3 SERIE NEOLUX PHOTOTHERAPY DEVICE AND SMARTTOUCH PC CONTROL SYSTEM

Description of Event or Problem

A64-YEAR-OLD PATIENT RECEIVED A NBUVB PHOTOTHERAPY TREATMENT FOR PSORIASIS ON (B)(6) 2023. THE DOSE WAS 500 MJ/CM2 WITH A TREATMENT TIME OF 45 SECONDS. THE PATIENT HAD A SECOND TREATMENT ON (B)(6) 2023 WITH AN ORDERED INCREASE OF 10% TO 550 MJ/CM2 AND TREATMENT TIME OF 45 SECONDS. THE RN ACCIDENTALLY ENTERED THE TREATMENT DOSE AS 5550 MJ/CM, NOT THE INTENDED 550 MJ/CM2 INTO THE SMART TOUCH SOFTWARE THAT IS USED WITH THE 3 SERIES NEOLUX PHOTOTHERAPY BOOTH. THE SOFTWARE AUTOMATICALLY CALCULATED THE TREATMENT TIME AS 4 MINUTES, 45 SECONDS, NOT THE INTENDED 45 SECONDS. THE RN WAS BUSY TREATING TWO ADDITIONAL PATIENTS. WHEN CONFIRMING THE DOSE, HE DID NOT RECOGNIZE THE DOSING ERROR GIVEN THE VISUAL SIMILARITY BETWEEN THE INCORRECT AND INTENDED DOSE (CONFIRMATION BIAS). WHEN THE RN WAS FINISHED ASSISTING A DIFFERENT PATIENT, HE REALIZED THE INITIAL PATIENT'S THERAPY WAS GOING LONGER THAT THE INTENDED 45 SECONDS. HE IMMEDIATELY ABORTED THE TREATMENT NOTING THAT 3146 MJ HAD BEEN DELIVERED OVER A TIME OF 4 MINUTES, 15 SECONDS. THE PATIENT EXPERIENCED BURNS TO HIS TRUNK (ABDOMEN, BUTTOCK, BACK) AND FACE. HE REPORTED SEVERE ITCHING, PAIN AND PEELING REQUIRING HIM TO TAKE TIME OFF OF WORK. IN REVIEWING THE EVENT THERE ARE SOME SOFTWARE CHANGES THE MANUFACTURER MAY WANT TO CONSIDER TO HELP USERS IDENTIFY DATA ENTRY ERRORS. THE DATA FIELDS ON THE COMPUTER SCREEN ARE RELATIVELY SMALL AND COULD BE ENLARGED. ALSO, THE MINUTES ARE SEPARATED FROM THE SECONDS IN THE TREATMENT TIME FIELDS. SO INSTEAD OF READING AS 4:45 THE UNITS ARE SEPARATED TO BE 4:45. THIS CAN ALSO CONTRIBUTE TO CONFIRMATION BIAS. IT MAY BE HELPFUL TO ADD A TOTAL SECONDS FIELD TO THE TREATMENT SCREEN TO ASSIST WITH IDENTIFICATION OF ERRORS. ALSO, SINCE TREATMENT CHANGES ARE MADE BASED ON % CHANGE PER DOSE/PER SESSION, IT WOULD BE HELPFUL TO HAVE A % CHANGE FIELD ON THE VIDEO SCREEN. IN SOME CASES THE CLINICIANS MAY DEVIATE FROM THE DEFAULT DOSAGES RECOMMENDED WITHIN THE SOFTWARE BASED ON PATIENT RESPONSE. THEREFORE, SEEING THE INTENDED % CHANGE ON THE COMPUTER SCREEN WOULD HELP. ALSO, THE ALERTS FOR A DOSE OUT--OF RANGE DO NOT HAVE DIFFERENT LETTERING FONT, SIZE OR COLOR TO ACTIVELY PREVENT A "ROUTINE" OVER-RIDE FROM A POTENTIALLY RISKY OVER-RIDE. IN ADDITION, THE MANUFACTURER MAY WANT TO HAVE A POP-UP TO REQUIRE RE-ENTRY OF THE DATA IN THE EVENT OF A PERCEIVED DEVIATION OR IN THE PRESCRIBED THERAPY TO DRAW THE USER'S ATTENTION TO THE ISSUE.