Bacterial contamination of multiple-dose vials: a prevalence study

doi:10.1016/j.ajic.2003.06.004

American Journal of Infection Control

Volume 32, Issue 1, February 2004, Pages 12-16

https://doi.org/10.1016/j.ajic.2003.06.004 Get rights and content

Abstract

Background

Two patients died of a meningitis caused by Pseudomonas aeruginosa in a hospital in Germany in July 2001, their infections having been caused by a contaminated contrast media (iomeprol [Imeron]) used as a multiple-dose vial (MDV) over 8 days. Therefore, a prevalence study was performed to investigate the use and contamination of multiple-use vials in a tertiary hospital.

Methods

In a 1300-bed hospital on a specific day in November 2001, all used MDVs were collected by the infection control nurses. Information was recorded about the medication, labeling of vials, storing temperature, wards, and dates of opening. Each vial was also tested for sterility.

Results

Opened vials were to be found in all wards. Of the 227 vials available, 1 vial and 1 spike were contaminated with Staphylococcus epidermidis (contamination rate 0.9%; 95% CI, 0.3-2.1). The opening dates were marked on only 114 (50%) MDVs, 15 (13%) of which had already expired. Only 44 (19%) MDVs had been stored in the refrigerator, whereas 109 MDVs contained medications without any preserving agent.

Conclusion

Results revealed somewhat risky handling of MDVs. In light of a possible high risk in this hospital of about 1 contaminated MDV per day, and in view of many reported outbreaks induced by contaminated MDVs, the following infection control measures were encouraged: alcohol hand hygiene, the disinfection of gums, observance of the manufacturer's recommendations, appropriate storing temperatures, marking the opening time, and avoiding the multiple use of medications not containing preserving agents.

Section snippets

MDVs—multiple-use vials

The term multiple-dose vial is used widely and in a confusing manner. In daily practice, the term designates any kind of vial that may have been used more than once and kept for potential reuse. A “true” MDV describes a vial in which antibacterial preservatives are present and which may be used more than once and following the manufacturer's recommendations (eg, insulin, heparin, and octeotride).⁶ Single-dose vials are intended to be used only once (eg, salines, antibiotics, anesthetics, etc).

Results

A total of 227 MDVs was collected from 47 wards (4.8 MDV/ward). Of these, 209 (92%) were bottles and ampoules and 18 (8%) were syringes prepared by nurses for flushing intravascular lines.

A total of 177 (77.9%) MDVs was collected in nursing rooms; none of them were marked with any patient's name, which indicated that they were probably not used for only 1 patient. Of these, 33 (14.5%) were collected in patients' rooms, the rest elsewhere. For 84 (37%) MDVs, mini-spikes were used; for 10 (4%),

Discussion

Results demonstrate the risk related to handling of MDVs. Almost any kind of medication was used for multiple-use vials. Cheap, preservative-free solutions, such as sterile saline and glucose, were used as MDVs; the potential contamination risk, possibly leading to severe infections in patients, had not been realized at all.

Contamination studies with inconsistent data have been presented for decades. In 1984, Longfield¹ studied 1223 samples from 864 MDVs and could not find any contamination,

Acknowledgements

We thank Ilka Fröse and Dagmar Stresemann for their technical assistance and Undine Baum, Juliane Bitsch, Dagmar Rotermund-Rauchenberger, and Uta Schoener-Fruehling for collecting all containers.

References (36)

J Bothe
Study shows contamination in multiple-dose vials
AORN J
(1973)
J Dade et al.
Hazards of multiple use of pharmaceutical solutions
Lancet
(2000)
B Henry et al.
An outbreak of Serratia marcescens associated with the anesthetic agent propofol
Am J Infect Control
(2001)
E.V Granowitz et al.
A pseudoepidemic of Alcaligenes xylosoxidans attributable to contaminated saline
Am J Infect Control
(1998)
G.J Webster et al.
Molecular epidemiology of a large outbreak of hepatitis B linked to autohaemotherapy
Lancet
(2000)
L.K Archibald et al.
Enterobacter cloacae and Pseudomonas aeruginosa polymicrobial bloodstream infections traced to extrinsic contamination of a dextrose multidose vial
J Pediatr
(1998)
A.T Tresoldi et al.
Enterobacter cloacae sepsis outbreak in a newborn unit caused by contaminated total parenteral nutrition solution
Am J Infect Control
(2000)
K Kidd-Ljunggren et al.
Nosocomial transmission of hepatitis B virus infection through multiple-dose vials
J Hosp Infect
(1999)
S Lacey et al.
Pseudomonas pickettii infections in a paediatric oncology unit
J Hosp Infect
(1991)
R Longfield et al.
Multidose medication vial sterility: an in-use study and a review of the literature
Infect Control
(1984)

S.M Kamishima et al.

