Surgical gowns, drapes and coverings

Will cotton fabrics be banned from use in operating theatres?
No
Hospitals may continue to purchase and use surgical gowns, drapes and coverings that meet their local requirements and in particular their infection control policies for surgical procedures.

Note: It is important to recognise that many 'traditional' cotton and polyester/cotton gowns and drapes do not claim to have any 'barrier' type properties or provide a high level protection to patients and theatre staff from infective agents.

Are there new European Regulations coming in for surgical gowns and drapes?
No
The European Medical Devices Directive 93/42/EEC (introduced in 1995) has been fully in force in the UK since 1998 via the Medical Device Regulations (SI 2002 No. 618) and Medical Devices (Amendment) Regulations (SI 2003 No.1697). All medical devices placed on the market have to bear the CE mark, demonstrating that they meet the essential requirements of the Medical Devices Regulations. This includes surgical gowns and surgical drapes that are placed on the market as medical devices.

Are all surgical gowns and drapes medical devices?
The MHRA's view is that operating theatre textiles described as 'surgical gowns' and 'surgical drapes' are medical devices. Other gowns and drapes not described as 'surgical' should not be CE marked as medical devices.

Is there a European standard for surgical gowns and drapes?
A new European standard is currently being drafted by a European standards working group (CEN/TC205/WG14) entitled: EN 13795: 'Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment'. The plan is to publish it in five parts. Part 1 'General requirements for manufacturers, processors and products' was published in November 2002. Part 2 'Test methods' was published in November 2004.

Note: this standard applies only to products that are intended to prevent the transfer of infective agents; it does not apply to other gowns and drapes.

Will all gowns and drapes have to meet the new European standard for surgical gowns and drapes when it is all published?
No
There is no legal requirement to comply with European or international standards, although meeting harmonised European standards is the easiest way to demonstrate compliance with the requirements of the Medical Devices Directive. Compliance with harmonised standards is voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements of the Medical Devices Directive based on the intended purpose of the product.

Which surgical fabrics should I use?
There are many different types of reusable and disposable surgical gowns and drapes available for use in operating theatres. All those involved in using operating theatre fabrics should establish their needs and priorities so they can assess and determine the most suitable fabrics to use for all types of surgical procedure and risk.

Note: a gown not intended to have 'barrier' type properties should not be expected to perform as a barrier!

There are several factors to consider in determining the most appropriate textile to use in the operating theatre. These will vary according to local priorities and procedures and are likely to include:

• The type of surgical procedure and the assessed level of risk involved
• A priority of properties desired, for example: wet and dry bacterial barrier properties, fluid resistance, liquid absorption, strength, linting etc.
• Disposable or reusable
• Processing requirements, for example: ability to be sterilized, rinse finishes in laundry
• Cost
• Expected life

Some of these priorities may well conflict and will need to be discussed and agreed with all persons involved in using surgical gowns, drapes and coverings, which could include:

• Surgeons
• Theatre managers and staff
• Sterile services departments
• Infection control staff
• Laundry staff

Links to further general guidance are provided under 'Featured Publications' and 'Related Links'.

If you have any queries about the above, please contact:

Sally Mounter
Tel: 020 7084 3168
E-mail: sally.mounter@mhra.gsi.gov.uk

or

Graham Nash
Tel: 020 7084 3125
E-mail: graham.nash@mhra.gsi.gov.uk