Performance and Safety testing of Medical Equipment(management programmes to Australian Standards AS 3551)
Medical equipment may cause physical harm to patients, or provide false or misleading data, or fail to operate as expected. Confirmation that medical equipment is performing accurately, reliablt and within manufacturer’s specifications is often not directly available to the user.
Australian Standards recommends that Responsible Owner of Medical Equipment, follow the guidelines of the “Management programs for medical equipment”, [AS 3551:2012] to ensure performance verification and safety testing is managed throughout the service life of medical equipment. U-Tech Medical supports this Standard and can provide assistance and guidance to adopt the best management program, specifically for the devices types in your practice.
How we can help?
- We can review your list of equipment and provide you with a recommendation for the specific tests required and the frequency of testing for each device.
- With our calibrated test equipment we can provide a validation and safety report indicating compliance with this standard.
- We can advise on the condition of your devices, and recommendation on the life cycle of each device so you can plan a replacement program before the equipment becomes non-serviceable.
- Management Programs for medical equipment
Frequently asked questions and answers
Q. How often does my equipment need to be tested?
A. The standard calls for a risk assessment of each device. The assessment should include, manufacturers recommended intervals, impact and likelihood of failure, experience with similar equipment, level of usage, statutory requirement, and service history. Typically, it is industry standard to test devices at least annually.
Q. If my equipment comes with manufacturers extended service warranty, do I still need do this testing?
A. Yes. The warranty of equipment is not related to the management program, however the tests recommended is this program, needs to be completed after any repairs or re-calibration is made.
Q. What happens if my equipment fails the test?
A. U-Tech Medical will advise the corrective action and the cost if repair is needed for compliance.
Q. Do I need to purchase a copy of the Australia Standards?
A. This is not required, however if you prefer to keep a copy, it is available on-line at:http://infostore.saiglobal.com/store/ and type “AS/NZS 3551” in the search window.
Q. How do I select the best biomedical service company for my equipment management plan?
A. See the “Service Provider Evaluation Checklist” on our homepage or ask one of our customer service team members to send you the report on “Mistakes Medical Professionals Make When Selecting A Biomedical Service Company and How To Avoid Them”.
Management Programs for Medical Equipment (AS3551: 2012)
As a responsible biomedical service company, U-Tech Medical recommends that all owners of Medical Equipment adopt the Australian Standard (AS3551:2012), “Management programs for medical equipment”, on an annual basis, to ensure performance verification and safety is maintained throughout the service life of medical equipment.
This will provide owners, with Peace of Mind, and ensure your equipment is ready to go, when needed. This is also important for patient well-being, and to minimise the possibility of litigation.
U-Tech Medical’s inspection of medical equipment will cover all the requirements of the Australian Standards including the following checks and testing:
- check that the medical equipment is free from obvious external damage.
- where internal damage to the medical device is suspected, a check that internal assemblies are secure, such as relays, connectors and printed circuit boards.
- check for any damage or defect in the accessories, such as connectors, plugs, appliance coupler and sockets.
- check that cord grips and protective casing, are effective.
- check expiry date on critical components and accessories, such as batteries, patient electrodes.
Calibration and Safety testing of equipment
- Testing of all patient inputs and outputs functions by applying calibrated patient simulated signals to ensure equipment is operating within manufacturers calibrated specifications.
- Electrical safety testing and tagging.
- verification of procedures recommended by the medical equipment manufacturer;
- verification of procedures that can be regularly undertaken by the medical equipment user;
- level and reliability of in-built self-testing, or self-verification within the medical equipment;
- cross verification within a single test regime, e.g. rate meter checked when alarm function checked;
- stability/maturity of technology;
- the operational environment in which the medical equipment is used;
- operational experience with the medical equipment, or similar types of devices, such as failure rate
- requirements of the preventive maintenance identified at the time of medical equipment acceptance.
But the testing is only as good as the Tester. This guide has been produced to help medical equipment owners commission appropriate testing and calibration contractors. We recommend that the following guidelines are used to ensure the best possible contractor is used:
- Contractors should be able to demonstrate that they have received the appropriate training from the relevant suppliers. U-Tech Medical has over 20 years, medical equipment service experience, and is authorised to service medical equipment.
- Contractors should Medical equipment Product & Public Liability have insurance for no less than $20 million cover and Work Cover Insurance for all employees. This is provided by U-Tech Medical
- Contractors must be able to demonstrate that their test equipment has itself been tested by an accredited calibration company within the last 12 months. This is provided by U-Tech Medical
- Contractors should demonstrate compliance to ISO9001 quality management system and Worker Health & Safety guidelines. Note: All of the above guidelines are used by U-Tech Medical