The relationship between bedding and face-down death in infancy: mathematical analysis of a respiratory simulation system using an infant mannequin to assess gas diffusibility in bedding

Rebreathing is a model for the relationship between a prone sleeping position and sudden infant death syndrome. This study used a mechanical simulation model to establish the relationship between types of bedding and rebreathing potential for an infant placed prone (face down) at different postnatal ages. The infant mannequin was connected to a respirator set to deliver physiologically appropriate combinations of tidal volume (V(T)) and respiratory rates (RR) across a range of postnatal ages (0-18 months). Before measurements were made, CO(2) flow was regulated to 5+/-0.1% of end-tidal PCO(2) (EtCO(2)). After the model was placed in a prone position, any increase in the fractional concentration of inspired CO(2) (FiCO(2)) was measured. FiCO(2) increased immediately and rapidly, and reached a maximum value within a few minutes. The maximum FiCO(2) ranged from under 2% to over 10%, depending on the bedding. FiCO(2) was also affected by V(T) and RR. This model is not applicable to actual infants because of the large tissue stores of CO(2) in infants; however, it is useful for evaluation of gas diffusibility of bedding and will simplify the investigation of sleeping environments when a baby is found dead with its face covered by soft bedding. In general, the higher the FiCO(2), the greater the rebreathing potential. Theoretically, considering the paucity of body stores of O(2), changes in FiO(2) would be affected not by changes in FiCO(2), but by CO(2) production and gas movement around the infant's face. The rapid decrease of FiO(2) is approximated at the inverse of the FiCO(2) timecourse, suggesting the significance of not only CO(2) accumulation but also O(2) deprivation in the potential space around the baby's face.     

Medical Devices; hematology and pathology devices; reclassification of automated blood cell separator device operating by filtration principle from class III to class II. Final rule

The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on adverse reactions to be filed by the manufacturer for a minimum of 3 years. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is reclassifying the automated blood cell separator devices operating by filtration principle into class II (special controls) because special controls, in addition to general controls, are capable of providing a reasonable assurance of safety and effectiveness of the device.     

The consequences of error: Recidivism prediction and civil-libertarian ratios

The utility of recidivistic prediction is limited by the false positive problem: predictions of failure (recidivism) that do not occur. False negatives (predicted successes but observed failures) are also worrisome, and together both types of error can be formally evaluated by what Blumstein, Farrington, and Moitra call the civil-libertarian ratio: the ratio of the subjective cost of a false positive to a false negative. Choice of a recidivistic criterion and selection of a proportion of offenders for criminal justice intervention have implications for the evaluation of the disutility or subjective cost associated with various civil-libertarian ratios. Logistic regression models of four recidivistic criteria are evaluated to demonstrate how base rate (observed failure rate) and selection ratio (proportion selected to fail) affect the disutility associated with a range of civil-libertarian ratios. Use of civil-libertarian ratios by criminal justice policy makers is demonstrated. Predictive utility is relatively difficult to achieve for rare recidivistic events if the decisions involve severe deprivation of liberty (incarceration decisions). Predictive utility is easier to achieve for more common forms of recidivism or in decision contexts where there is less concern for false positives, such as for “intermediate sanctions.”     

Medical devices; reclassification and codification of suction lipoplasty system for aesthetic body contouring--FDA. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to the American Society for Aesthetic Plastic Surgery (ASAPS) reclassifying the suction lipoplasty system for use in aesthetic body contouring from class III (premarket approval) to class II (special controls). The reclassification is based on information regarding the device contained in a reclassification petition submitted by ASAPS and other publicly available information. Accordingly, the order is being codified in the Code of Federal Regulations. This action is taken under the Medical Device Amendments of 1976 (the 1976 amendments) as amended by the Safe Medical Devices Act of 190 (the SMDA).     

The effectiveness of service work: An analysis of recidivism

The Israeli “service work” law of 1987 enables a court to commute prison sentences of up to 6 months to service work in the community. This paper examines the correctional effectiveness of this new sanction by comparing the rate of recidivism (over a period of 14 months) among 407 offenders sentenced to service work to that of 950 comparable offenders sentenced to imprisonment. As the research design is quasi-experimental, an adjustment for confounders is carried out using the propensity score (PS) methodology. The estimation of the odds ratio of recidivism with respect to sanction comprises two steps: (a) the PS, which is the conditional probability of assignment to a particular sanction given a set of confounders, is estimated by a logistic model; and (b) the conditional probability of recidivism, given the PS and other covariates, is estimated by a second model. The findings indicate that before an adjustment for the systematic differences between the two sanctions was carried out, the odds for recidivism among prisoners were 2.4 times higher than the odds for service workers. After the adjustment, the odds ratio was reduced to 1.7. This estimate indicates that the service work sanction has a considerable correctional effect. The need to address additional criteria for the effectiveness of service work (e.g., net-widening) is emphasized.     

