Tracking Surgical Instruments: Releasing massive untapped value in the surgical instrument life cycle.
The EU Commission, meeting the FDA regulations established last year, has clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, published at the beginning of May.
The motivation behind the requirements is based on:
- Improved Safety
- Increased Efficiency
- Unambiguous Accountability
What follows is a discussion of the broader context of UDI, tracking surgical instruments and some potential impacts for the field of surgical instrument sterilization, the use of radio tags (RFID) as a carrier of UDI in general, and how RFID tags on surgical instruments can allow ubiquitous tracking, in particular. An outline of how the technical challenges to radio tagging have been overcome and how the implementation of end-to-end systems can release rapid return on investment both in hospitals as well as in the centralized sterilization facilities.
RFID has had a strong and growing presence in hospital materials management for many years but not applied to tracking surgical instruments. TechNavio’s analysts forecast the Global RFID Smart Cabinet market to grow at a CAGR of 11.8 percent over the period 2013-2018. This growth has been driven in large part by falling prices for RFID tags and associated hardware. At the same time, healthcare facilities have also their use of RFID to other applications, including access/security, patient tracking, medication management, and patient file tracking. With the introduction of small, durable RFID tags, solutions are becoming available that can be used to manage clinical operations in the operating room, including tracking of surgical instruments. Perhaps unsurprisingly, the idea of using RFID tags to enable ubiquitous tracking of surgical instruments is not new. Several technical challenges have had to be overcome first:
- RFID tags attached to surgical instruments must not interfere with the use and function of the instrument
- RFID tags must be able to sustain thousands of sterilization cycles
- RFID tags must show an exponential added value over barcode or manual reading. (Automatic bulk reading of entire kits for example).
- End-to-End software platforms must manage the entire instrument lifecycle and be flexible enough to adapt to the many different instrument management scenarios (centralized, de-centralized, multi-site, shared facilities, etc.)
- RFID tags and readers bust not interfere with the with other medical equipment using radio frequencies in the hospital setting
Fine-tuning of the latest RFID technology to fit the rigorous demands of the complex, mission-critical and regulated processes of sterilization required a broad project with focused investment on each of these individual challenges.
The regulatory context in which these new systems will operate is part of a broader effort to establish unique and unambiguous identifiers on behalf of the FDA, EMA and other international regulatory bodies. From a technology perspective this is part of a larger movement toward the so-called ?internet of things? or IOT. ?IOT has the potential to release massive untapped value in some systems, and is currently, according to Gartner, the hottest trend in ICT.
It can be argued that the first applications of IOT should be in those systems where the value of each item and the cost of each item lifecycle are highest. For the purpose of this article we could call this the Internet of Important Things, (IOIT).
Sterilization and processing of surgical instruments is a perfect example of this kind of high value system where the return on investment could be exponential, even though, as mentioned above, the challenges of such an implementation are technically daunting.
Healthcare is a field that relies on sophisticated multidisciplinary cultures of managed regulated quality procedures. Being able to uniquely identify an object in such a system is only useful to the extent that it informs and improves this culture. To achieve this goal requires gathering data about the individual objects, their location, condition and history for example, and then transforming those into potentially useful information. ?Only then can that information become a source of knowledge about the system and its population of objects and thereby enable changes to the system itself. Over time, it is the knowledge gained and shared within the system that informs and influences the culture around the system as well. It is in this final step in which the greatest benefits will be achieved. These benefits come primarily from a more effective delegation of tasks between the automated and human participants i.e. fewer people performing routine tasks freeing them up to concentrate on high value added tasks, such as quality control, service, inspection, etc. It is for this reason that most of the benefits of implementing such systems will only be achieved when the entire lifecycle of the members of the system are automatically tracked.
: 1 From Data to Culture
What then are the key benefits of an intelligent system of tagging, tracking and tracing of surgical instruments?
First, Patient Safety from Tracking Surgical Instruments
The Annals of Surgery reported that tool and sponge count mistakes occur in 12.5 percent of surgeries, potentially leading to complications, infection or the formation of a mass, gossypiboma, which is often mistaken for a tumor.
Second, Improvements in the Clinic from Tracking Surgical Instruments
Given that clinical time costs roughly between 150 to 400 USD per minute, any activity that can be automated is a potential source of savings. Pre and Post-op manual counting of instruments is usually performed between 3 and five times per operation.? Add to this the occasional search for suspected retained equipment, for example, and the potential savings are vast. Just counting time alone is expected to be equal to at least one additional procedure per day per operating room.
