AS/NZS 3551 and AS/NZS 2500 - ongoing issues
The standards AS/NZS 3551:2012 Management programs for medical equipment and AS/NZS 2500:2004 Guide to the safe use of electricity in patient care purportedly represent the views of clinical engineering consultants and employees of healthcare organisations.
The AS/NZS 3551 standard has increasingly been included in invitations to tender by State health procurement organisations as a requirement for suppliers of medical devices to comply with and/or to provide certification of medical devices to this standard. Obviously, this is non-sensical, because AS/NZS 3551 is aimed at healthcare organisations only. The applicable standards for medical devices, manufacturers and distributors are:
- Type testing standards such as those in the IEC 60601-1 family of standards
- ISO 13485 for quality management systems of manufacturers
- ISO 9001 for quality management systems of distributors
MTAA has been raising concerns about AS/NZS 3551 since 2015, and in December 2018 submitted a project proposal with the HE-003 technical committee to address misleading or false statements, poor structure and a general lack of clarity and specificity in the requirements of AS/NZS 3551. The MTAA project proposal enjoyed strong and wide support from our membership.
The AS/NZS 2500 includes a so-called “safety triangle” which portrays AS/NZS 3551 as “the” safety standard for medical equipment reinforcing thus the misconception that MTAA has been diligently trying to correct (see Fig 4.1 in draft AS/NZS 2500 open for public comment as of 8 July 2019 reproduced below).
Some of the main problems with AS/NZS 3551:2012 are:
- Section 9 allows modifications (other than custom-made devices)/ refurbishments to be done by hospitals without any safeguards such as ensuring that the basic safety and essential performance of medical devices are still maintained. It states: “If the safety function or operability of the medical device has been changed, a legible and indelible label shall be permanently secured in a place clearly visible to the user.” Clearly, labelling alone is not enough!
- Section 10 fails to specify that if hospitals fail to maintain/ service medical equipment in accordance with manufacturer’s instructions such deviations should be documented and justified.
International best practice requires that healthcare organisations that modify/ refurbish medical devices not on behalf of the original manufacturer, ensure that the medical devices they manufacture/ modify are safe and effective. By undertaking a manufacturer’s activities, they assume the responsibility and liability of a medical device manufacturer.
The new EU Medical Device Regulations (MDR) require health institutions engaging in manufacturing or modifying medical devices for their internal use to meet certain conditions:
- Demonstrate compliance with applicable general safety and performance requirements (similar to Australian Essential Principles)
- Establish an appropriate quality management system (such as those defined in ISO 13485)
- Review experience gained from clinical use of the devices and take all necessary corrective actions
- Justify that the target group’s specific needs cannot be met by an equivalent device on the market
- Make information available to the regulatory authorities upon request
- Make a declaration containing relevant details about the device publicly available
For more details please refer to the MTAA spreadsheet detailing issues with AS/NZS 2500 and 3551 standards.
Australian medical regulations are in the process of being aligned with the EU MDR and it is only a matter of time until this regulatory loophole is closed in Australia as well. Until then, MTAA is calling on all stakeholders – industry, consumer representatives, healthcare providers – to join us and address the current problems in AS/NZS 3551 and AS/NZS 2500 in a constructive and collaborative manner.