Adverse events and technical complaints related to central venous catheters marketed in Brazil
Main Author: | |
---|---|
Publication Date: | 2013 |
Other Authors: | , , , , |
Format: | Article |
Language: | eng |
Source: | Revista brasileira de hematologia e hemoterapia (Online) |
Download full: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842013000300192 |
Summary: | 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 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. |
id |
ABHHTC-1_499fdd4fdc64578a58c4bcb6da314570 |
---|---|
oai_identifier_str |
oai:scielo:S1516-84842013000300192 |
network_acronym_str |
ABHHTC-1 |
network_name_str |
Revista brasileira de hematologia e hemoterapia (Online) |
repository_id_str |
|
spelling |
Adverse events and technical complaints related to central venous catheters marketed in BrazilCatheterCentral venous catheterHealth SurveillanceNational Health Surveillance AgencyBrazil 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 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. Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular2013-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842013000300192Revista Brasileira de Hematologia e Hemoterapia v.35 n.3 2013reponame:Revista brasileira de hematologia e hemoterapia (Online)instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)instacron:ABHHTC10.5581/1516-8484.20130054info:eu-repo/semantics/openAccessMorais,Luciene de OliveiraFriedrich,KarenMelchior,Stela CandiotoSilva,Michele FeitozaGemal,Andre LuisDelgado,Isabella Fernandes Delgadoeng2013-08-08T00:00:00Zoai:scielo:S1516-84842013000300192Revistahttp://www.rbhh.org/pt/archivo/https://old.scielo.br/oai/scielo-oai.phpsbhh@terra.com.br||secretaria@rbhh.org1806-08701516-8484opendoar:2013-08-08T00:00Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)false |
dc.title.none.fl_str_mv |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
title |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
spellingShingle |
Adverse events and technical complaints related to central venous catheters marketed in Brazil Morais,Luciene de Oliveira Catheter Central venous catheter Health Surveillance National Health Surveillance Agency Brazil |
title_short |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
title_full |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
title_fullStr |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
title_full_unstemmed |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
title_sort |
Adverse events and technical complaints related to central venous catheters marketed in Brazil |
author |
Morais,Luciene de Oliveira |
author_facet |
Morais,Luciene de Oliveira Friedrich,Karen Melchior,Stela Candioto Silva,Michele Feitoza Gemal,Andre Luis Delgado,Isabella Fernandes Delgado |
author_role |
author |
author2 |
Friedrich,Karen Melchior,Stela Candioto Silva,Michele Feitoza Gemal,Andre Luis Delgado,Isabella Fernandes Delgado |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Morais,Luciene de Oliveira Friedrich,Karen Melchior,Stela Candioto Silva,Michele Feitoza Gemal,Andre Luis Delgado,Isabella Fernandes Delgado |
dc.subject.por.fl_str_mv |
Catheter Central venous catheter Health Surveillance National Health Surveillance Agency Brazil |
topic |
Catheter Central venous catheter Health Surveillance National Health Surveillance Agency Brazil |
description |
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 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. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013-06-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842013000300192 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842013000300192 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.5581/1516-8484.20130054 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular |
publisher.none.fl_str_mv |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular |
dc.source.none.fl_str_mv |
Revista Brasileira de Hematologia e Hemoterapia v.35 n.3 2013 reponame:Revista brasileira de hematologia e hemoterapia (Online) instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC) instacron:ABHHTC |
instname_str |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC) |
instacron_str |
ABHHTC |
institution |
ABHHTC |
reponame_str |
Revista brasileira de hematologia e hemoterapia (Online) |
collection |
Revista brasileira de hematologia e hemoterapia (Online) |
repository.name.fl_str_mv |
Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC) |
repository.mail.fl_str_mv |
sbhh@terra.com.br||secretaria@rbhh.org |
_version_ |
1754213111971184640 |