Hospitals use various medical equipment throughout the different department pathways, including prevention, diagnosis, treatment, and monitoring. The proper functioning of this equipment is severe for healthcare providers whose spending on maintenance is significant. Medical device maintenance is essential for an effective and safe medical facility.
Patients expect high-quality care in decent diagnostic and treatment facilities. So, evidence-based maintenance is necessary for periodic monitoring of equipment performance. This is the responsibility of biomedical or clinical engineers to make the best use of resources. Medical equipment maintenance is divided into two categories: planned maintenance and corrective maintenance.
Medical devices directly impact human lives. They require significant initial investments and frequent maintenance. A well-planned and managed maintenance program can keep medical equipment reliable, safe, and effective for diagnosis, therapy, treatments, and patient monitoring. Moreover, such a program extends equipment life and reduces equipment ownership costs.
Health facilities should take the initiative to improve six areas or dimensions of quality. According to the WHO Quality of Care (QoC) framework, healthcare should be effective, efficient, accessible, patient-centered, equitable, and safe. To ensure all of these, a sound maintenance strategy is essential. A maintenance strategy includes inspection, preventive, and corrective maintenance procedures.
Performance inspections ensure proper operation. Safety inspections ensure patient and operator safety. And preventive maintenance (PM) aims to extend equipment life and reduce failure rates. A scheduled inspection may also reveal some hidden issues. However, monitoring equipment only ensures that it is in good condition during the inspection and does not eliminate the likelihood of future failure. Most electrical and mechanical components are susceptible to failure at any time. Corrective maintenance (CM) restores a device's function and allows it to be re-used.
Figure. Components of a maintenance program
Medical devices directly impact patient care and often mean the difference between life and death. A maintenance program reduces costs by reducing the need for new devices, also by keeping equipment safe and reliable.
Medical equipment plans are created and enforced by hospital administrators. The equipment management policy and procedure should include:
An effective maintenance plan has three tiers – planning, management, and implementation. Proper operation of the program is key to ensuring ideal equipment functionality.
When creating a maintenance management plan, financial costs, human resources, and physical logistics must all be considered. When putting a plan in place, these factors must be managed. So those finances are balanced, and resources are delegated in order of priority.
The management department can continuously examine how well sound plan elements are working.
Administrative and management departments must collaborate and communicate seamlessly once a plan has been confirmed and allocated resources. As a result, all aspects will be implemented in a timely and adequate manner.
The hospital must decide whether corrective and preventative maintenance is performed by in-house engineers or outsourced service engineers.
All details can be found in the medical equipment maintenance programme overview - WHO Medical device technical series.
Specific test equipment and devices are required for a medical device maintenance program. (WHO Medical device technical series: Medical equipment maintenance program overview, Appendix F; 2011)
Test equipment per medical device category
Medical device category |
Test equipment required |
Electrosurgical units |
Radiofrequency electrosurgical analyzer |
Defibrillators |
Defibrillator analyzer |
All electrical equipment |
Electrical safety analyzer |
Anaesthesia machines, ventilators |
Test lung |
Anaesthesia machines, ventilators |
Ventilation analyzer |
Heart-lung machines, hyper/hypothermia machines, warming |
Fluid flow meter |
Anaesthesia machines, ventilators, CO2 insufflators, vacuum regulators, air-O2 blenders, lasers |
Gas flowmeters |
Physiological monitors, intra-aortic balloon pumps, defibrillators, EEG machines, EKG machines |
Physiological simulators |
ICU monitors, EKG machines |
Arrhythmia simulators |
IV pump, surgical irrigation pump |
Graduated cylinder |
Radiographic and fluoroscopic equipment |
Ionization chamber/radiation analyzer/kVp meter |
Surgical and ophthalmic lasers |
Laser power meter/laser thermal imaging plates |
Most electronic equipment |
Multimeter/oscilloscope/function generator |
Radiographic, mammography, ultrasound, CT, MR |
Phantoms |
Air-O2 blenders, anaesthesia machines, medical gas systems |
Oxygen analyzer |
Pacemakers |
Pacemaker analyzer |
Scales, traction units |
Scales, spring scale, floor scale, balance, weights |
Ventilators, heart-lung machine, anesthesia machine |
Pneumatic tester, pneumatic flow meter |
Medical gas systems, insufflators, lasers, hemodialysis machines, suction regulators |
Pressure meter |
Incubators, infant warmers, laboratory ovens |
Temperature probe/thermometers |
Infusion pumps, traction units |
Stopwatch/timers |
Centrifuges |
Photo or contact tachometer |
Electrical outlets |
Receptacle testers |
Isolated power systems |
Isolated power tester |
Non-invasive blood pressure monitors |
Non-invasive blood pressure simulator |
Dialysis machine |
pH/conductivity meter |
Various |
Variable resistance box, variable capacitance box |
ISO 13485 is a global standard that establishes regulations for the medical device industry. This standard was developed to be applied by companies across the medical device life cycle, from manufacturing to post-production, including decommissioning and disposal. ISO 13485 can, however, be used by third parties, such as accreditation bodies, to aid in the certification process. Organizations can use ISO 13485 as a tool to design and maintain efficient operations. This standard will assist organizations seeking continual development by allowing them to deliver safe and competent medical equipment.
Providing high-quality medical care requires effective resource management and planning. Achieving this requires a compromise between the price of purchasing new equipment and the costs of maintaining it. A clear policy in the field, technical direction, and practical tools for maintaining the operational parameters of pre-function are all required for proper usage and maintenance of medical equipment. It will be feasible to considerably increase the quality of the medical act and the efficiency of such a service by employing functioning medical equipment. Consistent management methods in this area will improve healthcare efficiency.
Pico Labs Limited can help with any medical equipment maintenance needs you may have. We provide cost-effective services delivered by specialists who are technically qualified and trained for medical device maintenance.