New medical equipment maintenance standards require more hospital time, money and staff

New regulations and standards for medical equipment maintenance were recently announced by the Joint Commission (TJC), aligning TJC's accreditation with updated regulations from the Centers for Medicare and Medicaid Services (CMS) issued on December 20, 2013. The new regulations mandate substantial changes in the ways hospitals manage medical equipment – and these new requirements mean administrators will spend considerably more time, money and staff to maintain their facility's medical equipment.
To maintain compliance, hospital administrators must overhaul old medical equipment maintenance plans, compile full inventories, follow manufacturer maintenance recommendations to the letter, identify high-risk equipment, revise policies and procedures and closely monitor the credentials of those who maintain the equipment.
Not only will compliance mean more financial expenditures to maintain medical equipment, it will also require more attention and time from the individuals tasked with maintenance, compliance and record-keeping. In short, the new standards will require immediate attention from hospital leaders and more money, time and personnel dedicated to medical equipment maintenance.
Until these latest regulations were implemented, hospitals were given a great deal of flexibility in their medical equipment maintenance practices. During the past 25 years, TJC and CMS permitted hospitals to use a popular, risk-based approach, enabling administrators to streamline scheduled maintenance and minimize associated costs so long as patient and staff safety were not compromised.
This approach encouraged hospitals to focus scheduled maintenance primarily on the most critical medical equipment with histories that suggested replacing worn components and maintaining regular testing in order to combat equipment failure. Many hospitals dropped low-risk equipment maintenance in favor of cursory visual inspections and safety tests.
For more than two decades, this evidence-based approach allowed hospitals to focus limited resources on medical equipment maintenance issues that had a potential effect on patient safety and care. The new regulations require hospital administrators to formulate and implement medical equipment management plans for virtually all hospital medical equipment. Hospital administrators must:

• Maintain an inventory of all medical equipment used in their facilities, regardless of ownership. Because many hospitals use equipment owned by physicians, loaned or rented, this will likely increase hospital inventories significantly.
• Follow medical equipment manufacturer recommendations regarding maintenance procedures and frequency, particularly if the equipment is diagnostic or therapeutic radiologic (this represents at least half of a typical hospital's total medical equipment maintenance expenditure); if the equipment is medical laser-oriented; or if the hospital does not have access to detailed equipment services histories and has not analyzed those histories to demonstrate that deviating from the manufacturer recommendations would have no adverse effect on patient or staff safety.
• Obtain actual manufacturers' maintenance recommendations for all medical equipment, rather than relying upon general industry guidelines and practices for their equipment maintenance methods.
• Identify critical or high-risk medical equipment in their inventory, broadening the number of equipment categories for which 100 percent compliance is expected. Previously, life-support equipment was the primary focus. (High-risk equipment is defined as that in which there is a risk of serious injury or death to a patient or staff member should the equipment fail. Life-support equipment, in contrast, is equipment in which failure could lead to the death of a patient or staff member).
• Review and revise their medical equipment maintenance plans, medical equipment-related policies and procedures, and risk assessment processes to align with the new regulations.
• Maintain and monitor the credentials of all individuals providing maintenance on medical equipment, including in-house staff, vendors and manufacturers' staff, as well as all those overseeing the hospital's medical equipment maintenance program.

Under the new regulations, hundreds to thousands of additional pieces of medical equipment will be added to hospital inventories, with administrators required to track and ensure that manufacturers' recommended maintenance procedures are followed. Complying with new regulations will require significantly more time and expense.
Hospital leaders must ensure that their existing clinical engineering services – whether in-house or contracted through a vendor such as ABM Healthcare Support Services – have sufficient expertise and personnel to develop and implement an aggressive and complex compliance plan.
Adhering to the new regulations will be challenging. Even when equipment is serviced by the manufacturer, evidence suggests that they often may not follow their own published recommendations, primarily because the recommendations are based on worst-case environments not applicable to most hospitals. Until manufacturers provide more nuanced maintenance recommendations, hospitals will be required to comply and ensure that maintenance strictly abides by the published recommendations.
Even though the new regulations may permit hospitals to deviate from manufacturers' maintenance recommendations on some non-radiologic/non-laser medical equipment after the hospital documents a service history analysis, compiling such an analysis may be impossible. Most hospitals' medical equipment service histories do not contain the requisite detail to allow for a meaningful analysis, which means many hospital administrators must revise the type and detail of service histories they collect, or need to seek an authoritative source of service analysis.
Hospital leaders and compliance officers must be informed and understand the issue and work with those responsible for medical equipment management to ensure they develop a robust plan to achieve compliance.A comprehensive medical equipment maintenance plan should lay the necessary groundwork for compliance, as well as move the organization toward a fiscally prudent and timely path toward that goal. If hospital leadership recognizes that the needed expertise is not available through existing resources, administrators must be prepared to seek out and retain that expertise – because ultimately, any missteps are likely to incur a much higher institutional cost.

Stephen L Grimes, FACCE FHIMSS FAIMBE is Chief Technology Officer of ABM Healthcare Support Services. Mr. Grimes has more than 30 years' experience with hospitals, shared service organizations, and healthcare consulting firms. He is a nationally recognized authority on topics ranging from future challenges facing clinical engineering and healthcare technology integration to medical device security and risk management. Mr. Grimes is a frequent author and speaker at both national and international venues. He is a Fellow of the Healthcare Information and Management Systems Society (HIMSS) where he currently chairs their Medical Device and Patient Safety Task Force. He was also named a Fellow of the American Institute of Medical and Biological Engineering (AIMBE) a Fellow of the American College of Clinical Engineering (ACCE) where he is a past President. In February 2011, he received the joint industry ACCE/HIMSS Excellence in Clinical Engineering & Information Technology Synergies Award. Mr. Grimes is a graduate of Purdue University's Biomedical Engineering Program.

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