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Original article
Just-in-time delivery of sterilised surgical instruments
  1. A CP Guédon1,
  2. T J Rakers1,
  3. L S G L Wauben1,
  4. F C Meeuwsen1,
  5. V Hoeijmans2,
  6. M van der Elst3,
  7. J Dankelman1,
  8. J J van den Dobbelsteen1
  1. 1Department of Biomechanical Engineering, Delft University of Technology, Delft, The Netherlands
  2. 2Department of Information and Communication Technology, Reinier de Graaf Gasthuis, Delft, The Netherlands
  3. 3Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands
  1. Correspondence to Annetje Guédon, Department of Biomechanical Engineering, Delft University of Technology, Mekelweg 2, 2628 CD Delft, The Netherlands; a.c.p.guedon{at}tudelft.nl

Abstract

The unavailability of the required surgical instruments at the start of a procedure is undesirable. It causes delays and stress in the operating room (OR), which can lead to additional risks for the patients. Issues with availability of surgical instruments may become visible just before the start of the procedure but are induced earlier in the delivery process. Therefore, efficient and safe supply chain management is essential. Just in time (JIT) is a concept widely applied in industrial sectors to improve efficiency and quality. The aim of this study is to design a JIT process for the delivery of surgical instruments and to assess the potential risks. The JIT delivery process of surgical instruments was designed for a Dutch hospital working with an external Central Sterile Supply Department (CSSD). Hazards (ie, sources of potential adverse events) were identified according to the Healthcare Failure Mode and Effects Analysis (HFMEA) methodology. The risks of applying JIT principles to the delivery of surgical instruments were compared to the risks involved with the current situation of the hospital at the time of this study (supply-driven delivery). The results showed that the total (high-)risk score of the JIT situation was similar to that of the current situation, although the number of (high-risk) hazards was slightly higher. However, almost half of the hazards were ‘controlled’ (when actions to remove the hazard were taken later in the process), in contrast to the current situation in which only about 10% of the (high-risk) hazards were ‘controlled’. The JIT delivery of surgical instruments is expected to present less risks compared to the current situation. The multiple requirements for information technology support and a higher level of trust between the CSSD and OR department should be taken into account in order to improve the supply chain management of surgical instruments.

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Introduction

Today, the healthcare industry is focusing more and more on process and cost-efficiency.1–3 Supply Chain Management (SCM), which is the management of flow of goods and services from the supplier to customer, is therefore gaining importance in healthcare.1 ,2 SCM techniques have been applied mainly to optimise inventory levels and ordering processes of pharmaceuticals1 and materials like linen and equipment.4 Recent studies also focus on capacity planning and scheduling of patients as a means to improve efficiency.2 ,3 Particular attention went to the operating room (OR) as it is the most cost-intensive place of the hospital.5 ,6 Studies were performed to improve OR scheduling7–10 and resources capacity planning, such as nurses11 ,12 or medical equipment.13 Remarkably, the logistics of surgical instruments did not receive much attention in scientific literature, despite hospitals’ large investments and high sterilisation costs needed for safe use during surgery.14

Each type of surgery requires a certain set of sterile surgical instruments, organised in multiple instrument trays. Specific instruments can also be packed individually. After use in the OR, the instrument trays are sent back to the Central Sterilisation Service Department (CSSD). Then the instrument trays go through the sterilisation process (which consists of cleaning, disinfection and sterilisation) and are delivered back to the OR in a sterile packaging, ready for the next procedure. Instrument trays are usually delivered to the OR directly after sterilisation and stored in a dedicated room at the OR complex. Sets of instrument trays specifically needed for each surgery are collected and prepared prior to surgery, mostly by OR personnel. Besides the fact that this entire process of sterilisation, delivery and use of surgical instruments is time consuming, it also represents an important aspect of performing safe surgery. A previous study has shown that there is a large amount of hazards throughout the entire delivery process of surgical instruments.15 The unavailability of surgical instruments represented around 40% of equipment-related incidents in the OR.16 ,17 Each incident induces an average of 12 min of extra work for the OR team and 5 min of delay,16 and moreover, it increases the potential for errors in the OR.18 ,19 The importance of having sterilised surgical instruments available on time for each procedure shows the need for a high quality SCM.

