safety, warnings, precautions, prohibitions
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demands a systems integrator, in practice, also known as a system administrator who is responsible for ensuring that all
individual ME device to work satisfactorily in an integrated system.
The system integrator has to perform the following tasks and must have knowledge of:
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How to use the integrated system?
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What are the requirements for the performance of the integrated system?
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How the proposed system configuration looks like?
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What restrictions exist regarding the expandability of the system?
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Documents relating to the specifications of all ME devices and other devices to integrate.
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What is the performance of each ME unit and other devices?
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How does the information flow within and around the system?
Manufacturers can usually not take over the task of a system integrator in the hospital because they do not have the
complete information and data that were previously listed. The norm limits the liability of a manufacturer to supply the
required information on their device, they can not be split between different manufacturers. An operator such as a
hospital or medical practice can of course hire a manufacturer or maybe even a service provider to integrate their
system. In this case, the entire system gets an ME system, derive from the responsibility of the manufacturer or service
provider, is to create a properly integrated system.
The system integrator should have the expertise and experience to identify dangers and assess the most likely result
from the integration of a system and to ensure that remaining potential (rest-) risks are identified during the operation of
the system.
For the system integrator this means
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He has to plan the integration of all ME-devices or ME-systems and all non-medical devices according to the
manufacturer’s instructions.
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He has to perform the risk management for the integrated system.
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He has to forward any manufacturers information that is needed for the safe use of the integrated system to
the applier (hospital or medical practice).
The norm requires that manufacturer information include information and warnings about hazards that can arise from
configuration changes (upgrades, updates). This requires that manufacturers report all information regarding software
updates and upgrades, as well as hardware modifications to the designated system integrator.
The operator should ideally create a complete documentation of both network-based systems, including telemedicine
systems, and changes (technological changes, software changes, upgrades, etc.) or to update the document
accordingly.
For this job the system intergrator has to know and know how to apply the risk management norm EN 14971.
The following possible sources of risk in a network or data network may occur:
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Data loss
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inappropriate data exchange
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Data Corruption
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Inappropriate time allocation data
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unexpected data received
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non-authorized access to data
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destructive data.