Any person or organisation that uses or maintains medical devices is subject to the Standard AS/NZS 3551:2012 - "Technical management programs for medical devices".
The standard defines a medical device as “Any instrument, apparatus or appliance, including software, whether used alone or in combination, together with any accessories necessary for correct operation, which makes physical or electrical contact with the patient, or transfers energy to or from the patient, or detects such energy transfer to or from the patient, or is intended to diagnose, treat or monitor the patient."
The Standard is called up under Sections 25 and 91 of the Electricity (Safety) Regulations 2010.
DHBs, private hospitals, medical clinics, rest homes/hospitals and health entities often have a range of medical devices that are subject to the Standard.
What is the Standard about?
AS/NZS 3551:2012 covers the requirements for management of medical devices and includes:
Correct performance verification is critical to ensure safe use of the medical device for the patient and the operator.
A. Physical Inspection
- Check for signs of damage
- Check that the device is clean
B. Functional Testing
- Functional testing
- Basic Function
- Device inputs
- Device outputs, electronic and physical
C. Safety Testing
- Electrical testing
- Mechanical safety
- Radiation safety
- Gas safety
- Battery safety
Parameters are determined at time of device acceptance in accordance with manufacturers' specification.
HEALTH AND SAFETY AT WORK ACT 2015
The requirement to achieve compliance with the Standard AS/NZS3551:2012 is also supported by Health and Safety legislation. One of the key purposes of this act is to provide a balanced framework to ensure the health and safety of workers and workplaces by "protecting workers and other persons against harm to their health by eliminating or minimising risks arising from work or from potential high risk plant"
KEY COMPLIANCE NOTE
Medical devices are a specialist area which is subject to particular standards and legislation. Ensuring you get the right Service Engineer is critical to ensure correct compliance.
Testing of medical devices is normally undertaken by a professional biomedical engineer. The engineer will typically have an extensive electronics background, knowledge of medical devices and be fully conversant with the Standard AS/NZS3551:2012. The engineer will maintain the full suite of testing equipment to ensure that all necessary tests are undertaken for both electrical safety and performance (checking that the devices work correctly).
Electricians and other service technicians normally test to a different standard (AS/NZS3760:2012 Domestic Appliances). The testing they do is normally suitable for fridges and microwaves but not for medical equipment. Your organisation, staff and patients/clients may be subject to safety risk if your medical devices have not been tested to the correct standard compliance. Risk also exists where not all required electrical and performance tests have been completed.