Just in time (JIT) is an SCM concept widely applied in industry to improve efficiency and quality.20 It is a demand-driven and flow-oriented approach with the aim of eliminating waste and safety stocks and achieving continuous improvement.20 JIT can be divided into five main principles: (1) total quality management (continuous improvement, individual responsibility of workers), (2) production management (demand-driven system, standardisation), (3) supplier management (long-term relationship, effective communication), (4) inventory management (reduce inventory) and (5) human resources management (motivation of all workers). JIT principles present opportunities to improve the supply chain of surgical instruments and consequently increase the timely availability of surgical instruments for each procedure. However, methods originally developed for industrial settings are often problematic in the healthcare sector.1 First, the supply chain of surgical instruments represents a ‘closed loop system’ between the supplier (CSSD) and customer (OR) as the instruments are reusable and will be sent back to the supplier after each use, in contrast to other industrial products that are not meant to be sent back after use. Second, safety stocks are needed for the surgical instruments required for unplanned but frequent emergency surgeries. Third, the healthcare sector focuses primarily on quality of care and safety of patients, which differs from industrial settings. Therefore, risks involved with innovations in SCM must be carefully studied before implementation as costs and process efficiency should not conflict with patient safety. To the best of the authors’ knowledge, the risks related to this field of innovations have not as yet been described for the healthcare setting. The aim of this study is to design a JIT process for the delivery of surgical instruments and to assess the potential risks.

Methods

Design of a JIT process for the delivery of surgical instruments

This study was performed in a Dutch teaching hospital which comprises eight ORs and performs around 11 500 procedures a year. The hospital uses 1300 instrument trays consisting of 600 different types. The sterilisation process is outsourced by a CSSD located 4 km away from the hospital. Two JIT principles were used in the design of a JIT process for the delivery of surgical instruments: (1) Production management: a demand-driven approach was introduced, where only the required instrument trays for the procedures were prepared at the CSSD and delivered to the OR complex. The storage for instrument trays was divided into two locations: a main storage area was located at the CSSD, and a small emergency storage was kept in the OR complex in case of emergency surgeries and unexpected problems with instrument trays. (2) Supplier management where effective communication between the customer and supplier was facilitated. Here, information was centralised and exchanged through a digital patient planning system and was made accessible to the personnel involved.

We designed a JIT process, taking the JIT principles production management and supplier management into account. We gathered the needed information and adapted the design of the JIT process through individual meetings with the different team members, presented in the next section. The JIT process was described in main steps and sub-steps.

Risks assessment

The risks involved with the application of JIT principles to the delivery of surgical instruments were assessed by means of a Healthcare Failure Mode and Effects Analysis (HFMEA), a method widely used to identify errors and meet high safety standards.21 ,22

Focus. The HFMEA focused on the entire process of delivery of instrument trays for orthopaedic surgeries, from the decision to schedule a surgical procedure until the return of the instrument trays to the storage area at the CSSD.

Team. To perform the HFMEA, a multidisciplinary team was formed consisting of one orthopaedic surgeon, two OR nurses, one OR team leader, one CSSD employee, one CSSD manager, one scheduler for orthopaedic surgeries and two HFMEA facilitators.

Risk analysis. Potential ‘failure modes’ and their causes were identified for each sub-step of the process. Each combination of a failure mode and a cause was defined as a hazard and scored on a five-point scale on occurrence (O) and severity (S). The rating and meaning of the scores (table 1) were slightly adapted from national guidelines by the HFMEA team to describe the occurrence and severity related to the delivery of instrument trays. The risk score (R) was obtained by multiplying both scores (R=O×S). Hazards with a risk score equal to or higher than 10 or a severity equal to or higher than 4 were selected as high-risk hazards. Finally, the HFMEA team defined each high-risk hazard as ‘tolerated’ or ‘controlled’. A hazard was defined as ‘tolerated’ when no actions were taken to remove the hazard at a later stage of the process, and therefore the possibility for an adverse event to occur was just accepted. A hazard was defined as ‘controlled’ when there was a possibility to eliminate the hazard later in the process. For instance, controlling hazards can be carried out by actions such as an automatic or double check or by providing information to the right person at the right moment. This HFMEA was performed prospectively, as the JIT principles were applied at a conceptual level and were not yet implemented in practice.

Table 1

Hazard scoring matrix based on national guidelines for HFMEA22

Comparison with current risks

The risks of applying JIT principles to the delivery of surgical instruments were compared to the risks involved with the current situation of the hospital at the time of this study, where the delivery of instrument trays was supply-driven. This means that the instrument trays were sterilised and sent back as soon as possible to the dedicated storage room at the OR complex. The hospital worked with six deliveries a day. The required sets of trays were prepared by the OR personnel at the end of the day prior to procedures.

For the current supply-driven situation, an HFMEA was performed in the same manner as presented above for the JIT situation. The HFMEA was performed earlier for the current situation than for the JIT situation, because it allowed the results of the risk analysis to be taken into account while designing the JIT process. The process of delivery of instrument trays for the current situation was described by the HFMEA team in main steps and sub-steps. Note, however, that the HFMEA team had practical experience with the risks of the current situation, in contrast with the prospective JIT situation.

On the basis of both HFMEAs, the numbers of (high-risk) hazards were compared as well as the number of ‘controlled’ (high-risk) hazards. Additionally, the number of hazards related to non-effective communication was determined.

