Regulation on introducing process of the highly difficult new medical technologies: A survey on the current status of practice guidelines in Japan and overseas.

Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".

Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial.

BACKGROUND: The national pneumonia treatment guidelines in Kenya changed in February 2016 but such guideline changes are often characterized by prolonged delays in affecting practice. We designed an enhanced feedback intervention, delivered within an ongoing clinical network that provides a general form of feedback, aimed at improving and sustaining uptake of the revised pneumonia treatment policy. The objective was to determine whether an enhanced feedback intervention will improve correctness of classification and treatment of childhood pneumonia, compared to an existing approach to feedback, after nationwide treatment policy change and within an existing hospital network. METHODS/DESIGN: A pragmatic, cluster randomized trial conducted within a clinical network of 12 Kenyan county referral hospitals providing inpatient pediatric care to children (aged 2-59 months) with acute medical conditions between March and November 2016. The intervention comprised enhanced feedback (monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators) and this was compared to standard feedback (2-monthly written feedback on multiple quality of pediatric care indicators) both delivered within a clinical network promoting clinical leadership linked to mentorship and peer-to-peer support, and improved use of health information on service delivery. The 12 hospitals were randomized to receive either enhanced feedback (n = 6) or standard feedback (n = 6) delivered over a 9-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all admitted patients with pneumonia (fulfilling criteria for treatment with orally administered amoxicillin) who are correctly classified and treated in the first 24 h. The secondary outcome will be measured over the course of the admission as any change in treatment for pneumonia after the first 24 h. DISCUSSION: This trial protocol employs a pragmatic trial design during a period of nationwide change in treatment guidelines to address two high-priority areas within implementation research: promoting adoption of health policies and optimizing effectiveness of feedback. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02817971 . Registered retrospectively on 27 June 2016.

Mandatory public reporting of healthcare-associated infections in developed countries: how can developing countries follow?

The threat posed by increased transmission of drug-resistant pathogens within healthcare settings and from healthcare settings to the community is very real and alarming. Although the developed world has taken strong steps to curb this menace, there has been little pressure on developing countries to take any corrective action. If the reporting of alarming rates of healthcare-associated infections (HCAIs) from hospitals in India and many other developing countries was made mandatory, it would help to force stakeholders (e.g. healthcare workers, legislators, administrators and policy makers in hospitals) to acknowledge and tackle the problem. This would introduce quality control in a long neglected area of health care, and enable patient empowerment which is practically non-existent in India. Healthcare institutions should commit towards enforcing 'zero tolerance' towards lapses in prevention of HCAIs. Public pressure would force the Indian Government to acknowledge the problem, and to allocate more funds to improve resources and infrastructure; this could substantially elevate the standard of health care given to the average Indian. Despite the numerous challenges, overall public benchmarking of HCAIs is a commendable goal that would go a long way towards tackling this menace in developing countries such as India.

Public reporting of hospital-acquired infections is not associated with improved processes or outcomes.

Most US states have enacted or are considering legislation mandating hospitals to publicly report hospital-acquired infection (HAI) rates. We conducted a survey of infection control professionals and found that state-legislated public reporting of HAIs is not associated with perceived improvements in infection prevention program process measures or HAI rates.

Hospitals ineligible for federal meaningful-use incentives have dismally low rates of adoption of electronic health records.

The US government has dedicated substantial resources to help certain providers, such as short-term acute care hospitals and physicians, adopt and meaningfully use electronic health record (EHR) systems. We used national data to determine adoption rates of EHR systems among all types of inpatient providers that were ineligible for these same federal meaningful-use incentives: long-term acute care hospitals, rehabilitation hospitals, and psychiatric hospitals. Adoption rates for these institutions were dismally low: less than half of the rate among short-term acute care hospitals. Specifically, 12 percent of short-term acute care hospitals have at least a basic EHR system, compared with 6 percent of long-term acute care hospitals, 4 percent of rehabilitation hospitals, and 2 percent of psychiatric hospitals. To advance the creation of a nationwide health information technology infrastructure, federal and state policy makers should consider additional measures, such as adopting health information technology standards and EHR system certification criteria appropriate for these ineligible hospitals; including such hospitals in state health information exchange programs; and establishing low-interest loan programs for the acquisition and use of certified EHR systems by ineligible providers.

