Contamination Rates of 3‐in‐1 Total Parenteral Nutrition in a Clinical Setting

Abstract

Many studies have documented the prevalence of malnutrition in hospitalized patients. When the gut cannot function, the provision of proper nutrition through either a central or a peripheral vein can correct this state and reduce significantly the morbidity and mortality from many diseases. As parenteral nutrition has become widely available, numerous issues have arisen concerning infectious complications of this therapy.In the early 1970s, there occurred an epidemic of sepsis that was related to contaminated intravenous fluid. This led to a better appreciation of solutions as a possible source of sepsis in patients.' However, there have been only a few reports of sepsis related to microorganism contamination of nutritional formulas. Articles in the literature have documented that a variety of organisms, when inoculated into amino acid, glucose, or lipid solutions, may reach high concentrations in 24 hr, and lipid solutions may show no detectable change in color or appearance.2-4 This led the Center for Disease Control (CDC) and others to recommend for lipid containing solutions, a maximum infusion time of 12 hr.5 In 1982, the Food and Drug Administration approved the use of the admixture of amino acid, dextrose, andlipid. At that time our hospital routinely was hanging the amino acid-glucose solution for 24 hr with fat given separately. In 1985, for cost saving and reduced handling time, we began to add the lipid solution (Intralipid 10% or 20%) to the amino acid-glucose solution to make a one bag formula, (3-in-1 admixture) to be administered over a 24-hr period. This practice conflicted with the 1982 CDC guidelines recommending that lipid emulsions be infused within 12 hr of hang time. We therefore undertook an audit to see if these solutions became contaminated and supported growth in the routine clinical setting and whether this had a clinically observable association. MATERIALS AND METHODSOur audit was done at Proctor Community Hospital, a 250-bed general hospital. From January to May 1986, 99 admixed iv bags from 23 patients were collected and cultured. Of the iv catheters used during the study, central venous catheters were placed by attending physicians or surgeons, and peripheral catheters were placed by RNs. Each followed a previously developed set of policies and procedures for skin preparation, sterile techniques, and catheter insertion as recommended by the standards of the American Society for Parenteral and Enteral Nutrition and the National Intravenous Therapist Association All patients receiving parenteral feedings that included amino acids, glucose, and lipid were eligible for the audit if the solution infused over a full 24 hr. The solutions were mixed in large plastic bags in the pharmacy using aseptic technique under a laminar flow hood according to recommendations of the company supplying the solution, Kabi-Vitrum, and ASPEN. These containers were sealed and kept refrigerated in the pharmacy and then transported to the nursing units within 4 hr. The nurses then aseptically spiked the bag ac...

Central Venous Catheter Infection

“…Contamination rates of 0.2 to 38% have previously been observed: A rate of contamination of threein-one bags of 0.2-4% was found by Bozzetti (1990) where of ten patients found to have (TPN) infusate contamination (over a four year period), six developed sepsis of which one died. Dolin et al (1987) In this study, the organisms in each contaminated TPN bag were of different species and unlikely to have originated from a common source, suggesting contamination at ward level. The high rate of contamination observed may be due to 173 the practice of adding vitamin, lipid and mineral supplements to the bag on the ward by the nursing staff, rather than in pharmacy under laminar flow.…”

Microbiologic Quality‐Control Study for the Purpose of Extending the Use of Transfer Sets on the Automix 3+3 and Micromix Automated Total Nutrient Admixture Compounding Pumps

“…Nonetheless, the results from this secondary investigation were interesting in that many of the organisms that grew on the plates were listed by Dolin et al 12 as sampling contaminants during their study. They defined sampling contamination as growth that occurred on the agar plates but not in the broth media from which the agar plates were subcultured.…”

“…On the other hand, there are also studies that suggest there is no correlation between TNA contamination with clinical sepsis. Dolin et al 12 In the course of the study, 2 patients developed sepsis in which blood cultures could not be correlated with a positive culture in a TNA bag. As well, Montego et al 13 cultured 1294 TNA bags in which 59 bags were positive for S epidermidis and E cloacae.…”

Calfactant Sterility in Multiple Doses from Single-Use Vials

“…In clinical practice, the contamination rates for various intravenous solutions/emulsions have ranged from 0.39% to 4%. [16][17][18][19][20][21] Therefore, we considered the maximum acceptable contamination rate to be 4% and the desired contamination rate to be 0.01% (effectively zero for a binomial variable sample size calculation). We determined that in order to attain 90% power with a nominal 0.05 one-sided significance level (i.e., to determine whether the observed contamination rate was less than or equal to the maximum acceptable contamination rate of 4%), we needed to test 89 samples.…”