Packing medical devices

The importance of packing in the dental practice

The Sterile Barrier System and the UNI EN ISO 11607 standard

Each stage of the sterilisation process is essential if the entire protocol is to be followed properly and effectively. Making a good job of packing and sealing helps to make sure that both the instruments and all people involved, from healthcare operators to patients, are entirely safe.
Sterilisation protocol establishes that each single instrument and device must be bagged after it has been washed and disinfected.
Packing comes before sterilisation and it requires you to place the medical devices inside disposable packaging (Sterile Barrier System – SBS) whose main features have been outlined in the UNI EN ISO 11607-1 standard.
Therefore, the aim of packing is to serve as a preliminary stage to sterilisation, provide a physical barrier and ensure that the sterilised instruments remain sterile until they are ready for use.

Pouches and rolls for sterilising dental instruments

As far as packing is concerned, the standard requires the devices to be bagged and sterilised in disposable packaging in order to prevent any risk of infection. Items can be sealed in pouches made of polypropylene paper or with sheets of medical-grade paper. The most common paper pouches and rolls are:

  • flat pouches
  • gusseted pouches
  • flat rolls
  • gusseted rolls
  • self-sealing pouches

Self-sealing pouches come with an adhesive strip and do not need thermosealing. Even though they are easier to use, they often prove to be less effective and have a greater margin for human error. This is why we do not recommend using them. An excellent sealing method is of the paramount importance. Furthermore, thermosealing must not be less than 6 mm wide and the pouch must be large enough to ensure that the material contained therein does not occupy more than 3/4 of the entire volume.

Packing and traceability during the sterilisation process

In addition to guaranteeing and preserving the sterility of the instruments once sterilisation has taken place, the packing standard also requires compliance with a labelling and traceability system which is essential for the smooth running of any dental practice and keeping tabs on activities and operations. The following data are required for each single package:

  • the details of the operator who performed sterilisation;
  • the number of the sterilisation cycle indicated on the autoclave;
  • the packing date;
  • the expiry date is approximately 30 days after the packing was carried out, unless otherwise specified by the manufacturer as in the case of Eurosteril® rolls and pouches.

Concerning the expiry date, tests conducted have confirmed that items in Eurosteril® rolls and pouches will remain sterile for 6 months if they are kept in clean, dust-free settings away from direct sources of heat, at temperature between +5°C and +30°C, with relative humidity <50%.

This data is essential for complete and proper traceability of the process. The information identifies and certifies the sterilised material, meaning that it has actually been sterilised, and indicates the date when sterilisation ceases to be effective. It also indicates which patient the material was used on and when.

It is therefore clear that packaging and sealing dental instruments properly is an essential preliminary step on which the whole sterilisation process hinges. The proper bagging of instruments guarantees the effectiveness, traceability and correct storage of sterilised medical devices, making sure that the instruments are kept in optimal safety conditions until it is time for them to be used.