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
- Possible use errors by Laboratory Personnel
- Possible use errors by Healthcare Provider
- 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?
|What is the possibility that an incorrect result would be generated by the IVD medical device?||1||In a likely fault mode?|
|2||In normal use?|
|3||In reasonably foreseeable misuse?|
|What is the possibility that the incorrect IVD examination result would be detected by a user/laboratory?||1||Are control materials provided with the IVD medical device?|
|2||Are controls integrated into the device to detect the fault condition?|
|3||How effective would the controls be in detecting the fault condition?|
|4||Are there other quality assurance measures that might detect the incorrect result (e.g., critical value system, plausibility checks)?|
|5||Would error messages allow a user to correct the problems and obtain a valid examination result upon re-examination?|
|6||If the device intended for laboratory use, do laboratories have effective systems for detecting such an incorrect result?|
|What is the possibility that the incorrect IVD examination result would be detected by the physician?||1||Do current standards of medical practice require a confirmatory examination for this analyte?|
|2||Is a confirmatory examination performed automatically by the laboratory following a positive screening examination result?|
|3||Is this type of incorrect result recognizable in the context of other results, signs, symptoms and the patients’ medical history?|
|4||Do physicians routinely corroborate the results for this analyte by other means and question those results that do not fit the clinical impression?|
|5||Are there other plausibility checks for this analyte that would alert the physician to an error?|
|6||Is tile examination the sole basis for critical medical decisions? To what extent is the diagnosis based on the examination result (i.e., how does the examination contribute to the medical decision)?|
|7||Does the urgency of the situation require an immediate decision, without an opportunity to obtain confirmatory data or corroborating information? Does the examination result lead directly to a medical decision/treatment?|
|8||Are alternative examinations available?|
|What is the possibility that a physician would act or fail to act on the result?||1||Is the action irreversible?|
|2||To what extent is the action reversible?|
|3||To what extent is the action likely to injure the patient?|
|4||To what extent would failure to take action lead to death or injury?|
|5||What physiological conditions would contribute to the possibility of harm?|
|What is the severity of the resulting harm?||1||Death?|
|3||Reduction in life expectancy?|
|4||Irreversible deterioration of the state of health?|
|6||Permanent damage to a body function/structure?|
|7||Injury requiring medical intervention to prevent serious harm?|
|8||Reversible deterioration of the state of health?|
|9||Minor physical injury?|
|10||Temporary impairment not requiring medical intervention?|
How should the Risk Control Option Analysis be conducted?
For Option Analysis, Here, as per below mentioned chart, can be carried out.