EXECUTIVE SUMMARY
Following a request from the central procurement department, the CEDIT, a hospital based HTA agency of the Paris University Hospital (AP-HP), assessed the value of traceability for individual surgical instruments. Indeed, surgical instruments may get mixed up or be inverted with instruments from other procedures either in the operating area or in the sterilization process, with an associated traceability failure. A literature review retrieved few relevant studies on this subject and the current assessment report is essentially based on other sources (reports from scientific societies, documents from the industry and expert opinions).
Technical aspects: Individual instrument traceability is generally implemented to prevent risk of contamination (e.g. Creutsfeldt Jacobs disease) or strengthen the ability to identify and recall instruments in the framework of a medical device incident reporting system, or to follow the quality of the clinical procedures. A risk analysis, a strategic vision and careful technical and organizational preparation are prerequisites for implementation of (Individual instrument) traceability. It further requires a standardized codification system that enables unique instrument identification, symbols carrying the identifiers that are machine readable with a very low failure rate and which preserves the properties of instruments with respect to safety and performance Two-dimensional barcodes can be implemented with percussion dot matrix marking, laser engraving or adhesive labels. RFID chips can store more information and their functioning is not hampered by optically opaque media but in contrast with metallic objects.
Clinical aspects: None of the studies addresses the strengthening of safety in health care. The articles do describe how to implement traceability and the available technologies and in addition suggest methods of validating feasibility of implementation for each technology. One article describes a study thatidentified incidents regarding patients having been reported as cases of Creutzfeldt Jacobs disease only after their surgical procedure had taken place. The hospitals were unable to retrieve the kits in question in a majority of cases. The incapability to track the instruments complicates the management following exposure incidents.
Economic aspects: No economic evaluation on the subject was retrieved but only some pieces of information such as the unit price for marking instruments from 1 to 3.5€ for two-dimensional barcode and from 3 to 10 € for a RFID chip. The percussion dot matrix equipment is estimated from 20000 to 30000 €. The cost for implementing an adapted organization for individual instrument marking is unknown.
Organizational aspects: Choosing a traceability technology and software implies making important organizational choices, in particular the operator has to choose between free (generic instruments) or restricted recomposition of surgical procedure kits/trays (un instrument always has to be placed in the same kit).
Discussion: Individual surgical instrument traceability should contribute towards improvement of the sterilization process and the utilization of the sterile instruments. Furthermore there is regulatory pressure to improve traceability of instruments. Due to the great diversity of instruments in terms of size, shape and material it is not possible today to select a single marking technology that would ensure traceability for all instruments. From a regulatory point of view it appears useful to contact manufacturers to ensure that the marking will not compromise safety and performance of the instruments. It appears that the traceability technologies intrinsically also hold the potential of development outside the sterilization process: training; organization, safety etc. Due to the large number of hospitals within the AP-HP and their different organization, multiple systems could be implemented thereby hampering transfer of equipment and information thus
jeopardizing future co-operations in the field of sterilization.
CEDIT recommendation:
The CEDIT considers the subject important for the hospitals and consider that the implementation of individual surgical reusable instruments that need to be sterilized should be encouraged.
- The procurement officers should, in liaison with the persons in charge of implementing the marking system, request information from the medical device manufacturers regarding the marking’s potential impact on instrument safety and performance, and validity of product warranty
- For the acquisition of new instruments engage with surgical instrument manufacturers to perform marking during manufacturing wherever possible and appropriate.
- For the existing pool of instruments, prefer percussion dot matrix marking wherever possible.
- For the ancillary devices and material on loan use RFID chip marking where possible.
- Recognize as en objective for the different sites of the AP-HP the harmonization and adoption of recognized standards for the choice of codification systems and traceability software.
