Medical devices; procedures for investigational device exemptions--Food and Drug Administration. Final rule

This rule sets forth the procedures and conditions under which investigations of medical devices involving human subjects may be exempt from certain requirements of the Federal Food, Drug, and Cosmetic Act, in accordance with the Medical Device Amendments of 1976. The rule sets out the procedures to obtain an investigational device exemption (IDE); it delineates the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of medical devices; and the rule also prescribes informed consent requirements and specifies recordkeeping and reporting requirements.     

Embracing the new professionalism: self-regulation, mandatory reporting and their discontents

In response to perceived failures in medical self-regulation in Australia, first in two States (for doctors) and now under the National Registration and Accreditation Scheme (for all health practitioners), mandatory reporting of peer status or practice that poses risks to patients has been introduced. Yet now, in response to the lobbying of State and federal health ministers by the medical profession, mainly in relation to the impairment provisions, this is to be reviewed. This column argues that claims concerning the negative consequences for practitioners of mandatory reporting are illogical and lack supporting evidence. There is, however, evidence that the medical profession does not consistently act in accordance with its professed positions in the area of physician impairment and departure from accepted clinical standards. The call for a review of mandatory reporting reflects an outdated model of regulation that does not align with increasing calls for a "new professionalism". In its own interests, but primarily in the interests of patients, the medical profession should embrace new attitudes and practices that will at first appear to threaten the privilege of self-regulation, but on proper scrutiny will be seen as necessary to retain it.     

Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration--FDA. Tentative final rule

The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance.     

The Predisposition Report,Decision-Making,and Juvenile Court Policy

Abstract With the 1999 approach of the juvenile court's first centennial in this country, it behooves us to pick up the pace of policy reformulation for the entire juvenile justice system. Given the enormity of that task, it would be wise to encourage researchers to begin building a larger, empirical data base to enhance this reformulation. This study contributes to that task by focusing on a key major component, the decision-making process involving factors leading to institutional placement. Over seventy indicators drawn from the case histories of 162 male delinquents were examined. One half of these youths had been sent to a state training school; the other half consisted of a randomly matched sample of noninstitutionalized court referrals. A set of indicators which add insight into this crucial decision and which show promise for increasing court effectiveness is identified. Among other recommendations, the authors advocate reexamining an under-used resource – the mounds of closed juvenile cases, including the predisposition reports, subsequent developments, and outcomes.     

National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: amendments to data bank regulations to comply with court order and technical correction--HRSA. Final regulations

This final rule amends the existing regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank), codified at 45 CFR part 60, authorizing the reporting and release of information concerning: Payments made for the benefit of physicians, dentists, and other health care practitioners as a result of medical malpractice actions or claims; and certain adverse actions taken regarding the licenses and clinical privileges of physicians and dentists. This final rule revises sections 60.2 and 60.7 to require reporting only by entities which make medical malpractice payments, deleting the reference to reporting by persons (individuals). It also clarifies the reference to "professional society" in section 60.9.     

Delay of clinical manifestation and medical malpractice in a serious vascular complication of proximal locked tibial nailing

We are reporting on a case of complex lesion of the popliteal neurovascular bundle in a young woman, resulting from an operation for reduction and synthesis of a closed spiroid fracture of the mid-distal third of the left tibia by means of a Grosse-Kempf nail, with significant delay of clinical manifestation. Determining whether this is an "unavoidable complication" or "medical malpractice" is the target of the forensic investigation. In this case, the investigation leads to the conclusion that medical malpractice was the only explanation of the damage.     

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.     

Mandatory reporting by nurses of child abuse and neglect

Most Australian jurisdictions have mandatory reporting legislation to compel members of selected professional groups, including nurses, to report suspicions that a child has been or is likely to be subjected to abuse or neglect. This article details the legal obligations of nurses in each jurisdiction, and highlights differences between jurisdictions. Problematic features of the laws are identified, including the use of ambiguous concepts like "reasonable" suspicion and "significant" harm. Literature is reviewed to identify what is known about nurses' legal knowledge, actual reporting practice, and the practical problems that arise for nurses in this context. It is concluded that empirical research needs to be conducted, because it is not known if the laws are practically effective, whether nurses have sufficient training in, and knowledge of, their reporting duties, or what factors influence sound reporting. Such research can inform both the development of sound training systems and recommendations for legal reform.     

普遍服务理念下公共医疗卫生服务的法律调整

我国公共医疗卫生服务发展失范所引致该领域存在的诸多问题,在根源上归结于:在价值层面是"普遍服务"理念的缺失,在机制层面则是政府与市场双重失灵共同作用的结果。经济法因具备特有的赋权与限权的双重性质而成为调整公共医疗卫生服务这一领域的重要法律,可以通过对现有经济法资源的整合,适用、制定、修订或细化相关法律法规,构造保障公共医疗卫生服务领域实现"普遍服务"理念的法律规范体系,促进"普遍服务"理念的贯彻,推动新一轮医疗卫生体制改革顺利进行。     

Examining the Role of Static and Dynamic Risk Factors in the Prediction of Inpatient Violence: Variable- and Person-Focused Analyses

Although the construct of psychopathy is related to community violence and recidivism in various populations, empirical evidence suggests that its association with institutional aggression is weak at best. The current study examined, via both variable-level and group-level analyses, the relationship between standard violence risk instruments, which included a measure of psychopathy, and institutional violence. Additionally, the incremental validity of dynamic risk factors also was examined. The results suggest that PCL-R was only weakly related to institutional aggression and only then when the behavioral (Factor 2) aspects of the construct were examined. The clinical and risk management scales on the HCR-20, impulsivity, anger, and psychiatric symptoms all were useful in identifying patients at risk for exhibiting institutional aggression. These data suggest that factors other than psychopathy, including dynamic risk factors, may be most useful in identifying forensic patients at higher risk for exhibiting aggression.     

