Medical Materiel Research Articles

A-090 Performance of GFAP and UCH-L1 Biomarkers for Traumatic Brain Injury in the ARCHITECT i1000SR TBI Test

Abstract Background Traumatic Brain Injury (TBI) has been recognized as an important cause of death and disability and is a growing public health problem. An estimated 69 million people globally experience a TBI annually. The vast majority (80%) of patients evaluated for TBI in the Emergency Department will receive head CT scans, however less than 10% will have findings of acute traumatic abnormalities. This highlights the need for objective, rapid, accurate tools to help clinicians evaluate and triage patients with suspected TBI and reduce unnecessary radiation exposure. Blood based biomarkers such as glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) have shown utility to predict acute traumatic intracranial injury on CT scan after TBI. Methods The ARCHITECT TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays for the measurement of GFAP and UCH-L1 in plasma and serum. A method comparison study was performed to compare the GFAP and UCH-L1 assays on ARCHITECT i1000SR to the FDA cleared Alinity i assays. Performance characteristics such as detection limits, imprecision, linearity, and measuring interval were established following CLSI guidance. Results The analytical measuring interval (AMI) extends from the limit of quantitation (LoQ) to the upper LoQ and is determined by the range that demonstrates acceptable performance for linearity, imprecision, and bias. The AMI is 6.1 to 42,000 pg/mL for GFAP and 26.3 to 25,000 pg/mL for UCH-L1. Within-laboratory imprecision ranged from 2.2 to 6.2% CV for GFAP and 2.2 to 4.5% CV for UCH-L1. The Overall Reproducibility (includes repeatability, between-run, between-day, between-instrument variance components) results ranged from 2.7 to 6.8% CV for GFAP and 2.4 to 3.9 %CV for UCH-L1. The method comparison study evaluated 123 specimens across the range of 6.5-32,548.6 pg/mL for GFAP, and 51.5-24,127.7 for UCH-L1. The correlation coefficients were 1.0, with a slope of 1.03 and 1.06, an intercept of -0.6 and -6.0, for GFAP and UCH-L1, respectively. The results support use of the established GFAP and UCH-L1 cutoffs and clinical performance findings in a multi-site pivotal study which enrolled 1899 mild TBI (Glasgow Coma Scale score 13 to 15) subjects. 116 of the 120 specimens with a positive CT scan had a positive TBI interpretation (Sensitivity 96.7%). Of the 1779 subjects with negative CT scan results, 713 had a negative TBI interpretation (Specificity 40.1%). The negative predictive value (NPV) of the test was 99.4% (713/717). Conclusions The ARCHITECT TBI test performance was evaluated compared to the Alinity i TBI test across a broad concentration range of GFAP and UCH-L1. The results support equivalence of the ARCHITECT TBI test to the Alinity i TBI test. The established cutoffs were evaluated in a prospective cohort of mild TBI subjects and demonstrated high sensitivity and NPV relative to head CT scan results, supporting the utility to rule out the need for CT scan in mild TBI subjects presenting to the emergency department. Funding This work is in collaboration with the US Army Medical Materiel Development Activity, US Army Medical Research and Development Command CRADA 20-1266-CRA.

Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial

HIV type 1 (HIV-1) remains a global health concern, with the greatest burden in sub-Saharan Africa. Despite 40 years of research, no vaccine candidate has shown durable and protective efficacy against HIV-1 acquisition. Although pre-exposure prophylaxis in groups with high vulnerability can be very effective, barriers to its use, such as perceived low acquisition risk, fear of stigma, and concerns about side-effects, remain. Thus, a population-based approach, such as an HIV-1 vaccine, is needed. The current study aimed to evaluate the efficacy and safety of a heterologous HIV-1 vaccine regimen, consisting of a tetravalent mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) and aluminium phosphate-adjuvanted clade C glycoprotein (gp) 140, in young women at risk of acquiring HIV-1 in southern Africa. This randomised, double-blind, phase 2b study enrolled sexually active women without HIV-1 or HIV-2 aged 18-35 years at 23 clinical research sites in Malawi, Mozambique, South Africa, Zambia, and Zimbabwe. Participants were centrally randomly assigned (1:1) to receive intramuscular injections of vaccine or saline placebo in stratified permuted blocks via an interactive web response system. Study participants, study site personnel (except those with primary responsibility for study vaccine preparation and dispensing), and investigators were masked to treatment group allocation. The vaccine regimen consisted of Ad26.Mos4.HIV administered at months 0 and 3 followed by Ad26.Mos4.HIV administered concurrently with aluminium phosphate-adjuvanted clade C gp140 at months 6 and 12. The primary efficacy outcome was vaccine efficacy in preventing laboratory-confirmed HIV-1 acquisition diagnosed between visits at month 7 and month 24 after the first vaccination (VE[7-24]) in the per-protocol population, which included participants who had not acquired HIV-1 4 weeks after the third vaccination, received all planned vaccinations at the first three vaccination visits within the protocol-specified windows, and had no major protocol deviations that could affect vaccine efficacy. Primary safety outcomes were assessed in randomly assigned participants who received one study injection or more based on the actual injection received. The primary safety endpoints were the incidences of unsolicited adverse events (AEs), solicited local and systemic AEs, serious AEs, AEs of special interest, and AEs leading to discontinuation of vaccination. This trial is registered with ClinicalTrials.gov, NCT03060629, and is complete. Between Nov 3, 2017, and June 30, 2019, 2654 women were randomly assigned, of whom 2636 women (median age of 23 years [IQR 20-25]) were enrolled and received at least one study injection (1313 assigned vaccine, 1323 placebo; 1317 received vaccine, 1319 placebo). Analysis of the primary efficacy outcome in the per-protocol cohort included 1080 women in the vaccine group and 1108 women in the placebo group; the incidence of HIV-1 acquisition per 100 person-years over months 7-24 after the first vaccination was 3·38 (95% CI 2·54-4·41) in the vaccine group and 3·94 (3·04-5·03) in the placebo group, with an estimated VE(7-24) of 14·10% (95% CI -22·00 to 39·51; p=0·40). There were no serious unsolicited AEs, AEs of special interest, or deaths related to the study vaccine. In the vaccine group, 663 (50·3%) of 1317 participants had grade 1 or 2 solicited local AEs and ten (0·8%) of 1317 participants had grade 3 or 4 solicited local AEs. In the placebo group, 305 (23·1%) of 1319 participants had grade 1 or 2 solicited local AEs and three (0·2%) of 1319 participants had grade 3 or 4 solicited local AEs. 863 (65·5%) of 1317 participants in the vaccine group had grade 1 or 2 solicited systemic AEs and 34 (2·6%) of 1317 participants had grade 3 or 4 solicited systemic AEs. 763 (57·8%) of 1319 participants in the placebo group had grade 1 or 2 solicited systemic AEs and 20 (1·5%) of 1319 participants had grade 3 or 4 solicited systemic AEs. Overall, three (0·2%) of 1317 participants in the vaccine group and three (0·2%) of 1319 participants in the placebo group discontinued vaccination due to an unsolicited AE, and three (0·2%) of 1317 participants in the vaccine group and one (0·1%) of 1319 participants in the placebo group discontinued vaccination due to a solicited AE. The heterologous Ad26.Mos4.HIV and clade C gp140 vaccine regimen was safe and well tolerated but did not show efficacy in preventing HIV-1 acquisition in a population of young women in southern Africa at risk of HIV-1. Division of AIDS at the National Institute of Allergy and Infectious Diseases through the HIV Vaccine Trials Network, Bill & Melinda Gates Foundation, Janssen Vaccines & Prevention, US Army Medical Materiel Development Activity, and Ragon Institute.

