Biomedical Electrical Testing - Why it's vital to get it right
Updated: Dec 3, 2019
Biomedical Electrical Safety is a legal requirement under New Zealand Law -
Reads these excerpts from the The Royal New Zealand College of General Practitioners – doc 'Foundation Standards Interpretation Guide APR 2016' – pages 33-36
Indicator 17 - section 2 - Medical equipment and resources are available and maintained
17.5. There is an audit trail to monitor the servicing of all medical equipment according to Electrical (Safety) Regulations 2010 Clause 60 & 91 and relevant standards (AS/NZS 3000;3003;3551), maintenance and operating instructions.
Treatment or consulting rooms with medical electrical appliances are certified as ‘Body Protected Areas’ in accordance with AS/NZS 3003.
Documented record of servicing, which may include
– Evidence that equipment has been tested/serviced by way of annual tagging equipment by the service company.
– Annual electromedical testing documents.
– Records of calibration
17.6. Residual Current Devices (RCDs) are used to protect patients and members of the practice team in accordance with the Electrical (Safety) Regulations 2010.
Documented record of assessment by an authorised person in accordance with AS/NZS3003; and
RCDs must be medical grade 10 mA.
All medical equipment and resources must be suitable for supporting comprehensive primary care, safe resuscitation and safe performance of any additional procedures offered.
All essential medical equipment and resources must be available when needed, and members of the practice team must know how to use the equipment. Equipment must be calibrated as required, in working order and have current expiry dates for servicing.
Medical equipment testing and servicing
Medical equipment must be inspected, tested and serviced in accordance with the Electricity Act 1992 and Electricity (Safety) Regulations 2010, other relevant standards and the manufacturer’s operating instructions.
The practice should hold:
a register of the medical equipment with a schedule and reminder process to ensure it is safe and in working order
a copy of the annual medical equipment servicing report.
Body Protected Area
Any area within a medical facility where patients are treated, diagnosed or monitored using medical electrical appliances must be classed as a Body Protected Area. This almost always includes treatment or procedure rooms, and may include consulting rooms where medical electrical appliances are used. Some larger facilities may have other specialised areas that need to be Body Protected, such as an X-ray room or a plaster room. The specific requirements for Body Protected Areas are described in a joint Australian/New Zealand standard AS/NZS3003. The Electricity Safety
Regulations 2010 require that all medical facilities be compliant with this standard as a means of ensuring patient safety.
What are the key features of a Body Protected Area?
There are several requirements, but the important ones are:
All socket outlets must be protected by medical grade 10mA RCDs. The RCDs must be within the Body Protected Area they service, they can’t be in another room or on the switchboard.
The area must be designated by a green Body Protected Area sign on the wall as below:
The sign is of a specified size, must be located in a visible location at a height of 2000 mm from the floor to the top of the sign. The area to the top right of the sign gives the test date and signature of the certifying person. The certification is current for 12 months from the test date.
All appliances used within the area (both medical appliances and general appliances) must be tested to the AS/NZS3551 standard.
At least one socket outlet shall be provided for cleaning equipment and shall be marked ‘Cleaning Purposes Only’. In some cases this can be outside the Body Protected Area.
The area must be certified annually to the requirements of AS/NZS3003.
How often must a Body Protected Area be recertified?
A Body Protected Area must be recertified every 12 months. This involves checking that all the switch socket outlets and other electrical fittings and fixtures are in good condition, and that the RCDs trip at the correct current and within the correct time frame. Part of the check ensures that all required labels markings and indicators are in place.
Our treatment room is not currently a Body Protected Area What do we need to do?
There are a number of approaches to this, but for most existing buildings it is possible to establish a Body Protected Area to comply with the standard relatively easily. In many cases it is just a case of replacing the standard socket outlets with outlets that incorporate a built-in RCD of the correct type. In a new building the entire Body Protected Area could be protected by one RCD, but for existing buildings this might require substantial rewiring and the cost of using multiple RCDs will be less. There is of course the consideration of ongoing costs as each RCD will need to be individually tested on an annual a basis. Your electrician can advise you on the best approach for your building. Once the RCDs are installed, a green Body Protected Area sign is placed on the wall and a label is affixed to it to indicate that the area has been tested and is compliant.
Who can install RCDs or undertake other work required for a Body Protected Area?
This work can only be undertaken by a Registered Electrician. Some electricians will be more experienced with the requirements for Body Protected Areas than others.
Who can certify a Body Protected Area?
The inspection and testing requirements for Body Protected Areas have been formulated so as an electrician’s licence is not required, however it is essential that the person undertaking the tests has a comprehensive knowledge of the requirements of AS/NZS3003. Usually this means the person who undertakes testing will be a qualified biomedical technician or engineer, or a registered electrician with experience of medical locations.
Under what circumstances can medical electrical appliances be used outside a Body Protected Area?
1. In an emergency where a patient’s life or safety is at risk. For example, when an ECG is taken after a patient has collapsed.
2. In situations where it is known that treatment will be required outside a Body Protected Area, a portable or built-in RCD may be used. For example a therapeutic ultrasound used for sports medicine. Ideally battery operated equipment should be utilised in such situations wherever possible.
We have a computer in our treatment room. Does this need to be tested for electrical safety?
Yes to does. Any mains powered electrical appliance within the designated Body Protected Area must be routinely tested to AS/NZS3551. This includes non-medical appliances such as computers, radios and electric fans.
MegaTest Biomedical Electrical Technicians are here to help and guide you through this legislation
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