Technological advances in surgical practices and medical procedures not only require a professional development of support services, but also demand greater speed of assistance and response from the providing areas. For this reason, CSSDs must be up to the task.
Tasks such as maximizing and ordering work times, reducing operating and non-quality costs, eliminating paper records, controlling and optimizing the rotation of instruments and surgical kits, and avoiding conflicts due to operating problems, among other needs, are vital today.
Imagine a system that supports production day by day, process by process, tracing, validating, standardizing tasks and alerting preventively to errors. A system that in turn allows the integration of data to solve conflicts and make management decisions based on updated and real information, accessing the information remotely and in real time, 24 hours a day, 7 days a week. Sounds good, doesn’t it?
A good traceability software should fulfill these functions and more, being a standard for efficient and professional management. However, many times it is not thought of as a work tool, but as a document digitalization, which means one more task in the working day.
So, what factors should be taken into account when contracting this type of software for a CSSD? Let’s begin with the first step: To understand what traceability is, why it is essential to ensure health and its direct impact on patient safety during a surgical practice or medical procedure.
What is traceability?
Traceability implies the ability to reconstruct the history of a product or batch by means of a recorded identification, i.e. to know all the places and status through which a product or batch has passed from its production to its consumption or use.
In the case of traceability in a sterilization center, it is essential to track all the places and processes through which the surgical instruments have passed from their reception to their delivery to the operating room, especially for three key aspects: infection prevention, measurement of surgical services, and management of financial assets.
The surgical safety
Six facts about surgery safety according to the WHO:
- At least seven million patients are affected by surgical complications each year. At least one million die during or immediately after the operation.
- Up to 25% of hospitalized surgical patients suffer postoperative complications.
- The crude mortality rate after a major surgery is 0.5-5%.
- In industrialized countries, almost half of all adverse events in hospitalized patients are related to surgical care.
- The damage caused by surgery is considered avoidable in at least half of the cases.
- The recognized principles of surgical safety are unevenly applied, even in the most advanced settings.
Source: “Safe Surgery Saves Lives,” WHO/IER/PSP/2008.07 © World Health Organization, 2008.
Up to 60% of surgical site infections (SSIs) could be avoided by applying adequate prevention programs and verifying compliance. SSIs have a prominent place in nosocomial infection surveillance and control programs, due to their high prevalence and severity, increased direct and indirect health care costs, and the availability of scientifically proven effective prevention measures for each type of surgical procedure, including adequate sterilization of instruments.
Good traceability software will improve the overall performance of your CSSD, OR and any other area where you want to trace surgical instruments and medical devices. Undoubtedly, the choice of the right system is not an immediate one, but is thought of in the medium and long term. Therefore, it is very important to consider the passage of time when acquiring software of these characteristics.
Key points to analyze when acquiring traceability and management software
First, the technology used by the software. In this case, a 100% web-based system, i.e. one that uses a browser (Chrome, Mozilla Firefox, MS Edge, among others) for local or online execution, is preferable to a desktop system, which involves installation on each of the computers that use the system.
Why? On one hand, web systems are expanding rapidly, are more secure, easier to maintain and allow online access from different devices, even remotely, which is essential for monitoring critical incidents from anywhere, at any time.
As it was mentioned above, when a software is 100% web-based, any PC within the facility’s network can be used as a workstation, through the use of a web browser. This technology allows the IT Department to quickly replace hardware failure and easily add new PCs, which lowers their associated costs and radically simplifies software maintenance.
On the other hand, the main risks of desktop software are:
- Vendor dependency to scale and maintain the system
- Errors in database consistency, resulting in instrument replacement costs
- Staff confusion and decreased productivity
- Increased maintenance and support costs
Moreover, in a world where more than 55% of online visits worldwide come from cell phones, a system that does not include this possibility will soon become obsolete.
Scope and Scalability
A good system should have a wide scope and scalability, to reach any area that wishes to trace a procedure on a patient. The software should, preferably, be implemented in successive stages to accompany the maturation of the project over time in a progressive and simple manner, starting with the sterilization center, up to the operating room and other areas. This will include not only the CSSD, but also other critical areas such as consulting rooms, ORs, pharmacy, hemodynamics, endoscopy and maternity.