A-094 Performance Evaluation of GFAP and UCH-L1 Biomarkers for Traumatic Brain Injury in the Alinity i TBI Test (in development)

Abstract Background Traumatic Brain Injury (TBI) has been recognized as an important cause of death and disability and is a growing public health problem. An estimated 69 million people globally experience a TBI annually. Blood-based biomarkers such as glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) have shown utility to predict acute traumatic intracranial injury on head CT scan after TBI. Methods The Alinity i TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays for the measurement of GFAP and UCH-L1 in plasma and serum. Performance characteristics such as detection limits, imprecision, linearity, measuring interval, expected values, and interferences were established following CLSI guidance. A feasibility cohort of 354 subjects was used to establish cutoffs which assist in determining the need for a CT (computed tomography) scan of the head. A prospective study was conducted to assess the clinical performance of the TBI test. Fresh plasma specimens from 97 mild TBI subjects presenting to Level I trauma centers were collected within 12 h of injury from subjects ≥18 years of age who presented with suspected TBI and had a head CT scan performed. The TBI interpretation is considered positive if either GFAP or UCH-L1 is greater than or equal to the cutoffs. The TBI interpretation is considered negative if both GFAP and UCH-L1 are less than the cutoffs. Results The analytical measuring interval (AMI) extends from the limit of quantitation (LoQ) to the upper LoQ and is determined by the range that demonstrates acceptable performance for linearity, imprecision, and bias. The AMI is 6.1 to 42 000.0 pg/mL for GFAP and 26.3 to 25 000.0 pg/mL for UCH-L1. Within-laboratory imprecision (20 day) ranged from 2.8% to 5.3% CV for GFAP and 2.1% to 5.6% CV for UCH-L1. Cutoffs for GFAP and UCH-L1 of 35.0 pg/mL and 400.0 pg/mL, respectively, were selected using both 10-fold cross validation and bootstrapping methods and applying a selection criterion of negative predictive value (NPV) (prevalence adjusted) ≥99% and Sensitivity ≥96%. Of the 97 mild TBI subjects evaluated, 14 had positive head CT scan results. All 14 of the subjects with positive head CT results had a positive TBI interpretation (Sensitivity 100.0%; 95% CI:78.5%,100.0%). There were 23 subjects with a negative TBI interpretation, all 23 had a negative head CT scan result. The NPV of the test was 100% (95% CI:85.7%,100.0%). Conclusion The Alinity i TBI test shows robust analytical performance across a broad concentration range of GFAP and UCH-L1 and may serve as a valuable tool to help evaluate TBI patients across the spectrum of mild to severe injury. The established cutoffs were evaluated in a prospective cohort of mild TBI (Glasgow Coma Scale score of 13–15) subjects and demonstrated high sensitivity and NPV relative to CT scan results, supporting the utility to rule out the need for CT scan in mild TBI subjects presenting to the emergency department. FUNDING: This work is in collaboration with the US Army Medical Materiel Development Activity, US Army Medical Research and Development Command CRADA 20-1266-CRA.

