Gowns and drapes standard developments.

Introduction

A European committee (CEN/TC 205/WG14) has been set up to develop standards for disposable and re-useable gowns and drapes. The Swedish standard has been for gowns and drapes has been used as the basis for the discussions.

A UK technical committee (TCI/100) has been shadowing the CEN work in the UK for the last 2 years, but a formal BSI committe is in the process of being set up, CH/117/2 (Surgical clothing and drapes).

In addition, the EEC is funding a research programme named "BIOBAR", whose aim is to develop test methods for the evaluation of barrier materials for protection against biological hazards (liquids and aerosols). BIOBAR is not related to the CEN/TC 205/WG14 work, even though the results of their research will be highly relevant to that committee. BIOBAR is expected to report by the year 2000.

The CEN WG timescales are:

Draft standard by end of 1998
draft for public comment by 2000
published standard by 2001

Autumn Meeting 1999

The latest meeting of CEN/TC 205 WG 14 took place in Salzburg in October 1999.

The draft standard is now split into 3 parts (terms and definitions, test methods and limits). Much discussion is taking place to finalise the test methods. An article on the current status can be found in the Nov 1999 SMTL newsletter.

Spring meeting, 1997

The following areas of the standard were discussed:

Whether the standard should be a mandatory standard.
How to develop clearer lines of communication between BIOBAR and the working group.
Test Methods
- The WG voted to include a number of microbial penetration tests (wet, dry etc).
- Cleanliness after laundering - discussions centred around whether re-useable gowns and drapes should be subject to batch testing or whether there should instead be process validation.
- Body liquid penetration and liquid absorbency were included in the standard.
- Water vapour penetration, drapeability and air permeability were thought to be factors relating to comfort NOT control of infection (the scope of the standard states that it specifies tests etc for single-use and re-useable coverings for patients, clinical staff and equipment intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures). Comfort factors will therefore be included as a separate annex of the standard.
- Tests for conductivity were removed from the standard.
- Tests for linting are still under discussion.
- Biocompatibility was removed as it is included in the harmonised standards, and will be referred to in the introduction to the standard.
- Scrub suites vs special scrub suits - the standard will probably only refer to special scrub suits (but a definition of a special scrub suit is still required).

The actual test methods which will be used to test the performance criteria referred to above are still under discussion, and some will be determined by the outcome of BIOBAR.

The next CEN meeting is in Sept 1997.

This site was originally set up with the aid of sponsorship from the Value for Money Unit, Welsh Office and an educational grant from Sophos Convatec.

URL: http://www.smtl.co.uk/MDRC/Standards/gowns-drapes.html
Last Modified: Tuesday, 21-Dec-1999 16:19:11 GMT