Critical evaluation of migration studies of silver nanoparticles present in food packaging: a systematic review.

The large use of silver nanoparticles (AgNPs) has provided safety concerns due to the risks of exposure to this nanomaterial caused by the possibility of transfer of the AgNP from the polymer to the food. The gap in scientific knowledge regarding AgNP's migration capacity has been high in the number of publications. This article critically analyzes AgNP migration studies in food packaging, showing which parameters should be followed to ensure reliability in the results found. A systematic review (SR) of the literature was performed in the electronic databases PubMed, SCOPUS, SciELO, LILACS/BVS, and Embase and in the gray literature, without date restrictions, until August 21, 2017, to identify studies who evaluated the migration of AgNP in food packaging. Among the 26 articles that have been part of this SR, only 2 (M3 and M5) showed no migration evidence; however, these results are questionable, because all studies present conflicting, contradictory, or questionable results. From this RS, it was not possible to assure that the AgNPs present in food packages tend to migrate to the food matrix, since some methodological inconsistences were identified in all studies evaluated, demonstrating the need for standardization of methodological guidelines for the new migration studies.

Adverse events and technical complaints related to central venous catheters marketed in Brazil.

AIM: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. METHODS: NOTIFICATIONS WERE CATEGORIZED AND EVALUATED TO: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel((r)) 2010 was used to categorize and systematize the data. RESULTS: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. CONCLUSION: These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff.

Adverse events and technical complaints related to central venous catheters marketed in Brazil

Aim: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods: Notifications were categorized and evaluated to: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data. Results: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion: These data support a necessity for cooperation between all entities of the ...