Measurement of the activity of radiopharmaceutical dosages: Nuclear Regulatory Commission. Proposed rule

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations on human uses of byproduct material, to require specific medical licensees to (1) Measure the total activity of each radiopharmaceutical dosage, except those containing less than 10 microcuries or a pure beta-emitting radionuclide, before it is administered to a patient; (2) verify that smaller dosages contain less than 10 microcuries; and (3) keep a record of the measurements. The assary of each radiopharmaceutical dosage before it is administered to a patient is currently required as a condition for a specific license. Measurement of the total activity of radiopharmaceutical dosage helps to protect patients from unnecessary radiation resulting from errors in labeling, calculating or dispensing dosages. The purpose of this rulemaking is: (1) To simplify licensing by replacing a condition that appears in all medical licenses with one regulation, and (2) To enhance patient radiation safety by minimizing potential misadministrations caused by not measuring the patient dosage.     

Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.     

The skin as a repository and masker of evidence

The role of the skin as a repository and masker of evidence is evaluated. Skin examination and testing are very important in the (a) identification of victims and suspects (for example, by fingerprints, lip prints, and fingernail marks), (b) recognition of patterns and shape of injurious energy impacts (for instance, recognition of type of injury and particular weapon), and (c) recovery of embedded evidence (for example, glass, wood, powder, explosives, and paint). It is also important to realize that the skin may conceal evidence by masking significant and/or lethal internal injuries.     

New developments in SPME Part 2: Analysis of ammonium nitrate-based explosives

Solid-phase microextraction (SPME) followed by gas chromatography-mass spectrometry (GC-MS) is a simple, reliable technique for the recovery and analysis of many organic explosives. However, this technique is impractical for the analysis of ammonium nitrate-type explosives due to the extreme polarity, low molecular weight, and high volatility of the amine moiety. This article describes an initial investigation of a derivatization process utilizing alkylchloroformates that converts ammonium nitrate and methylammonium nitrate into a form suitable for recovery by SPME and analysis by GC-MS.     

A comparison of adjustment methods to test the robustness of an STR DNA database comprised of 24 European populations

An aim of the European Network of Forensic Science Institutes (ENFSI) is to produce a DNA database of second generation multiplex (SGM) STR profiles that is representative of the resident cosmopolitan populations. To achieve this, data were collected from 24 different populations. All of the data were combined to form one database of 5700 profiles from which allele proportions were calculated. The robustness of this combined European database was tested by estimating parameter d for every DNA profile, where d=log(10)(Pm(c)/Pm(E)) Pm(c) is the match probability of the profile calculated from its cognate database and Pm(E) is the match probability of the combined European database. Overall there was a small tendency for Pm(c)>Pm(E) primarily because of sampling bias. This bias was removed by the simple expediency of applying an adjustment factor to the calculation of Pm(E). These were selected from the Balding size bias correction, the Balding and Nichols Fst correction, a minimum allele proportion (between 0.01 and 0.02), an upper bound of a 95% confidence interval (CI) and a lower bound on the genotype match probability. It was demonstrated that a single European database is a feasible proposition. A combination of different adjustment methods can be used to ensure that the result is conservative relative to the cognate database, and their effect measured by parameter d.     