Utilization of “used” vials: cost-effective technique for MR arthrography

J Magn Reson Imaging

(2000)

Meningitis: Kontrastmittel war infiziert

Hamburger Abendblatt

(2001)

Meningitis-Skandal: Zwei Ärzte entlassen

Hamburger Abendblatt

(2001)

P Melnyk et al.

Contamination study of multiple-dose vials

Ann Pharmacother

(1993)

H.C Stetler et al.

Outbreaks of group: A streptococcal abscesses following diphtheria-tetanus toxoid-pertussis vaccination

Pediatrics

(1985)

B.D Tarr et al.

Stability and sterility of biosynthetic human insulin stored in plastic insulin syringes for 28 days

Am J Hosp Pharm

(1991)

E.J Monti

The safe use of disposable syringes in anesthesia: cost effective or costly?

CRNA

(1995)

N.P O'Grady et al.

Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention

MMWR Recomm Rep

(2002)

Cited by (65)

Bacterial contamination of single and multiple-dose parenteral injection vials after opening and antibiotic susceptibility of isolates at Jimma Medical Center, Jimma, Southwest Ethiopia
2023, Infection Prevention in Practice
Single- or multiple-dose vials are prone to bacterial contamination after improper handling and can be potential reservoirs of microorganisms that could be transmitted to the patient through the parenteral route. The present study aims to assess the magnitude of the problem and associated factors at Jimma Medical Center (JMC), Jimma, Southwest Ethiopia.
A cross-sectional study design was conducted at JMC from July 2021 to October 2021. A total of 384 parental medications and nurse interviews that were administered in 11 wards and 3 intensive care units were included. Samples were processed and identified by conventional bacterial culture methods.
The overall prevalence of vial contamination due to aerobic bacteria was 21 (5.5%) among multiple-dose vials and none of the single-dose vials. The highest level of contamination (8, 38.1%) was found in the paediatric ward. Pseudomonas aeruginosa and Klebsiella pneumoniae were the most common microorganisms identified vial contamination, 6 cases (28.5%) and 5 cases (23.8%) respectively Multidrug resistance was identified in 95.2% of the isolates, with all Gram-negative isolates showing a multidrug resistance against the tested antibiotics. In multivariate logistic regression analysis, vial contamination was strongly associated with reuse of syringe and/or needle, the environment where medication was handled, and the storage conditions.
In this study, the prevalence of vial contamination was high. The bacterial isolates from vials were also resistant to commonly prescribed antimicrobial drugs. Healthcare professionals must strictly adhere to basic infection control practices as per standard guidelines to reduce the risk of infection from contaminated vials.
Outbreak of Pseudomonas aeruginosa infections after CT-guided spinal injections
2021, Journal of Hospital Infection
Citation Excerpt :
In Germany, an outbreak of two P. aeruginosa-associated cases of meningitis after SI was published in the newspapers in 2001 [16]. The source of the outbreak was a bacterially contaminated contrast media single-dose vial which was used as a multiple-dose vial [17]. In the present case, it was not possible to verify possible contamination of the vials with P. aeruginosa because the original vials used for SI were not available by the time of the investigation.
Meningitis and spinal infections with Gram-negative bacteria after local injections for treatment of chronic back pain are rare. This study investigated an outbreak of Pseudomonas aeruginosa infections following computed tomography (CT)-guided spinal injections (SI).
A case was defined as a spinal infection or meningitis with P. aeruginosa after SI between 10^th January and 1^st March 2019 in the same outpatient clinic. Patients without microbiological evidence of P. aeruginosa but with a favourable response to antimicrobial therapy active against P. aeruginosa were defined as probable cases.
Twenty-eight of 297 patients receiving CT-guided SI during the study period developed meningitis or spinal infections. Medical records were available for 19 patients. In 15 patients, there was microbiological evidence of P. aeruginosa, and four patients were defined as probable cases. Two of 19 patients developed meningitis, while the remaining 17 patients developed spinal infections. The median time from SI to hospital admission was 8 days (interquartile range 2–23 days). Patients mainly presented with back pain (N=18; 95%), and rarely developed fever (N=3; 16%). Most patients required surgery (N=16; 84%). Seven patients (37%) relapsed and one patient died. Although the source of infection was not identified microbiologically, documented failures in asepsis when performing SI probably contributed to these infections.
SI is generally considered safe, but non-adherence to asepsis can lead to deleterious effects. Spinal infections caused by P. aeruginosa are difficult to treat and have a high relapse rate.
Cleaning and Disinfection of Patient Care Items, in Relation to Small Animals
2015, Veterinary Clinics of North America - Small Animal Practice