Other improvements are subtler.? As the principal objective of the entire sterilization system is to put the right instrument in the hands of medical staff at the right moment, and in perfect condition, the kit itself needs to be composed to best suit the medical staff for that specific procedure. ?With ubiquitous tracking, suggestions for Improvements in the composition of kits or requests for repairs and servicing of instruments, can be made directly in the OR at the time of bulk scanning (either before or after the procedure). This distributed access to the knowledge base is an example of the pyramid structure mentioned above. Data are collected and transformed into potentially useful information in the system. Information is then available where it is needed and in a friendly form, so that real world knowledge can be gained. That knowledge is then available to inform the system, with the appropriate checks in place, so that the culture of quality is able to evolve. Without an appropriate decision support system, in other words, the medical staff would be reluctant to suggest the reduction of the size of a particular kit. Given the appropriate knowledge they are empowered to do so.
Third, ROI in the Sterilization Center from Tracking Surgical Instruments
As we mentioned above, until recently the application of radio tags to instruments was not feasible. Dramatic improvements have been made in the tags, their application to the devices, the readers and system software needed to cover the entire sterilization, preparation, transportation, storage and use cycle. Many companies are focusing their attention on this potentially massive unmet need.
Man Machine: Wet Brain Dry Brain Collaboration or the ?Cultural ROI?
As mentioned above, finding the right mix of automated and skilled tasks can free up untapped knowledge in the minds of collaborators and allow them to concentrate on human-skilled tasks such as inspection, QA, finding new efficiencies, etc. ?Establishing a sustainable equilibrium between automated and human tasks, while respecting the existing culture of the organization is made possible by the implementation of complete, end-to-end systems covering the entire lifecycle of the instruments. Once the ubiquity of the system is achieved, new avenues of releasing value and realizing efficiencies become visible and can be implemented organically.
Recognizing this emerging trend, major surgical instrument companies have begun to accept the reality of RFID or other touchless tracking systems on their products. There are several converging and competing approaches.? The software systems are based on an historical view of each individual item including rules, hierarchies and the subsequent statistical reporting.
In conclusion the following trends illustrate the emergence of a strong value proposition for infrastructure investments in the ubiquitous tracking of surgical instruments:
- Increased patient safety though ubiquitous touch less scanning
- Efficiencies of scale through centralization of services
- Efficiencies of speed through automation
- Better control of logistics through centralization and predictive delivery, Improved understanding of logistical flow
- Precise matching of instruments with their precise owners, even down to the precise surgeons.
- Reduction in loss of instruments (this alone achieves rapid ROI, average hospital ROI >18 months from ?go-live? of implementation
- Improved maintenance of individual instruments through implementation of automatic rules for the number of cycles for each instrument type
- Increased quality of inspection, service cycles and thereby increased life cycle of instruments.
- Dramatic reduction in pre-op and post-op counting leading up to one added procedure per day per operating room.
- Ability to automatically suggest changes in the composition of kits on-site leading gradually to a reduction in kit size and therefore release of greater efficiency across the entire lifecycle
- Reduction in hospital storage of kits
- Reduction in loss of instruments on wards
- Tracking allows unbiased information about the status of each instrument to reduce ambiguity about liability and procedures when faced with claims.
- A complete history of the lifecycle for each instrument/device is a powerful tool in investment planning as the performance of each supplier can be identified more objectively.
- Instruments are becoming more customizable to the surgeon, as above, end to end systems allow kits to be personalized to the procedure and to the surgeon
- Sterilization and service are a part of the overall cost of each patient intervention, Hospitals and other medical facilities are under tremendous pressure to improve patient safety and health outcomes, while at the same time attempting to cut costs and increase productivity.
- RFID has a strong track record of improving efficiency and productivity at hospitals in asset tracking, patient tracking, security, specimen tracking, and medication management applications. Now, passive RFID can further promote patient safety and improve outcomes by helping hospitals manage surgical tools, tracking the use and sterilization of equipment.
Global RFID Smart Cabinet Market 2014-2018, Technavio, 20.08.2014
Gartner’s Hype Cycle Special Report for 2014, Betsy Burton | David A. Willis
The Retained Surgical Sponge Kaiser, C. William; Friedman, Sissie; Spurling, Kathleen Pfeifer
Annals of Surgery. 224(1):79-84, July 1996.