A-093 Clinical Performance of Biomarkers for Traumatic Brain Injury

Abstract Background An estimated 5 million people are evaluated in emergency departments (ED) for Traumatic Brain Injury (TBI) in the United States each year. The vast majority (80%) of patients evaluated for TBI in the ED will receive head CT scans, however less than 10% of those will have any findings of acute traumatic abnormalities. This highlights the need for objective, rapid, accurate tools to help clinicians evaluate and triage TBI patients and reduce unnecessary radiation exposure. The Alinity i TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays used to measure glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum. TBI performance was evaluated in a multi-center study by performing reproducibility and a pivotal study. Methods A pivotal study using prospectively collected archived (frozen) plasma specimens was conducted to establish the clinical performance of the TBI test on the Alinity i system. The testing of the archived specimens was performed at three clinical sites in the United States. The specimens tested were originally collected in a prospective, multi-center clinical study and were from individuals 18 years of age or older who presented to a health care facility or emergency department with suspected traumatic brain injury. These subjects had an initial Glasgow Coma Scale (GCS) score of 13–15 and had a computed tomography (CT) scan of the head performed per the clinical site’s standard of care. Reproducibility was assessed using multiple panel/control members for 5 days based on guidance from Clinical and Laboratory Standards Institute EP05-A3. Testing was conducted using 3 lots of GFAP and UCH-L1 reagents, and 1 Alinity i system at each of 3 testing sites. Results Of the 1899 mild TBI subjects, 120 had positive head CT scan results; 116 of the 120 specimens had a positive TBI interpretation (Sensitivity 96.7%;95%CI:91.7%,98.7%). Of the 1779 subjects with negative CT scan results, 713 had a negative TBI interpretation (Specificity 40.1%;95%CI:37.8%,42.4%). The negative predictive value (NPV) of the test was 99.4% (713/717, 95%CI:98.6%,99.8%). Within-Laboratory imprecision (includes repeatability, between-run, and between-day variance components) results ranged from 2.2% to 3.5% CV for GFAP and 1.8 to 3.2 %CV for UCH-L1. The Overall Reproducibility (includes repeatability, between-run, between-day, between-lot, between-site, and site-lot interaction variance components) results ranged from 2.5% to 4.7% CV for GFAP and 2.6 to 6.6 %CV for UCH-L1. Conclusion The Alinity i TBI clinical performance results demonstrated that the TBI test is characterized by high sensitivity and high NPV, which supports the clinical utility to assist in determining the need for a CT scan of the head in subjects presenting with suspected mild TBI. The GFAP and UCH-L1 assays demonstrated acceptable reproducibility across a wide dynamic range. These assays can report results within 18 min and be conveniently loaded into the Electronic Health Records to aid clinicians in their triage (or imaging) decisions. Funding The study was funded by Abbott Laboratories and in collaboration with the US Army Medical Materiel Development Activity, US Army Medical Research and Development Command CRADA 20-1266-CRA.

The Application of Pearls in Traditional Medicine of China and Their Chemical Constituents, Pharmacology, Toxicology, and Clinical Research.

Although pearls are well known by most people, their medicinal value has not been popularized. This article collates the medicinal history of pearls over 2,000 years in China, including the application of pearls in the traditional medicine of China and their various preparations, as well as the progress of their chemical constituents, pharmacology, toxicology, and clinical research. Pearls from three different sources are used as medical materiel by 9 nationalities and 251 prescription preparations in China. In addition, pearls contain various inorganic constituents, such as calcium carbonate, trace elements, and water, and organic constituents, such as amino acids. In terms of pharmacology, pearls have many effects such as calming, improving cognitive ability, being anti-epileptic, promoting bone growth and regeneration, promoting the proliferation and migration of human microvascular endothelial cells, protecting the heart, anti-hemolysis, and anti-oxidation. In terms of toxicology, pearls are safe to take for a long time without exerting obvious adverse reactions. In terms of clinical application, pearls have been used to treat many diseases and conditions, such as convulsions, epilepsy, palpitations, eye diseases, ulcer diseases, skin diseases, or skin lesions. This article provides a reference for the application and research of pearls in the future.

Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study

Acute febrile illness is a common presentation for patients at hospitals globally. Assays that can diagnose a variety of common pathogens in blood could help to establish a diagnosis for targeted disease management. We aimed to evaluate the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood specimens run on the BioFire FilmArray System, in the diagnosis of several pathogens that cause acute febrile illness. We did a prospective, multicentre, cross-sectional diagnostic accuracy study to evaluate the GF Panel. Consenting adults and children older than 6 months presenting with fever in the previous 2 days were enrolled consecutively in sub-Saharan Africa (Ghana, Kenya, Tanzania, Uganda), southeast Asia (Cambodia, Thailand), central and South America (Honduras, Peru), and the USA (Washington, DC; St Louis, MO). We assessed the performance of six analytes (chikungunya virus, dengue virus [serotypes 1-4], Leptospira spp, Plasmodium spp, Plasmodium falciparum, and Plasmodium vivax or Plasmodium ovale) on the GF Panel. The performance of the GF Panel was assessed using comparator PCR assays with different primers followed by bidirectional sequencing on nucleic acid extracts from the same specimen. We calculated the positive percent agreement and negative percent agreement of the GF Panel with respect to the comparator assays. This study is registered with ClinicalTrials.gov, NCT02968355. From March 26, 2018, to Sept 30, 2019, 1965 participants were enrolled at ten sites worldwide. Of the 1875 participants with analysable results, 980 (52·3%) were female and the median age was 22 years (range 0-100). At least one analyte was detected in 657 (35·0%) of 1875 specimens. The GF Panel had a positive percent agreement for the six analytes evaluated as follows: chikungunya virus 100% (95% CI 86·3-100), dengue virus 94·0% (90·6-96·5), Leptospira spp 93·8% (69·8-99·8), Plasmodium spp 98·3% (96·3-99·4), P falciparum 92·7% (88·8-95·6), and P vivax or P ovale 92·7% (86·7-96·6). The GF Panel had a negative percent agreement equal to or greater than 99·2% (98·6-99·6) for all analytes. This 1 h sample-to-answer, molecular device can detect common causative agents of acute febrile illness with excellent positive percent agreement and negative percent agreement directly in whole blood. The targets of the assay are prevalent in tropical and subtropical regions globally, and the assay could help to provide both public health surveillance and individual diagnoses. BioFire Defense, Joint Project Manager for Medical Countermeasure Systems and US Army Medical Materiel Development Activity, and National Institute of Allergy and Infectious Diseases.

