Current good manufacturing practices for blood and blood components: notification of consignees receiving blood and blood components at increased risk for transmitting HIV infection--FDA. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that Whole Blood, blood components (including recovered plasma), Source Plasma and Source Leukocytes at increased risk for transmitting human immunodeficiency virus (HIV) infection have been collected. This final rule requires that when a donor who previously donated blood is tested on a later donation in accordance with the regulations and tests repeatedly reactive for antibody to HIV, the blood establishment shall perform more specific testing using a licensed test, if available, and notify consignees who received Whole Blood, blood components, Source Plasma or Source Leukocytes from prior collections so that appropriate action is taken. Blood establishments and consignees are required to quarantine previously collected Whole Blood, blood components, Source Plasma and Source Leukocytes from such donors, and if appropriate, notify transfusion recipients. The Health Care Financing Administration (HCFA) is also issuing a final rule, published elsewhere in this Federal Register, which requires all transfusion services subject to HCFA's conditions of Medicare participation for hospitals to notify transfusion recipients who have received Whole Blood or blood components from a donor whose subsequent donation test results are positive for antibody to HIV (hereinafter referred to as HCFA's final rule). FDA is requiring transfusion services that do not participate in Medicare and are, therefore, not subject to HCFA's final rule, to take steps to notify transfusion recipients. FDA is taking this action to help ensure the continued safety of the blood supply, and to help ensure that information is provided to consignees of Whole Blood, blood components, Source Plasma and Source Leukocytes and to recipients of Whole Blood and blood components from a donor whose subsequent donation tests positive for antibody to HIV.     

Tissue distribution of intubation-related lidocaine in brain-dead patients

Tissue distribution of lidocaine that was used for endotracheal intubation during cardiopulmonary resuscitation (CPR) was measured in 3 patients who were brain-dead or near brain death. Case 1 was a 69-year-old female whose heartbeat was restored by CPR but stopped 10 hours later. The lidocaine ratios of cerebrum to blood (2.04) and diencephalon to blood (1.01) were within ranges of those found in non-brain-dead patients. Case 2 was a 77-year-old female whose heart resumed beating after CPR but stopped 66 hours later. The lidocaine ratios of cerebrum to blood (5.69), diencephalon to blood (18.7), and cerebellum to blood (11.3) were much higher than those in non-brain-dead patients. Case 3 was a 48-year-old male who had cardiopulmonary arrest following an acute subarachnoid hemorrhage. His heart resumed beating after resuscitation but ceased beating 114 hours after admission. Lidocaine was detected only from the cerebrum, cerebellum, and blood clots in the superior sagittal sinus at levels of 0.028, 0.024, and 0.007 mug/g, respectively. Tissue distribution of intubation-related lidocaine in brain-dead patients is useful as supplementary data for reviewing hemodynamic changes in their brains during medical treatment.     

The role of ethanol abuse in the etiology of heroin-related death

Toxicology analyses and other forensic science data were used to examine the mechanisms through which ethanol increased the risk for death caused by injected street preparations of heroin. The authors studied 505 victims of fatal heroin overdose and compared subjects who had concentrations of blood ethanol greater than 1000 mg/L (n = 306) with those who had concentrations less than, or equal to 1000 mg/L (n = 199). We found significant negative correlations between concentrations of ethanol and morphine (a heroin metabolite) in blood (R2 = 0.11, P = 0.0001 for log10-transformed variables) as well as between concentrations of blood ethanol and bile morphine (R2 = 0.16, P = 0.0001 for log10 bile morphine versus blood morphine). Toxicologic evidence of infrequent heroin use was more common in decedents with blood ethanol concentrations greater than 1000 mg/L than in those with lower concentrations. Our data suggest that ethanol enhances the acute toxicity of heroin, and that ethanol use indirectly influences fatal overdose through its association with infrequent (nonaddictive) heroin use and thus with reduced tolerance to the acute toxic effects of heroin.     

Measurement of delta 9-tetrahydrocannabinol (THC) in whole blood samples from impaired motorists

The major psychoactive cannabinoid in marihuana, delta 9-tetrahydrocannabinol (THC) was measured in 1792 randomly selected blood specimens from erratic motorists arrested for impairment who submitted to blood alcohol sampling. Of these specimens, 14.4% were positive for THC (greater than or equal to 5.5 ng/mL). In those erratic driver specimens negative for alcohol THC positives rose to 23%. Drivers who used marihuana covered a broad age range. Aliquots of hemolyzed blood (10 microL) were analyzed by a sensitive radioimmunoassay (RIA) not requiring extraction. RIA accuracy and specificity were validated by gas liquid chromatography/mass spectroscopy (GLC/MS) split pair analysis (correlation coefficient = 0.93). This initial experience should facilitate and amplify a program designed to set forth the epidemiology of marihuana use in motorists and possible behavioral correlates.     

