PURPOSE: Following the introduction of the Regulation (EU) 2017/745 by the European Parliament, any bioactive substance or surgical implant introduced into the human body must be documented. The regulation requires any implant to be traced back to the manufacturer. Lot numbers need to be available for every single medical implant. Also, the manufacturer is required by law to provide implants individually packaged and sterilized. Previously, model tray systems (MOS tray) were used for osteosynthesis in oral and maxillofacial surgery, in which the individual implants could not be registered separately. The new regulation made it impossible to use such processes during surgery anymore and a need for a change in the medical practice surged. We examined a possible solution for the new legislation. The aim of this prospective cohort study is to analyze the MOS tray systems to osteosynthesis materials prepackaged in sets. We record and evaluate parameters such as surgical time and documentation time. We perform a short cost analysis of our clinic. The primary aim is to determine how much time is gained or lost by the mandatory increased patient safety. The secondary aim is to describe change in costs.

METHODS: Patients that underwent standard surgical procedures in the clinic of oral and maxillofacial surgery of the faculty hospital Carl Gustav Carus in Dresden were included. We chose open reduction and internal fixation (ORIF) of anterior mandibular corpus fractures as well as mandibular advancement by means of bilateral sagittal split osteotomies (BSSO) as standardized procedures. Both of these procedures require two osteosynthesis plates and at least four screws for each plate. MOS trays were compared to prepackaged sterilized sets. The sets include a drill bit, two plates, and eight 5-mm screws. A total number of 40 patients were examined. We allocated 20 patients to the ORIF group and the other 20 patients to the BSSO group. Each group was evenly subdivided into a MOS tray group and a prepackaged group. Parameters such as the incision-suture time (IST) as well as the documentation time (DT) by the operating room (OR) staff to complete documentation for the implants are the main focus of investigation.

RESULTS: For open reduction, the incision-suture time was significantly different in favor of the MOS tray (p < 0.05). There was no difference in the BSSO groups. However, we observed a significantly different (p < 0.01) documentation time advantage for the prepackaged sets in both the ORIF and BSSO groups. On top of that, we find that by using the prepackaged kits, we are able to reduce sterilization costs by €11.53 per size-reduced container. Also, there is also a total cut of costs of €38.90 and €43.70, respectively, per standardized procedure for implant material.

CONCLUSIONS: By law, a change in the method of approaching surgery is necessary. For standardized procedures, the right choice of implants can lead to a reduction of documentation time and costs for implant material, sterilization, as well as utilizing less instruments. This in turn leads to lower costs for perioperative processing as well as provision of state-of-the-art implant quality implementing higher patient security.