Vital Resus Australia offers biomedical testing for all medical practices to assist in compliance and ensure the accuracy and reliability of equipment for patients.
We have compile a list of commonly asked questions in relation to the equipment testing and maintenance at medical practices. You can download the PDF version of this by clicking here.
All practices are required to have biomedical equipment testing in accordance with the Work Health and Safety Act, Australian/New Zealand Standard 3551:2012 and RACGP requirements.
Under the Work Health and Safety Act, a person conducting a business or undertaking at a workplace must ensure that electrical equipment is regularly inspected and tested by a competent person in accordance with guidance provided in AS/NZS 3760:2010 In-service safety inspection and testing of electrical equipment.
AS/NZS 3551:2012 Management programs for medical devices provides guidance for the testing and maintenance requirements of medical devices and electrical devices used in patient care areas which are excluded from AS/NZS 3760:2010. In this standard it details that each item of equipment is to be tested, as referenced below, and therefore all practices are required to test medical devices and electronic devices used in patient care areas.
Each item of equipment is—
In addition to the Work Health and Safety Act, accredited practices are guided by the RACGP Standards for general practice (currently 4th edition). The standards detail that all equipment that requires calibration or that is electrically or battery operated requires regular servicing in accordance with the manufacturer’s instruction.
There are a number of tests to ensure the safety, accuracy and longevity of biomedical equipment. Routine testing and maintenance can assist in mitigating the risk associated with the use of medical equipment on patients and the operators. Some of the general types of testing are summarised below.
Electrical Safety Test
Electrical safety testing is intended to ensure that risks arising from electrical hazards are maintained at acceptable levels during the useful life of the equipment. AS/NZS 3551:2012 specifies what parameters should be tested and these include (where appropriate):
Throughout the lifetime of medical equipment in clinical use, there is a need for regular assessment and testing of the medical equipment to ensure it is safe and continues to be safe, for its intended clinical application. It is also likely that medical equipment will, from time to time, be subject to various corrective or preventative maintenance activities. In accordance with AS/NZS 3551:2012 performance verification generally involves both physical inspection and functional testing in accordance with manufacturer guidelines (including device inputs, outputs, alarms and safety or protective functions).
In some cases medical equipment requires calibration either periodically or when it is found to be operating outside the design specifications during routine testing.
Some medical equipment requires regular maintenance to keep it operating at optimum performance. In accordance with AS/NZS 3551:2012 and the RACGP Standards for general practice (4th edition), equipment is required to be maintained as prescribed by the medical equipment manufacturer, but may also be influenced by local operational conditions or the environment in which the medical equipment is used. Recommended preventative maintenance activities shall be performed as an integral element of the medical equipment management program. Examples of routine preventative maintenance include replacing parts with a service kit, inspection and calibration.
An increasing amount of medical equipment now contains microprocessors or computers and as a result often rely on installed software for their operation. From time to time software needs to be upgraded or updated to add new features or to resolve bugs.
The frequency of equipment testing and maintenance varies on an item by item basis and generally falls back to manufacturer recommendations. It is generally accepted that testing should occur at least every 12 months and in high use or adverse environments then this should be more frequent. Vital Resus Australia will assess your equipment and conditions and recommend testing and maintenance intervals to ensure the safety and accuracy of your equipment.
For a closer look at the specific guidance on the frequency of testing, please see a summary below.
Manufacturer recommendations vary on an item by item basis and therefore need to be reviewed separately. Through our equipment service database and many years of experience, Vital Resus Australia is able to assist in confirming the manufacturer recommendations. Based on the most common equipment items seen in practices, it is generally recommended by manufacturers to test and service (where required) equipment at least every 12 months.
In addition to compliance, safety and accuracy there are a number of other benefits of testing and maintaining medical equipment. Some of these include: