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Blood Transfusion = Trasfusione Del... Jul 2013Timely and efficient recall of products known or suspected to be non-conforming is an important measure in the prevention of adverse events and in patients' safety....
BACKGROUND
Timely and efficient recall of products known or suspected to be non-conforming is an important measure in the prevention of adverse events and in patients' safety. Product recall in the transfusion service is regulated by professional standards and legal acts, but publications presenting results related to the implementation of these procedures are quite rare.
MATERIALS AND METHODS
Data from the Croatian Institute of Transfusion Medicine (CITM) on the procedures of product recall during an 11-year period (2000-2010) were retrospectively analyzed. Reasons for product recall, their frequency, level of severity and efficiency of the procedures are presented and discussed.
RESULTS
During the study period, there were 245 procedures of product recall, for an average of 22 (18-29) procedures/year, all of low extent (1-25 products). Recall was required for 1/3,571 blood products issued, while the frequency of laboratory test report recalls was 1/5,447 patients. The leading reasons for product recall were suspected bacterial contamination of blood products (30.2%) and suspected or demonstrated non-conformity of laboratory test reports (28.6%). In total, 99 (40.4%) product recalls were categorized as class I, 30 (12.2%) as class II and 116 (47.3%) as class III.
DISCUSSION
According to the available literature data, the product recall procedures were performed quite infrequently by the CITM and were of low extent. There was a remarkable decreasing trend in the rate of product recall due to non-conformities or errors made at the CITM, along with a constant or increasing rate of recalls because of biological variability of blood products.
Topics: Blood Component Transfusion; Croatia; Drug Recalls; Female; Humans; Male; Retrospective Studies
PubMed: 23114522
DOI: 10.2450/2012.0054-12 -
JAMA Oct 2022
Topics: Continuous Positive Airway Pressure; Humans; Intermittent Positive-Pressure Ventilation; Medical Device Recalls; Respiratory Insufficiency
PubMed: 36194232
DOI: 10.1001/jama.2022.15444 -
Biomedical Instrumentation & Technology 2014
Topics: Biomedical Engineering; Equipment Failure Analysis; Equipment Safety; Medical Device Recalls; United States; United States Food and Drug Administration
PubMed: 25408970
DOI: 10.2345/0899-8205-48.6.402 -
Journal of Diabetes Science and... Sep 2019
Topics: Computer Security; Humans; Insulin Infusion Systems; Safety-Based Medical Device Withdrawals; United States; United States Food and Drug Administration; Wireless Technology
PubMed: 31313589
DOI: 10.1177/1932296819865655 -
Journal Francais D'ophtalmologie Oct 2020
Topics: Adult; Biomedical Research; Blindness; Device Approval; France; Fund Raising; Germany; Humans; Implants, Experimental; Product Recalls and Withdrawals; Prosthesis Failure; Prosthesis Implantation; Retina; Retinal Diseases; Societies, Medical; United States; Visual Prosthesis
PubMed: 32622631
DOI: 10.1016/j.jfo.2020.06.003 -
Journal of Clinical Psychopharmacology Oct 2017
Topics: Antipsychotic Agents; Drug Recalls; Drugs, Generic; Humans; Paliperidone Palmitate; United States; United States Food and Drug Administration
PubMed: 28786829
DOI: 10.1097/JCP.0000000000000765 -
The Journal of Pediatrics Jul 2017To evaluate the effectiveness of a mandatory product recall on the frequency of multiple mini-magnet ingestion at a large tertiary pediatric hospital, and to examine the...
OBJECTIVES
To evaluate the effectiveness of a mandatory product recall on the frequency of multiple mini-magnet ingestion at a large tertiary pediatric hospital, and to examine the morbidity and mortality associated with these ingestions.
STUDY DESIGN
In this retrospective chart review, we searched our institution's electronic patient record for patients aged <18 years who had been diagnosed with ingested magnetic foreign bodies between 2002 and 2015, a period that included the mandatory product recall. We compared the frequency and character of ingestions before and after the recall.
