11.1 Equipment and medicines
All medical equipment and resources must be suitable for supporting comprehensive primary care, safe resuscitation and safe performance of any additional procedures offered in the practice.
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11.1 The practice has the available equipment and medicines specified in Appendix 1. |
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All required equipment and medicines listed in appendix 1 must be available in the practice. If the practice needs time to purchase a piece of equipment, such as an automatic external defibrillator (AED), you can apply to the College for a short term exemption to enable time to do this without delaying your certification.
When you purchase an automatic AED for your organisation, make sure you buy it from a New Zealand medical supplier. This is because all medical devices which are imported into NZ have to be approved by Medsafe and are therefore evaluated for safety and effectiveness.
AEDs with US Food and Drug Administration (FDA) approval have undergone vigorous and substantial testing to ensure they operate as they should. A list of FDA approved AEDs can be found here. St John and the New Zealand Red Cross both sell and rent AEDs which are FDA approved.
Please note, the government is currently developing new legislation for therapeutic goods, the Therapeutic Products Bill, which will include the regulation of medical devices. On the release of the Bill, this guidance will be updated accordingly.
All essential medical equipment and supplies listed in appendix 1 must be available when needed, and competency in the use of the equipment must be current.
An electrical medical device is any piece of medical equipment as defined by the Medicines Act 1981 that involves an applied part to a patient and that part is electrically connected to equipment that has a power source that is earthed.
When using or operating any type of equipment, including electrical medical devices, it is important to assess the following factors:
- Environment:
- Is the space configured to use the equipment?
- Equipment safety:
- Is the equipment safe? Safety can be demonstrated by acceptance testing before new equipment is released and maintenance activities like annual testing and performance verification, etc.
- Is the equipment in working order?
- If using electrical medical devices, is appropriate residual current device (RCD) protection used?
- If the equipment is from overseas, does it meet New Zealand and/or international standards and is it compatible with New Zealand power (230 Volts 50 hertz)?
- Training and competence:
- Does the operator know how to use the equipment?
- Is the operator using the equipment safely?
- Are instructions and rules around its use provided?
Automated external defibrillators (AEDs)
When you purchase an automatic external defibrillator (AED) for your organisation, make sure you buy it from a New Zealand medical supplier. This is because all medical devices which are imported into NZ have to be approved by Medsafe and are therefore evaluated for safety and effectiveness. AEDs with US Food and Drug Administration (FDA) approval have undergone vigorous and substantial testing to ensure they operate as they should.
A list of FDA approved AEDs can be found here. St John and the New Zealand Red Cross both sell and rent AEDs which are FDA approved. Please note, the government is currently developing new legislation for therapeutic goods, the Therapeutic Products Bill, which will include the regulation of medical devices. On the release of the Bill, this guidance will be updated accordingly.