TECNAN (Spain)

Currently, a large part of the health centers use surgical instruments labeled by the manufacturer as single-use material. This material, on the recommendation of the manufacturer, should be discarded through its initial use, becoming a biohazard waste. In this context, the need for financial savings of health centers and the ecological awareness that has increased in recent years, unleashed the reutilization of this material (In 2012, 45.2% of European hospitals with more than 250 beds, according to the FDA, performed this practice). This is defined as the use of a MD, more times than those specified by the manufacturer on the label and is normally preceded by reprocessing and remanufacturing, which includes all the steps taken to convert a contaminated single-use device into a device ready to be used in another patient. These stages are the following: washing, functionality tests, packaging, labeling and sterilization. Reprocessing is foreseen in the new EU legislation on MDs, (Article 17).

TECNAN is applying some of their nanocoatings to confirm the potential use of this technology to enhance reprocessing chances for the MDs. Surgical instruments of different materials have been treated showing good results. It was found that easy-to-clean properties were achieved that would facilitate the cleaning processes in the reprocessing of the material and also allow including the antibacterial property of silica particles and hydroxyapatite in cooperation with CIBER. Antibacterial properties are also interesting for other surfaces, being synergistic with Pilot test case 2.

The proposers will need OITB services according to the current stage of development, including:

→ Regulatory

→ Assessment of existing data

→ Evaluation of the potential of nanoparticles leakage, biocompatibility, cytotoxicity, surface integrity and sterility.

→ Production

→ Business model.