Five Reasons to Keep Your Medical Device Equipment Maintained
1. Patient Safety
For the health care industry, the patient always comes first! The patient is “in-the-hands” of the medical personnel, and so the utmost care and protection must be given. One way to ensure the safety of the patient is to ensure your medical equipment is operating correctly. Periodic electrical safety test measurements can reduce electrical hazards by uncovering early signs of equipment degradation. Additionally, every device needs to be regularly serviced (Planned Maintenance) and verified (Calibration) for correct operation – these procedures are necessary to discover and correct performance problems before they compromise patient care or personnel safety. A simple analogy involves our vehicles ̶ these require regular oil changes and service to operate as expected. Medical device equipment is no different and is even more important because of the patient.
2. Regulatory & Accreditation Requirements
Medical facilities, including ambulatory surgery centers, hospitals, physician’s offices (clinics), dental practices, nursing homes, office-based surgery centers, behavioral health treatment facilities, and providers of home care services, are now encased in a vast array of governmental regulations and codes, from the Federal level to the State level. For one example regarding maintenance, the Centers for Medicare and Medicaid Services (CMS) dictates that “Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.” (CMS §482.41(c)(2)), which is further addressed in the NFPA-99 (Y2015) – Health Care Facilities Code Handbook.
Along with governmental oversight, facilities must also comply with other non-governmental accreditation organizations, such as the Joint Commission (JC) and the American Association for Accreditation of Ambulatory Health Care (AAAHC), in order to be recognized by private insurers, and Medicare/Medicaid, for reimbursement of covered procedures. These organizations in turn require that medical facilities maintain their equipment on a periodic basis, which includes electrical safety inspections, planned maintenance, calibration and repair, based on standards put forth by such organizations as the National Fire Protection Association (NFPA-99); Association for the Advancement of Medical Instrumentation (AAMI); Underwriters Laboratory (UL); National Electrical Code (NEC); and international standards such as the International Electrotechnical Commission (IEC).
F.E.O.'s equipment service programs are designed to service medical equipment in compliance with the above regulations and standards; recommended practices; and other voluntary consensus standards.
3. Risk Assessment and Management
Our medical equipment management program is designed to ensure that medical equipment is safe and effective for use by staff on patients. There is not a government-recommended, specific documentation structure for monitoring/measuring risks, but government agencies do require a fixed logical system that documents equipment malfunctions (and repairs) as a quality improvement effort to reduce the number of patient injuries, and proof that the facility is following it. F.E.O.'s equipment database program ensures your facility meets this requirement.
Scheduled maintenance performed on a regular basis has proven to be an effective method of controlling service-related costs, and can ensure proper performance, all while reducing the possibility of equipment failure. Keeping equipment in optimal condition results in: (a) patient and personnel safety, which leads to a better reputation and fewer incident reports; and (b) reduced facility downtime, which results in increased revenue. You don't have to worry. We keep track of your scheduled maintenance.
5. Legal Liability
Legal liability can be greatly reduced and liability insurance requirements can be met by proper and adequate documentation from our medical equipment management program. The failure of a medical facility to have a regular scheduled equipment service program, as part of a management program, and use of adequately trained personnel, can be considered negligent and/or non-compliant. For example, CMS §482.41(c)(2) and NFPA-99 (Sections A.10.5.6.2 and 10.5.8.3) requires adequate device maintenance logs (documentation) on work performed by a qualified biomedical engineer/technician. Additionally, manufacturers require qualified biomedical engineers to service their equipment when performing their defined maintenance procedures and repairs.
CMS §482.41(c)(2): “Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.” A‐0724 (Rev. 103, Issued: 02‐21‐14, Effective: 02‐ 21‐14, Implementation: 02‐21‐14)