Results

Design of a JIT process for the delivery of surgical instruments

The entire process of JIT delivery of surgical instruments consisted of seven main steps and 36 sub-steps. The process is visualised in figure 1 and an overview of the main steps and sub-steps is shown in table 2.

Table 2

Main steps and sub-steps in the process of JIT delivery of surgical instruments

Figure 1

Entire process of JIT delivery of surgical instruments. Steps 1, 4 and 5 (in orange) are performed mainly by the OR staff and steps 2, 3, 6 and 7 (in green) by the CSSD. CSSD, Central Sterile Supply Department; JIT, Just in time; OR, operating room.

Risk assessment

The results of the risk analysis are shown in table 3. A total of 74 hazards were identified; 47% (n=35) of the hazards were considered as ‘controlled’ later in the process, whereas the others were considered as ‘tolerated’. Thirty-four hazards were defined as high risk, and 41% (n=14) of these were considered as ‘controlled’ later in the process. The highest number of (high-risk) hazards were found in the main steps ‘Necessity’ (n=23), ‘Preparation in OR’ (n=20) and ‘Use in OR’ (n=12).

Table 3

Results of hazard analysis for the JIT and current situation

The high-risk hazards in the main step ‘Necessity’ were related to incomplete or incorrect information filled in in the patient planning system. An example of a ‘tolerated’ hazard is ‘A wrong procedure code is chosen’. Such a hazard is neither visible nor controlled in the process until it is discovered in the OR and can cause a surgery to be delayed or cancelled. An example of a ‘controlled’ hazard is ‘The OR scheduler forgets to check the procedures that miss information’. This hazard is controlled by an added feature in the patient planning system that provides an overview of these procedures.

The high-risk hazards in the main step ‘Preparation in the OR’ were mainly related to the missing instrument trays in the emergency storage and incorrect deliveries. An example of a ‘tolerated’ hazard is ‘The sterile packaging of an instrument tray is damaged’. An example of a ‘controlled’ hazard is ‘The delivery is incomplete because the list of instrument trays coupled with a particular procedure code is incomplete’. This is controlled by appointing an OR nurse to each domain of surgery, who is responsible for keeping the digital lists up to date.

The high-risk hazards in the main step ‘Use in OR’ were related to non-sterility of instruments and unexpected course of the procedure that requests additional instruments. All the hazards were considered as ‘tolerated’. An example is ‘An instrument has accidentally come into contact with a non-sterile area’.

Comparison with current risks

For the current supply-driven situation, the process consisted of six main steps and 34 sub-steps. The differences between the processes of delivery in the JIT situation and the current situation are shown in figure 2. The results of the hazard analysis for each main step are shown in table 3. Comparing the results for the JIT situation with the ones for the current situation, the highest number of (high-risk) hazards was observed in the same main steps (‘Necessity’, ‘Preparation in OR’ and ‘Use in OR’) and the total (high) risk scores were similar. Both total risk scores equalled 556 and the total high-risk scores equalled 348 and 369, respectively, for the JIT and current situations. However, the JIT situation presented a larger amount of ‘controlled’ hazards (n=35) and high-risks hazards (n=14) compared to the current situation (n=5, n=4).

Figure 2

Process of delivery of instrument trays for the JIT situation (left) and for the current situation (right). Steps in orange are performed mainly by the OR staff and steps in green by the CSSD. The differences between both processes are highlighted by black borders. CSSD, Central Sterile Supply Department; JIT, Just in time; OR, operating room.

The high-risk hazards in the main step ‘Necessity’ in the JIT situation differed from the ones in the current situation. For the latter, the hazards were related to a lack of overview of the ability of instrument trays and a lack of centralisation of information. However, some high-risk hazards related to filling in incorrect information about the procedure were similar.

Some high-risk hazards in the main step ‘Preparation in OR’ related to incorrect delivery (such as a damaged sterile packaging or an incomplete instrument tray) were similar for both situations. Others were different as they related to the lack of overview about the delivery of instrument trays and to unavailability of up-to-date information about the required instruments for a particular procedure. More high-risk hazards were observed for the JIT situation because opening the sterile packaging of the instrument trays and preparing the instrument table for a procedure was chosen by the HFMEA team to be part of this main step, in contrast to the current situation where it was taken into account in the main step ‘Use in OR’. For the JIT situation, the preparation is carried out in a sterile area common for multiple ORs, and is consequently more separated from use in the OR.

The high-risk hazards in the main step ‘Use in OR’ were similarly related to the non-sterility of instruments and unexpected course of the procedure. The JIT situation presented a less high-risk hazard in this main step because of the same reason as mentioned above.

