After the dissolution of the European Society for Hospital Sterile Supply (ESH) many felt the need to maintain contact with European sister associations. This is the reason why the Irish Decontamination Institute (IDI) was established. This is an informal group whose aim is to provide the following information through a website.
Telling what's going on in each other societys like topics on congresses, educational programs etc.
Giving information about current and new European legislation.
Indicating interesting scientific articles and literature.
Linking with international sites.
A question and answer corner.
Commercial information and links with commercial sites.
Every society that takes part has a page at their disposal.
The IDI website emerged from the EFHSS website which was created on 19 June 1999. The web address of the WFHSS website is http://www.wfhss.com.
The big advantage of the site is that now information is available to everyone.
As you see we want to keep our members informed about what's happening in the various TC (Technical Committess) and WG (Working Groups) of CEN (Comitée Européen De Normalisation - European Committee for Standardization).Their decisions have important implications on the daily activity in the CSSD (Central Sterile Supply Department).
That's why we ask you if your willing to cooperate. What we would like is that now and then you update the forum on the state of affairs in your Working Group or Technical Committee so we can spread this through our website and also the journal Central Service if you have no objection.
We find it important that everybody stays informed about what we can expect in the future in the workplace and also to bring Europe closer together by shortening the distance.
We hope that we can count on you. For more information you can
The CEN Affiliates are the national standards bodies of Central and Eastern European countries which can in principle become members of the Union or EFTA, and which therefore can become full National Members of CEN. You can find/contact the CEN Affiliates through the following web address:
The safety of medical devices such as surgical equipment or implants is to be significantly improved after the adoption of a proposal by the European Commission, today by the European Parliament. There will be stricter rules for the use of potentially toxic materials, for which adequate labelling will be required. Furthermore the safe single use of devices is enhanced. A study will be done to see how better reprocessing of devices can be achieved. Apart from this, specialized medical software will fall under the scope of the new Medical Device Directives, which have been updated in the light of new technological developments. The European Parliament vote is based on a compromise, reached with the Council, which is expected to adopt the package shortly.
Commenting on the vote, Commission Vice-President GŁnter Verheugen, responsible for enterprise and industry policy, stated: "This is good news, as today's vote allows for enhanced patient protection and supports medical progress and innovation. It will improve the functioning of the internal market, and strengthen the competitiveness of European industry."
Medical devices have become an increasingly important health care sector and have an increased impact on health and health care expenditure. Medical devices encompass some 10,000 types of products, ranging from simple bandages and spectacles, through life sustaining implantable devices, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment. The public expects that such medical devices meet the highest safety standards.
The new legislation will clarify essential elements for safety of medical devices such as clinical evaluation and conformity assessment, as well as bringing new, positive, provisions such as those aimed at increasing transparency. The package agreed today aims at reinforcement in the following fields:
To bring clarification to the area of reprocessing of medical devices, the definition of the term 'single use' and subsequent labelling will be uniform within the EU;
Manufacturers should avoid the use of carcinogenic, mutagenic or toxic to reproduction (CMR) substances used in medical devices. A total ban of these substances is not possible without banning many medical devices which are indispensable for the protection of health. But the following improvements are foreseen:
Devices which could possibly release phthalates to the body of the patient should be labelled accordingly.
Manufactures should strive at developing alternative substances or products with a lower risk potential.
It is necessary to clarify that software, is in its own right a medical device, when specifically intended by the manufacturer to be used for diagnostic or therapeutic purposes, for instance to assist people who have suffered from a brain haemorrhage. Software for general purposes when used in a healthcare setting is not a medical device.
The issue of the medical devices combined with cells and tissues of human origin, the so called "combined products" will not be tackled. Other planned legislation should deal with this question, such as the Regulation of advanced therapy medicinal products.
As design for patient safety initiatives, the manufacturer should place particular emphasis on the working environment in which device is used and possible reduction of potential accidents.
We only maintain a list of the CEN Standards and Directives with relevance to hospital sterile supply on the IDI Website. Please check out the CEN Website at http://www.cen.eu for information on how to obtain the standards. Information on the directives can be found on http://europa.eu.int.
Lists of standards with relevance to hospital sterile supply: