Clinical traceability in sanitary sterilization3 min read

Recently, an important hospital group contacted us regarding the current issue they are facing with clinical traceability in general, and specifically in the surgical sterilization process. They stated the following problem:

Clinical traceability consists of including all information about the journey of the material used in a surgery in the patient’s medical history, so that in case of an error, we have evidence of where it occurred.

The RD 1591/2009 stipulates that any instrument that penetrates the human body, either through natural orifices or through skin or mucous membranes, must be traced. In addition, the ISO 13485 standard emphasizes the need for a responsible person for the activity, so that the name of the person in charge of the procedure must appear at each step of the traceability.

These standards also require that the systems used for this traceability process ensure that the collected information cannot be altered or manipulated in any way, and that each step of the process has an assigned and identified responsible person for complete security and audit control.

Most current clinical traceability computer systems do not fully comply with these requirements, as any person with sufficient access permissions can access and manipulate the data (either intentionally or accidentally). Additionally, there are many cases of sharing access credentials or generic user accounts, which makes it impossible to know with certainty which individuals have participated in the process.

If we add to all of this that our internal audits are carried out mainly through sampling, since we have no way of analyzing 100% of the samples, all of this creates great legal and professional responsibility insecurity.”


Technology: Blockchain and Digital Identity

In light of this situation, there are two technologies that can solve these problems: Blockchain and verified digital identity.

  • Blockchain is a distributed and decentralized cloud-based ledger that, thanks to cryptography, guarantees data immutability (non-manipulation) by design. Blockchain technology provides integrity, security, transparency, and traceability, generating automation and oversight of processes with full legal guarantees, thus facilitating audit processes.
  • Digital identity consists of digitizing the entity that carries out the actions of the process in question, previously verifying it to eliminate possible impersonations. Once it has been verified, a digital identity is created that is uniquely assigned to the entity (which can be a natural person, legal entity, or machine). Digital identity plays a key role in creating accountability for the entity that carries out the actions, as this eliminates the possibility of repudiation and alterations or manipulations of information. This is because when an entity carries out an action and it is registered in blockchain, if that entity manipulates or alters it, it will still be recorded in blockchain, generating proof of such alteration that, thanks to digital identity, can be identified unequivocally.


iCommunity’s Solution: iBS

iCommunity provides iBS, a solution that allows these technologies to be integrated into any traceability software quickly and easily, both in cloud and on-premise solutions. This is thanks to its simple API, which allows any company to integrate both technologies into its processes without the need for extensive development.

As simple as inserting calls to iBS’s API within the traceability software to generate blockchain evidence for each step of the traceability process. This way, each evidence is assigned to the digital identity of the person/machine who carried out that step (and who has previously been authenticated in the system), thus being able to build the “digital passport” of the entire process and include it in the patient’s medical history, with a link to each evidence generated in each step of the process.

If you are interested in using iBS to improve your traceability, you can contact us here.

2023-03-15T11:08:31+01:0015 de March de 2023|Blockchain traceability, Blockchain use cases, Health sector|
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