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Traceability of surgical instruments

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Total recall using In-Sight

ID technologies that have already proven themselves in other industries are now opening up previously untapped potential in hospitals. Potential for both patient safety and cost efficiencies. Traceability and transparency for instrument management are critical factors in hospitals and clinics. Ulrich Swiss has developed the Kenus® system using Cognex In-Sight® machine vision systems which has already proven effective in many clinical practices when it comes to the traceability of sterile surgical instruments. This is setting new standards in operating theatre safety, central sterilisation units as well as administrative efficiency for hospital cost centres.

Surgical instruments — how can hospitals achieve “total recall”?

Like in the aviation industry, bad publicity for a hospital or clinic as a result of badly managed procedures must be avoided at all cost. For example, a hospital administration needs to be able to recall which instrument was used to operate on which patient even long after the fact in order to be able to identify the source of any infectious particles. In Europe, depending on the clinic, a figure of somewhere between 5 and 15 million euro is invested in surgical instruments and implants. Sterilising one instrument is currently estimated to cost around 1 to 1.5 €. Traceability of each instrument on a piece by piece basis is crucial. Instruments are stored in filters, which are like small buckets or sieves. A filter can hold around 50 to 100 instruments and each of these filters is marked with a barcode which allows clinic personnel to know that a filter has been correctly packed with the specific instruments for a particular department. This kind of individual identification allows detailed calculations to be performed for the corresponding cost centre. Now hospitals and clinics can benefit from the Kenus System using vision technology to make things easier.

In-Sight — the ID reader that makes the difference

When the Kenus system was first being developed, Ulrich was still using cameras with a link to a PC that was running code reading software. The company needed to find something that would make the system more powerful and flexible. Their partnership with Cognex, global leader in machine vision, and use of the In-Sight vision system has raised the Kenus system to a new level of quality and made it much simpler to operate. A compact vision system, the Cognex In-Sight can manage jobs that were previously reserved for PC-based systems. The robust stainless steel housing allows the In-Sight vision system to be used even in the toughest of environments. The IP68 (NEMA 6P)rating means safe operation even in the most sterile, hygiene-conscious environments. It’s high resolution guarantees reliable code reading, while the powerful integrated processor allows for a high read rate. Powerful machine vision tools such as IDMax are available for enhanced code reading. Each filter is fitted with a barcode, read using the hand-held reader. The clinic staff see a picture of the filter on their workstation monitor, showing with which registered instruments it can be loaded. This rules out errors resulting from human carelessness. Only instruments that are intended for this specific filter can be read. Each correct reading is displayed immediately on the monitor. Unintentional duplicate assignment of instruments is ruled out, because the In-Sight code reader will not register the second identical read operation. Implementing a traceability program within instrument management means that central sterilisation can be sure that their filters contain the correct instruments. This is a crucial for safety and legal evidence in case of potential claims for damages. Also, clear identification and documentation allows for better/improved advance planning for operations.

Even the smallest instruments identified and tracked

Each instrument is permanently marked with 2D Data Matrix code, 100% reliable when it comes to counterfeit-proof identification codes. The code contains the information necessary to keep track of the instrument. Then a drill is used to incorporate the dots of the matrix code into an additional recessed surface on the instruments making the code damage resistant and guaranteeing the quality. This means that even if solvents used in sterilisation caused chemical reactions such as rust the code remains resistant. The matrix code used in the Kenus system requires a minimal area of just 0.8 x 1.6 mm so even the smallest instruments used in clinics can be marked and identified. Unlike other types of part marking, Data Matrix code can record extensive information in a tiny area, while the codes can still be read and verified reliably.

By marking each instrument with a Data Matrix code it is possible to have a permanent record of permanently attached to each instrument provides detailed documentation of the complete and correctly stocked filter. This rules out a situation in which several sterile filters have to be opened until the required instrument is available which optimises filter use saving money. Instrument usage is documented allowing audits to be planned in good time.

The system includes software tools from the In-Sight Explorer version 3.1 development environment which provide time-saving, application-specific solutions for challenging vision tasks and are easily integrated into quality management programs.

Lukas Giovanettoni, Chief Executive of Ulrich Swiss AG comments: “What has impressed us the most is the accuracy and reliability of the In-Sight solution. I am fascinated by the fact that different codes can be read quickly and one hundred percent accurately with a simple workstation configuration and very easy handling.”

40 readings per second

The Kenus system has a modular structure, including code marking, code reading and the complete management of surgical instruments at filter and instrument level. Plus the system can incorporate full cost accounting. Instrument management can be adapted to the individual requirements of clinics. Ulrich Swiss sees itself not only as a supplier for code marking, code reading and management software but also as an expert partner when it comes to setting up a complete quality management system. The data management functions allow staff to identify how often an instrument has been sterilised and used. For example, code reading indicates that a pair of scissors have been used too often and need to be sent for an audit and regrinding. A reading is confirmed by an acoustic signal, a visual signal and on the monitor. The code reader stands on the desk. Instruments loaded by hand do not need to be precisely positioned when the code reader is used, as it automatically detects the matrix code in the subject field. The In-Sight can perform around 40 readings per second. Integration of the In-Sight into the Kenus system has significantly improved its performance and reliability, reflected in the fact that numerous clinics have now upgraded and expanded their own systems.

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