and
effectiveness of the new health technology; Evaluation of the health technology for use in ACT Health; Recommendations to the DG on the introduction of the health technology including: Resourcing implications; Clinical practice guidelines; Risk assessment and risk management; and In-service management, use, operation and maintenance; and The review of the performance of the health technology and associated
recommendations to the DG should the health technology not achieve performance indicators.
Medical and Dental Appointments Advisory Committee (MDAAC) MDAAC is responsible for credentialing and defining the scope of clinical practice for
senior medical and dental practitioners prior to the introduction of new health technologies to ACT Health (refer to Review of Credentials and Defining the Scope of Clinical Practice prior to the Introduction of New Health Technologies procedure).
Related Policies, Procedures, Guidelines and Legislation
Policies ACT Health Management of Health Technology Policy ACT Health Work Health and Safety ACT Health Infection Prevention and Control
Procedures
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Review of Credentials and Defining of Scope of Clinical Practice prior to the Introduction of New Health Technologies
Guidelines AS/NZS 3551 Management programs for medical equipment AS/NZS 3200 Family of standards; AS/NZS 2500 Guide to the safe use of electricity in patient care AS/NZS 3003 Electrical installation - patient areas; AS/NZS 4173 Guide to the safe use of lasers in health care; ISO 14971 Medical devices - Application of risk management to medical devices; AS ISO 55000 Asset management-Overview principles and terminology; AS ISO 55001 Asset management-Management systems-Requirements; IEC 80001-1 Application of Risk Management for IT-Networks incorporating Medical
Devices:o Part 1 Roles, responsibilities and activitieso Part 2-1 Step by Step Risk Management of Medical IT-Networks; Practical
Applications and Exampleso Part 2-2 Guidance for the communication of medical device security needs, risks
and controls;o Part 2-3 Guidance for wireless networks;o Part 2-4 General implementation guidance for Healthcare Delivery
Organisations;o Part2-5 Application guidance – Guidance on distributed alarm systems;o Part 2-6 Application guidance – Guidance for responsibility agreements.
Legislation Health Records (Privacy and Access) Act 1997 Human Rights Act 2004 Work Health and Safety Act 2011
Definition of Terms
Health technologies: are defined as “Therapeutic devices, medical or surgical procedures used in medical care, and the organizational and supportive systems with which such care is provided.” This definition includes therapeutic, diagnostic and screening procedures and equipment but not the evaluation of new drugs, either for addition to the formulary or as an individual patient therapy.
The Health Technology Management Committee (HTMC) coordinates the adoption of technologies that are new to ACT Health. It also coordinates the adoption of modifications to, and upgrades of, existing technologies. The introduction of a new health technology requires appropriate consultation with, and is subject to the in-principle approval of the Medical Services Advisory Committee (MSAC) as well as the final approval through the appropriate governance structures.
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Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
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Search Terms
Technology, Introduction of New Technology, Health Technology Management Committee
Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.
Policy Team ONLY to complete the following:Date Amended Section Amended Divisional Approval Final Approval 16/03/2018 Complete Review Boon Lim, A/g CMO CHHS Policy
Committee
This document supersedes the following: Document Number Document NameDGD12-055 Introduction of New Health Technology Policy
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Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register