The contribution of statistics in the forensic appraisal of post-transfusion contamination by hepatitis C virus

Many patients were contaminated by blood products in the 1980s and early 1990s, a period during which there was no means of detecting hepatitis C virus (HCV) and measures of vigilance in French blood transfusion centers were lacking in rigor, and it has become a real public health issue by now. The blood transfusion centers which produce and distribute the products are liable for such contamination, as long as the expert appraisal has established a link of causality between the transfusion and the contamination. When the viral serologic status (i.e. the contaminating potential) of the donors is not known, experts often resort to indirect evidence, including use of probability estimates calculated according to the following method. The probability (P) that there was at least one contaminating donor among those having provided the blood given to a patient, is calculated using the following formula:P=1.(1.pHCV)(N)where pHCV is the prevalence of subjects who have tested positive for anti-C virus antibodies in a population of blood donors, and N is the number of donors having contributed to the transfusion in question. Although the polymerase chain reaction (PCR) is very sensitive, its threshold, below which weak replication is undetectable, varies depending on the technique used. One study has demonstrated that below a dilution of 10(-4), RNA is no longer detected by the majority of laboratories. The specificity of PCR is not flawless either, since false-positive results are found, probably resulting from contamination of the samples. Considering that 0.10% is a reasonable approximation of the prevalence of subjects who had anti-HCV antibodies that were detectable by recombinant immunoblot assay during that period, one can calculate the probability that there is a contaminating donor among the blood donors who contributed to the product that was administered and determine a curve.     

Forensic and chemical determination of methane in cadaveric samples

Conditions were elaborated for the determination of methane, through gas chromatography, in blood and the lung by using a 2% methanol solution as an internal standard and with the below gas-chromatography column being applied: dimensions--200 x 0.3 cm, 15% di-2-ethylhexyl sebacate on Dinochrome II (0.16 x 0.21 mm) at 110 0 degree C. The detector is of the flame-ionization type. The normal content of methane was determined for blood and for the lung--0.122 +/- 0.0074 microgram/ml and 0.20 +/- 0.04 microgram/g, respectively. Biological samples from cadavers of other persons who died due to trauma were suggested for use as controls. The method was used to examine expertise objects, blood and the lung from the cadavers of peoples who died in fire.     

论输血及血液制品感染的侵权责任——基于日本法上的经验

在医学界,血液被称为"生命的源泉"。然而,近年来,随着临床用血和血液制品使用的大量增加,患者感染梅毒、肝炎、甚至艾滋病的案例已屡见不鲜。而上世纪末,我们的邻国日本也曾遭遇过同样的"血液之殇",日本司法实践在处理诸如"东大梅毒事件"、"药害肝炎事件"、"药害艾滋事件"上的成功经验会带给我国怎样的启示,以下将对日本法上血液的法律属性、医疗过失的判断标准、因果关系的证明以及医药产品责任主体的责任分配等进行分析,并结合我国《侵权责任法》相关规定,从法解释学的角度出发,针对我国司法现状,探讨日本法对我国在法律解释适用方面的借鉴意义。     

The use of bacteriological analysis of the blood in the diagnosis of death by drowning

Investigation of blood samples from the femoral vein of subjects drowned in water and died of other causes (control) was carried out. Penetration of microflora contained in water into the bloodflow of the drowned people was shown. Possibility of using bacteriologic analysis of the postmortal blood to diagnose death from drowning was stated. Ps. putida and Ps. fluorescens. that were not present in the blood of persons who had died of causes other than drowning were recommended as test bacteria. Selective media and methods to isolate the bacteria from the cadaveric blood were chosen.     

8例利多卡因过敏性休克死的血药浓度分析

目的研究利多卡因过敏性休克死者利多卡因血药浓度及其与死因的关系。方法采用高效液相色谱法(HPLC),分别对使用利多卡因麻醉术中各项指标均正常的8例术中因利多卡因过敏性休克死者的血液和11例顺利完成手术患者的血液进行利多卡因浓度的检测,对比分析两者结果。结果 8例死者利多卡因血药浓度(1．61mg± 0．45mg／L)低于11例正常患者利多卡因血药浓度(2．44mg±0．47mg／L)。结论利多卡因过敏性休克死者血药浓度在正常值范围内,与发生过敏性休克致死无关。     

Forensic-biochemical indices of serum amilase and cholinesterase activity in lethal poisoning with heroin

The examination of the activity of serum amilase and cholinesterase in the blood from subjects who had died of heroin poisoning showed significant elevation of such activity. These findings allow experts to use the activity of the above enzymes as effective markers in detection of narcotic drugs in cadaveric blood, opiate narcotics, in particular.     

