Evidence map›Paper›PMID 30425757›Full record

ReviewJournal of clinical medicine research2018

Biovigilance for the Quality and Safety of Medical Products of Human Origin.

Vasiliki Gkioka, Panagiotis Tsirigotis, Markos Sarris, Sotiris Soulis, Athanasios Apostolou, Michel Noutsias, Georgios Dimitriadis, Alkiviadis Kostakis, Ioannis Boletis, Andreas Karabinis

Open access · diamondAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of clinical medicine research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 89% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

Vasiliki GkiokaBiomedical Research Foundation Academy of Athens, Athens, Greece.
Panagiotis TsirigotisSecond Propedeutic Department of Internal Medicine, "Attiko" University General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Markos SarrisHealth and Social Care Management, University of West Attica, Athens, Greece.
Sotiris SoulisHealth and Social Care Management, University of West Attica, Athens, Greece.
Athanasios ApostolouDepartment of Immunology and Histocompatibility, School of Health Sciences, Faculty of Medicine, University of Thessaly, 41500, Larissa, Greece.
Michel NoutsiasDivision of Cardiology, Department of Internal Medicine III, Mid-German Heart Center, Angiology and Intensive Medical Care, University Hospital Halle, Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Strasse 40, D-06120 Halle (Saale), Germany.
Georgios DimitriadisSecond Propedeutic Department of Internal Medicine, "Attiko" University General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Alkiviadis KostakisBiomedical Research Foundation Academy of Athens, Athens, Greece.
Ioannis BoletisNephrology Clinic and Kidney Transplant Unit, "Laiko" General Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Andreas KarabinisThe Onassis Cardiac Surgery Center, Cardiac Surgery Intensive Care Unit, National and Kapodistrian University of Athens, Athens, Greece.
National and Kapodistrian University of Athens · GRAcademy of Athens · GRUniversity of West Attica · GRMartin Luther University Halle-Wittenberg · DEUniversity General Hospital Attikon · GRUniversity of Thessaly · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Progress in science and technology in the health services has led to the development of methods of regenerating and replacing solid organs, tissues and cells, using human body components to create medical products of human origin intended for clinical use. In the activities in which products of human origin are used, however, from the point of donation and harvesting to the subsequent care of the recipient, medical products of human origin are exposed to the risk of specific complications related to the transmission of infectious diseases, and further side-effects. Biovigilance system application is a basic requirement for ensuring the quality and safety of tissues and cells intended for human use. The quality system focuses on error prevention, maintaining a consistent pattern of agreed assays for tissues and cells intended for clinical use. The implementation of quality and safety standards, the development of medical protocols and cooperation protocols between member states, the implementation of Single European Code (SEC), and the development of electronic traceability systems, all aim at vigilance and the surveillance of medical products of human origin from donation to transplantation.

Indexed as

AssuranceBiovigilanceCellsSafetySerious adverse eventSerious adverse reactionTissues

Identifiers

PMID30425757
PMCPMC6225864
OpenAlexW2899357659

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.