For the current situation, 17 hazards were related to non-effective communication or information sharing. These were caused by a lack of information in the patient planning system (n=4), a lack of overview of trays used for other procedures (n=7), trays being sterilised or defected (n=2), and by lists of required instrument trays for a specific procedure being not up to date (n=4). Only two of these hazards were considered as ‘controlled’ later in the process. For the JIT situation, 10 hazards were related to non-effective communication of information sharing. These were caused by errors in filling in information in the patient planning system (n=7) or by digital lists of required instrument trays for a specific procedure being not up to date (n=2). Only one hazard was caused by a lack of overview of trays used for other procedures. Seven of these hazards were considered as ‘controlled’ later in the process.

Conclusion and discussion

An overview of the risks of applying JIT principles to the delivery of surgical instruments was provided by performing an HFMEA. The risks involved in the JIT situation were compared to those involved in the current situation for delivery of surgical instruments at the time of this study. The results showed that the total risk score of the JIT situation was similar to the current situation and showed a slightly lower total high-risk score, although the number of (high-risk) hazards was slightly higher. However, in the JIT situation, almost half of the hazards were ‘controlled’ later in the process, in contrast to the current situation in which only about 10% of the (high-risk) hazards were ‘controlled’. Therefore, the JIT delivery of surgical instruments is expected to present less risks compared to the current situation.

A limitation is the prospective character of the risk analysis of the JIT situation. The HFMEA team did not yet experience the hazards involved in this JIT situation. Nonetheless, at the time of this study, the hospital was already performing small-scale JIT pilots and the personnel already acquired some practical knowledge. Additionally, this study only focused on the risks involved with changing the SCM of surgical instruments. The effects on costs and process efficiency were not taken into account.

This study focuses on the application of the two JIT principles production management and supplier management. In our opinion, the changes induced by the production management principle are accountable for an increase in safety. Such a change is, for instance, the fact that the OR personnel must be more attentive in communicating the required instruments for a procedure. Moreover, bottlenecks in the process are rapidly detected in a JIT situation and immediate solutions are enforced.20 For example, the lists of required instruments for a specific procedure are not up to date. This will induce an incomplete delivery and will motivate the personnel to keep the lists updated. The JIT principle supplier management was achieved with the support of Information Technology (IT), by centralising information in a digital planning system, which facilitated information exchange and accessibility. The importance of IT as a tool to apply JIT principles was recognised in previous studies.1 ,23 ,24 Although effective communication is not necessarily related to IT, it is almost inevitable to rely on IT systems in the case of complex processes involving a large number of personnel. This is also confirmed by the study by van de Klundert et al14 who underline the value of IT in optimising the logistics of sterilised instruments. Moreover, supplier management also relies on a high level of trust between the supplier and customer. This was underlined by the HFMEA team as an area that needs to be improved in order to implement JIT principles in practice.

Risk analysis was performed assuming that the process was supported by an IT system that fulfilled certain requirements. The results of the HFMEA are inseparable from these requirements as many of the hazards and risk scores depend on the features of the IT system. An example is the check performed by the OR scheduler on the day prior to the scheduled surgical procedures. This check is supported by IT as the patient planning system displays the procedures that miss information and automatically checks if the planning is achievable according to the availability of instrument trays. The most important requirements were as follows: information about the stage of processing and availability of the instrument trays must be available (with the help of track and trace technology); the system must be able to work with two inventories (one at the CSSD and a small emergency inventory at the OR); lists of required instruments for all procedures must be available, systematically filling in information about surgical procedures, and searching information in the system must be supported by intuitive interface design. Furthermore, this study was performed assuming an adequate emergency inventory that is closely monitored (with the help of track and trace technology) in order to be replenished as soon as possible.

The aforementioned requirements for adequate emergency inventory lead to recommendations for future studies. Inventory management, one of the main JIT principles, should be closely studied in order to reduce and optimise inventory at the CSSD and the emergency inventory at the OR. The two other JIT principles, total quality management and human resources management, should be further studied as well in order to fully optimise the SCM of sterilised surgical instruments.

To conclude, this study revealed that the JIT delivery of surgical instruments is expected to present less risks compared to the current situation. The JIT process relies on multiple requirements for IT support and a high level of trust between CSSD and OR in order to facilitate effective communication. The insights gained in this study are valuable for improving the SCM of surgical instruments.

Acknowledgments

The authors would like to thank Marion Poot, Sandra Tas, Mieke Schildmeijer, Joost van Linge, John Vermeer, Jos Mee, Marjolein van der Toorn and Bianca van Nelfen from the Reinier de Graaf Gasthuis and Combi-Ster (CSSD) for their help in the HFMEA process.

References

View Abstract

Footnotes

  • Funding This work was supported by the Dutch healthcare insurance company DSW Zorgverzekeraar.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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