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Doyen Clamp: Types, Sizes, FDA Class and Reprocessing

Doyen intestinal clamp explained: atraumatic use, 23 cm, 17 cm and 10 inch variants, FDA Class 1 product code HXD, and steam reprocessing.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A Doyen clamp is a reusable stainless-steel intestinal clamp used in abdominal surgery to hold a section of bowel closed without crushing it. Clinic staff, instrument buyers and students searching the name usually need three things: what it is, which variants and sizes exist, and how it is classified and reprocessed. Each is answered below.

Who uses it: surgical teams performing abdominal procedures, and the central-sterile and procurement staff who supply and reprocess the instruments.

What a Doyen clamp is

A Doyen clamp, also listed as a Doyen intestinal clamp or intestinal clamp forceps, is a hinged, scissors-like instrument with ring handles and long, soft jaws. The UNFPA Global Supply specification gives its purpose as atraumatic clamping or occlusion of a section of intestine during suturing and anastomosis resection. An International Red Cross catalogue entry describes the same use: atraumatic clamping of the bowels in abdominal surgery.

The AccessGUDID record cites GMDN term 62468, which describes surgical soft-tissue forceps designed to grasp, manipulate, dissect and/or clamp soft tissues such as organs and blood vessels, with a scissors-like hinged design and ring handles, reusable and intended to be sterilized before use.

How it is built

The UNFPA specification for the 23 cm Doyen intestinal clamp lists martensitic stainless steel (quenched, magnetic steel) with 0.20% carbon and 13% chromium. It describes long jaws with shorter shanks, jaws that are springy and soft, a box lock and a multiple ratchet. The Red Cross catalogue likewise lists martensitic steel and soft, spring-type jaws. The UNFPA page calls the clamp non-crushing. For a different clamping instrument, see what a hemostat is.

Types and sizes

Suppliers use several naming families for similar instruments. The table shows only variants and lengths stated in the sources named in each row.

Variant Length Jaw shape Source
Doyen intestinal clamp, straight 23 cm Straight UNFPA Global Supply, product 1000278
Doyen intestinal clamp, curved 23 cm Curved UNFPA Global Supply, product 1000279
Doyen-Baby, atraumatic 17 cm Straight and curved International Red Cross item catalogue
Doyen-DeBakey intestinal clamp forceps, atraumatic jaws 10 inch Straight AccessGUDID record 00192896024168 (Sontec Instruments, model 142-207)

The UNFPA listings differ between straight and curved versions only in jaw shape. The Red Cross catalogue also lists a Kocher intestinal clamp at 26 cm, elastic and atraumatic, curved, which is a separate named instrument.

FDA classification and labelling

The AccessGUDID record for the Doyen-DeBakey model above shows FDA product code HXD, named “Clamp”. The openFDA classification record for HXD lists Class 1, regulation number 21 CFR 878.4800, medical specialty General, Plastic Surgery. The device record marks the product as premarket-notification exempt, prescription (Rx), reusable (not single-use) and not supplied sterile, with sterilization prior to use, and lists moist heat (steam) and dry heat as sterilization methods. The record does not flag latex.

This describes how one named model is filed. Other manufacturers may file comparable clamps under other product codes, so check the record for the exact product you are handling.

How to choose

The specifications above state the intended use (atraumatic occlusion of bowel), the length, straight or curved jaws, and that the instrument is reusable and supplied non-sterile. The UNFPA page lists ISO 7153-1:1991, ISO 7151:1988, ISO 17664:2004 and ISO 13402:1995 as standards the item should comply with; ISO 17664 concerns the reprocessing information a manufacturer supplies. Selection of an instrument for a procedure is a clinical decision for the surgical team and is outside this page.

Reprocessing and handling basics

The UNFPA specification states: “This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.” The AccessGUDID record likewise lists steam and dry heat sterilization before use. Always follow the manufacturer’s instructions for use for the exact model. For background on the methods, see sterilization technology, what an autoclave is and the Spaulding classification.

Common mistakes

  • Treating Doyen, Doyen-Baby and Doyen-DeBakey as the same size: the sources below list 23 cm, 17 cm and 10 inch respectively.
  • Assuming the instrument arrives sterile: the UNFPA specification and the AccessGUDID record both show it is supplied non-sterile and must be reprocessed before use.
  • Substituting another clamp: the Doyen clamp is specified as atraumatic with soft jaws. See other instruments in medical forceps types and surgical retractors.

FAQ

What is a Doyen clamp used for?

Atraumatic clamping or occlusion of a section of intestine during suturing and anastomosis, per the UNFPA Global Supply specification.

Is a Doyen clamp reusable?

Yes. The UNFPA specification says it must be cleaned, disinfected after each use and steam sterilized, and the AccessGUDID record for a Doyen-DeBakey model marks it not single-use.

What FDA class is a Doyen clamp?

The Doyen-DeBakey model checked here is filed under product code HXD, Class 1, 21 CFR 878.4800, and is premarket-notification exempt.

How long is a Doyen clamp?

It depends on the variant: 23 cm for the UNFPA Doyen clamp, 17 cm for Doyen-Baby, and 10 inch for the Doyen-DeBakey model in AccessGUDID.

Sources

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