Hospital committee proceedings and reports: their legal status.

This Article examines the legal status of hospital committee proceedings and reports, focusing on how they may be used in a medicolegal context. Specific topics dealt with include the hospital medical staff in legal perspective, the concept of institutional responsibility, liability considerations arising from committee work, and the discovery and admissiblity of committee records in litigation cases. The author concludes that the danger of committee members facing liability for their activities is slight and that the fear that these reports and proceedings may be subject to discovery or be admissible into evidence in subsequent litigation is remote because candid and conscientious evaluations of clinical practices within every institution are essential and, therefore, public policy must encourage such evaluations by maintaining the confidentiality of committee activities.     

Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document.     

Medical Ethics at Guantanamo Bay and Abu Ghraib: The Problem of Dual Loyalty

Although knowledge of torture and physical and psychological abuse was widespread at both the Guantanamo Bay detention facility and Abu Ghraib prison in Iraq, and known to medical personnel, there was no official report before the January 2004 Army investigation of military health personnel reporting abuse, degradation or signs of torture. Military medical personnel are placed in a position of a "dual loyalty" conflict. They have to balance the medical needs of their patients, who happen to be detainees, with their military duty to their employer. The United States military medical system failed to protect detainee's human rights, violated the basic principles of medical ethics and ignored the basic tenets of medical professionalism.     

Use of "therapeutic complication" as a manner of death

Analyses of deaths due to therapeutic complications (TCs) provide important quality of care information for medical providers. In New York City, 463 deaths were investigated by the Office of Chief Medical Examiner and certified with TC as the manner of death in 2003. The TC manner of death is used for fatalities due to predictable complications of appropriate medical therapy. All death certificates and select autopsy, hospital, and investigation reports were reviewed. Data concerning cause of death, contributing conditions, age, race, and sex were extracted. The types of complications and the causes of death were classified into various types of surgical and nonsurgical categories of complications. These included: postoperative infections, pulmonary emboli, and technical and medication complications. The use of TC as a manner of death has benefits and limitations. Without the TC option, one is forced to certify certain deaths (e.g., penicillin anaphylaxis) either as natural or accident. The TC option allows easy identification and tracking of medical complications for public health purposes and also allows more consistent reporting of natural and medical-accidental deaths. In general, complications that occur during emergency surgeries/procedures for natural disease, tend to be certified with a natural manner. The "but for" test may be used to distinguish natural from TC deaths. There are criteria for distinguishing TC from accidents and homicides. TCs that occur during treatment of a potentially life-threatening injury, are superseded by the manner dictated by the circumstances of the initiating injury. The certification of TC usually does not address errors of omission, clinical judgement/management, or missed diagnoses.     

Medical Errors: Mandatory Reporting,Voluntary Reporting,or Both?

This work evaluates policy recommendations on medical error reporting systems presented in, To err is human, a report published by the Institute of Medicine. Here mandatory reporting should be applied for adverse events, while voluntary reporting is recommended for near misses. This analysis shows that an error reporting scheme of this type is not an optimal one since both near misses and adverse events may remain unreported. This work makes evident that penalising health care providers for not reporting errors, independent of error category, is crucial for reaching the first-best solution.JEL D82, I18, K42     

Whistleblower protection for nurses and other health care professionals

Because most employees in the United States, including health care professionals, are employed "at will" (which means their employment can be terminated for any reason or no reason, as long as the reason isn't illegal), retaliatory actions by employers toward employees who speak out (i.e., blow the whistle) are not uncommon. Additionally, the law protecting whistleblowing employees varies greatly depending on the state where the employee works or if he or she works for the federal government. This article examines when and under what conditions a nurse or other health care professional may be protected from having an adverse employment action taken against him or her for reporting such issues as patient safety violations or health care fraud. The authors offer issues a nurse or other health care professional should consider before making the decision to blow the whistle. Finally, the authors also discuss the remedies such as reinstatement, back pay, or other compensatory mechanisms that may be available to employees terminated for reporting wrongdoing.     

Analysis of Forensic Autopsy in 120 Cases of Medical Disputes Among Different Levels of Institutional Settings

Despite advances in medical science, the causes of death can sometimes only be determined by pathologists after a complete autopsy. Few studies have investigated the importance of forensic autopsy in medically disputed cases among different levels of institutional settings. Our study aimed to analyze forensic autopsy in 120 cases of medical disputes among five levels of institutional settings between 2001 and 2012 in Wenzhou, China. The results showed an overall concordance rate of 55%. Of the 39% of clinically missed diagnosis, cardiovascular pathology comprises 55.32%, while respiratory pathology accounts for the remaining 44. 68%. Factors that increase the likelihood of missed diagnoses were private clinics, community settings, and county hospitals. These results support that autopsy remains an important tool in establishing causes of death in medically disputed case, which may directly determine or exclude the fault of medical care and therefore in helping in resolving these cases.     

International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E2F Development Safety Update Report." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR can be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.