Managing Equipment Service
July 6, 2015 | Healthcare Risk, Quality, & Safety Guidance
Determining an appropriate equipment servicing plan for a healthcare facility requires much thought and consideration. Service is typically arranged through one or more of the following options: the facility’s clinical engineering department, the original equipment manufacturer (OEM), or an independent service organization (ISO). While risk management may not play a central role in determining equipment service management, it is important for the department’s staff to understand the factors associated with this type of decision, and to determine whether risk management needs to be involved in certain processes (e.g., contract review). This Risk Analysis* outlines the pros and cons associated with various service options and provides resources to help decision-makers identify the best choice for the facility.
_______________ * Unless otherwise noted, information in this Risk Analysis is taken from June 2010, March 2011, and August 2011 Guidance Articles about equipment service management in ECRI Institute’s Health Devices journal. To order these issues, contact ECRI Institute’s circulation department at (610) 825-6000, ext. 5888. _______________
Hospitals have a legal duty to maintain safe patient care equipment, regardless of whether the hospital, manufacturer, or a third-party organization performs the service. In addition to having a legal duty, ensuring that equipment is properly and safely maintained is essential for the services that a hospital provides on a daily basis, thus making decisions about effective service vital to the facility’s success.
Some may believe, especially when considering devices that carry a high risk of patient injuries, that the potential for legal liability is a strong reason to favor other alternatives over in-house service, hoping that this move shifts liability to other parties. In reality, however, the risk to a hospital varies only slightly with the various service options. The hospital is likely to be named as a defendant in any legal action involving an equipment-related patient injury, regardless of whose personnel actually serviced the device. Thus, the hospital has the inescapable burden of taking reasonable measures to ensure that service is properly performed.
The hospital has another obligation that should routinely be met as an integral part of selecting and using third-party service vendors: to take reasonable steps to ensure that the vendor personnel qualified to perform the equipment support required under the contract. If a hospital is aware of a vendor’s substandard performance of service support, through a vendor’s general reputation or the hospital’s experience, and nonetheless contracts...