It must also allow for other key functions to match the typical operation of a CSSD:
- traceability by product batch and by unique device identifier (UDI)
- the possibility of tracing up to the patient, passing through multiple areas
- compatibility with all surgical instrument marking methods
- the ability to connect to sterilizers and washers
- the ability to contain all functions for digitizing existing documentation
The equipment and the staff training
The expansion and scaling of a system not only contemplates the costs and specifications associated with the software itself, but also requires cost analysis of other infrastructure resources (hardware and peripherals, networks, server, etc.). It is important to know the hardware required for the use of traceability software and the costs associated with its implementation. The systems often require specific, expensive hardware and many, being desktop software, require special installations or vendor support to scale. This complicates the long-term support, renewal and expansion of the system.
The current trend is to standardize equipment in order to optimize costs, improve operational safety and simplify the maintenance of hospital hardware. Therefore, it is necessary to assess whether the system supplier adapts to the corporate requirements and the local availability to acquire and maintain that hardware. Also, whether there are restrictions regarding the number of users, versions, possibility of simultaneous connection (recurrence), number of PCs, modules and functionalities, access, training and support hours, and regarding the surgical instrument marking methods recognized by the software, which must be specified. Marking is a further step towards total traceability, the main objective of such a system.
Likewise, every organization goes through a natural process of staff turnover, so it is necessary to know whether training new staff on the system will have an additional cost.
Integration with other software
Finally, it should be considered that any scaling process requires integration with other software over time. The greater the potential for integration with other hospital management systems and sterilization equipment, the better it will be for the long-term usability of the system, so these resources, needs and costs must be considered when evaluating your investment.
In short, it is essential to think of scalability as a long-term investment. Unrestrictedly and simply, the system should be scalable to the needs of each health care institution.
Simplicity of Use
The choice of a system to be used in hospitals, clinics and/or health centers involves a comparison of the operational functions of each proposal.
A system can be solid, but complex and cumbersome in its functionality and interface.
Therefore, the software must be solid, but at the same time simple for users to use and understand. In other words, to provide them with autonomy in their daily work and allow the standardization of work processes with a friendly, stable, and complete system.
Currently, there is a new worldwide trend that seeks to program the system interface taking into account the user’s key characteristics, adjusting the different visualizations to the user, in such a way that the functionalities are simplified and the steps and time spent in the software are reduced. In other words, a computer system for a specialized function such as the management of surgical instruments must address critical functions in a simple and fast way in order to meet the work times required by the sector, and not generate an abandonment rate or omission of records.
To this end, it is vital to evaluate the simplicity of use of the tool in the functions of:
- Reception of in-house instruments and instruments from external suppliers
- Registration and loading of washers
- Control and preparation of trays
- Registration and loading of sterilizers
- Sterile warehouse management
- Delivery in surgery carts
- Integration with other Hospital Information Systems (HIS)
- Automatic integration with medical equipment, including sterilizers, washers, incubators, etc.
- Tailored reports with key statistics to improve CSSD performance
- 100% digital multiparametric validation of sterilization and washing processes through chemical, biological, and physical controls.
Support and Assistance
The helpdesk: as important as software
A CSSD operates 365 days a year. Patient health cannot wait: when critical incidents occur, rapid response and resolution is essential.
In this sense, support is as important as software. All systems have problems, the difference is in how they solve them.
As with the purchase of equipment, the chosen software should have an after-sales service for its maintenance.
Therefore, this is what should be taken into account:
What the help desk looks like. Who receives and manages the support? The supplier must be prepared to respond quickly to critical incidents.
The type of assistance provided. This may be through a third party, usually the system distributor, or directly with the software developer. The second option will always be recommended, in order to achieve the correct use of the software and a higher speed of response in the assistance. In this sense, it is important to know the supplier’s Service-Level Agreement (SLA), which determines the performance, times and response rate. It is always recommended that the SLA of the system supplier be less than the total average processing time of the CSSD, so that the resolution of the incident is done within the production cycle.
Support language. It should be provided using the user’s native language.
Kind of support. Several options, such as remote support, on-site, via email, tickets, and phone call.
A key: evolutionary support
Another relevant issue to take into account is that the support must be evolutionary, an essential condition for the success of the investment in the long term. Through system updates, current and future errors are reduced, root errors not detected in regular use are resolved, and both operational and database security of the system is improved.
Technical support is the only way to:
- Minimizing non-occupancy and system downtime rates
- Preventing omission of registration by users
- Decreasing the incident rate through continuous improvement
- Minimize the chances of fraud or theft of virtual data
- Avoiding technological obsolescence of the system
- Maximize the “plasticity” of the system in the face of adjustments, changes and scaling.
- Improving the use and functions of the system
- Improving the learning curve and the tool usage rate
- Expanding and scaling the system
Upgrades and updates
Regarding the upgrades and enhancements, we should evaluate the vendor based on the following issues:
- Does the supplier make operational, technological, security, usability and functional improvements? How and how often are system upgrades implemented?
