Safety of medical devices – international Standard
Medical devices – Application of risk management to medical devices, ISO 14971:2007, is the definitive worldwide Standard for the medical device sector. It is a management Standard, covering the entire life cycle of all types of medical devices. It helps manufacturers and other users to ensure the safety and effectiveness of medical devices used in healthcare facilities worldwide.
Within the Standard is a defined risk management process. Since no medical device can be completely safe, there is a need for risk management to support manufacturers, clinicians, regulatory authorities, and the public in making decisions about the health and safety of specific products.
The Standard builds on well-established risk management principles and on the work of other risk frameworks, and provides a recognised process for manufacturers of medical devices. All the key principles of risk management apply – the Standard provides a management system and specifies that the steps of hazard identification, risk estimation, risk evaluation, risk control, and risk review must be included in any manufacturer's risk management process.
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Summarised from an article by Alfred Dolan, Convenor of ISO/IEC working group 1, and Stan Mastrangelo, working group 1 member, in ISO Focus magazine, June 2009.
NEW PUBLICATION
NZS 8135:2009 Non-therapeutic use of human tissue Standard
Specifies the quality and safety requirements for the non-therapeutic use of human tissue, in support of the Human Tissue Act and should be interpreted in a manner that is consistent with donor/family/whānau rights and providers' obligations under the Code of Health and Disability Services Consumers' Rights (the Code) and the requirements under the Human Tissue Act (the Act). This Standard applies to human tissue collected from both living and deceased people before and after the enactment of the Human Tissue Act 2008.
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DRAFT STANDARD FOR COMMENT
Free to download from our website: www.standards.co.nz
DZ 8134.7 Health and Disability Services – Pharmacy Standard
The Pharmacy services Standard defines the quality and safety requirements for the provision of community and hospital-based pharmacy services and clinical pharmacy services not provided from a pharmacy. The Standard allows for a closer alignment with the wider health sector and forms part of the wider NZS 8134:2008 Health and disability services Standards suite of documents by aligning with the core Standards. Public comment on this draft closes on 7 October 2009.
STANDARD IN DEVELOPMENT
Pharmacy services Standard
Committee: P8120
Project Manager: Carolyn Gay
Estimated Publication Date: February 2010
Comments: The Pharmacy services Standard is progressing well through its development stage. The committee met in May and again in late June/early July to finalise the content before the project progressed to the public comment stage. The draft is available for public comment until 7 October. All comments submitted during this phase will be individually reviewed by the committee before the final version is sent to the Standards Council for approval. A balanced expert committee from across the sector is working to ensure the Standard demonstrates that consumers are clear about their rights, and providers are clear about their responsibilities for good and safe outcomes.