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Learning from incidents in medically assisted reproduction: the Notify Library as a learning tool.

Alessandra Alteri¹, Evangelia Petrisli², Paula Nolan³

¹Obstetrics and Gynaecology Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy.

Reproductive Biomedicine Online

|September 1, 2021

Summary

Biovigilance monitors serious adverse events in medically assisted reproduction (MAR) to ensure safety. The Notify Library aids MAR professionals by cataloging these events, offering valuable risk management insights and improving quality standards.

Keywords:

Biovigilance Medically assisted reproduction (MAR)Notify Library Serious adverse event Serious adverse reaction

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Area of Science:

Reproductive Medicine
Biotechnology
Public Health

Background:

Biovigilance is crucial for monitoring serious adverse reactions and events (SARE) in tissues and cells for human application.
Medically Assisted Reproduction (MAR) relies on robust safety protocols for reproductive tissues and cells.

Purpose of the Study:

To introduce the Notify Library as a resource for understanding adverse occurrences in MAR.
To highlight the educational and risk management value of documented SARE in MAR.

Main Methods:

The Notify Library compiles SARE types from published literature and vigilance programs.
It is not a SARE register but a curated collection of incident types.
The database is updated with novel incident types as they are reported.

Main Results:

The Notify Library contains numerous documented adverse occurrences in MAR.
It serves as a valuable tool for MAR professionals to assess clinical risks.
The library provides examples of SARE with potential teaching value.

Conclusions:

Sharing lessons learned from MAR incidents is vital for improving center processes.
Utilizing the Notify Library can enhance quality and safety standards in MAR.
The database supports continuous risk management and didactic opportunities in MAR centers.