Risk Factors for HIV Seroconversion in a High Incidence Cohort of Men Who Have Sex with Men and Transgender Women in Bangkok, Thailand

Background: In order to assess feasibility for future HIV prevention trials, we measured HIV incidence, retention, and assessed risk factors for seroconversion among men who have sex with men (MSM) and transgender women (TGW) in Bangkok, Thailand between 2017-2019. Methods: We conducted an 18-month prospective cohort study of HIV-uninfected Thai cisgender men and transgender women who reported sex with men in the past six months. HIV and syphilis testing and computer-based behavioral questionnaires were administered at each visit. We utilized Poisson regression to calculate HIV incidence rates. A survival random forest model identified the most predictive risk factors for HIV seroconversion and then used in a survival regression tree model to elucidate hazard ratios for individuals with groups of selected risk factors. Cox proportional hazards (PH) regression evaluated the strength of association between individual covariates and risk of seroconversion. Findings: From April 2017-October 2019, 1,184 participants were screened, 167 were found ineligible, and 1,017 enrolled. Over the 18-month study, visit retention was 93·4% (95% CI 91·6%-94·8%) and HIV incidence was 3·73 per 100 person-years (95% CI 2·79-5·87). Utilizing survival regression tree modeling, those who were 18-20 years of age, reported sexual attraction to mostly or only men, and had five or more lifetime sexual partners were 4·9 times more likely to seroconvert compared to other cohort participants. Factors associated with HIV incidence utilizing Cox PH regression included sexual attraction to mostly or only men (adjusted hazard ratio (aHR) 14·9 (95% CI 20·1-107·9), younger age (18-19 years, aHR 10·88 (95% CI 4·12-28·7), five or greater lifetime sexual partners (aHR 2·0, 95%CI 1·1-3·6), inconsistent condom use with casual partners (aHR 2·43, 95% CI 1·3-4·5), and prior HIV testing (adjusted HR 2·0, 95% CI 1·1-3·5). Interpretation: HIV incidence remains high among Bangkok-based MSM and TGW. These key populations have high retention and are ideal candidates for efficacy evaluation of future prevention strategies. Funding Statement: This work was supported by the US Army Medical Research and Materiel Command (Military Infectious Diseases Research Program) (cooperative agreements W81XWH-11-2-0174 and W81XWH-07-2-0067 with the Henry M. Jackson Foundation for the Advancement of Military Medicine), the US Army Medical Materiel Development Activity, and the National Institute of Allergy and Infectious Disease (interagency agreement Y1-AI-2642-12 with the US Army Medical Research and Materiel Command) and the Division of AIDS Interagency Agreements (DAIDS IAA Y1-AI-2642-16). Declaration of Interests: T.C. reports grants from U.S. Army, grants from NIH, M.R. and S.V. reports grants from US Army Medical Research and Materiel Command with Henry M. Jackson Foundation for the Advancement of Military Medicine, during the conduct of the study. All other authors report no potential conflicts. Ethics Approval Statement: The study was reviewed and approved by the institutional review boards at Walter Reed Army Institute of Research (WRAIR), Faculty of Tropical Medicine at Mahidol University, and the Royal Thai Army. All participants provided written informed consent prior to enrollment.

