Regulatory requirements for vaccine authorisation.

Vaccines are one of the most important tools available in the prevention and control of diseases in animals. It is therefore of the utmost importance that when vaccines are used, such use should meet with the requirements of the World Organisation for Animal Health Terrestrial Animal Health Code and must be authorised by the recognised licensing body in the country/region where the vaccines are to be used, in accordance with the three key criteria of quality, safety and efficacy. This article provides a comprehensive and comparative description of the regulatory requirements in place for veterinary vaccines in major regions of the world, highlighting the similarities and pointing out also where there are differences. Recent advances in harmonisation of such testing requirements achieved through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) are also described. The contents will provide a valuable guide to those engaged in the research and development of vaccines globally, and reassure those involved in the prevention and control of animal diseases that veterinary vaccines, when fully authorised and used according to the label instructions, are safe and efficacious.

Comparison of four bedside indicators used to predict duodenal feeding tube placement with radiography.

The validity of four indicators to predict successful duodenal feeding tube placement was evaluated in a prospective trial. Data were collected on each indicator at prepyloric (< or = 65 cm) and postpyloric (> or = 75 cm) feeding tube lengths. Feeding tubes were placed in 106 patients. Eighteen feeding tubes were located in the stomach, and 88 were in the duodenum. Auscultation (progression of loudest sound locations from the left to the right abdomen) had a positive predictive value of 85% (negative predictive value, 31%). The vacuum effect (a change from 40 mL of aspirated air to < or = 10 mL after 60 mL of air instillation) had a positive predictive value of 86% (negative predictive value, 45%) and was significantly correlated with duodenal placement (p = .02). Aspirate was present at prepyloric and postpyloric lengths in 35 cases. Ten of these 35 cases had the defined change in pH from < or = 4.0 to > or = 6.0 (positive predictive value, 100%; negative predictive value, 28%). The positive predictive value of color (a change to yellow) was also 100% (n = 11); the negative predictive value was 29%. The low negative predictive values of the indicators suggest that the absence of defined changes is of no assistance in discriminating between stomach and duodenal placement. A positive auscultation or vacuum effect test is not conclusive for duodenal placement. A positive pH or color change test may obviate the need for a confirmatory radiograph.(ABSTRACT TRUNCATED AT 250 WORDS)

Accuracy of enteral pumps: in vitro performance.

There are few data on the accuracy of pumps used to deliver enteral formulas. Enteral pump manufacturers claim that accuracy is within 10% of the selected flow rate. We evaluated 15 pumps: Flexiflo Companion (n = 5), Travenol 2100 (n = 5), and Kangaroo 324 (n = 5). Three types of formula at room temperature were infused at 10, 100, and 300 mL/h. The formulas used were Jevity, Ensure Plus, and Suplena with added Promod. The Flexiflo Companion and Kangaroo 324 pumps delivered 90% to 110% of the expected volume using the ready-to-feed formulas. The Travenol 2100 pumps averaged less than 90% of the selected flow rates for the three formulas infused. All three pumps delivered less than 90% of the expected volume using a formula with an added powder, but the Travenol 2100 delivered the highest volume of this same formula. There was no significant difference in the delivery of Jevity with the Flexiflo Companion (104% +/- 5% SD) and the Kangaroo 324 pumps (99% +/- 4% SD), but the flow rate was significantly lower with the Travenol 2100 pumps (80% +/- 6% SD). There was no significant difference in the flow rate of Ensure Plus with the Kangaroo 324 (95% +/- 7% SD) and the Travenol 2100 pumps (89% +/- 4% SD). The flow rate of Ensure Plus with the Flexiflo Companion pumps was significantly higher (107% +/- 4% SD).(ABSTRACT TRUNCATED AT 250 WORDS)