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Present-day performance qualities of cardiotocographs
1Department of Obstetrics & Gynaecology, St Mary's Hospital Medical School, London, UK.
British Journal of Obstetrics and Gynaecology
|March 1, 1993
Summary
Current cardiotocographs perform well, but defining physiological variables is crucial for clinical needs. This review discusses performance, data quality factors, and evaluation measures for fetal monitoring equipment.
Area of Science:
- Medical device regulation and biomedical engineering.
Background:
- Medical electrical equipment is governed by legislation and standards.
- No official standards exist for cardiotocographs, necessitating de facto standards.
- Understanding cardiotocograph performance is key for accurate fetal monitoring.
Purpose of the Study:
- To review legislation and standards for medical electrical equipment, specifically cardiotocographs.
- To define de facto standards for cardiotocographs.
- To assess current performance qualities and influencing factors of cardiotocographs.
Main Methods:
- Review of existing legislation and standards.
- Analysis of factors affecting cardiotocograph data quality.
- Discussion of evaluation measures for fetal heart rate and uterine activity monitoring.
Main Results:
- Cardiotocographs generally exhibit good performance.
- Factors influencing data quality have been identified.
- Evaluation measures for accuracy in fetal heart rate and uterine activity detection are discussed.
Conclusions:
- While current cardiotocographs perform well, further definition of physiological variables is needed.
- Equipment development should align with defined clinical needs for improved fetal monitoring.
- Establishing de facto standards can guide the development and evaluation of cardiotocographs.