Army Antimalarial Drug Development: An Advanced Development Case Study for Tafenoquine.

Malaria is classified as a top-tier infectious disease threat associated with a high risk for mortality among U.S. service members deployed overseas. As malarial drug resistance degrades the efficacy of current gold standard drugs for malarial prophylaxis and treatment, it is vitally important to maintain a robust drug pipeline to discover and develop improved, next-generation antimalarial prevention and treatment tools. The U.S. Army Medical Materiel Development Activity (USAMMDA) manages the medical product development of the malarial drug tafenoquine for malarial prophylaxis to address the threat to U.S. service members. Tafenoquine is an effective prophylactic drug against all parasite life cycle stages and all malaria species that infect humans. Thus, it provides broad capabilities in a single drug for malarial prophylaxis and treatment. Partnerships with industry are a crucial part of USAMMDA's medical product development strategy, by leveraging their drug development experience and manufacturing capabilities to achieve licensure and commercial availability. Additionally, these partnerships capitalize on expertise in the commercial market and help ensure that USAMMDA successfully translates a Department of Defense capability gap into a commercially available product. This article will highlight the strategies used to move this critical antimalarial drug through the development pipeline.

Derivation and implications of patient condition estimates

Computer-based medical materiel item estimation is accomplished by clinically coupling injuries and illnesses to the supplies necessary to treat these conditions. In a relatively straightforward way, the materiel necessary to treat a stream of patients can be calculated by summing across the supplies necessary for each malady in any given patient stream. This method was formalized by the Naval Health Research Center in the patented process embodied in the Estimating Supplies Program. The success of this method depends on an accurate probability estimate for the occurrence of each illness and trauma. There are several methods for estimating these discrete probabilities. This paper documents and defines the various types of estimates and explains the differences between them to reduce confusion and to standardize nomenclature.

Field-User Acceptability Evaluation of a New Stick Camouflage Face Paint Formulation With and Without the Insect Repellent DEET

Two newly designed formulations of stick camouflage face paint, one with 30% N,N-diethyl-3-methylbenzamide (DEET) and the other without DEET, were evaluated for acceptability among soldiers upon completion of normal military field training exercises. A total of 156 soldiers participated and completed a self-administered survey answering questions about product acceptability, packaging, and ease of use. Results of the study indicated that soldiers found stick formulations, with and without DEET, to be acceptable for use (62.9% and 83.7%, respectively). This data will be used by the Program Management Office at the U.S. Army Medical Materiel Development Activity to support a request to the Armed Forces Pest Management Board to assign a National Stock Number.

(A169) Strategic National Stockpile: American Preparedness to a Domestic Biological Attack

This session offers an overview of the Strategic National Stockpile (SNS) and the Cities Readiness Initiative (CRI), including CHEM PACK. Managed by the US Department of Health and Human Services Centers for Disease Control and Prevention (CDC), “push-packs” of this critical federal cache of pharmaceuticals and medical materiel are at sites located throughout the country. The CDC's CRI is a federally funded program designed to compliment the SNS and enhance preparedness in the nation's largest cities and Metropolitan Statistical Areas (MSA) where more than 50% of the US population resides. Through CRI, state and large metropolitan public health departments continue refining plans to respond to a large-scale bioterrorism attack by dispensing antibiotics to the entire population of an identified MSA with 48 hours. The SNS Technical Assistance Review (TAR) will be reviewed, as well as best practices and lessons learned from successful public health emergency preparedness and response programs throughout the US.

A View From the Corner Command Post

A View From the Corner Command Post

Electronic catalog reshapes how federal government buys supplies.

