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 is called up under Sections 25 and 91 of the Electricity (Safety) Regulations 2010.
AS/NZS 3551:2012 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 patent, or detects such energy transfer to or from the patient, or is intended to diagnose, treat or monitor the patient.”
DHBs, private hospitals, medical clinics, rest homes/hospitals and health care businesses 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:-
- Acceptance process
- Scheduled (WOF) testing
- Breakdown/fault repairs
Correct scheduled (WOF) testing is critical (and a legislative requirement) to ensure safe use of the medical device for the patient and the operator. This WOF testing must be done yearly.
When an asset is tested to ASNZ3551 (WOF tested), we record the following:-
- Physical Inspection
- Preventative Maintenance
- Replacement of scheduled maintenance parts that will keep the unit at optimal functioning level
- Functional Testing
- Device Inputs and Outputs
- Safety Cut out and Protective Functions
- Gas and/or Liquids
- Electrical Testing
- Protective Earthing
- Insulation Resistance
- Earth Leakage Current
- Patient Leakage Current
Parameters are determined at time of device acceptance in accordance with manufacturers’ specification and suitable risk categorisation.
Once completed, you will receive a copy of our findings and a documented list of your assets to comply with ASNZ3551 – asset management