RESULTS
Comparing the postrecall years (January 1, 2014, to December 31, 2015) with the 2 years immediately preceding the recall year (January 1, 2011, to December 31, 2012) yields an incidence rate ratio of 0.34 (95% CI, 0.18-0.64) for all magnet ingestions and 0.20 (95% CI, 0.08-0.53) for ingestion of multiple magnets. Based on the Fisher exact test, the incidence of both magnet ingestion (P < .001) and multiple magnet ingestion (P < .001) decreased, and the morbidity associated with magnet ingestion decreased. There were no deaths in either study period.
CONCLUSION
There was a significant decrease in multiple mini-magnet ingestion following a mandatory product recall. This study supports the effectiveness of the recall, which should bolster efforts to keep it in place in jurisdictions where it is being appealed. More broadly, the result provides general evidence of a recall helping decrease further harm from a product that carries a potential hazard.
Topics: Adolescent; Canada; Child; Child, Preschool; Eating; Emergency Service, Hospital; Female; Foreign Bodies; Gastrointestinal Tract; Hospitals, Pediatric; Humans; Incidence; Infant; Magnets; Male; Product Recalls and Withdrawals; Retrospective Studies
PubMed: 28291530
DOI: 10.1016/j.jpeds.2017.02.002 -
AJNR. American Journal of Neuroradiology Jun 2021
Topics: Humans; Product Recalls and Withdrawals; Software
PubMed: 33707280
DOI: 10.3174/ajnr.A7063 -
Nicotine & Tobacco Research : Official... Jul 2018While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and...
INTRODUCTION
While research has documented associations between recall of point-of-sale (POS) tobacco marketing and youth tobacco use, much of the research is cross-sectional and focused on cigarettes. The present longitudinal study examined recall of tobacco marketing at the POS and multiple types of tobacco use 6 months later.
METHODS
The Texas Adolescent Tobacco Advertising and Marketing Surveillance System (TATAMS) is a large-scale, representative study of 6th, 8th, and 10th graders in 79 middle and high schools in five counties in Texas. Weighted logistic regression examined associations between recall of tobacco advertisements and products on display at baseline and ever use, current use, and susceptibility to use for cigarette, e-cigarette, cigar, and smokeless products 6 months later.
RESULTS
Students' recall of signs marketing e-cigarettes at baseline predicted ever e-cigarette use and increased susceptibility to use e-cigarettes at follow-up, across all store types. Recall of e-cigarette displays only predicted susceptibility to use e-cigarettes at follow-up, across all store types. Both recall of signs marketing cigars and cigar product displays predicted current and ever cigar smoking and increased susceptibility to smoking cigars at follow-up, across all store types. Recall of cigarette and smokeless product marketing and displays was not associated with tobacco use measures.
CONCLUSION
The POS environment continues to be an important influence on youth tobacco use. Restrictions on POS marketing, particularly around schools, are warranted.
IMPLICATIONS
Cross-sectional studies have shown that exposure to POS cigarette marketing is associated with use of cigarettes among youth, though longitudinal evidence of the same is sparse and mixed. Cross-sectional studies have found that recall of cigars, smokeless product, and e-cigarette tobacco marketing at POS is associated with curiosity about tobacco use or intentions to use tobacco among youth, but limited longitudinal research has been conducted. Findings from the present longitudinal study suggest that recall of tobacco marketing at retail POS predicts ever use of e-cigarettes and cigars, current use of cigars, and susceptibility to cigar and e-cigarette use among youth.
Topics: Adolescent; Adolescent Behavior; Cross-Sectional Studies; Electronic Nicotine Delivery Systems; Female; Follow-Up Studies; Forecasting; Humans; Longitudinal Studies; Male; Marketing; Product Recalls and Withdrawals; Smoking; Students; Texas; Tobacco Products; Vaping
PubMed: 29069425
DOI: 10.1093/ntr/ntx237 -
Urology Feb 2015
Topics: Female; Health Knowledge, Attitudes, Practice; Humans; Medical Device Recalls; Pelvic Organ Prolapse; Surgical Mesh
PubMed: 25623678
DOI: 10.1016/j.urology.2014.08.059