Risks associated with supports and support arms
The Federal Office for Safety in Health Care (BASG) / AGES PharmMed provides information on holders and carrier arms.
Wall mountsAuser in Austria was injured after an image intensifier mounted with a height-adjustable bracket fell off the wall. The cause of the wall mount breakage was lack of maintenance of the lead screw assembly. Backlash of the image intensifier was noticed in the vertical direction. The lead screw and lead screw nut (highly stressed mechanical parts) had run dry from lack of cleaning and lubrication and were severely damaged.
Several near-miss incidents were reported in Germany of monitors' mounts detaching from the rails and the monitors falling to the floor or patient bedside tables along with the mounts or parts of them. The investigation revealed that the mounting clips on the rails had loosened and slipped off the rails when the monitors were operated. The manufacturer improved the design of the rail clamps as a corrective action.
Support armsTwoincidents were reported from Germany in which the front joint of the support arm broke along the weld while positioning an operating room light. In one case, the lamp was held in place by a cable; in the other, the nurse present injured herself while trying to catch the lamp. In these and other cases in Austria and internationally, the breakage of the welds could be attributed to aging due to corrosion or material fatigue. The fractures were caused by special stress during impact or jerky movements, by improper use or by design deficiencies. Depending on the weight and position of the luminaire head, it cannot be assumed that a luminaire is held by a cable in the event of a joint fracture.
GasstrutsInternationally, incidents have been reported of strut arms falling off unexpectedly during use after extended periods of non-use. Gas struts, which balance weight in medical device mounts, can gradually degrade gas pressure over years. As long as such a holder is used and maintained regularly, a loss of pressure will be detected in time and will not pose a risk. However, if a gas spring is not used or maintained for several months, a loss of pressure may go undetected until the device is operated again. Rapid movement of the medical device mounted with it may pose a risk to patients and users or damage equipment. For wall and ceiling mounts, proper installation and weight balancing are especially important. When replacing the medical device originally attached to the mount with another one and when attaching additional loads, readjustment of the counterbalance is required.
What are the reporting requirements for incidents?Incidents, near incidents and serious quality defects in connection with the use of medical devices must be reported by professional users and manufacturers to BASG / AGES PharmMed (Institute Inspections, Medical Devices & Hemovigilance).
Forms can be found here.
Queries:
Institute SurveillanceDipl.-Ing. Dr. Ronald BauerE-mail: ronald.bauer @ages .at