Changes to Medicare Secondary Payer (MSP) provisions--HCFA. Notice

This notice describes how subsections 6202(b), (c), and (e) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) affect the Medicare Program These subsections: Create uniform rules for computing Medicare secondary payments for all MSP situations; Exempt from the MSP provisions services performed for a religious order by members of the order who take a vow of poverty; Prohibit group health plans (GHPs) from "taking into account" that an individual is entitled to Medicare when Medicare is the secondary payer; Prohibit GHPs from differentiating, in the services they provide, between individuals with end-stage renal disease (ESRD) and other individuals covered by the plan; Require that GHPs of employers of 20 or more employees provide the same benefits under the same conditions to employees age 65 or older and employees' spouses age 65 or older as they provide to employees and spouses under age 65; Impose a 25 percent excise tax on contributions that employers and employee organizations make to nonconforming GHPs, i.e., plans that do not comply with the MSP provisions; Extend to all MSP situations the Federal Government's right to take legal action to collect double damages if a primary plan fails to comply with the Medicare secondary payment requirements of the law; Make the provisions for special enrollment periods for the disabled parallel to those in effect for the working aged. The statutory changes made by subsections 6202(b), (c), and (e) can be put into effect without first issuing regulations because it is clear on the face of the statute what the Congress intended.(ABSTRACT TRUNCATED AT 250 WORDS)     

Screening postmortem blood and tissues for nine classes [correction of cases] of drugs of abuse using automated microplate immunoassay

A commercially available enzyme-linked immunosorbant assay (ELISA) was evaluated as a screening procedure for the detection of nine classes of abused drugs in postmortem blood and tissue specimens. Specifically, postmortem blood, fluid and/or tissue homogenates were screened for amphetamine (AMP), methamphetamine (MET), barbiturates (BARB), benzodiazepines (BZD), cannabinoids (CNB), cocaine (benzoylecgonine; BE), morphine-specific (MOR), opiates (class; OPI), phencyclidine (PCP) and lysergic acid diethylamide (LSD) by ELISA and by coated tube radioimmunoassay (CTR) (BARB, BE, OPI, PCP, LSD) or double-antibody radioimmunoassay (DAR) (AMP/METH, BZD, CNB). Specimens that screened 'positive' by any method were confirmed and quantitated by gas chromatography/mass spectrometry (GC/MS). The only assay that appeared to perform less optimally than RIA was the MOR assay (five false negatives). However, this assay is very specific for free morphine while the GC/MS confirmation method provided a total morphine value. The OPI assay was more sensitive, producing fewer false negatives, and is recommended for broad class opiate screening. EIA is an adequate alternative to RIA for screening postmortem specimens, including blood and tissue, for nine major classes of drugs.     

Informed consent elements. Final rule

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.     

A test to identify cyanide origin by isotope ratio mass spectrometry for forensic investigation

Cyanide is one of the common poisons in murders. When cyanide has been used, to identify the origin of cyanide may be necessary in the forensic investigation. We have examined the possibility of distinguishing different commercial cyanide samples through the δ(13)C and δ(15)N values and developed a protocol for the isotope analysis of cyanide extracted from several matrices as food and medicine. Several cyanide precipitates were tested for the isotope analysis. The results show that cupric ferrocyanide Cu(2)[Fe(CN)(6)] is the most appropriate precipitate for the analysis. Thirteen batches of KCN and nine batches of NaCN chemicals were randomly chosen from different suppliers. The cyanides were converted to cupric ferrocyanide and then analysed by isotope ratio mass spectrometry coupled to elemental analysis (EA-IRMS). The isotopic signature of the commercial samples varied from -51.96 to -25.77 ‰ for δ(13)C and from -4.51 to +3.81 ‰ for δ(15)N, highlighting the potential of applying EA-IRMS technique to identify cyanide from different batches and sources. The influence of the cyanide extraction and isolation from spiked matrix on the isotopic analysis was also studied. Three matrices: orange juice, yogurt drink and a medicine were tested. In many cases, the isotopic analysis results obtained from the original cyanides precipitates and those isolated from the matrices showed a good accordance, especially for δ(15)N. In some matrices, the (13)C analysis was interfered by co-precipitates. With carefully elaborated working protocol, determining the isotope ratio of N and C in cyanide by EA-IRMS is a promising method for forensic investigations.     

