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Dissemination of a knowledge based system for determining appropriate intervention during labour based on a qualified analyses of the foetal electrocardiogram

Objective

The expectation of society is that the application of the results of health technology assessment will improve quality of care and ensure that available resources are used effectively. The objective of the proposal is to develop and validate a model whereby the user aspects are put to the fore to stimulate postgraduate training and an appropriate management structure.
The new STAN(r) 9903 fetal heart function monitor has been constructed and built by a dedicated SME; Neoventa Medical according to the regulatory requirement of the EU - Medical Device Directive, MDD and the US - Quality System Regulations, QSR.
Today there are no specific requirements regarding the implementation of a medical device knowledge transfer process. Action according to regulatory requirements is only required when things go wrong - obviously too late in a situation, such as labour, when oxygen deficiency may institute a threat to life and intact survival. The prime objective of the project is to develop a model whereby primarily ten academic centres across Europe, as a joint effort, are made partners of this, currently industry driven, knowledge transfer process. These centres of excellence then become the regional hub of experience. A system for continuous technology surveillance is also developed.
Fetal surveillance during labour constitutes a challenge in information management. To give birth is a natural process for women. For the child it may constitute a threat for intact survival and ominous changes may appear within minutes putting labour ward management to the fore front of medical high risk management. Today the nurse/midwife/obstetrician manages this complex situation by visual analysis of a host of information constituting clinical, as well as directly recorded data from the fetus in particular. ST waveform analysis of the fetal electrocardiogram has emerged as a valuable tool to diagnose adverse fetal events during labour utilising a computer assisted data interpretation module. The introduction on the labour wards of a new medical device, STAN(r)9903, required to obtain accurate information from the foetus will form the technical component of the program.
The non-technical issue addresses the implementation of a more thorough understanding of fetal reactions to the stress and strain of labour in the management of obstetric care. To achieve this we will use new teaching tools such as a trainer/simulator which allows midwifes and doctors to earn their own experience from displaying real cases from our data base virtually. This enables exposure to rare but important cases otherwise not experienced and handled during ordinary training. A dedicated teaching module is developed to fit with the different cultural aspects. Staff certification becomes essential with continuous assessment of skills through dissemination of test cases. The ultimate test will be a surveillance of clinical outcome regarding frequency of interventions and cases born with clinical and biochemical evidence of fetal distress This will be part of the research element.
At the core of the programme is the trans European dissemination of knowledge and experience gained and validated in a few European countries. To bring the STAN(r) technology into general use requires the creation of a critical mass of internationally and nationally recognised obstetric centres. For many years, European scientists have been dominating and it would be most relevant for the EU to support the commercialisation phase thereby safeguarding:
1. The introduction of a thoroughly validated, safe and cost-efficient health care technology.
2. The support of an SME with the potential of gaining world wide acceptance for its knowledge based technology.
3. The testing of a new management oriented method of knowledge and technology transfer.
4. The further enhancement of European centres of excellence.

Coordinator

Neoventa Medical AB
Address
1,Lilla Bommen
411 04 Göteborg
Sweden