Outbreak of Burkholderia cepacia bloodstream infections traced to the use of Ringer lactate solution as multiple-dose vial for catheter flushing, Phnom Penh, Cambodia
2013, Clinical Microbiology and Infection
The Burkholderia cepacia complex is a group of Gram-negative bacteria known as respiratory pathogens in cystic fibrosis patients, but also increasingly reported as a cause of healthcare associated infections. We describe an outbreak of B. cepacia bloodstream infections in a referral hospital in Phnom Penh, Cambodia. Over a 1.5-month period, blood cultures from eight adult patients grew B. cepacia. Bloodstream infection occurred after a median of 2.5 days of hospitalisation. Three patients died: 7, 10 and 17 days after blood cultures were sampled. As part of the outbreak investigation, patient files were reviewed and environmental sampling was performed. All patients had peripheral venous catheters that were flushed with Ringer lactate drawn from a 1 L bag, used as multiple-dose vial at the ward. Cultures of unopened Ringer lactate and disinfectants remained sterile but an in-use bag of Ringer lactate solution and the dispensing pin grew B. cepacia. The isolates from patients and flushing solution were identified as B. cepacia by recA gene sequence analysis, and random amplified polymorphic DNA typing confirmed clonal relatedness. The onset of the outbreak had coincided with the introduction of a dispensing pin with a screw fit that did not allow proper disinfection. Re-enforcement of aseptic procedures with sterile syringe and needle has ended the outbreak. Growth of B. cepacia should alert the possibility of healthcare associated infection also in tropical resource-limited settings. The use of multiple-dose vials should be avoided and newly introduced procedures should be assessed for infection control risks.
Microbial contamination of single- and multiple-dose vials after opening in a pulmonary teaching hospital
2013, Brazilian Journal of Infectious Diseases
Citation Excerpt :
In the current study 165 of 205 vials (80.49%) were SDVs that were used as multiple-dose vials. This finding is more than reported percentage of 50% in the literature.10,11 On the other hand MDVs contain antibacterial preservatives and may be used more than once when preparation and storage is according to the manufacturer's recommendations. (
Intravenous therapy is a complex procedure usually requiring the preparation of the medication in the clinical area before administration to the patient. Breaches in aseptic technique may result in microbial contaminations of vials which is a potential cause of different avoidable infections. We aimed to investigate the prevalence and pattern of microbial contamination of single- and multiple-dose vials in the largest pulmonary teaching hospital in Iran.
In a period of 2 months, opened single- and multiple-dose vials from different wards were sampled by a pharmacist. The name of the medication, ward, labeling of the vials, the date of opening, and storing temperature were recorded for each vial. Remained contents of each vial were cultured using appropriate bacterial and fungal growth media.
Microbial contamination was identified in 11 of 205 (5.36%) of vials. The highest contamination rate was 14.28% for vials used in interventional bronchoscopy unit. The most frequent contaminated medication was insulin. Gram-positive bacteria (81.82%) were more significantly involved than gram-negative ones (9.09%) and fungi (9.09%), with the highest frequency for Staphylococcus epidermidis.
Our data demonstrate that repeated use of vials especially if basic sterility measures are disobeyed can cause microbial contamination of administered products to the patients. Infection preventionists are responsible to train health care workers regarding aseptic techniques and apply guidelines for aseptic handling of intravenous solutions.
Pseudo-outbreak of brevundimonas diminuta attributed to contamination of culture medium supplement
2017, Infection Control and Hospital Epidemiology

View all citing articles on Scopus

View full text

Major articleBacterial contamination of multiple-dose vials: a prevalence study

Abstract

Background

Methods

Results

Conclusion

Section snippets

MDVs—multiple-use vials

Results

Discussion

Acknowledgements

AORN J

Lancet

Am J Infect Control

Am J Infect Control

Lancet

J Pediatr

Am J Infect Control

J Hosp Infect

J Hosp Infect

Multidose medication vial sterility: an in-use study and a review of the literature

Infect Control

Utilization of “used” vials: cost-effective technique for MR arthrography

J Magn Reson Imaging

Meningitis: Kontrastmittel war infiziert

Hamburger Abendblatt

Meningitis-Skandal: Zwei Ärzte entlassen

Hamburger Abendblatt

Contamination study of multiple-dose vials

Ann Pharmacother

Outbreaks of group: A streptococcal abscesses following diphtheria-tetanus toxoid-pertussis vaccination

Pediatrics

Stability and sterility of biosynthetic human insulin stored in plastic insulin syringes for 28 days

Am J Hosp Pharm

The safe use of disposable syringes in anesthesia: cost effective or costly?

CRNA

Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention

MMWR Recomm Rep

Major article
Bacterial contamination of multiple-dose vials: a prevalence study