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.
The adequacy and appropriateness of basic equipment may be determined by the practice’s circumstances. The practice may be asked to justify any omissions.
All essential medical equipment and supplies listed in appendix 1 must be available when needed, and competency in the use of the equipment should be current.
If an electrocardiograph is not available in the practice, an agreement should be in place for the practice team to access the equipment when needed. Clinical team members should be appropriately trained to use them.
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:
- 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?
- Instructions and rules around its use are provided.
Calibration and validation
Calibration is the process that confirms the quantitative accuracy of instruments or equipment (e.g. scales, sphygmomanometers).
Validation is the process of confirming the effectiveness of the equipment that it is achieving the required outcomes (e.g. steriliser/autoclave).
The staff will need to keep records of annual servicing, calibration and validation of key pieces of equipment in the practice.
Safe storage of medical equipment, medicines and pharmaceutical products.
The Medicines Act 1981 – Section 47 states:
Storage and delivery of medicines
- No person who is in possession or in charge of any prescription medicine or restricted medicine shall put it:
- In any cupboard, box, shelf, or other place of storage in which articles of food or drink are stored or kept for ready use
- In any place to which young children or unauthorised persons have ready access.
- No person shall pack any medicine, or prepare it for use, in any room, or on any table or bench, that is used for the purpose of packing, preparing, or consuming any food or drink.
- Except as otherwise provided in any regulations made under this Act, no person who is in possession, for the purposes of any business, of a prescription medicine or a restricted medicine that is kept for the time being within any building or vehicle shall leave that building or vehicle unattended, unless they have taken all reasonable steps to secure that building or vehicle, or the part of it in which the medicine is kept, against unlawful entry.
Testing residual current devices (RCDs)
RCDs should be tested regularly to ensure that their capacity to ‘trip’ is still functioning. This is something that the practice staff can do.
Socket outlet or portable RCDs can be tested by plugging in a small electric appliance (such as a lamp). Press the ‘test’ button. If the appliance turns off, the RCD is working. If it stays on, get the RCD checked by a licensed electrician. Make sure to press ‘reset’ once the test is complete.
Switchboard RCDs should be tested every six months by checking that they trip when the ‘test’ button is pushed. However, be aware that tripping circuits will turn off the power to any appliances on that circuit (be careful with the vaccine refrigerator). Appliances with electronic clocks will have to be reset. For this reason, test the switchboard RCDs when changing to and from daylight saving, when clocks must be reset anyway, and it will be about six months since the RCDs were last tested.
In addition, all 10mAmp Type 1 RCDs should be annually tested by an electrician with proper test equipment and documented. The testing details can be sent by email for the records.
The staff should keep a dated and signed record of any RCD testing – electronic records are acceptable.
The electrical testing records should include:
- Who did the testing?
- What equipment was tested (list what was tested)?
- What they are claiming (e.g. it is safe, it has been verified it is performing properly, etc.)?
- What is the basis/evidence for the claim (e.g. test results, etc.)?
Body Protected Areas
In some situations, the practice may decide to set up areas specifically dedicated for using electrical medical devices that are used to diagnose, treat, or monitor a patient. These areas are referred to as a Body Protected Area.
Specialised services such as X-ray, minor surgery (involving diathermy and monitoring) or even a plaster room may benefit from the use of Body Protected Areas.
The features of a Body Protected Area are:
- They use isolating RCDs (10mAmp Type 1).
- They use socket indicators (lights on/off).
- RCDs need to be accessible in the Body Protected Area/room or be labelled with lights on the switchboard in accordance with AS/NZS 3003:2011.
The specific requirements for Body Protected Areas are described in AS/NZS 3003:2011.
A general practice may not need to set up Body Protected Areas to use electrical medical devices if they are following safety standards as outlined above.
If a practice is setting up Body Protected Areas within the practice, then is it essential that advice and direction is received from a suitably qualified person.
Where the practice has deemed an area is a Body Protected Area, this area is to be certified and maintained in accordance with AS/NZS 3003:2011. Keep a documented record of assessment by an authorised person. The practice will need the correct sign on the wall with correct, current stickers.
It is the responsibility of each practice to ensure they have checked their individual requirements to ensure compliance with the relevant legislation or standards.
Body Protected Areas need to be inspected annually by someone appropriately qualified. On each occasion the Body Protected Area signage will need to be updated with the latest inspection date.
The practice should hold a:
- register of the medical equipment with a schedule and reminder process to ensure everything is current
- copy of the annual medical equipment servicing report (this should be certified and dated)
- record confirming the date when RCDs have been tested.
Documented checking of all stock levels and expiry dates at a practice- agreed frequency although it is recommended that this would be atleast six-monthly and would depend on the practices stock usage, expiry date length etc. The checking process should also include checking stock levels of epidemic/pandemic specific materials and equipment.