Section 1:   SCOPE OF THE CODE

1.1.
The Surgical Dressing Manufacturers Association (SDMA) has as members the majority of manufacturers of surgical dressings supplying the UK health care market and therefore largely represents this sector of the health care industry.

1.2.
The SDMA is dedicated to:

(i) Encouraging and expanding the use of safe and effective surgical dressings in health care markets.

(ii) Creating an environment whereby the innovation of technically advanced products and concepts can be developed.

(iii) Working in partnership with health care professionals.

(iv) Influencing in a responsible way the creation of a favourable regulatory environment.

(v) Encouraging the adoption of high ethical standards of practice in the advertising and promotion of products.

1.3.
Surgical dressings subject to this Code are those materials which are used on wounds or the skin for one or more of the following purposes:

As a mechanical barrier; for the absorption of or the transmission of exudates; to debride or to manage the micro-environment of a wound; for the support, bandaging, padding or splinting of limbs.

These dressings can be used alone or in combination and are intended by the manufacturer for human use, solely or principally for the prevention, treatment or alleviation of disease, injury or handicap but exclude active medical devices, devices for contraception and devices for incontinence.

1.4.
The SDMA Code of Practice is specifically to cover the promotion of surgical dressings in the U.K. to bodies and individuals employed in the professional medical market where the decision maker could be; a health professional (e.g. surgeon, doctor, hospital nurse, community nurse, pharmacist, dentist, chiropodist, physiotherapist, occupational therapist) or a health product buyer or a supplier or a distributor.

1.5.
All SDMA member companies have agreed as a condition of membership of the SDMA to fully comply with the SDMA Code of Practice (The Code).

Compliance with the Code and decisions of the Complaints Committee following the investigation of a complaint and a review is mandatory for member companies of the SDMA and failure to comply with the outcome of a complaint could lead to expulsion from membership, in accordance with clause 8. of the Constitution of SDMA.

1.6.
Dressings are medical devices which are used in the fields of wound care and skin health.

1.7.
In addition, non member companies can agree to abide by The Code by providing a Declaration signed by a Director of the company.

1.8.
All SDMA member companies and signatories to The Code agree to accept and abide by the results and decisions of the Complaints Committee following the investigation of a complaint and review.

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