Traceability at CSSDs

Técnica en esterilización utilizando el software de trazabilidad y gestión de Interlab

Traceability is present in the day-to-day supply chain of several industries. Due to the awareness of safety in production processes in recent years, traceability has been extended to a wide range of fields, including the hospital sector.

Traceability implies the ability to reconstruct the history of a product or batch using a recorded identification, i.e. to know all the places and states through which it has passed from its production to its consumption or use.

Today, the concept is spreading globally as a consequence of the SARS COVID-19 pandemic, acquiring an unprecedented relevance about its importance. Currently, the discussions are about the right of patients to know the traceability of the medical devices used in their procedures, supported by the FDA in its new regulations regarding Unique Device Identification (UDI).

In the surgical field, traceability becomes important in the sterilization process of medical instruments and devices, since the results of this process are not completely verifiable through inspection and testing, given the risk that the sterilized material loses this property.

This is how a traceability system becomes key to knowing the history of each instrument reuse after reuse, allowing a multiparametric control of the sterilization process through physical, biological, and chemical indicators, and the follow-up of where each medical device was, where it is and where it should go. In other words, a record is kept of the quality and of all the places and processes through which the surgical instruments have passed from their reception at the sterilization center to their delivery to the operating room, making it possible to reconstruct the history of the medical device or surgical instruments from their use on a given patient to the moment they are received at the sterilization center for processing.

In summary, traceability becomes fundamental to the sterilization process for several reasons:

  • Assurance of patient safety.
  • Prevention and quick action in the event of instruments in poor condition.
  • Standardization of work methodologies.
  • Incorporation of process control statistics to improve the quality of care.
Surgical Instrument with micro TAGs

Surgical instruments identified with micro tag.

Traceability through specialized software

CSSDs, as part of their commitment to total quality, implement traceability to know the history of medical devices, their location, and the processes they have undergone.

In this sense, to achieve total traceability, it is necessary to univocally identify surgical instruments, textiles, medical devices, and disposables, among others, in order to link such identification with the values that guarantee the quality of sterilization.

The digital recording and storing of information have clear advantages over manual recording:

  • It induces greater speed for the recording and the subsequent search of the stored information.
  • It avoids errors due to incorrect writing.
  • It saves physical storage space.
  • It cross-references information and allows direct and instant access and export of data.

Some of the key data that can be recorded with traceability software are the washer, the sterilizer, the medical device, the package, sterilization date and shift, the person in charge of each stage of the process, the patient and the batch.

At the same time, through the univocal identification of each of the instruments, valuable information about the item can be stored; for example, measurements, sterilization methods, user ownership, and internal inventory codes, among others. It also makes it possible to obtain information on the sterilization processes in each of its stages, to know key data to maximize the efficiency of the CSSD, to manage replacements, to prevent errors, and to develop a quality management system within each CSSD.

Nowadays, CSSDs must have highly complex technology for the development of each of their processes, so having software integrated into such equipment will make a traceability system an agile and reliable tool, where specialists can make the right decisions in each of the phases, with the patient safety as the main goal.


Finally, a traceability system makes it possible to retrieve information on the sterilization process of any product and to assess whether it was performed correctly or incorrectly. It is much better if this system is computerized, as it will have great advantages over manual recording.

If you want to learn how to choose the best traceability software for a CSSD, this article may be useful.