The safety and quality of medical products
The safety and sterility of medical products must be provided by their producer. All requirements concerning medical products are specified in regulations and acts on medical products and their producer must confirm the fulfilment of the requirements arising from legal standards:
- The Directive on General Product Safety 92/59/EEC,
- The Medical Device Directive 93/42/EEC,
- Act of 20 April 2004 on Medical Devices,
- PN EN 13795,
- ISO 13485.
The guarantee of the quality of the offered medical products is given by appropriate certificates. All medical products from the Matodrape group are marked with the CE mark and have the actual Declaration of Conformity – a document, in which a manufacturer having a certified Quality Management Standard declares that the product is in conformity with the essential requirements of the Directive 93/42/EEC and basic requirements.
It is obligatory and obvious for the producer to fulfil all the legal standards concerning medical products. For the users – in the case of OP-drapes these are both the patient and the staff in the operating theatre – the directive concerning medical products and the standards required by the law are beneficial by all means.
TAG LABELS
A TAG label – it is a complex label. On its surface there are adhesive elements, which can be individually removed without destroying the rest of the structure, and then attach (inset) to the documentation of a given surgical procedure.
All sets of OP-drapes Matodrape have the TAG label. It is composed of a firm part and two removable elements, which can be easily and quickly removed in order to add to the documentation. On the stickers you can find the code of the product – which enables identification, lot number and the expiry date as well as the producer.
The proceeding: in the operating theatre after the opening of a sterile product which is to be used for a given surgical procedure, one sticker is attached to the documentation of the operating theatre, and the second one – in the patient’s documentation. It is terror-free and quick way of giving the information about the used product in the documentation (without the need to copy the information from the labels).
