Process efficiency was increased based on the four pillars of the 4S program: 1) a standardized inventory, 2) a sterile implant portfolio, 3) a barcode system that enables a digital safety certification, and 4) a digital service for restocking. Its introduction in the perioperative process management of surgical sets for ORIF trauma surgeries resulted in a reduction in set processing times, number of sterilization cycles, and processing costs. Furthermore, post-implementation of the 4S program, staff satisfaction was increased and there was a positive sustainability effect due to the reduction in water and electricity usage.
A key improvement noted after the implementation of the 4S program was the increased speed of set processing. Post-4S program implementation, total time spent in the OR, sterilization and purchasing departments decreased by 10.5 minutes, freeing up staff to undertake other tasks. Over 1,000 surgeries, this equates to a time saving of 174 hours. The removal of all implants (screws and plates) from the sets leads to a reduction in size and variability of sets, thereby optimizing inventory management and allowing for the use of one central depository per OR. Surgeons may have concerns about the additional time burden of opening separately packaged implants, thus increasing OR time. However, a hospital in Germany assessed how the 4S program impacted surgical set management practices in trauma surgeries. It was reported that there was no significant difference in median incision-to-suture time after the change in surgical set management practice, and a numerical reduction of 4 minutes post-implementation, indicating that separately packaged implants and screws did not confer an additional time burden during surgery, contrary to the authors' initial expectations.(14)
The introduction of a stock management system and the digitalization of supply chain procedures such as consumption, purchasing and invoicing, aims to reduce the timings in the purchasing department. However, in this study, timings reported for the purchasing department were not significantly decreased post-implementation of the 4S program. Possible explanations for this were that one employee broke her hand after the 4S program was implemented, reducing her productivity and that the 4S stock management tool (eSims) was not fully integrated with the hospital’s enterprise resource planning (ERP) system. This would have eliminated all manual transactions in the hospital’s ERP system, since each report would have been automatically sent to the system instead of being sent via email to the responsible team.
The provision of pre-sterilized implants separately to the surgical instrument sets reduces the number of sterilization cycles required in the hospital and results in fewer containers requiring sterilization per procedure, reducing the workload for sterilization staff. Sterilized surgical sets no longer need to be opened to add new or missing implants, thereby avoiding unnecessary reprocessing and further reducing the burden on hospital staff.
The combination of decreased set processing times and the requirement for fewer sterilization cycles translates into measurable cost savings. Analysis found that the whole process was €30.93 more expensive pre-4S program implementation compared to post-implementation (see the Supplementary Data for calculations). Over 1,000 procedures, the mean process cost saving was calculated to be €30,930. This may be of particular importance for healthcare systems, given the growing concern over the increasing rates of healthcare expenditure in Spain and other developed countries.(15)
Reduced environmental impact is another important outcome of the implementation of the 4S program. The United States healthcare system is responsible for 10% of the national total greenhouse gas emissions and other environmental pollutants.(16) Hospitals have a key role to play in addressing resource consumption levels and must find ways to reduce their carbon footprint.(17) Studies have shown that ORs are the most resource intensive area in the hospital, with surgical instruments being the main driver of the environmental impact of surgical procedures.(18-20) Several studies looking into ways to reduce waste and carbon footprint in hospitals and in the OR have found that simple changes can have a significant impact.(6, 21) For example, simply reducing the number of trays used in the OR, and thus the amount of tray wrapping used, leads to a reduction in waste.(6) In this study, the implementation of the 4S program reduced the number of sterilization cycles required by more than 50% and reduced the number of containers entering the autoclave per procedure, leading to a reduction in water and electricity consumption, resulting in a positive environmental impact in the sterilization department. Over 1,000 procedures, the water usage is calculated to be reduced by 320,000 L and electricity usage by 5,770 kW, resulting in potential cost savings of €608 and €701, respectively.
The final improvement observed was in staff satisfaction. The new standardized sets in the 4S program are much lighter than those typically used (6 kg versus ~12 kg), making them easier for OR personnel to transport and set up, and potentially reducing the risk of injury from transporting heavy sets. With the standardization of sets, there are fewer procedure-specific sets which simplifies the overall process. Carrying out inventory of every implant used is also easier, since surgical personnel only need to read the barcode label on the packaging. These improvements were captured in the results of the NASA-TLX and the efficiency questionnaire. Staff reported reduced physical and mental demands and an overall reduction in workload following implementation of the 4S program. They also noted that it was easier to trace implants following implementation of the program and that fewer administrative errors occurred in the purchasing department. The utilization of barcoding allows for tracking of implants, increases the ease with which hospitals can comply with MDR traceability requirements and simplifies the purchasing process as single items can be easily identified and reordered. Digitalization of the stock management results in the immediate flow of information from the OR to the administrative teams, with enhanced security compared to paper-based methods which are more easily damaged or lost.
The findings of our study are in line with published literature in that several studies have reported measurable improvements in efficiency when changes are made to the management of surgical sets. Implementation of a perioperative efficiency program for elective orthopedic surgeries, which involved the optimization of surgical tray contents, resulted in a reduction in instrument processing time and associated costs.(9) A review of surgical sets used in otolaryngology surgeries found that the removal of unused instruments could reduce set size by approximately 60%, thereby increasing process efficiency.(6) Moderate cost-savings have been reported in a cost-analysis study of the streamlining of instrument trays for otolaryngology procedures.(5) Resource savings have been shown to not be limited to adult surgeries. A systematic review of the standardization of surgical sets in pediatric surgical cases found costs were reduced, without an observable impact on OR time or safety.(10)
This study had some limitations. Lack of randomization may have impacted the results by introducing bias. Only procedure-related data were collected during the study, and no patient baseline characteristics were recorded, e.g. comorbidities. It was therefore not possible to control for potential confounders in the analyses. Additional confounding factors that may have influenced surgical set processing were not recorded but had the potential to have a significant impact on findings (e.g. the additional time required if one instrument was missing/damaged). In-person observation of OR staff may have influenced behavior and subsequent outcomes (e.g., via the Hawthorne effect).(22) Although the surgical procedures remained consistent throughout the study, patient outcomes were not recorded. In future studies, it would be valuable to collect data on surgical and safety endpoints for patients. Whilst the implementation described here is specific to DePuy Synthes Trauma (a subsidiary of Johnson & Johnson), it is our belief that the principles underpinning the 4S program are nonetheless transferable to other surgical specialties to realize similar benefits from the perspective of reduced resource use and costs, and improved sustainability of these procedures. Further research would be advisable to understand the potential benefits after a complete integration of the stock management tool.
Key strengths of this study include the prospective study design, broad patient inclusion criteria and standardized data collection instruments. The same hospital staff were present pre- and post-implementation of the 4S program, thereby reducing variability in potential confounding factors, despite the necessary pause of the study during the COVID-19 pandemic.
To our knowledge, this is the first study evaluating time efficiency, cost savings and the environmental impact of streamlining perioperative management of surgical sets via the 4S program in trauma surgery. Although this was a single-center study in Spain focusing on ORIF surgeries, the broad and comprehensive changes made to surgical set management within this approach, and subsequent positive impact, are anticipated to be generalizable to other surgical specialties across the world.