Document Detail


Quality of medical devices and in vitro diagnostics in resource-limited settings.
MedLine Citation:
PMID:  21955331     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The phenomenon of poor-quality medicines in resource-limited settings is well documented, and field observations reveal similar problems with medical devices (MDs) and in vitro diagnostics (IVDs). In scientific literature, however, there are only scarce reports and documents providing evidence of quality problems of MDs or IVDs in resource-limited settings. This discrepancy may be ascribed to (i) the poor regulatory oversight of MDs/IVDs in resource-limited settings, (ii) a general lack of awareness of the problem of poor-quality MDs/IVDs amongst the scientific community and decision-makers, and (iii) poor quality assurance in diagnostic laboratories in resource-poor settings, precluding tracing quality problems of IVDs from the other potential causes of diagnostic inaccuracy. The problem of poor-quality MDs/IVDs in resource-limited settings is a complex one to address. Firstly, operational definitions for substandard and counterfeit MDs/IVDs are required, as well as ad hoc field surveys, to ensure proper appraisal of the real extent of the problem. Investments are needed to reinforce the national regulatory oversights on MDs/IVDs in resource-limited settings, and to encourage a proactive and transparent exchange of information between Northern and Southern regulatory authorities. Industrialized countries can play a role by expanding and strengthening their regulatory oversight and quality labels to those MDs/IVDs that are frequently used in resource-poor settings. Hopefully, the combination of these measures will result in better protection of patients in resource-poor countries from the effects of being exposed to poor-quality MDs and IVDs.
Authors:
Marcella Mori; Raffaella Ravinetto; Jan Jacobs
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-9-29
Journal Detail:
Title:  Tropical medicine & international health : TM & IH     Volume:  -     ISSN:  1365-3156     ISO Abbreviation:  -     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-9-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9610576     Medline TA:  Trop Med Int Health     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2011 Blackwell Publishing Ltd.
Affiliation:
 Unit of Tropical Laboratory Medicine, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium  Clinical Trials Unit, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium  Department of Medical Microbiology, Faculty of Health, Medicine and Life Sciences, Maastricht, The Netherlands  Operational Unit Genito-pathology, Operational Directorate Bacterial Diseases, Veterinary and Agrochemical Research Center, Brussel.
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