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Review
. 2021 Sep 1;105(9):1921-1929.
doi: 10.1097/TP.0000000000003589.

Vigilance for Medical Products of Human Origin-Progress on the Notify Library's Global Effort to Share Information and Learning

Evangelia Petrisli  1 , Claudia Carella  2 , Aurora Navarro  3 , Deirdre Fehily  2   4 , Douglas Michael Strong  5 , Massimo Cardillo  2 ; on behalf of the Notify Editorial Board
Affiliations
Review

Vigilance for Medical Products of Human Origin-Progress on the Notify Library's Global Effort to Share Information and Learning

Evangelia Petrisli et al. Transplantation. .

Abstract

Background: World Health Assembly Resolution 63.22 mandated World Health Organization to facilitate Member State access to appropriate information on medical products of human origin (MPHO), including collecting data on serious adverse events and reactions. To meet this challenge, the Italian National Transplant Center, with a mandate from World Health Organization, has built and maintained an open-access searchable database of instructive records on disease transmission and other MPHO adverse occurrences.

Methods: One record in the Notify Library describes a specific type of adverse occurrence in 1 type of MPHO and might be linked with 1 or multiple different references. The record inclusion criteria are that it has been reliably documented in a published article or official vigilance reporting system and that it has instructive value for the fields of transfusion, transplantation, or assisted reproduction. The selection and review of references for publication is performed by international experts who collaborate in 5 topic-specific editorial groups: infection transmission, malignancy transmission, living-donor reactions, process-related incidents, and clinical complications. New relevant references are identified through systematic searches and proactive communication by the experts.

Results: The Library contains 1733 records, quoting 2632 references. Of the records, 41.8% are related to organs, 20.8% to blood and blood components, 16.5% to hematopoietic progenitor cells, 15.2% to tissues, 4.2% to reproductive tissues and cells, and 1.5% to other MPHO.

Conclusions: Notify Library is the first open-access, searchable database of systematically identified reports of disease transmission and other adverse occurrences arising from the donation and clinical application of MPHO.

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Conflict of interest statement

The authors declare no funding or conflicts of interest.

Figures

FIGURE 1.
FIGURE 1.
Current search methodology and editorial group case evaluation process. MPHO, medical products of human origin.
FIGURE 2.
FIGURE 2.
Breakdown of Notify Library records by MPHO type (as of the end of September 2020). HPC, hematopoietic progenitor cell; MPHO, medical products of human origin.
FIGURE 3.
FIGURE 3.
Breakdown of Notify Library records by adverse occurrence type (as of the end of September 2020).
See this image and copyright information in PMC

Comment in

  • Donor-derived Disease-Who to Notify?
    Chapman JR. Chapman JR. Transplantation. 2021 Sep 1;105(9):1909-1910. doi: 10.1097/TP.0000000000003590. Transplantation. 2021. PMID: 33449610 No abstract available.

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References

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