Regular testing and ongoing maintenance of your medical equipment is essential for ensuring patient safety, better performance and reduced downtime, resulting in greater productivity and cost savings.
This guide breaks down the key elements that should be considered and understood by anyone who uses medical equipment.
What are performance verifications on medical equipment?
Performance verification means providing objective evidence that medical equipment complies with the manufacturer’s specifications. These specifications define the accuracy, precision, and other qualities of the equipment that allows it to meet the requirements of its intended use. Verification testing can help qualify the device to continue to be used and identify equipment that needs attention before it can be safely used again. During verification tests, engineers may detect damage, wear, and other variables that can lead to device failure, and perform preventive maintenance to ensure the equipment will continue to be reliable.
Performance verification is a process that ensures equipment is safe to use and will function as you expect it to throughout the device’s lifespan. Performance Verification is one of the minimum requirements from the standard, Management Programs for Medical Equipment (AS/NZS 3551:2012). The equipment must also undergo acceptance testing prior to clinical use and be maintained according to the manufacturer’s instructions. Manufacturers develop their specifications within a risk management system – the information provided in these specifications and instructions for maintenance are included to reduce the risk associated with that equipment.
Who requires equipment testing and maintenance?
Generally, any facility which utilises medical devices equipment must demonstrate compliance with the Work Health and Safety Act. This includes all medical practices, hospitals, dental offices, care facilities, surgical practices, and other organisations. Most importantly is any facility that owns and operates electrical medical equipment. Whether you have one device or thousands in your facility, testing and maintenance must be performed on each item.
In fact, a comprehensive effective maintenance program for a facility’s medical equipment is another requirement for compliance with AS/NZS 3551:2012. It is the organisation’s responsibility to ensure that medical equipment safety and performance is constantly maintained. The organisation must utilise regular assessments, verification testing, and preventive maintenance of the equipment throughout the organisation’s facilities to be able to demonstrate to inspectors that all efforts have been made to ensure the safety of all workers and patients.
Medical facilities are also subject to requirements of the Royal Australian College of General Practitioners (RACGP), along with many other regulatory requirements. The RACGP Standards for General Practice also requires regular servicing of electrical or battery-operated equipment. By implementing an equipment testing and maintenance program, the organisation can demonstrate compliance with many of these requirements.
What types of testing and maintenance are there?
There are many specific tests that may be performed to ensure your equipment meets all performance specifications. These tests generally fall into one of four primary categories, or verification methods:
- Inspection – usually a visual inspection of a physical component, but may also refer to testing done for software
- Demonstration – use of a device as intended to verify it performs as expected
- Test – A controlled input is used to directly measure a specific output
- Analysis – Testing equipment is used to evaluate a device over its entire operable range (the most rigorous type of verification)
Some types of tests are specifically to check for higher risk hazards, such as electrical shock and fire. Electrical testing requirements from AS/NZS 3551:2012 apply specifically to medical electrical devices, which includes where appropriate:
- Visual inspections of power mains supply
- Measurement of protective earth resistance (electrical ground)
- Insulation resistance
- Touch Current
- Earth Leakage Current
- Patient Leakage Current
- Mains Contact Current
There is a plethora of maintenance activities that can be performed to maximise the useful lifespan of equipment. All equipment manufacturers provide their own guidelines on how equipment can be maintained. The methods vary broadly in their specific instructions, but generally include:
- Electrical/Sensor Calibration
- Repair or replacement of parts designed for wear, or damaged parts
- Lubrication of moving parts
- Physical adjustments
- Routine Cleaning
- Cleaning air vents and filters
How often does equipment need to be tested and maintained?
Preventive Maintenance may be either Calendar-based or Utilisation-based. In a Calendar-based program, maintenance is performed at planned intervals regardless of actual use. Utilisation-based maintenance requires that maintenance be performed after a set number of hours, cycles, treatments, or another threshold is crossed. The latter is the kind of preventive maintenance commonly done for a car, where the oil is changed every few thousand kilometers.
The most common answer is at least annually – but all equipment is different, and you should refer to your manufacturer’s guidelines. For example, some lasers and electrosurgical equipment specifically require maintenance to be performed every few thousand pulses. Some equipment elements may only need to be inspected or replaced every few years, such as electrical fuses.
If you currently have or acquire any equipment that has not been used in over a year, it is also advisable to have it tested prior to use. Equipment that sits idle for a length of time may produce unexpected results. Equipment should be tagged and clearly marked after maintenance is performed to identify the date, and the date when the equipment will require testing and maintenance again.
Are there any other benefits of testing and maintaining medical equipment?
Improved accuracy can result from regular maintenance, especially for high-usage equipment. Diagnostic equipment often requires regular calibration as part of its preventive maintenance routine. Testing can check for when devices are due for calibration, but also detect minor issues before they result in full failure of the device.
Many types of risks are mitigated when equipment is properly tested and maintained. Most importantly, the risk of injury by equipment failure is dramatically reduced. Safety increases as risk decreases, which also more broadly affects the business risk profile. Equipment maintenance costs significantly less than equipment replacement! Most equipment requires years, if not decades, of maintenance cost to amount to the replacement cost. Maintenance can actually help extend the useable lifetime of equipment, so the organisation does not have to purchase new equipment as often.
Finally, you can be confident in your organisation’s ability to pass routine inspections and thoroughly demonstrate regulatory compliance. You can instill peace of mind in your patients, community, workers, and organisational leadership by simply implementing an effective maintenance program. You can integrate equipment maintenance into your organisation’s quality system, which helps improve the odds that your patients have the best experience possible and view your organisation as one of highest quality.
What will happen if equipment is NOT tested and maintained?
Failure to properly test and maintain equipment may result in harm to patients, workers, and/or damages to the business. Serious injuries and death may result from preventable equipment failure. Physical harm can also be accompanied by psychological harm, where the injured person(s) may be affected by long-term suffering from distress, depression, and even PTSD depending on the nature of their injuries. The business may not only lose revenue from equipment downtime, but also must pay for the replacement of equipment. Damages may need to be paid to injured person(s), putting further financial strain on the organisation.
Regulatory authorities may investigate your organisation in the event of an injury or other serious incident. The risk of legal trouble is significant, as inspection findings can result in warning for non-compliance with regulations, loss of practice accreditation, and potentially even legal action. Insurance coverage may be invalidated if there is not substantial evidence to support the organisation made every effort to properly maintain all equipment.