Health sector employees have made requests looking for clarification of regulations that apply to electrical medical equipment used to treat patients in their homes. We have made the following response.
WorkSafe provides this guidance in response to health sector requests for clarification of the Electricity (Safety) Regulations(external link) regarding the requirements applying to the use of electrical medical equipment for treatment of patients in home environments, particularly (Type 1- not double insulated) equipment used for renal peritoneal dialysis equipment and some respiratory humidifiers.
While double insulated, medical-electrical equipment classified as BF or CF, may be used in home locations without specific Residual Current Device (RCD) protection, the provisions of AS/NZS 3003 Electrical installations – Patient areas specify that where Type 1 equipment is being used for an extended period of time a permanently installed RCD is required.
The health sector has noted that the cost of installing an RCD specifically for this purpose is relatively high and requires the treatment to be carried out in only one location within the home unless more than one RCD is installed, and therefore asks whether the continued use of portable RCDs is unacceptable or unsafe.
The relevant Regulation in this case is Regulation 25(external link), which is structured principally around risk and sets out practices that are recognised as being safe. It is through this Regulation that compliance with AS/NZS 3003 is established for the safe use of electrical medical equipment.
Because compliance with AS/NZS 3003 is a recognised (deemed to be safe) method of achieving the general safety requirements for the use of electrical medical equipment, in the regulation’s risk based approach, its application is not mandatory, nor does the Standard represent a minimum benchmark by which an alternative safety methodology must be assessed.
Regulation 24(5)(external link) however sets the minimum requirements for RCDs that provide protection for medical treatment and for portable RCDs.
Therefore, for example, the use of a 10 mA RCD protected supply using a portable RCD, where the users of the equipment (or trained medical staff) perform their own safety checks of the functioning of the RCD on a regular basis, is not necessarily inadequate. The checks could be performed using the test feature that is required to be part of a “safe” RCD.
Review of Regulations
It is expected that this this aspect of home care safety will be considered during the next revision of AS/NZS 3003 and the Regulations. In the short term the NZ experts serving on the Standards committee responsible for AS/NZS 3003 have given their support for this guidance note.