4 Safety and monitoring
4.1 Safety
NICE's patient safety oversight group has recommended additional data collection to monitor the safety of the Genedrive MT-RNR1 ID Kit on:
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false positive results leading to use of antibiotic regimes that might drive cephalosporin resistance
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delay in use of antibiotics while waiting for results.
The group should be notified of any data collected that could indicate a safety concern, and the proposed response.
4.2 Monitoring
The technology developer must contact NICE:
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within 6 months of evidence generation plan publication to confirm agreements are in place to generate the evidence
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annually to confirm that the data is being collected and analysed as planned.
Technology developers should tell NICE as soon as possible of anything that may affect ongoing evidence generation, including:
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any substantial risk that the evidence will not be collected as planned
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new safety concerns
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the technology significantly changing in a way that affects the evidence generation process.
If data collection is expected to end later than planned, the technology developers should contact NICE to arrange an extension to the evidence generation period. NICE reserves the right to withdraw the guidance if data collection is delayed, or if it is unlikely to resolve the evidence gaps.