- Who receives and develops the improvements? Is it an individual or is it a company that allows continuity beyond its employees?
- Does the developer have a quality system that allows for long-term continuity?
- Is the supplier investing in product and organizational development?
- Can the solution be integrated with other software and medical equipment?
In conclusion, software is never a finished product: the supplier company must specialize, update, grow and evolve over time. Without an evolutionary support, there is no medium and long term planning of a traceability project, nor of any software, regardless of the industry or function.
It is important to have a secure system that is not vulnerable to hacking. The information contained in the system is linked to the patient, so it must be safeguarded.
Security is closely related to two of the points mentioned above: technology and support.
Regarding technology, web systems are always more secure than desktop systems. This is due to the protection of the database, which is not exposed to the user, and to the security of the server itself.
On the other hand, evolutionary technical support involves updates that improve not only the system’s performance but also its security. These updates provide many revisions to the system. For example, they add new features and remove obsolete ones, update drivers, provide bug fixes and, most importantly, fix detected vulnerabilities.
It is important to select a supplier specialized in computer systems of this nature and complexity, since the particularities, restrictions and knowledge of how to handle surgical instruments and medical devices are vital for the development of the software.
At this point, it becomes crucial to detect the company’s capacity to innovate with specific improvements to daily operations and to apply new technologies taking the of the reality of a CSSD into account. This experience can be verified through the opinion and assessment of customers and users.
Many times, “canned” solutions are acquired or companies without knowledge in the field are hired. This lack of knowledge can lead to shortcomings ranging from cost overruns to functionalities that do not meet requirements and greater vulnerability to resignation or organizational changes of key players.
On other occasions, the aim is to replace this need with an operational/administrative module of the Hospital Information System (HIS), which in the short term is partially occupied because it does not contemplate the nature, use cases and particularities of this sector, and ends up being replaced by specific software, since expanding, adjusting or redefining the HIS module is very costly, requires a large number of working hours and on many occasions the HIS developer is not interested in the business unit, interrupting the development of the specific module for traceability.
It can also occur that the institution seeks, in the first instance, to address the solution with its own team and it is subject to the availability of resources, which are relocated, in the medium and long term, for various reasons, making it impossible to develop the software. One thing that worsens the situation is the fact that self-developed hospitals and clinics work in the same way as a software factory, so re-development, whether it is done to fix bugs, improve it, create new modules or update it, requires a waiting time based on the priority of other internal projects.
In conclusion, supplier expertise not only increases the probability of a successful execution of a traceability project by planning objectives, but also reduces the time horizons of the different project phases (implementation, fine-tuning, support and improvement).
A traceability system is not purchased every day. Therefore, at the time of analysis, it is important to bear in mind that its use and costs will be long term.
This contracting is usually complex and requires a thorough investment analysis. The following costs should be analyzed throughout the useful life of the project:
- Costs per number of licenses for current and future users
- Costs per installed software per PC
- Costs for version changes and upgrades
- Costs for work modules contracted initially and in the future
- Cost per recurring or simultaneous users
- Monthly or annual technical support and consultation costs
- Monthly or annual additional license costs (license expirations requiring long-term repurchase)
- Cost of hardware and refurbishment in both current configuration and future expansion
- Cost of inputs required on a day-to-day basis for the execution of the software. Over time, as the project expands, the consumption of labels, ribbons, markers, etc. increases.
- Integration costs with other software, since system expansion sooner or later requires integration with other systems.
- Cost of integration with existing and future sterilizers, washers, incubators and other medical equipment
- Cost of in-person and virtual training, both initial and induction or expansion training
- Cost of obsolescence of licenses, software, and languages
- Cost of database custody, backup and storage.
As in any investment project, the estimated long-term flows must be completed: a software must have a study horizon of at least 5 years.
Important: Free or low-cost software often includes large hidden costs. All direct and indirect costs throughout the different stages of the project must be thoroughly and quantitatively evaluated.
At this point, we can affirm that a traceability system is a strategic project and a long-term commitment that involves carefully evaluating technological aspects, operational functionalities, the different stages of product life and the associated costs over time.
It is very important to emphasize that support and continuous improvement are as important as the software itself. Both points should be included in the analysis.
Finally, all traceability projects are always growing in hospitals and clinics, so it is essential to be certain that the tool can effectively accompany this growth, taking into account both direct and indirect costs.
Learn about our technological solutions for traceability focused on patient health and safety and custody of surgical instruments on our website. Contact us through WhatsApp or by email at firstname.lastname@example.org