A Patient Treatment Area is any space where electrical equipment is used to evaluate, treat, or monitor a patient. Specifically, it is an area within a medical facility such as an operating theatre, or any room used for recovery, exams, minor procedures, intensive care, or coronary care.
The patient treatment area is a space from which a patient may not be readily moved, irrespective of the time the patient may spend in the room. The responsible organisation must document the location of all Patient Treatment Areas and their classification, whether the area is designated as body-protected or cardiac-protected. These areas will typically be called out on drawings and building plans from design engineers if the original building construction included these areas.
Some common Patient Treatment Areas are:
In general, any medical, dental, or health-care facility requires certification of their Patient Treatment Areas. Subsequent to the original certification, annual recertification is mandatory. The responsible person or organisation must verify that electrical installations meet the requirements of AS/NZ 3003 prior to normal use. This applies to any new installations, new construction, or alterations to existing facilities including additions or repairs.
If you operate any electrical equipment involved in patient care, this certification and annual recertification, is a requirement for your facility. For organisations involved in the transportation of patients, the vehicle you use in transport may be considered a Patient Treatment Area if there is electrical equipment used during transport. Other medical facilities that focus on “wellness” may still require certification to this standard: Naturopathic and Chiropractic centers may also operate equipment that requires Body Protected electrical areas.
AS/NZ 3003 is the current electrical safety standard that specifies requirements for medical electrical equipment used on patients. It also applies to home-care facilities and medical transport vehicles. The standard defines how to identify, inspect, and test electrical installations in patient areas.
This standard is used in conjunction with AS/NZ 3000 Electrical Installations, or “wiring rules”, that covers general electrical installation safety. Like all low voltage equipment, there are certain general rules that apply, but there are additional considerations for patient electrical areas. There are two major classifications of patient electrical areas defined by the AS/NZ 3000 standard: body protected and cardiac protected. A single room must be one or the other: it cannot be both body and cardiac protected.
A body protected patient area includes all full height walls and doors bounding an area where patients are stationed. That means dividers such as bed curtains, desks, or partial walls do not separate a body protected area from a common area: the body protected area encompasses the entire room. Certain types of medical equipment cannot be used within these areas because they are cardiac applied. A cardiac protected patient area is like a body protected area; in that it includes an entire room. The primary difference is that these areas include stricter controls to allow for cardiac applied equipment to be used. Cardiac applied equipment directly involves contact with the heart and is associated with a significantly higher risk of electrical complications (i.e., microshock electrocution).
The standard defines requirements for electrical general-purpose outlets (GPOs), residual-current devices (RCDs), miniature circuit breakers (MCBs), and all components related to the safe supply of electrical power. It includes rules for where these fixtures must be installed, labeling of the circuits, and methods to test and inspect these protected areas to assure their continued safety.
The certification process begins before an electrical installation is brought into service. The area and all components of the system are inspected, tested, and verified.
Your electrical installer will complete a “Statement of Conformity with AS/NZ 3003” to document whether the installation is for a new area or repairs/alterations to an existing area, and what type of protected area is in question. They check that each area has the proper number of socket-outlets required for medical personnel to carry out their duties. Additionally, they document their company information, the location of the facility, and the date the work was completed.
Upon completion of the installation, an inspection must be carried out as far as practicable. The inspection covers over 90 points required to demonstrate compliance. The inspector checks to see if the proper boundaries are applied and works through the area to ensure the proper safety equipment has been installed prior to testing. They will confirm that general purpose outlets are not readily accessible within the Patient Treatment Area. Another part of the inspection is reviewing that all socket-outlets are appropriately labeled, and that the labels are appropriately placed.
Testing involves using specialised equipment to take measurements; the first part of testing is checking electrical continuity of the earthing system. The inspector will determine if the equipment can safely discharge electrical energy by measuring the resistance of the earthing conductor for each low voltage socket-outlet. They will also measure insulation resistance and perform additional tests on circuit connections. Testing may require troubleshooting until all tests are passed without fault.
The Patient Treatment Area is verified to comply with all required rules of AS/NZ 3003. These rules include, among others:
Additional rules cover color coding and other factors, for example: red socket-outlets designate essential supply, white indicates non-essential supply and blue indicates UPS enabled supplies.. Verification includes all confirmation, substantiation, and authentication that the area meets the requirements for certification. A commissioning inspection checklist is completed to confirm that each requirement has been passed.
A Body Protected or Cardiac Protected Electrical Area sign is securely fixed at a height of 2m from the floor to the top of the sign.. A Certification and Verification label is placed on the sign to permanently display the original commission date.
Certification is required for any new patient treatment area. A routine inspection is also required by AS/NZ 3003 every 6 to 12 months. Inspection is a prerequisite for alterations and recertification.
Alterations can be made to any such treatment area only if the area is within the in-date of the attached routine safety test label. After the alteration is made, the changes are documented in a report and the area is retested and recertified. As part of recertification, the alteration is marked on a label affixed to the Electrical Area sign.
Safety for cardiac protected and body protected electrical areas is a serious matter: failure to comply with AS/NZ 3003 can result in life-threatening risks to patients.
Medical facility electrical systems are held to a higher standard than general electrical systems because of the intended application. First and foremost, not certifying cardiac-protected electrical areas carries the highest risk of death or other serious injury. Cardiac applied equipment is highly sensitive and can directly shock the heart and electrocute a patient if a malfunction occurs.
Failure to certify body-protected electrical areas could still carry a high level of risk for your patients. Electrocution is not the only type of failure that conforming to this standard helps you avoid. Electrical shock, burns, equipment damage, and even electrical fire could result from failure to properly install and certify electrical systems in Patient Treatment Areas.
If the safety of your staff and patients were not reason enough, you and your organisation may face legal penalties and even criminal prosecution when an injury occurs. It is the responsibility of the organisation that owns and operates the facility to ensure that it is safe for staff and patrons.
A qualified and experienced contractor must perform Patient Treatment Area Certification. Typically, the person who performs the inspection, testing, and certification are the same person, or a small team may be involved in the process. The contractor may have a background in biomedical engineering, electrical engineering, or a similar field.
Certification is normally completed by an independent organisation that operates certified, calibrated, and compliant electrical testing equipment. Without the proper equipment, it is impossible to collect proof necessary to verify that the installation meets all applicable requirements.
A licensed inspector, qualified medical physicist, field service engineer, or other such person(s) that are acceptable to your facility may perform the certification. The installer may be involved with the testing and certification process also – but typically an independent contractor is used. Having an independent reviewer of the work completed adds objectivity to the findings and helps ensure that mistakes are not overlooked.