METROLOGIA 2003 – Metrology for the Quality of Life

Brazilian Society for Metrology (SBM)

September 01-05, 2003, Recife, Pernambuco – BRAZIL

ACCURACY AND RELIABILITY OF MEASUREMENTS IN

MEDICINE AND CLINICAL LABORATORIES

Rainer Macdonald 1, Jörg Neukammer 1, Stephan Mieke 1, Herbert Rinneberg 1

1
Physikalisch-Technische Bundesanstalt, Berlin, Germany

ABSTRACT:
Physical, chemical and biological measurements are essentials for the prevention, the diagnosis, and the
treatment of disease as well as for risk assessment and monitoring of patients. Hence results of clinical
measurement must be accurate, reliable, and comparable between different clinics or laboratories and over time
to ensure optimum patient care as well as most efficient use of available health care funds. To ensure that results
of medical measurement are of known quality and to improve their accuracy and reliability, reference methods,
certified reference materials, and calibrations are needed.
Major promoters to accomplish for these needs in Europe – but with huge impact on the global marketplace
and for health-care systems worldwide - are presently the European Commision Directives on (i) Active
Implantable Medical Devices (90/385/EC), on (ii) Medical Devices (93/42/EC), and on (iii) In Vitro Medical
Devices (98/79/EC). In particular the needs for comparability of measurements are addressed in the Medical
Devices Directive (MDD) and the In Vitro Medical Devices Directive (IVDD). In consequence of these
directives ISO 17025 and other standards come into play.
In the present lecture the peculiarities of measurements in medicine will be discussed and problems to fulfil
the above mentioned requirements will be pointed out. One key element to ensure that results of different
medical laboratories are comparable is traceability which still needs to be established for most of the medical
measuring procedures. By research, development of innovative measuring procedures and state-of-the-art
instrumentation as well as by tests of procedures and devices the Physikalisch-Technische Bundesanstalt (PTB)
contributes to improve the accuracy and reliability of measurements in medicine and clinical laboratories, hence,
to assure the quality of diagnosis and therapy. Examples will be given for the development and provision of
standards for metrology in medicine, and reference measuring procedures in the field of laboratory medicine
(haematology).

Keywords: medical measurements, quality assurance, traceability.