Through this article, Dr. Haniff Murray stresses the vital role of maintenance in upholding the accuracy and effectiveness of medical devices in patient care. Highlighting the significance of adhering to manufacturers' and healthcare organizations' guidelines for calibrations and preventive maintenance, he underscores the responsibility of various stakeholders in ensuring device safety. The article emphasizes regulatory compliance and proper maintenance practices to certify user safety.
Perhaps illnesses or health concerns obscured patients’ attention on the devices used to treat and diagnose their health challenges, or the assumption of the accuracy of these medical devices. To many patients, medical devices such as blood pressure or EKG machines display accurate measurements. Therefore, the maintenance of these medical devices might not remotely pose a concern. Device maintenance remains integral to their accuracy and effectiveness, hence healthcare professionals, engineers and technicians hold responsibility for the proper working conditions of these devices.
Following the original equipment manufacturer's (OEM) and or the healthcare organizations’ recommended guidelines, medical equipment/devices undergo calibrations and or preventive maintenance (PM) semi-annually or annually depending on equipment type. For example, a defibrillator undergoes a PM semiannually while a vital signs machine (blood pressure machine) annually. Other periodic PM exists for other machines as defined by the recommended maintenance schedules. Preventive Maintenance adheres to procedures specifically designed for the type of device/equipment to determine proper functionality and safety for use. Equipment/devices failure to pass the procedures undergo repairs or removal from service. PM ensures medical devices perform according to the periodic tests set and could take hours to complete by the healthcare professionals. Additionally, the OEMs perform PMs on some devices not assigned to the healthcare facilities’ professionals. Hence, PMs follow manufacturers’ or facilities' guidelines to verify proper operational functionality, especially electrical safety.
Some healthcare facilities develop a medical equipment management plan (MEMP) which dictates the purpose, scope, objectives, responsibilities and other features connected to the risk of the devices and for those tasked with adherence to the plan. Plans aim to minimize risks associated with selection, support, usage and the final disposition for end-of-life or lack of support from the OEM. For such purpose, the application of policies and procedures, laws and regulations seeks to minimize risks.
The scope of the plan could extend to software, devices or systems used in the diagnosis or treatment of any illness with objectives to ensure the safety of the patients. Engineers and technicians including imaging engineers hold responsibilities for adherence to the maintenance plan. However, monitoring entities or bodies such as the environment of care committee (EOC), risk management department, materials management and the administration hold responsibility for oversight and monitoring policies and procedures associated with medical device performances and associated risks. Outside of the healthcare facilities, other external entities monitor and evaluate healthcare institutions on different platforms including equipment maintenance and safety.
One monitoring entity outside of the healthcare institutions includes the joint commission (TJC), a regulatory/accrediting organization evaluating healthcare industries on many different programs including the maintenance of medical devices. Additionally, medical devices used in healthcare institutions should acquire certification from nationally recognized testing labs (NRTL), for example, UL to verify the integrity of the device. Other monitoring organizations/standards include the national fire protection association (NFPA 99), the occupational safety and health administration (OSHA), and the association for the advancement of medical instrumentation (AAMI) among others. For example, the NFPA 99 establishes criteria for minimizing risks associated with patients, staff, or persons in healthcare services for fires, electrical and explosion hazards. OSHA sets and enforces standards for safety and healthful conditions for workers and AAMI sets standards for safety, technology and the certification of healthcare professionals.
With the many regulatory entities and standards, safety for patients in part lies with the proper maintenance of the medical devices utilized in their care. Hence, maintenance or PMs ensure medical devices undergo the recommended timely procedures to certify the safety of all users including clinicians and patients.
