Accreditation Testing

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:

 

1. 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.

 

2. Contractors should have Medical Equipment Product & Public Liability  insurance for no less than $20 million cover and Work Cover Insurance for all employees. This is provided by U-Tech Medical

 

3. 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

 

4. Contractors should demonstrate compliance to ISO9001 quality management system and Worker Health & Safety guidelines. U-Tech Medical is ISO9001 Quality Management System Accredited.

 

U-Tech Medical complies with all of the above guidelines.

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.

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.

This is not required, however if you prefer to acquire a copy, click here “AS/NZS 3551”

U-Tech Medical will advise the corrective action and the cost if repair is needed for compliance.

There are a number of factors to consider when choosing the correct service company:

Click here to see the “Service Provider Evaluation Checklist” 

Click here to see the report on “Mistakes Medical Professionals Make When Selecting A Biomedical Service Company and How To Avoid Them”.

Click here to see the scope document Australian Standards AS/NZS 3551:2012 Management programs for medical equipment

Click here to shop online to purchase the complete standards AS/NZS 3551:2012

Orr simply ask one our customer service team members on 1300 488 324

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.

 

U-Tech Medical’s inspection of medical equipment will cover all the requirements of the Australian Standards including the following checks and testing:

 

Physical inspection

 

  • 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.

 

Performance verification

 

  • 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.

 

So here are some ways to avoid mistakes when choosing a biomedical service provider that ensures you remain compliant with Australian Standards.

 

 

Click here to see the “Service Provider Evaluation Checklist” 

 

Click here to see the report on

“Mistakes Medical Professionals Make When Selecting A Biomedical Service Company and How To Avoid Them”.

 

Click here to se the Australian Standards AS/NZS 3551:2012 Management programs for medical equipment

 

Click here to shop online to purchase the Complete Standards AS/NZS 3551:2012

 

Or simply ask one our customer service team members on 1300 488 324

U-Tech Medical is a Biomedical Technical Engineering Services Company and proud to be an ISO9001 Certified Service Provider.