DORA and the TU-Delft
The introduction of sophisticated technical equipment in minimally invasive surgery (MIS) has made the surgical environment more complex, thereby creating opportunities for errors or incidents to occur. Verdaasdonk et al. (2007) studied the frequency of incidents in laparoscopic cholecystectomies and reported one or more incidents (up to six) with technical equipment or instruments in 86 percent of all studied procedures. In 45 percent of the reported incidents the laparoscopic equipment was either not present or was not optimally positioned. Other incidents were related to malfunctioning of the equipment caused by faulty connections or incorrect settings. Only in a minority of all cases a defect of the equipment caused the problem and most problems occurred during the initial phases of the procedure. With each incident, operating time was lost.
All hospitals have clear guidelines and protocols to prevent incidents related to technical equipment. However, lack of time and training of OR personnel makes that the protocols are hardly ever followed completely or are used incorrectly.
Source: DORA TU-Delft
The role of MediShield
The DORA project aims at preventing incidents by developing a monitoring system that automatically checks the presence, positioning and status of the equipment and informs the OR personnel about irregularities. Within the DORA project, MediShield BV and the Instrumentation department of the LUMC develop a trocar system that recognizes all instruments that enter the abdominal cavity that are sealed with a ShaftShield. Medishield guided the medical device approval and first clinical in-patent tests performed at the Or-7 of the Leiden medical center. During 10 different Total Laparoscopic Hysterectomies (TLH’s) the system was used for phase recognistion performed within DORA.
Colour palls system and Shaftshield in use during a TLH at OR-7
News: First use of instrument tracking in the Leiden Medical Centre