Ensuring the safety and reliability of medical equipment is crucial in healthcare. The standard plays a pivotal role in this regard, providing guidelines for performance testing and electrical safety testing of medical devices.
In this article, we will delve into the key aspects of this standard, its requirements, benefits, and best practices for compliance.
What Medical Equipment May Need Electrical Testing?
Medical equipment that requires electrical testing typically includes devices that operate on electrical power and are used for diagnostic, therapeutic, or monitoring purposes.
Here are some examples of medical equipment that may need electrical testing and tagging:
Infusion pumps
Defibrillators
Dialysis machines
ECG machines
Blood pressure cuffs
Thermometers
Ultrasound scanners
Pulse oximeters
Blood pressure monitors
Temperature monitors
Electrosurgical units (ESUs)
Surgical lights
Operating tables
Electrical mobile hoists
Electric bed frames
Air mattress pumps
Electrically powered hospital furniture
NOTE: Equipment located outside of the patient’s environment but physically connected to medical equipment inside the patient’s environment, such as computers, printers, and other peripherals. these are considered medical equipment and should be tested accordingly.
Medical Electrical Safety Rules
Medical electrical safety is paramount in healthcare environments to protect patients, healthcare workers, and equipment from electrical hazards. These safety rules encompass various standards and guidelines designed to ensure that all medical devices operate safely and effectively.
Key standards include:
1. AS/NZS 3551:2012: This standard is titled "Management Programs for Medical Equipment" and provides a framework for the management of medical equipment within healthcare facilities. It establishes comprehensive requirements to ensure that medical devices are safe, reliable, and properly maintained.
2. AS/NZS 3760:2022: This standard covers in-service safety inspection and testing of electrical equipment, commonly known as test & tag. It outlines procedures for ensuring that electrical devices remain safe to use over time.
3. Electrical (Safety) Regulations 2010: These regulations set out the requirements for electrical installations and the use of electrical equipment to ensure safety.
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Our offerings include medical equipment testing, test & tag services in accordance with AS/NZS 3760:2022, first aid supplies, fire extinguisher inspection and replacement and AED testing. We are your all-in-one solution for ensuring safety and compliance.
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Key Requirements of AS/NZS 3551:2012
The AS/NZS 3551:2012 standard outlines several crucial requirements to ensure the safety and performance of medical equipment. Here are the key requirements:
1. Performance Verification
Medical devices must undergo performance verification according to manufacturers’ specifications. This ensures that the equipment functions correctly and meets the necessary performance criteria.
Performance verification under AS/NZS 3551:2012 consists of three main components:
Manufacturer Specifications: All medical equipment must undergo performance testing as per the manufacturer’s specifications. This ensures that the equipment performs correctly and meets the necessary operational criteria.
Physical Inspection: Involves checking the physical condition of the equipment to identify any signs of wear, damage, or other issues that may affect performance.
Functional Testing: Ensures that the medical equipment operates according to its intended functions.
2. Electrical Safety Testing
Regular Electrical Testing: The standard mandates regular electrical safety tests to prevent electrical hazards. This includes testing the equipment’s insulation, grounding, and overall electrical integrity.
Compliance with Safety Standards: Equipment must meet specific electrical safety standards to ensure safe operation under normal and fault conditions.
3. Preventative Maintenance
Maintenance Schedules: Different types of medical equipment require varying frequencies of preventive maintenance. The standard specifies that all equipment undergoes regular maintenance to ensure ongoing compliance with safety and performance standards. Contact us to learn more.
Annual Performance Verification: At a minimum, all equipment must undergo annual performance verification. This ensures that the equipment continues to meet performance and safety standards throughout its lifecycle.
Electrical (Safety) Regulations 2010
According to the New Zealand Electrical (Safety) Regulations 2010, Section 91 (1):
91 Periodic assessments of electrical medical devices
(1) The owner of an electrical medical device must ensure that the device is periodically assessed in accordance with AS/NZS 3551 to determine whether it is electrically safe and complies with that standard.
(2) The results of each periodic assessment must be recorded in accordance with AS/NZS 3551, and the owner must retain the record.
(3) The person who completes the assessment must —
give the record of the assessment to the person who requested the assessment; and
keep a copy of it for at least 3 years, or send a copy to WorkSafe
(4) A person who owns an electrical medical device commits an offence and is liable on conviction to a level 1 penalty if the device is not assessed in accordance with subclause (1).
(5) A person who owns or operates an electrical medical device commits an offence and is liable on conviction to a level 1 penalty if the person uses, or allows another person to use, the electrical medical device knowing that it has not been assessed as required by this regulation, unless, because of an emergency, use of the device is justified in the circumstances
How Often Does Medical Equipment Need a Complete Checkup?
Every 12 months.
While annual performance verification is a general requirement for all medical equipment, the exact frequency of complete checkups can vary based on the type of equipment, manufacturer recommendations, and the specific usage environment.
According to the AS/NZS 3551:2012 standard, all medical equipment should undergo at least annual performance verification. This involves comprehensive testing to ensure that the equipment meets safety and performance standards. Annual checkups help identify any potential issues before they lead to equipment failure, ensuring continuous safe operation.
Documentation
Full Testing Documentation and Report: All tests performed must be thoroughly documented. This includes providing a comprehensive report that details the findings of performance and electrical safety tests.
Record Keeping: Accurate and up-to-date records of all testing and maintenance activities are essential for compliance and for future reference during audits or inspections.
It is essential for maintaining the safety and reliability of medical equipment. By following the guidelines for performance and electrical safety testing, healthcare facilities can enhance patient care, ensure regulatory compliance, and improve overall operational efficiency. Don't delay — ensure your facility is compliant today.
For further information on AS/NZS 3551:2012, please refer to the official standard documentation and relevant regulatory bodies.
Sources:
Medsafe New Zealand Regulatory Guidance
WorkSafe New Zealand Electrical Safety
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