The Significance of Behaviour-Related Criteria for Textual Exegesis—and Their Neglect in Indian Studies

Against the background of the fact that speakers not seldom intend to convey imports which deviate from the linguistically expressed meanings of linguistic items, the present article addresses some consequences of this phenomenon which appear to still be neglected in textual studies. It is suggested that understanding behaviour is in some respect a primary objective of exegesis and that due attention must be attributed to the high diversity of behaviour-related criteria by which interpretations of linguistic items are to be evaluated. Although we intimate in addition that individual (meaningful) sentences occurring either in oral conversations or in written documents generally exhibit a multiplicity of contents of diverse types and that the circumstance that sometimes only a content equalling the linguistic significance of a pertinent unit matters for purposes of interpretation is caused by a material coincidence of different varieties of content, the tenets advocated in the paper do not essentially depend on that view. On the other hand, the following assumptions are relevant in the present connection: (a) A number of deviances between imports conveyed by linguistic utterances and literal meanings of expressions occur due to maxims of linguistic behaviour that are quite independent of lexical and syntactic features of individual natural languages. (b) It is by no means an exceptional phenomenon that imports not derivable by grammatical rules of a particular language alone possess primary importance for interpretation and textual exegesis. In view of significant affinities between understanding of sentences and of texts it is argued that the consideration of diverse aspects of behaviour possesses relevance for textual exegesis at least in the following respects: (1) By delivering a heuristic device for discerning problems affecting adopted interpretations it encourages searches for alternatives. (2) It provides means for evaluating the degree of acceptability of particular textual exegeses and possibly rejecting them on a more rational basis than mere intuition. (3) It offers possibilities for critically assessing the validity of explicit arguments advanced in favour of or in opposition to some interpretation. (4) It furnishes a background for assessing certain disputes about translation. The dimension of linguistic behaviour also attains importance in connection with questions of exegesis which are not concerned with assessments of (propositional) contents intended to be communicated, such as the ascertainment of the function which some argument possesses in a context. For substantiating the thesis that omission of raising relevant questions concerning behaviour is not an isolated phenomenon two examples will be employed: (1) A discussion concerning the exegesis of a crucial passage of Dignāga’s Pramā?asamuccaya and the Pramā?asamuccayav?tti, (2) a critical appraisal of a recent publication dealing with the interpretation of the second chapter of Nāgārjuna’s Mūlamadhyamakakārikā-s.     

Toll-free number for reporting adverse events on labeling for human drug products. Interim final rule

The Food and Drug Administration (FDA) is issuing an interim final rule to codify the provisions of the proposed rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" (69 FR 21778, April 22, 2004) (the toll-free number proposed rule or proposed rule) that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act (the act). The added statement includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints.     

Establishment of a public docket for medical device/radiological health policy statements and operating procedure guides--FDA. Notice

The Food and Drug Administration (FDA) is announcing that it is establishing a public docket for policy speeches, policy statements, and standard operating procedure guides pertaining to product evaluation and regulatory enforcement for its medical device and radiological health programs. The docket will operate on a 1-year trial basis and will serve both as a repository for critical policy documents generated by the Center for Devices and Radiological Health (CDRH) and as a public display mechanism for access by representatives of the industry and other interested persons. This action is one element of an overall communications initiative to ensure uniform and timely access to important information.     

GC双检测器技术筛选常见毒(药)物的可行性研究

利用气相色谱仪 ,在样品进样经单柱分离后通过Y形管连接至两个不同选择性检测器 (NPD/FID)的方法 ,考察气相色谱操作条件对双检测器响应比值的影响及其该法用于复杂样品测定的可行性。结果表明当实验条件保持不变时 ,NPD/FID响应比值具有较好的重现性。改变检测器操作参数和色谱条件对NPD/FID响应比值都有影响 ,但相对于某一参比物计算得到的相对NPD/FID响应比值受影响很小。样品中待测组份的浓度改变不影响NPD/FID响应比值。在有标准品比对的情况下 ,NPD/FID响应比值或相对NPD/FID响应比值可以作为定性分析的一个参数。     

The extraction and infrared identification of gamma-hydroxybutyric acid (GHB) from aqueous solutions

The chemical analysis of gamma-hydroxybutyric acid (GHB) in most forensic laboratories is complicated by the highly polar nature of the GHB molecule, which makes it unsuitable for direct analysis by gas chromatography (GC). Consequently, a popular analytical approach is to convert GHB into the corresponding lactone or a derivative compound that is then identified by mass spectrometry employed in conjunction with GC (GC/MS). An alternative approach is presented here where GHB may be isolated as a free acid specie from complex aqueous solutions employing a liquid-liquid extraction technique. This approach can yield a relatively pure residue of GHB that presents an infrared transmission spectrum that is sufficiently distinct for identification purposes. Infrared spectroscopy (IR) is a very popular technique that is available to most crime laboratories. The liquid-liquid extraction behavior of GHB is examined in detail and the uniqueness of the infrared spectrum is discussed.