Traceability in sterilization

Directive 93/42/EEC, amended by Directive 2007/47/EC, regulates medical devices and stipulates that any instrument that enters the human body either through a natural orifice or through the skin or mucous membranes must be traceable.[1] [2] 

The traceability of a process or a product is defined as the series of pre-established, self-sufficing procedures that makes it possible to following the evolution of a process or the route and location of a product in each of its stages, both directly and inversely.

Each country has its own regulations regarding medical devices, but all of them refer to the international law UNE-CEN/CLC/TR 14060:2014.

Clinical traceability consists of including in the patient’s clinical records all the information regarding the route of the material used for intervention on the patient, so that if any error has occurred, we have a record of the point at which it happened.

Clinical traceability consists of including all information about instruments used during an operation in clinical records in order to certify that the whole sterilization procedure has been carried out correctly.

The UNI EN ISO 13485 standard is based on and complementary to the UNI-EN ISO 9001 standard. This standard covers all the requirements for quality control of medical devices. This law places great emphasis on the control of documentation and its storage for at least 5 years. There must be a person responsible for the activity, which is why the name of the person responsible for carrying out the procedure must be specified at each step in the traceability process. This standard also refers to the proper storage of the material until it is used, paying particular attention to the expiry date of the product. This standard applies to all medical devices, including biomaterials.

The UNI/TR 11408:2011 standard refers to the reuse of medical instruments and devices. The instruments we use will be subjected to a “special product” treatment. In other words, because we cannot ascertain sterility directly on the final product, we have to validate each phase of its processing to be sure that the whole of the sterilized batch has effectively been sterilized successfully.

Traceability is a mandatory process for anyone who cleans and sterilizes instruments, from a large hospital to a small tattoo parlour. Sterilization will be performed in different functional areas. It is not necessary for each area to correspond to an isolated physical space; these are functional areas where the different phases of sterilization are carried out. Thus, a dentist will have a dirty area where the material enters, where a sink and a washing area will be located, another area for drying and checking the instruments, the area where they will be packed and at the end of the route there will be the autoclave, where we will perform the sterilization. In each area there must be a specific protocol, with a series of records of all procedures (See Table). 

It should serve as tool to manage our instruments efficiently, and not as a solution to problems. It must be carried out at all stages, from cleaning to sterilization, and the data must be easily accessible to anyone who requests them. The main function is to provide support in order to detect any problem as soon as possible, and if necessary, remove the rest of the instruments involved in the failure and stop the corresponding autoclave.

In short, the purpose of traceability is to achieve quality control and certification that each instrument used has been disinfected and sterilized and is in perfect condition for use. The aim is to achieve a high level of protection for our patient.

There are two ways to carry out traceability. We can do it manually or by computer.

The manual way is the simplest and most economical. The date and the corresponding sterilization cycle should be written on each pouch. This is the slowest system, and will gradually become obsolete. Another drawback is the physical space occupied for filing the records. Gradually, dental practices have adapted their patient records to computer systems that eliminate paper. Each piece of information on the pouches can be noted by hand on the patient’s record, but this is time-consuming and can be done using computerised systems.

Computerised traceability is the ideal mechanism, because it is much quicker and requires less physical space.

To do this, the first thing we need is a suitable computer program to process the data. This program can send all the data we have collected to our patient’s record. These programs integrate these data with the patient management program we have in our practice to file both complete data of the procedure performed on the patient and detailed information on the entire process the instrument has undergone until it is used. Secondly, we need our equipment to give us a series of records. Some B-type autoclaves have an SD card or USB or labelling systems for this purpose. Other devices, such as sealing machines or the latest generation of thermodisinfectors, also have recording systems for efficient, easy traceability. The collected data can be transferred to the program using a label reader, as well as manually or via LAN or WiFi.

Labelling of instruments is mandatory. This can be done by means of a sticker with the data or with QR codes. These labels must show the date, the batch of the load, the expiry date and the person who carried it out.

EC Directive 95/46 of 24 October, in addition to reaffirming the legal status and the rights and obligations of health professionals, citizens and health institutions, clarifies the obligation to keep clinical records of patients.

Each country has its own legislation in this regard. In Spain, article 17 of Law no. 41/2002 states that health centres are obliged to store medical records in conditions that guarantee their safety and maintenance, although not necessarily in the original format, to guarantee proper care for patients for the time appropriate to each case, and for at least five years from the date of discharge. The minimum time is 5 years, with variations depending on the legislation of each country or province.

• Physical-chemical parameters of the washing, disinfection and sterilization processes.
• State of control and periodic verification of the correct functioning of our equipment.
• Periodic maintenance checks.
• Production lot
• Test results (Helix, Bowie Dick, Vapor Line, …)
• Composition of the kit
• Person in charge.
• In the case of limited use instruments, the number of sterilizations.

In short, traceability will make it easier for us to locate a batch in the event of a problem emerging in the sterilization chain. It will also help us in the rotation of the material, its location and the early detection of problems in the sterilization chain. All of this is aimed at ensuring maximum safety for our patients.

1. Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff: U.S. Department of Health and Human Services; 2015.
2. Decontamination: Health technical memorandum 01-05, decontamination in primary care dental practice (2013 edition)
3. ADA’s Guidelines for Infection ControlThird (2015) Australian Dental Association DOI:www.ada.org.au/Dental-Professionals/Publications/Infection-Control/Guidelines-for-Infection-Control/1ADA_GuidelinesforInfectionControl_3.aspx