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Health authority bfarm forwarded an incident report from a physician, who reported that a female patient experienced a skin reaction post spiroergometry procedure involving a mask that was processed with cidex® opa solution.The patient developed the skin reaction 45 minutes after using the mask, and she exhibited symptoms of grey skin discoloration, urticaria, and skin burning sensation for a duration of 3 days, and desquamation for a duration of 4 days.No medical treatment was required, and no prescriptions or over-the-counter medications were received.There was no permanent impairment related to this event and the patient¿s outcome was noted as ¿resolved¿.Additionally, the patient¿s medical history included no medical conditions or diseases, and no known allergies; however, it was noted that the patient often experiences skin reactions.The physician reported additional information that the mask was manufactured by cosmed, model not provided; however, she indicated that it was made of silicone rubber and is a semi-critical device, and noted that the mask manufacturer recommends reprocessing with cidex® opa.The physician stated that she had read the cidex® opa instructions for use (ifu), but ¿did it wrong¿.She noted that the cidex® opa bottle was first opened in july 2021, and the mask was manually processed 21 days prior to using on patient on 24-feb-2022; per the ifu, the remaining solution may only be stored up to 75 days in the original container.The physician also reported that she did not use cidex® opa test strip to test for the minimum effective concentration (mec) and did not monitor the temperature of the solution during use.The mask was placed in cidex® opa in a tray/basin with tight-fitting lid for 30 minutes, and the solution was in the secondary container for one day.Lastly, it was reported that the mask was flushed continuously under running water and not ¿bathed,¿ and the mask was rinsed once more prior to use.Per the ifu, the device must be thoroughly rinsed by immersing completely in a large volume of water (e.G.8 liters) for a total of 3 rinses to remove cidex® opa solution residue.The reported skin reaction resolved and did not require medical intervention; therefore, the injury has been determined to be minor.However, this event is being reported as a malfunction subsequent to a previous serious injury due to human contact with a medical device that was not rinsed as per the ifu after processing with cidex® opa.In addition, the physician reported three other use errors and noted cidex® opa solution was not tested for mec, temperature was not monitored, and the solution was beyond its open bottle expiration date.Although no prior incidents have resulted in serious injury related to these stated use errors, asp has determined that high level disinfection cannot be assured, and this event is reportable for the additional malfunctions.
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Per the ifu: ¿cidex opa solution is a high level disinfectant for semi-critical devices when used or reused, according to the directions for use, at or above its minimum effective concentration (mec) of 0.3% as determined by cidex opa solution test strips, at 20°c (68°f) with an immersion time of at least 5 minutes for a reuse period of up to 14 days.¿ and it is recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met.Additional information will be provided to the physician for retraining on the cidex® opa ifu requirements.Asp investigation summary: the investigation included a review of the batch record, trending analysis for the lot number, and system risk analysis (sra).The batch record review was performed and test specifications for product release were met.No anomalies were observed that would contribute to the reported issue.Trending analysis for the lot number was reviewed for the prior six months from open date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material and biohazardous, pathogenic, or infectious material to be "low." product evaluation and supplier investigation are not required due to the reported issues are determined to be use errors.The most likely assignable cause for the skin reaction can be attributed to failure to follow the cidex® opa ifu by not using the cidex® opa test strips to verify the mec of 0.3%, not monitoring the temperature to confirm the solution is at 20 degrees celsius or above, not discarding the solution beyond the 75 days bottle open date, and not thoroughly rinse the medical device by immersing it completely in a large volume of water.Asp will continue to track and trend this issue.Asp complaint ref #: cmp-(b)(4).
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