Bacterial contamination of multiple-dose vials: a prevalence study

Mattner, Frauke

doi:10.1016/j.ajic.2003.06.004

Cited by 63 publications

(58 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Overall, this mortality rate must be rejected for the following reasons. First, according to the literature between 1990 and 2002 reviewed by Mattner and Gastmeier, 4 who have more closely reported the true values, the number of patients (survivors) included in outbreaks caused by propofol contamination was, in total, 92 patients (>>29 reported by Vonberg and Gastemeier) in 7 outbreaks (>6 reported by Vonberg and Gastemeier). 5 Second, as we discussed above, Bennet et al 3 reported 7 outbreaks traced to propofol contamination, including 62 patients and 2 deaths; In summary, limitations of the inclusion criteria were likely caused by natural methodological issues concerning the bibliographic source used by Vonberg by Gastemeier.…”

Section: Inconsistencies Regarding the Number Of Outbreaks And Mortalmentioning

confidence: 99%

“…Indeed, F. tularensis ranks among the 5 most frequently reported laboratory-acquired infections, and inhalation of infectious aerosols is considered a major transmission route in these cases. 4 After a recent case of ulceroglandular tularemia at our hospital, we investigated the possibility of tularemia as an airborne healthcare-associated infection in the operating room.…”

Section: Potential Risk Of Aerosol-borne Francisella Tularensis Transmentioning

confidence: 99%

See 1 more Smart Citation

Inconsistencies Regarding the Number of Outbreaks and Mortality Rate of Hospital-Acquired Infections Caused by Contaminated Propofol

Zorrilla-Vaca

Vaca-Gonzalez

2015

Infect. Control Hosp. Epidemiol.

View full text Add to dashboard Cite

Section: Inconsistencies Regarding the Number Of Outbreaks And Mortalmentioning

confidence: 99%

Section: Potential Risk Of Aerosol-borne Francisella Tularensis Transmentioning

confidence: 99%

Inconsistencies Regarding the Number of Outbreaks and Mortality Rate of Hospital-Acquired Infections Caused by Contaminated Propofol

Zorrilla-Vaca

Vaca-Gonzalez

2015

Infect. Control Hosp. Epidemiol.

View full text Add to dashboard Cite

“…The multi-dose vial contamination rate is estimated to be up to 27%; the consequences of said contaminations may be severe and may lead to nosocomial outbreaks of fungal, viral, and bacterial infections (Henry et al, 2001;Kirschke et al, 2003;Mattner et al, 2004;Melnyk et al, 1993;Moro et al, 1990).…”

Section: Risks Associated With Fractioning Multi-dose Vials Of Parentmentioning

confidence: 99%

“…In daily practice, the term means any kind of vial that has been used more than once and that was stored for potential re-use. (Mattner,Gastmeier, 2004).…”

Section: Risks Associated With Fractioning Multi-dose Vials Of Parentmentioning

confidence: 99%

Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration

Barbosa

Tavares

et al. 2014

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

Age-related macular degeneration (AMD) is an ocular inflammatory diseases treated mainly by means of a bevacizumab (Avastin ® ) or ranibizumab (Lucentis ® ) intravitreal injection. Among these drugs, only ranibizumab has a specific therapeutic indication for AMD. Considering that, the off-label use on ophthalmic therapy seems to become a rule when it should be an exception. Furthermore, bevacizumab presentation consists of multi-dose vials although it does not contain preservatives in its formula. The current literature review aimed at assessing the risks for the patient related to the use of off-label indication and multi-dose vials on AMD treatment. Considering this, the proposal related to the Brazilian Public Consultation no.10, dated September 12, 2012, which proposes the Clinical Protocol and Therapeutic Guidelines for AMD treatment, was evaluated. This systematic review allowed to conclude that the bevacizumab off-label indication results in increased risks for the patient when compared to the product with specific therapeutic indication for AMD treatment (ranibizumab), especially referring to the significant raise in the adverse events. The risks for the patient related to the multi-dose vial use, referring to the microbiological stability and dose precision, were also made clear.Uniterms: Age-related macular degeneration/treatment. Ranibizumab/intravitreal injection. Bevacizumab/ intravitreal injection. Ophthalmic therapy/off-label use. Off-label indication/patients risks. Multi-dose vials/patients risks.A degeneração macular relacionada à idade (DMRI) é uma doença ocular inflamatória tratada principalmente por injeção intravítrea de bevacizumabe (Avastin ® ) ou de ranibizumabe (Lucentis ® ). Entre os medicamentos citados, apenas o ranibizumabe tem indicação terapêutica específica para uso oftálmico. Considerando essa realidade, o uso off-label na terapia oftálmica parece constituir regra quando deveria ser exceção. Ademais, a apresentação do bevacizumabe consiste em frascos de múltipla-dose, embora esse medicamento não contenha conservante em sua fórmula. A presente revisão da literatura avaliou os riscos ao paciente relativos ao uso indicado off-label e de frascos de múltipla-dose no tratamento de DMRI. Nesse sentido, avaliou-se a proposta relativa à Consulta Pública Brasileira nº 10, de 12 de setembro de 2012, que propõe o Protocolo Clínico e Diretrizes Terapêuticas para o tratamento de DMRI. O levantamento sistemático de trabalhos científicos e de informações relevantes de banco de dados eletrônicos permitiu concluir que a indicação off-label do bevacizumabe acarreta riscos maiores ao paciente, quando comparado ao produto com indicação terapêutica específica para o tratamento de DMRI (ranibizumabe), especialmente quanto ao aumento significativo de eventos adversos. Evidenciaramse, também, os riscos ao paciente relativos ao uso de frascos de múltipla-dose, quanto à estabilidade microbiológica e à precisão da dose.Unitermos: Degeneração macular /tratamento. Ranibizumabe/injeção intravítrea. Bevacizuma...

show abstract

“…Consequently, this species has been shown to be associated with a high mortality rate, as reported in several studies. 3,4 …”

Section: Endotoxin Overproduction Of Enterobacter Cloacae and Mortalimentioning

confidence: 99%

Endotoxin Overproduction of Enterobacter cloacae and Mortality Rate

Zorrilla-Vaca

Zorrilla‐Vaca

2014

Infect. Control Hosp. Epidemiol.

View full text Add to dashboard Cite

show abstract

Bacterial contamination of multiple-dose vials: a prevalence study

Cited by 63 publications

References 29 publications

Inconsistencies Regarding the Number of Outbreaks and Mortality Rate of Hospital-Acquired Infections Caused by Contaminated Propofol

Inconsistencies Regarding the Number of Outbreaks and Mortality Rate of Hospital-Acquired Infections Caused by Contaminated Propofol

Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration

Endotoxin Overproduction of Enterobacter cloacae and Mortality Rate

Contact Info

Product

Resources

About