Maintenance and Compliance for Life-Safety Medical Equipment
Deborah C. Bauers, M.A., D.C.C.
The average individual goes about his or her daily routines with little conscious thought about whether his or her day could be interrupted by a life-threatening emergency. For a majority of people, health-safety concerns focus on the home environment and involve activities like salting icy walkways and picking up toys that someone could trip on. Safety measures in the hospital setting, however, are of a much bigger magnitude and often mean the difference between life and death. For most families, critical safety issues do not surface until an illness, accidental injury or trauma require a trip to the emergency room where life support and monitoring systems are an essential part of saving a life.
In the hospital setting, safety issues are multidimensional and involve everything from computer systems to maintenance of lifesaving equipment. Professionals who are tasked with the oversight, maintenance and execution of mandated safety measures must also document and be able to demonstrate the efficacy of their compliance with state and federal regulations. Lifesaving equipment must be maintained and careful records kept to ensure readiness and reliability. As technicians work behind the scenes, the smallest label is often a critical component of saving a life. The information it records assures doctors, nurses and technicians that durable equipment is ready at exactly the moment it is needed.
The hospital is a setting where people receive essential treatment for disease and injury. It is a place where the hoped-for outcome is recovery. In cases of serious injury or sickness, the National Institutes of Health’s MedlinePlus defines “critical care” as “close, constant attention by a team of specially trained health professionals.” Whether a critical patient lives or dies depends upon multiple factors. The hands-on care of doctors, nurses and diagnostic technicians plays an up-front and very visible role in patient outcomes and recovery. Behind the scenes, however, there are other professionals who play an equally vital role in maintaining lifesaving equipment that is used to resuscitate, provide life support, monitor vitals and perform diagnostic imaging that is essential for proper treatment. Maintenance and documentation are the keys to making certain that critical care equipment such as defibrillators and hemodialysis machines are accessible and regularly tested to provide optimal life support. Failure to comply with life-safety protocol can result in injury or death of a patient.
Inventory and maintenance of lifesaving equipment is mandated by both federal and state regulatory boards. Hospitals are required to differentiate between critical and noncritical equipment. This means that critical care equipment is subject to more stringent regulation and oversight.
HHS has issued mandates to ensure that lifesaving equipment and all new apparatuses are tested, inspected and maintained according to specified manufacturer’s guidelines. In the absence of specific guidelines, hospitals should follow the manufacturer’s recommended schedule for maintenance services. Noncritical equipment may be maintained less frequently with appropriate risk outcome data that supports and justifies changes made. According to the most recently revised CMS Regulations 482.41(c)(2), governing acceptable levels of safety and quality of medical facility equipment, “Equipment that is critical to patient health and safety is not a candidate for an alternative less frequent maintenance activity schedule.” This means that upkeep of critical care equipment must either meet or exceed the manufacturer’s guidelines.
Maintenance does not end when a technician has completed necessary repairs or performed a routine test to determine that equipment is in working order. Biomedical personnel and/or contracted individuals must maintain compliance with safety regulations through careful documentation of equipment maintenance. This is most effectively accomplished by concise notations affixed to each piece of vital equipment that document preventive, predictive, reactive and reliability types of maintenance. Such documentation ensures that medical staff will have timely access to the quality of hospital equipment needed to save lives.
Labeling equipment is an efficient and recommended practice that provides ready access to accurate and essential information about equipment maintenance schedules. Labels commonly include an assigned identification number that codifies each specific piece of equipment and assures that maintenance records and equipment are correctly matched. Labels also note the dates of scheduled testing as well as brief records of technical maintenance and the initials and/or name of the technician or service provider who performs the activity. Documentation in the form of labels provides clinicians with the assurance that the equipment is in good operating order and safe to utilize. Technicians use this information to determine when reactive maintenance has been performed as well as when mandated preventive forms of maintenance should be executed. In general, labels that are manufactured for hospital use include space for notation of preventive maintenance, inspection, testing and usage status.
Labels come in assorted sizes and are tailored to provide necessary documentation for virtually every biomedical application. Hospital labels generally include appropriate spaces for notations of preventive and reactive maintenance as well as periodic inspection, testing and calibration. Labels used in the hospital setting should meet the ISO requirements for providing necessary information to maintain quality assurance. Additional tamperproof features and a wide variety of face stocks are available that include metallics and synthetics that are made to resist smudging from cleaning agents, alcohol and blood. Some labels provide self-contained protective coverings, while others require an additional application to ensure preservation of recorded information. They are routinely made of paper or vinyl and often come without protective coverings. Without protection, however, they are subject to degradation from normal wear and tear on the equipment and exposure to harsh chemicals commonly used to clean and minimize the presence of bacteria. For this reason, a top coat of a synthetic nature is recommended to preserve critical data. Separate labels are available that form a protective coating and can be affixed on top of the original label. Such labels are not customized and must be trimmed to fit.
Perhaps the most effective labels are those that are self-laminating. Rather than having two individual labels, they come with an integrated, made-to-fit adhesive shield that seals and preserves the underlying label after maintenance, testing and calibration is done. A self-laminating label is convenient, comprehensive and time-saving.
In the world where CMS and Life Safety Code requirements strictly regulate biomedical and clinical engineering systems, careful documentation and preservation of critical maintenance data is a closely monitored system of checks and balances. Yet when it comes to preservation of essential data, a label can make all the difference in helping to maintain lifesaving equipment. Labels come in an assortment of sizes, colors and materials and can be customized to meet the need of each hospital department. What is essential, however, is that the integrity of recorded vital information on labels be protected in order to demonstrate the readiness and reliability of equipment that is critical to positive patient outcomes.
CMS Office of Clinical Standards and Quality/Survey & Certification Group, Ref: S&C 12/07/2011-Hospital.
Comparison of CMS Preventive Maintenance Regulations. State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, 482.41(c)(2) and 482.41(c)(2).
John J. Dougan, Associate Director/Field Services. Life Safety in the Hospital Setting. Antillean Adventist Hospital, 02/02/2009.
National Institutes of Health. MedlinePlus: Critical Care.
United Ad Label. RR Donnelly. 1998–2012.
World Health Organization. Medical Equipment Maintenance Programme Overview. 2011.
United Ad Label is an RR Donnelley product line providing labels and products to the healthcare industry. You may order via our website www.unitedadlabel.com or toll-free 800-423-4643.