CIR NO.847/05/2007-CX, DT. 06/03/2007

CIR NO.847/05/2007-CX, DT. 06/03/2007

IV cannulas –availablity of exemption under NTF. NO. 06/2006, DT. 01/03/2006

I am directed to say that S.No. 61 of notification No. 6/2006-CE dated 1.3.2006 [earlier S.No. 267 of notification No. 6/2002-CE dated 1.3.2002] exempts products mentioned at S.No. 34 in list 37 appended to notification No. 21/2002-Customs dated 1.3.2002. S.No. 34 in list 37 of notification No. 21/2202-Customs dated 1.3.2002 reads “Disposable and non-disposable cannula for aorta, vena cavae and similar veins and blood vessels and cannula for intra-corporal spaces”.

2. A doubt has been raised whether the exemption under notification No. 6/2006-CE dated 1.3.2006, S. No.61, would be available to IV cannulas. In other words the question raised is whether IV cannulas are covered under the description “Disposable and non-disposable cannula for aorta, vena cavae and similar veins and blood vessels and cannula for intra-corporal spaces”.

3. The matter has been examined by the Board. Advice tendered by Directorate General of Health Services, New Delhi, is enclosed as Annex A for guidance. It may be seen that:

(i) IV cannulas are primarily used in the peripheral veins and arteries for purpose of blood sampling, blood transfusion, single and multiple drug infusion, arterial pressure monitoring,etc.

(ii) Aorta and venae cavae are not similar to peripheral veins and arteries as there are various anatomical and physiological differentials which distinguish between (a) aorta and venae cava and (b) peripheral veins and arteries.

(iii) In exigencies, where specific catheter is not available, IV cannulas are rarely used in abdominal/pleural cavities but this does not justify their use and they are not recommended by standard medical text-books for use as cannula for intra-corporal spaces.

4. Therefore, it is clarified that IV cannula, which is primarily used in the peripheral veins and arteries, is not covered by the description “Disposable and non-disposable cannula for aorta, vena cavae and similar veins and blood vessels and cannula for intra-corporal spaces” and exemption under notification No. 6/2006-CE dated 1.3.2006 [earlier notification No. 6/2002-CE dated 1.3.2002] would not be available to such IV cannulas.

5. Trade and field formations may be suitably informed. Pending assessments may be disposed of accordingly.

6. Receipt of this Circular may kindly be acknowledged.

(Gaurav Sinha)
Under Secretary (CX.I)

Annex A

(i) IV cannulas(Venlon,Neoflan etc) are primarily used in the peripheral veins and arteries for the purpose of blood sampling,blood transfusion,single and multiple drug infusion,arterial pressure monitoring etc.

(ii) Aorta and venae cava are not similar to peripheral arteries and veins.

Anatomical Differentials

Aorta and vena cava are anatomically classified as great vessels, whereas the peripheral arteries and veins are small vessels.

The great vessels are close to the heart and opens into heart. The peripheral vessels(arteries and veins) are indirectly connected to the heart through the large and medium size vessels.

The great vessels have big lumens whereas the peripheral vessels have small lumens.

The thickness of the walls of the Aorta and Venae Cava and that of peripheral arteries and veins differ .

Aorta is an elastic artery while peripheral arteries are classified as muscular arteries.

Inferior and superior vena cava are large veins with thick wall with no valves. While peripheral veins have valves.

Physiological Differentials

The great vessels and the peripheral vessels differ in pressure gradient, volume of blood etc

(iii) Cannulas for Aorta,inferior cava & superior cava used in cardiac surgeries are totally different from IV cannulas in length, diameter of the lumen and shape. These cannula are big, of the size of drumstick and have holes for drainage of blood and have twisted wires all along its length to prevent twisting/kinking of the cannula. The CVP cannulas for measuring the Central venous pressure are placed in the right atrium through internal jugular or subclavian vein, both of which are large veins. They measure 20 cm for adults and 10 cm for children;if it is through cubital fossa, then it measures 75 cm for adults and 40 cm for children. In contrast, the IV cannulas are of short length(4-6 cm) with small lumen and cannot be used for monitoring CVP.

(iv) If IV Cannulae are used for access to medium/great vessels, the plastic can get detached and then may cause embolism, threatening the life of the patient.

(v) In Pediatric Cardiac surgery, cardoplegia cannula is used for inducing cardioplegia. However, if cardoplegia cannula is not available, IV cannula can be used in emergencies but is not a substitute for cardioplegia cannula. However,the standard texts do not advocate the use of IV cannula for such procedure.

(vi) Intra corporal spaces imply non-visceral cavities inside the body. There are specific catheters/drainage tubes available for accessing the pleural cavities, the peritoneal cavities, the sub-diaphragmatic cavities and intra ventricular spaces. These are larger in size, have bigger lumen, and have trochars for their introduction. In exigencies, where specific catheter is not available, IV cannula are rarely used in abdominal/pleural cavities but this does not justify their use and they are not recommended by standard medical text books for this purpose.

F.No. 90/01/2005-CX.I