Your pharmacy is moving in the opposite direction of everyone
else. Bacteriostatic saline is limited to no more than 30 mls in a 24
hour period for adults. So using 10 mls before and after 2 doses per
day will exceed this limit. You and I both know that most hospital
patients will receive much more than 2 daily doses of intermittent
meds. Also I can see how it would be very easy to move these vials
from patient to patient, although they are intended to be dedicated to
one patient. The use of multidose vials is a serious risk to patients
and ISMP, JCAHO, INS, and CDC have statement about their use. There
have been numerous outbreaks of infections including HBV, HCV, and
AIDS attributed to their use.
The limitation of 30 ml per day is derived from animal studies
published in 1971 in:
1.
Kimura, E., et al., Parenteral toxicity studies with benzyl
alcohol. Toxicology and Applied Pharmacology, 1971. 18: p.
60-68.
Reports of reactions to these
and other preservatives can be found in:
1.
Parisian, S., The potential for adverse reactions due to the
presence of additives and preservatives in intravenous solutions and
medications. Journal of Vascular Access Devices, 1996. 1(1): p.
5-14.
You may have to contact AVA
to obtain this one.
The limitation is found in
the USP literature and
1.
Gahart, B.L. and A.R. Nazareno, Intravenous Medications. 20th
ed. 2004, St. Louis: Mosby Year-Book.
These statements have been in
this yearly textbook since at least 1996, the first year I noticed
it.
The infection reports with
multidose vials are taken from my presentation on flushing technology
given at the 2005 INS conference:
7.
Kidd-Ljunggren K, Broman E, Ekvall H, Gustavsson O.
Nosocomial transmission of hepatitis B virus infection through
multiple-dose vials. Journal of Hospital Infection.
1999;43(1):57-62.
8.
Katzenstein T, Jorgensen L, Permin H, et al.
Nosocomial HIV-transmission in an outpatient clinic detected by
epidemiological and phylogenetic analyses. AIDS.
1999;13:1737-1744.
9.
Krause
G, trepka M, Whisenhunt R, et al. Nosocomial transmission of hepatitis
C virus associated with the use of multidose saline vials. Infect
Control Hosp Epidemiol. 2003;24(2):122-127.
10.
Archibald L, Ramos M, Arduino M, et al. Enterobacter
cloacae and Pseudomonas aeruginosa polymicrobial bloodstream
infections traced to extrinsic contamination of a dextrose multidose
vial. Journal of Pediatrics. 1998;133(5):640-644.
11.
Lagging L, Aneman C, Nenonen N, et al. Nosocomial
transmission of HCV in a cardiology ward during the window phase of
infection: An epidemiological and molecular investigation. Scand
Journal of Infect Disease. 2002;34(8):580-582.
12.
Widell
A, Christensson B, Wiebe T, et al. Epidemiologic and molecular
investigation of outbreaks of hepatitis C virus infection on a
pediatric oncology service. Annals of Internal Medicine.
1999;130(2):130-134.
13.
Hutin
Y, Godlstein S, Varma J, O'Dair J, Shapiro EMC, Alter M. An outbreak
of hospital-acquired hepatitis B virus infection among patients
receiving chronic hemodialysis. Infect Control Hosp Epidemiol.
1999;20(11):731-735.
14.
Abulrahi H, Bohlega E, Fontaine R, Al-Seghayer S,
Al-Ruwais A. Plasmodium falciparum malaria transmitted in hospital
through heparin locks. The Lancet. 1997;349:23-25.
15.
MMWR.
Transmission of hepatitis B and C viruses in outpatient settings --
New York, Oklahoma, and Nebraska, 2000-2002. Morbidity and
Mortality Weekly Report. 2003;52(38):901-906.
16.
Mattner F, Gastmeier P. Bacterial contamination of
multiple-dose vials; A prevalence study. American Journal of
Infection Control. 2004;32(1):12-16.
17.
Goetz
A, Rihs J, Chow J, Singh N, Muder R. An outbreak of infusion-related
Kelbsiella pneumoniae bacteremai in a liver transplantation unit.
Clinical Infectious Diseases. 1995;21(6):1501-1503.
18.
Chodoff A, Pettis A, Schoonmaker D, Shelly M.
Polymicrobial gram-negative bacteremia associated with saline
solutions flush used with a needleless intravenous system. American
Journal of Infection Control. 1995;23:357-363.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
Pegues
D, Carson L, Anderson R, et al. Outbreak of Pseudomonas cepacia
bacteremia in oncology patients. Clinical Infectious Diseases.
1993;16(3):407-411.
20. Cohen M. Intravenous bags as
multiple-dose containers pose danger. Hospital Pharmacy.
1994;29:724-725.
20.
Good luck! Lynn
At 3:28 PM -0500 1/16/06, [EMAIL PROTECTED] wrote:
I know this has been discussed in the past, but since the old archives were lost I can't find it anymore. The pharmacy in my facility is proposing to switch to 30cc vials of bacteriostatic saline (one for each patient/per day) as opposed to the 2cc flush vials that they were suppling for PIV flushes. I know there was discussion regarding the limit of bacteriostatic NS that could be used in a 24 hr period, but I forget what the references were to support that. Can anyone point me in the correct direction?
Sarah Jones RN, BSN, OCN, CRNI
Oncology Nurse Clinician/Infusion Services Coordinator
Upper Valley Medical Center
T: (937) 440-4827
--
Lynn Hadaway, M.Ed., RNC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861
