|
Dear Mr. Mc Loughlin,
"Removal of reusable linen from packs/sets."
You are probably refering to the European Standard prEN 13795: "Surgical drapes, gowns and clear air suits, used as medical devices for patients, clinical staff and equipment".
First of all: this standard is not yet accepted, for the moment only the Part-1 is in the fase of Final Draft (part 1: general requirements for manufacturers, processors and products).European standard EN13795 is series of standards, wich will consist of 5 parts and is likely to be completed within the next 2 years.
If this EN would be accepted as he is now, cotton drapes and gowns will not meet the performance requirements relating to microbial penetration (wet), linting, etc.
I would like to refer to the comment made by Prof. Dr. med. H-P. Werner (Covenor of the CEN / TC 205 / WG14): "It has been confirmed in many studies that under surgical conditions, cotton is not a barrier to the spread of micro-organisms, especially in liquids.It has been shown that the transfer of micro-organisms to the incision is greater when cotton drapes are used." He also stated: "It is time for a fundamental change: Cotton drapes and gowns must be replaced by qualified medical devices with adequate barrier action."
Another important statement by Prof.Werner: Altough this standard is not yet acepted...."Even though this European Standard has not yet been adopted it is the responsibility of a hospital to assure optimal protection of patients and users. In a lawsuit this could lead to the burden of proof being shifted to the hospital with risk ol liability. The difficult situation arises in wich one must proof that one has acted equivalent or to better than the standard procedures, or that ons has made no mistakes.Because of the risk of liability alone, one should consider very carefully the question of what surgical materials to use in the future."
In my opinion this EN standard will (and this process has already started in our country - Belgium) start this "fundamental change". As you can see this standard speaks about "drapes" used as "medical device" for "patients" and "equipment". So the question is: for what purpose are you using your reusable linen in your pakcs/sets? If you use them as draping material on a patient or to put them on the instrument table, than this linen will fall under this norm.
Hope this explanation can help you.....
Marc Corthals
Belgium
http://www.malysse-sterima.be
|
:: Questions & Answers