Policyholder Services

I just received a recall notice regarding equipment I use. Am I covered if I continue to use this equipment?

Depending upon the allegation, coverage most likely would apply. OMIC does not exclude otherwise covered claims related to patient harm from recalled equipment. Claims alleging errors or omissions in the delivery of direct patient care or in the physician’s choice to use the equipment would be covered subject to OMIC’s standard policy provisions. However, if the claim were based solely on allegations with respect to the fitness or performance of the device, the product liability exclusion would apply. In that event, no defense nor payment of damages or supplementary payments would be extended.

When deciding whether to continue using equipment after a recall, always use your best professional judgment. You will want to consider many factors: What is the nature of the recall, and what are the known problems? Has your equipment experienced any of the problems addressed in the recall? What is the manufacturer’s position regarding continued use of the equipment? Are there steps that can be taken to help minimize the risk of injury? Is alternate equipment available and in good working order? Is so, are you and staff familiar with the equipment, or will using it introduce more risk? If alternate equipment is not available or introduces more risk, do the benefits of proceeding with treatment outweigh the potential risks of the known problems or of delaying treatment?

If you believe it is in the patient’s best interest to proceed with treatment, carefully document your rationale in the medical record. In addition, be prepared to manage the known equipment issues as instructed by the manufacturer. Furthermore, ensure that everyone in the surgical team is familiar with the known problems and is prepared to manage them as instructed.

Please contact OMIC’s risk management staff at (800) 562-6642, ext. 641 (option 4), regarding any other questions or concerns you have regarding the use of recalled equipment.

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