By ECRI
Of all the things to worry about during surgery, proper functioning of the OR table probably isn’t high on most people’s list.
But incidents do occur – sometimes during setup; occasionally during the procedure itself. Tabletops have drifted from their set positions, or table sections have shifted unexpectedly. Components have collided with the floor or themselves while the table was being lowered. Tables have even sparked electrical fires. If an incident were to occur with the patient on the table or at a critical moment during surgery, grievous harm could result.
As clinical engineers know, proper functioning can’t just be assumed for devices that will be involved in patient care. “When evaluating any medical device, aspects of basic performance need to be tested and verified,” explains Jaime Schlorff, senior project engineer in ECRI Institute’s Health Devices Group. ECRI Institute performed such testing – and more – for its recent evaluation of six popular models of OR tables.
In addition to assessing table performance, the nonprofit organization critiqued each product’s feature set; examined factors relating to workflow, safety and interoperability; and analyzed the cost of ownership. “Input from clinicians in the field helped us identify the key, real-world considerations that matter most to frontline staff,” Schlorff adds, “and we judged the models accordingly.” The study also includes guidance for the safe and effective use of OR tables once they have been put into service.
Form and Function
OR tables provide an elevated surface or tabletop to support the patient’s body during surgical procedures, stabilizing the patient’s position and providing the operating surgeon with optimal access to the surgical field. A multi-section tabletop allows the patient to be positioned as needed, with table sections being raised or lowered as appropriate for the surgical procedure or according to physician preference. Typically, the tabletop includes individual sections to support the head, back, center and legs of the patient.
Some OR tables have features or accessories to facilitate positioning the patient, and some have special tabletops to facilitate C-arm and radiographic/fluoroscopic studies. Tables intended for bariatric procedures, for example, have large load capacities to avoid instability when the table is positioned. Similarly, tables designed to accommodate intraoperative imaging will have radiolucent (e.g. carbon fiber) tabletop sections and integrated channels to hold the radiographic cassettes required for certain types of imaging; these tables also allow specialized movements to maximize the field of view for acquiring images.
Safety Considerations
While safety concerns may not be top of mind for this technology, ECRI’s research and testing shows that such issues do warrant attention – not only when making selection decisions, but throughout the table’s useful life. Factors related to the design and construction of individual components, the table controls and indicators, and the methods of use all can contribute to adverse incidents, such as those outlined below.
1. Inappropriate table movement
Tables or table sections that move in an unexpected fashion can cause considerable harm, either to the patient or to surgical team members – particularly if the incident occurs during surgery.
ECRI Institute’s Health Devices Alerts database includes numerous reports of unexpected downward motion of the tabletop. Some incidents can be attributed to hardware or software issues; some to component wear or fluid intrusion; and some to misuse, such as exceeding a table’s maximum weight capacity. In one case, a table tipped because it was inadvertently used in reverse orientation, a configuration that reduced the table’s weight capacity.
During ECRI Institute’s testing, a tabletop section on one model shifted downward while testers were loading the table with weights to simulate use for a bariatric patient. In this instance, the tabletop components appeared to be correctly locked in place (as illustrated by a visual marking under the table), when in fact one component was not fully engaged. This allowed part of the table to shift when loaded to a certain weight.
To minimize the likelihood of such incidents: Assess table controls and safety indicators, positioning options, and weight limits before purchase. Educate staff about proper assembly of tabletop sections and weight capacity restrictions for the various table configurations before use. And perform proper table maintenance and service as required.
2. Fluid intrusion, leading to electrical failures and fire.
ECRI Institute has received reports of fires caused by liquids seeping into the base of OR tables and shorting the tables’ electrical systems. In one case, a staff member was burned.
OR tables typically incorporate seals or shields on the base to prevent liquid on the exterior from reaching the electronics inside. However, seals can degrade and ultimately fail: They may be inadequately designed, become compromised with repeated use and cleaning, or be misassembled following repair.
Housekeeping personnel, service technicians, and OR staff need to be aware of the safety implications of liquid ingress. Appropriate service and maintenance should be performed at recommended intervals, and damage that might allow fluid intrusion should be corrected.
3. Component collisions.
Many OR tables incorporate anti-collision features to stop the movement of components if they are in danger of colliding with the floor, base, column or other components of the table. Capabilities vary, however; and these features will not take into account objects placed on the base or floor around the table.
A table’s anti-collision capabilities should be verified prior to purchase; and before use, staff should be educated about limits on the table’s ability to detect potential collusions. During testing of one table, ECRI Institute found that despite the presence of an anti-collision feature, the leg section of the table was able to collide with the base and floor.
Other Selection Considerations
ECRI Institute found that all the models tested offered acceptable performance. Differentiating factors centered on each model’s capabilities and aspects of performance for particular circumstances. “The best choice will typically depend on facility-specific preferences, such as your specific needs, the intended area of use and the procedures that will be performed,” notes Rebecca Kwasinski, the project engineer who led ECRI Institute’s testing. “Features or aspects of performance that might be advantageous in one environment, may not be needed in another.”
For instance:
Table configurations. Range of motion is an important consideration; but more is not necessarily better when it comes to table configurations. Users may not need some of the configurations offered, and some positions could even be dangerous if proper care is not exercised.
Automatic drive. Several models offer a feature that facilitates moving the table from one location to another. While some facilities will find this to be a helpful option, others may rarely use it.
Imaging window. The size and position of the tabletop section that allows for intraoperative imaging will be a key selection factor for some applications. ECRI Institute identified notable differences among the evaluated models.
This article is adapted from ECRI Institute’s “Evaluation Background: Operating Room Tables” (Health Devices 2018 Dec 7). The complete article – including model-specific test results and product ratings, along with additional guidance for purchasing and using OR tables – is available to members of ECRI Institute’s Health Devices System and associated programs. To learn more about membership, visit www.ecri.org/HealthDevices, or contact ECRI Institute by telephone at 610-825-6000, ext. 5891, or by e-mail at clientservices@ecri.org.