Validation, traceability
and retrievability

10/11/2017

Sterilisation and traceability

Improve internal procedures in the dental practice and prove they have been properly done

When we talk about safety of the sterilisation process, we can refer to many different aspects, each of which are important and necessary. Developed to restore sterility to instruments and safeguard patient and operator health, sterilisation today is also required to provide evidence that all stages have been properly executed. The process must be kept track of; past records about the instruments and how they were used must be stored in the database.

In a nutshell, guaranteed safety in a legal and statutory sense as well as an operational one. Information and data must be able to show, prove and reconstruct at any given time (and in the event of any disputes) that the dental practice adhered correctly to its own internal procedures.

Validation, traceability
and retrievability

To ensure that the sterilisation protocol took place completely and properly with due storage of evidence, Euronda Pro System has developed three different procedures and key indicators: validation, traceability and retrievability.

Validation: gives confirmation that an operation has taken place successfully (whether this be for cleaning, sterilisation or pouch sealing) so the subsequent protocol phase can be dealt with rapidly and safely without wasting time.

The term “validation” is defined by ISO 9000 standard section 3.8.5 as being: “Confirmation, through the provision of objective evidence (3.8.1) that the requirements (3.1.2) for a specific intended use or application have been fulfilled. Note 1. The word “validated” is used to designate the corresponding status.  Note 2. The “use conditions” for validation can be real or simulated.

Therefore, for validation to take place the process must:

  • be controlled and documented;
  • always work in the same way;
  • be repeatable and reproducible.

Traceability: this allows us to check the information that certifies instrument sterility prior to use, indicating relevant data on the pouch, namely: sterilisation date, type of cycle, serial number, cycle outcome, operator in charge of the cycle and expiration date as established by the internal sterilisation protocol.

We must be able to reconstruct past activities that took place on a sterilised device, so that the user and relevant bodies are able to retrieve the information required.  European directive 93/42 on medical devices (now superseded by directive 47/07) highlighted the concept of retrievability and this notion was incorporated and reiterated in the Italian Legislative Decree implementing the EU Directive.

Traceability (computerised systems are recommended) must ensure the recording of all data, showing the procedure followed: decontamination, washing, packaging, sterilisation and storage.

A combination of these three aspects of sterilisation is an essential procedure, not only because it enables the dental practice to work independently and in utter safety, but also because it provides the dentist with an effective defence should any legal disputes arise. Then, there is another kind of safety which is no less important.

Data safety

Therefore, for documentary and operational purposes, the data and information generated for the various devices taking part in the sterilisation process are of fundamental importance.

Safety of the paper label: traceability

The label is for here and now: it serves to check sterilisation data prior to instrument usage and it gives us the green light so we can continue with the task at hand. The label produced by the Euronda Pro System Print Sets contains vital safety information: the date on which sterility expires so you know how long the instrument can be stored inside the pouch. Because to preserve what sterilisation has achieved – sterility – we must protect the instrument inside a bag. A tightly sealed pouch acts as a barrier, preventing any contaminants from compromising the sterility of its contents, but it has a use-by date. This date is shown by a label on the pouch holding the sterilised instrument and is attached at the end of the sterilisation process.

Safety of the digital file: retrievability

The digital file is for the future: you need it to retrieve sterilisation data after the instrument has been used and to prove that it was suitable for use at the time.  Indeed, the digital file produced by the Euronda System contains essential information for safety: it certifies that the instrument was sterilised, that its sterility status has not expired and that its usage during dental procedures took place in compliance with health and hygiene regulations.

Data management safety: connectivity

Properly transmitting, sharing, managing and filing the data sent by the equipment is therefore of paramount importance both to benefit from the information itself and to preserve evidence for future use.

This is why Euronda has developed various integrated and integrable connection systems (Ethernet, Memory Card, Wi-Fi) and a set of software such as E-Data and E-Memory which can convey and relate data to the dental practice’s management programme, creating a complete systematized database. Like this, even if any patient complaints come up, you will always be able to demonstrate and document the fact that procedures took place properly, that the sterilisation process was carried out according to safety criteria and that applicable regulations were abided by.

Further protection against patient complaints can also be had by acquiring the sterilisation data of a particular load used on a particular patient and associating it to the patient record. This can be done:

  • as a hard copy: in which case, the label attached to the pouch can be stuck to the patient record (but remember to make photocopies of the patient record at some later stage, since the labels are heat printed and fade over time)
  • on a data-storage device: in which case, the label with a bar code can be printed and the sterile load can be linked to the patient’s computer record (if you have a management software that registers this kind of data).

Regulations on sterilisation and traceability

In conceptual terms, both validation and traceability are of vital importance and also covered under applicable statutory regulations. The purpose of the former is to guarantee and document the fact that the various phases were implemented and took place successfully so that the validity of the entire process can be vouched for. The latter is a form of proof which enables a dental practice to reconstruct with accuracy all the various stages during the sterilisation process which have been recorded on hard copy or on a data-storage device (the best solution).

Being familiar with regulations and laws on sterilisation and duly applying them is fundamental for dentists, both from a moral point of view and a legal one.

Failure to take any necessary precautions that would avoid the risk of cross infections can be construed as professional negligence. In such unfortunate circumstances, the dental practitioner would be bound to compensate any third parties for damage incurred by this oversight and may even be liable for criminal prosecution. On the other hand, penalties can be applied regardless of whether damage was caused or not. For instance, failure to take prevention and protection measures (which naturally include equipment used for instrument sterilisation) and non-fulfilment of this obligation of technical feasibility is punishable by arrest or by fining each single breach.

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