Sensitivity of the Luminol Test with Blue Denim

Abstract: An article appearing in this journal in 2000 suggested that the sensitivity of the luminol test performed on denim fabric is usually no greater than at a 1:100 dilution of blood. This study shows that the luminol test may be unambiguously interpreted at substantially greater dilutions of blood. In this study, four different types of denim were tested by spraying a swatch of fabric with a typical formulation of the luminol reagent. Testing was conducted of dilutions of blood up to 1:1000, all of which showed distinct chemiluminescence. Diluted blood was applied to denim material in the form of a random number. A successful test was obtained only when a “blind” observer, i.e., an observer who was uninformed of the number, correctly reported the number.     

The analysis of an intracerebral hematoma for drugs of abuse

Toxicological investigations were performed on an intracerebral hematoma, antemortem blood, and postmortem blood of an individual who was found unresponsive in his home. The hematoma was found to have ethanol at a concentration of 0.05% (w/v), and benzoylecgonine (a cocaine metabolite) was also confirmed at a concentration of 0.43 mg/L by specific analysis using gas chromatography/mass spectrometry (GC/MS). These results enabled the pathologist to record the cause of death as intracerebral hemorrhage due to acute cocaine intoxication.     

Motor accidents and blood samples in New South Wales

In the 12 months to June 2007, more than 26,000 people were injured in motor accidents on New South Wales roads. More than 400 people were killed. Alcohol was an important factor in a significant number of these accidents. The Road Transport (Safety and Traffic Management) Act 1999 (NSW) contains provisions for the mandatory taking of blood samples from drivers who have caused death while driving and who are suspected of having driven under the influence of drugs or alcohol. This article considers the law regarding the requirement of hospital staff to collect blood samples from drivers involved in motor vehicle accidents in New South Wales.     

Survival time and acting capability after fatal injury by sharp weapons

Autopsy reports from 109 victims of fatal injury from sharp weapons were investigated with regard to type and number of lesions, blood loss, degree of alcohol intoxication, survival time and acting capability after the injury. Of the 13 who died immediately, nine had penetrating lesions of the heart. This group also had the highest number of lesions. Sixty-four victims survived for some time. The survival time increased with decreasing number of lesions. The greatest blood loss and the highest blood alcohol concentrations were found in those who survived between 0.5 h and 1 h. Twenty-four victims were able to make physical efforts after the injury and the movements varied from a few steps to the running of several hundred meters. Decisive factors for decrease in survival time and acting capability are penetrating lesions to the heart and the great vessels, and multiplicity of injuries.     

Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Final rule

This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.     

临床输血感染病毒相关法律问题研究

因临床输血感染病毒而引发的病患纠纷越来越多,明析此类纠纷证明责任的承担、归责原则的确认是要求作为纠纷当事人的医院方、血液供应方和患者承担法律责任的前提和基础,而对献血者来说,应根据其在献血时的主观认识来确定其相应的法律地位和法律责任。     

Biological products: reporting of biological product deviations in manufacturing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the regulation requiring licensed manufacturers of biological products to report errors and accidents in manufacturing that may affect the safety, purity, or potency of a product. FDA also is amending the current good manufacturing practice (CGMP) regulations for blood and blood components to require establishments involved in the manufacture of blood and blood components, including licensed manufacturers, unlicensed registered establishments and transfusion services, to report biological product deviations in manufacturing. The final rule requires licensed manufacturers, unlicensed registered blood establishments, and transfusion services who had control over the product when a deviation occurred to report to FDA the biological product deviation if the product has been distributed. The final rule also establishes a 45-day reporting period. FDA is issuing the final rule as part of a retrospective review under Executive Order 12866 of significant FDA regulations to improve the effectiveness of FDA's regulatory program.     

An unusual case of post-mortem redistribution of ethanol

We report an unusual case of post-mortem redistribution of ethanol in a woman diver who died by drowning in seawater. The ethanol concentrations were right heart blood 0.60 g/l, left heart blood 2.08 g/l, femoral venous blood 0.63 g/l, gastric contents 5.87 g/l, bile 0.83 g/l. The mechanisms of post-mortem redistribution of ethanol described in the literature, that is, early redistribution from the stomach or the lung parenchyma in the case of inhalation of gastric contents, are inadequate to account for the degree of variation observed between the measurements. We believe that this difference in concentration is explained by the presence of seawater in the pulmonary alveoli at the time of death.     

The state of brain ventricles and their ependima in different scenarios of traumatic blood loss

The objective of the present study was to evaluate the state of ependima and the subependimal layer of the brain ventricles after death from the traumatic blood loss and in the cases of the blood loss under conditions of acute alcoholic and narcotic intoxication. The methods used for this purpose included light and scanning electron microscopy. It was shown that in subjects who died from the traumatic blood loss during acute alcoholic and narcotic intoxication ependima showed the signs of progressive polymorphism and had extensive areas of discontinued cell layers. Neuropil contained numerous vacuoles and blood effusion sites. The surface of ependima exhibited pathological erythrocytes, agglomerations of detritus, and crystalloid structures. The blood loss during combined alcoholic and narcotic intoxication resulted in more pronounced alterations in the ventricular walls.