Margareta Blombäck, SSC Liaison Officer to CEN TC 140 mabl@mb.ks.se
 

   Anders Kallner, SSC Liaison Officer to IUPAC

Drs. Blombäck and Kallner attended the annual meeting of the CEN/TC 140 in November 1997. It was held at the CEN office in Brussels and they participated as observers. Technical Committee 140 has nine Working Groups, many of which address several work items. Only those reports with importance to the SSC/ISTH are summarized here.

Self-testing in Monitoring of Anticoagulation Treatment

One Working Group has studied instruments for self-testing and prepared a list of elements that should be observed by manufacturers and users of such instruments. The list particularly addresses glucose meters for self-testing. We believe that the new instruments for self-monitoring of coagulation factors during oral anticoagulation treatment need special attention. A number of instruments are presently introduced to the market, using different principles both for the assay and detection. We therefore approached the chairman of the TC 140, Dr. H. Jung (Roche-Boehringer-Mannheim, DE), to initiate inclusion of these instruments. The request was not thought appropriate for TC 140, and we have therefore approached the ISO TC 212 that also deals with in vitro diagnostic medical devices. This TC will meet in Geneva July 7-9 and the proposal will be on the agenda. At this moment, support has been secured from the Nordic countries; Germany is likely to join after a decision June 18; and Dr. Craig Jackson might comment on the US reaction after this report.

Chairmen of the SSC's Scientific Subcommittees, particularly of the Subcommittee on Control of Anticoagulation, should get involved in this work. Since the ISO only deals with national standardization bodies, it is necessary that these are made aware of the importance of the subject and take an active position in establishing and sponsoring the work of such an international standardization group; therefore, you should go home and find your representative to ISO TC 212 and inform him/her about the proposal. The proposal has been sent out together with a number of other documents, but an active interest for the question would improve the likelihood that a standardization of these instruments will be added to the list of work items of the TC. The formal ballot on including this topic as a work item is closed on 21 July and communicated to the national standardization bodies. In case of a positive result, the standardization bodies will be asked to appoint participants in the working group.

Reference Measurements, Reference Materials and Traceability of Calibrators

Another WG focuses on the metrological requirements of reference methods, materials and calibrators. Their first two standards on reference methods and materials have been accepted and the third, on the traceability of calibrators, is in its final draft. This standard will be of great importance for correct measurements. The use of calibrators is comparatively simple in the case of inorganic and small molecules but becomes very complex for biological materials, e.g., antigens and antibodies and enzymes. The Working Group is presently struggling with the latter type of compounds. It might be useful for the SSC/ISTH to approach the convener, Dr. René Dybkaer, and offer its expertise. In particular this area is of interest for the Factor VIII and Factor IX and for the Fibrinolysis Subcommittees.

External Quality Assessment Schemes

Accreditation requires that laboratories participate in interlaboratory comparisons. Traditionally this is achieved by participating in various types of External Quality Assessment Schemes or Proficiency Testing. It is important that SSC/ISTH becomes more involved in the development of suitable interlaboratory comparison schemes. Again, it is advisable to get in touch with the CEN TC 140 convener of this work, Dr. Adam Uldall in Copenhagen or Dr. Jean-Claude Libeer, Brussels.

Single Use Containers for Venous Blood Specimen Collection

A WG has circulated a draft standard on this subject. A number of comments have been received and will be addressed by the WG. It is noteworthy that in the coagulation field, and others alike, when accurate proportions of anticoagulants (e.g., citrate) should be added increased demands on the vacuum, storage and handling of the tubes must be enforced. It is important that the national representatives to CEN 140 who are to vote on the standard and to produce comments are aware of the special demands that must be met to suffice examinations in haemostasis and, therefore, alerted to the upcoming standards.

EU Directive on in vitro Diagnostic Medical Devices

The EU Directive for the TC 140 has been worked on for several years and now seems to be finally adopted. The Directive indicates the need for vigilance and responsibility of the manufacturer to comply with specifications. This is a delicate balance between what the profession wants and what it is prepared to pay for, i.e., what the industry is prepared to do. The general spirit of the Directive has been long established, but the final document has not yet been endorsed.

Quality Management in Medical Laboratory

Accreditation of laboratories follows the ISO Guide 25 and the European Norm 45001. These are generic documents that need explanations and adjustments to be useful for the accreditation of medical laboratories. ISO has recently revised its Guide 25, but this revision has not been accepted by the ISO TC 212 which accordingly has set out to produce a standard of its own to meet the needs of the medical profession. The Committee draft, CD15189, is now being circulated for comments and will hit the national standardization bodies during the Fall 1998. If such a document is accepted, a worldwide acceptable accreditation of medical laboratories could be achieved. The draft document is scheduled to be circulated to the national standardization bodies later this year, and it is important that SSC participates in its evaluation.