Evidence map›Paper›PMID 33616002›Full record

ArticleIslets2021

Failure mode and effect analysis in human islet isolation: from the theoretical to the practical risk.

Quentin Perrier, Vanessa Lavallard, Nadine Pernin, Charles-Henri Wassmer, David Cottet-Dumoulin, Fanny Lebreton, Kevin Bellofatto, Axel Andres, Ekaterine Berishvili, Domenico Bosco and 2 more

Abstract read
In one paragraph

Article in Islets, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Article
  2. Adenosine as a modulator of human islet function and hypoxic tolerance.Frontiers in bioengineering and biotechnology · 2026
    Article
  3. Comprehensive biocompatibility profiling of human pancreas-derived biomaterial.Frontiers in bioengineering and biotechnology · 2025
    Article
  4. Article
  5. Article
  6. Article
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

12 authors.

Quentin PerrierCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Vanessa LavallardCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Nadine PerninCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Charles-Henri WassmerCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
David Cottet-DumoulinCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Fanny LebretonCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Kevin BellofattoCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Axel AndresCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Ekaterine BerishviliCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Domenico BoscoCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Thierry BerneyCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.
Géraldine ParnaudCell Isolation and Transplantation Center, Department of Surgery, Geneva University Hospital, Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed to assess the global mapping risk of human islet isolation, using a failure mode and effect analysis (FMEA), and highlight the impact of quality assurance procedures on the risk level of criticality. Risks were scored using the risk priority number (RPN) scoring method. The risk level of criticality was made based on RPN and led to risk classification (low to critical). A raw risk analysis and a risk control analysis (with control means and quality assurance performance) were undertaken. The process of human islet isolation was divided into 11 steps, and 230 risks were identified. Analysis of the highest RPN of each of the 11 steps showed that the 4 highest risks were related to the pancreas digestion and islet purification stages. After implementation of reduction measures and controls, critical and severe risks were reduced by 3-fold and by 2-fold, respectively, so that 90% of risks could be considered as low to moderate. FMEA has proven to be a powerful approach for the identification of weaknesses in the islet isolation processes. The results demonstrated the importance of staff qualification and continuous training and supported the contribution of the quality assurance system to risk reduction.

Indexed as

Healthcare Failure Mode and Effect AnalysisHumansRisk Assessmenthuman isletmanufacturing procedurePancreatic islet isolationquality subjectrisk criticalityrisk mapping

Identifiers

PMID33616002
PMCPMC8018422

What OpenQuestion holds

Textmetadata
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.