Risk Management of IVD – Medical Devices

What is In-Vitro Diagnostic (IVD) Medical Devices?

A medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimen deprived from the human body solely or principally to provide information on diagnostic, monitoring or compatibility purposes.

These devices include reagents, instruments, software, sample collection devices and receptacles, calibrators, control materials and related accessories. These devices can be used alone or in combination as a system.

Risk Management of IVD Medical Device

Tools mentioned in ISO 14971 can be used for preparation of Risk Management of IVD Medical Device. In Annexure H of ISO 14971, detailed guidance on risk management has been provided.

Laboratory use of IVD Device? What shall be considered in Risk Management?

  • A failure of a manufacturer’s quality management system initiates the sequence of events like defective or malfunctioning the IVD medical device.
  • A failure in Laboratory, incorrect result of the examination is produced.
  • If incorrect result will not be identifies by the laboratory then the incorrect result only be reported to the healthcare provider.
  • If the incorrect result will not be identified by the healthcare provider then the diagnosis of the patient and at the end the treatment of the patient will be affected which will create a hazardous situation for the patient.

Basic Risk Model of factors that can affect the Risk Management of the IVD Medical Device

Identification of Possible Use Errors which can be inputs for Risk Management Report

  1. Possible use errors by Laboratory Personnel
  2. Possible use errors by Healthcare Provider
  3. Possible use errors by Patients in Self-Testing

What other risks can we find out for IVD Device?

For IVD Medical Device, just like other medical devices, devices in normal use and devices in fault conditions have to be considered for inputs of Risk Management Report.  But in IVD, its performance characteristics has to be considered as an input of the Risk Management Report.

From where Risk Information can we get of IVD Device?

Which points we should consider to estimate risks to patient?

How should the Risk Control Option Analysis be conducted?

For Option Analysis, Here, as per below mentioned chart, can be carried out.