UNITED

NATIONS	ST

Secretariat	Distr.

GENERAL

ST/SG/AC.10/1998/47

25 September 1998

Original: ENGLISH
COMMITTEE OF EXPERTS ON THE

TRANSPORT OF DANGEROUS GOODS

(Twentieth session,

Geneva, 7-16 December l998,

agenda item 2 (d))

WORK OF THE SUB-COMMITTEE OF EXPERTS

ON THE TRANSPORT OF DANGEROUS GOODS

New proposals

Classification of Diagnostic Specimen

Transmitted by the Expert from Germany

Introduction

Routine Diagnostic Specimen are shipped in high numbers throughout the world. The question whether Diagnostic Specimen taken for routine analysis are subject of the requirements of division 6.2 of the Model Regulations has several times been discussed.

Eventhough infectious micro-organisms are ubiquitous, that does not mean, that a real risk of contamination or spreading of disease exists with every Diagnostic Specimen during transport. Much depends on the capabilities of a micro-organism of being contagious and by the route of exposure. So it would be unjustified to cover all routine Diagnostic Specimen in division 6.2.

The classification of an infectious substance can only be made by medical experts. The person (doctor, medical personal) is trained as expert to realise clinical or medical indications from a patient before ore while taking blood etc. for analysis. This may come from symptoms or investigation of the patient.

GE.98-

If in such a case the responsible medical person has knowledge or indication of a potentially infected patient, he should classify the Diagnostic Specimen according to division 6.2. But if there is no indication or if the purpose of analysis is only control of values like blood sugar, a classification in division 6.2 would be unnecessary from a safety point of view and unjustified from a point of view of effective medical care and treatment.

However, the Model Regulations in chapter 2.6.3.1.3 does not provide a clear indication whether a routine Diagnostic Specimen is covered by division 6.2 or not.

Furthermore letter c) is misleading. For a routine Diagnostic Specimen it is never really known not to contain pathogens before analysis is made. But analysis is the purpose they are shipped for. And only decontaminated (e.g. sterilised, disinfected) specimen are known not to contain pathogens, but they are no longer suitable for analysis. Additionally they can no longer be regarded as infectious (see notes 1 and 2 to 2.6.3.1.1).

Proposal

To clarify the situation and to avoid unnecessary and unjustified burden from medical care and treatment, a note should be added to 2.6.3.1.3 to read:

"Note: Routine Diagnostic Specimen for analysis are not subject to the Regulations for this division, if the responsible medical person after investigation has no knowledge or indication, that the patient may be infected. If analysis is made for examination of a concrete pathogen, the Diagnostic Specimen shall be assigned to this division."

Delete letter c) in 2.6.3.1.3.

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