Biomedical Instrumentation & Technology 335 The Directorate of Medical Materiel of the Defense Supply Center Philadelphia (DSCP) is a government contracting agency that provides acquisition and logistical support to U.S. Department of Defense (DOD) and other federal customers, including DOD's hospital facilities and field hospitals in the United States and abroad. Presently, we are providing support to Operation Enduring Freedom and the Homeland Security effort. One tool that helps us accomplish this mission is the Medical Electronic Catalog (ECAT) a Web-based ordering system that enables our customers to order medical devices and laboratory, dental, and optical products from anywhere in the world, 24 hours a day, 7 days a week, 365 days a year. ECAT provides paperless contracting, electronic ordering, electronic invoicing, electronic payments, and deep unit price discounts.

Monitoring temperature-sensitive vaccines and immunologic drugs, including anthrax vaccine.

The experience of the U.S. Army Medical Materiel Center, Europe (USAMMCE), in monitoring temperature-sensitive vaccines and immunologic drugs, including anthrax vaccine, during storage and shipment is discussed. USAMMCE uses an electronic monitoring device to monitor and archive the time-temperature history of shipments of various vaccines, immunoglobulins, and other drugs requiring refrigeration. Using these monitors, USAMMCE can track its carriers' performance, reduce product loss, and validate quality. USAMMCE trains people to pack refrigerated items and to activate and place the monitoring device inside the packing container. Over 1200 temperature-monitor readings from 44 U.S. military logistical depots, hospitals, and clinics located outside the United States are evaluated annually by the USAMMCE pharmacist; each reading represents one shipment or packed box. When deactivated during unpacking, the device flashes green for a successful shipment (all temperature readings within the ideal range) or red for a potentially problematic shipment. From January through October 1998, the device was used in 750 temperature-sensitive shipments; 72% of the devices were returned to USAMMCE in green condition and the remainder in red. Of the red-flashing monitors, 15% were determined to signal that the drugs were received in unacceptable condition. USAMMCE successfully shipped more than 26,000 vials of anthrax vaccine from February through October 1998 within the manufacturer's guidelines for storage temperature. Temperature monitoring is essential for proper storage and transport of vaccines and immunologic drugs.

Pharmaceutical Logistics in the European Theater

This article describes the responsibilities and objectives of the pharmacy officer for the U.S. Army Medical Materiel Center, Europe. Pharmacists' experiences and knowledge offer advantages in the ordering, storage, and distribution of medical materiel. Exploitation of new technology and a customer-focused attitude encourage a working environment that capitalizes on pharmaceutical expertise. The use of temperature monitors, enhanced automation opportunities, expired drug return credits, and other customer-focused initiatives exemplify pharmacists' value to military medical logistics organizations. An overview of the pharmaceutical pipeline to U.S. military and State Department customers in the European theater is provided.

Environmental Testing of a Blood Gas/pH and Electrolyte Analyzer for Field Hospital Use

In 1983 the U.S. Army Academy of Health Sciences developed a Letter Requirement for a Blood Gas/pH Analyzer for use in Echelon 3 and 4 facilities. Field trials of several nondevelopment items and a subsequent market survey did not produce a suitable instrument. Recently, a relatively small, lightweight, and simple device became commercially available, and was tested for field applicability in accordance with MIL-STD-810D. Results indicated that with minor modifications, the instrument would be sufficiently rugged to withstand the severe storage temperature extremes and transit shock and vibration conditions associated with deployment of field medical materiel.

Metrological security of development and production for medical materiel in the tenth five-year plan

Metrological security of development and production for medical materiel in the tenth five-year plan

Emergency medical packet for one hundred personnel.

My presentation concerns what we in the military medical services have termed the medical materiel program for nuclear casualties. I will briefly discuss the concepts of the program, with special emphasis on phase 1 and additional comments on phase 2. Older concepts of general war held that medical support in both manpower and resources would increase gradually and concurrently in relation to the total military manpower buildup, that the United States base would remain intact, and that medical care would be provided by or under the direct personal supervision of a military physician. The advent of thermonuclear weapons has caused a radical change. Wide-scale destruction and damage to our resources here and in our oversea commands and the imposition of a military masscasualty load which can occur with dramatic suddenness are distinct possibilities. These conditions were the basis of the recommendations of the Assistant Secretary of Defense (Health and Medical)