[Reevaluation criteria for health care capacity allocation according to current legislation in Hungary]. / Az egészségügyi kapacitásfelosztás módosításának szempontjai a hatályos törvény alapján.

Act CXXXII of the year 2006 - amended several times - on the development of the health care system requires that health insurance authorities should regularly review utilization of the contracted capacity of professional medical care providers, and the need for change of capacities. The first such analysis should be carried out in 2013, according to the current laws in Hungary. The law lists 16 items, which are the basis for evaluation of the performance of providers. Among them some items are difficult to analyse specifically even for health insurance specialists. This study aims to review aspects of the reevaluation process and their associated concepts. Author wants to provide help for setting up the analysis in practice by going through and analysing the requirements of the law in detail.

Legal responsibility and accountability.

Shifting boundaries in healthcare roles have led to anxiety among some nurses about their legal responsibilities and accountabilities. This is partly because of a lack of education about legal principles that underpin healthcare delivery. This article explains the law in terms of standards of care, duty of care, vicarious liability and indemnity insurance.

[Competition between hospitals--from a legal perspective]. / Wettbewerb zwischen Krankenhäusern--aus uristischer Sicht.

Competition between hospitals exists in many different fields. In legal terms this competition is shaped by disputes over the status of "hospitals forming part of the Hospital Plan" (Plankrankenhaus). The German Federal Constitutional Court's ruling of January 14, 2004 granted hospital authorities the right of action for unfair competition. According to the Federal Administrative Court's ruling of September 25, 2008, however, third-party protection is limited to cases where the hospital filing the suit has itself unsuccessfully applied for inclusion in the state-level hospitals plan for the market segment served by the accepted hospital. In contrast, action that merely challenges an unfair preference of a competitor will remain inadmissible. Third-party protection between hospitals is also under way in the field of "Integrated Healthcare" (Integrierte Versorgung) (Sect. 140a et seqq. Book V of the German Social Security Code-SGB V): in the case of ECJ C-300/07 on December 16, 2008 (Oymanns/AOK Rheinland & Hamburg) the Advocate General in his final submissions not only expressed the opinion that the statutory health insurance funds are contract-placing authorities, but also argued that integration contracts are public orders. If the European Court of Justice (ECJ) takes the Advocate General's view, future integration contracts will become subject to the regulations governing public orders and thus also subject to the relevant verification procedure.

Nueva gestión de los gases medicinales como medicamento. Una visión desde la experiencia / New management of medical gases as a medicine: a view from experience

El génesis de esta reflexión o artículo se manifiesta ante la necesidad generada por la nueva legislación sanitaria, que asimila los gases medicinales como medicamentos, y como los diversos colectivos involucrados en esta nueva situación hemos ido afrontando su aplicación. Dentro de este colectivo pluridisciplinar están farmacéuticos hospitalarios, empresas gasistas, gestores de hospitales e ingenieros de mantenimiento (AU)

The origin of this reflection or article is found in the requirements generate by the new health legislation which considers medicinal gases as medicines, and how the different groups involved in this new situation have been applying it. This multidisciplinary group includes hospital pharmacists, gas companies, hospital administrator and maintenance engineers (AU)

Prevención y tratamiento del tabaquismo en el medio hospitalario / Prevention and treatment of the smoking habit in the hospital setting

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[Comments on the EszCsM (Ministry of Health, Welfare and Family) decree No. 60/2004. (VII. 6.) about the rules of admission of psychiatric patients to mental health facilities and the restraints applicable in their care]. / A pszichiátriai betegek intézeti felvételének es az ellátásuk során alkalmazható korlátozó intézkedéseknek a szabályairól szóló 60/2004. (VII. 6.) ESzCsM rendelet margójára.

The authors compare the human right and medical aspects of the restraints which can be used in care of psychiatric patients. They outline the legislation in force and legislative objectives which were taken into consideration when codifying the ESzCsM (Ministry of Health, Welfare and Family) decree No. 60/2004. (VII. 6.) about the rules of admission of psychiatric patients to mental health facilities and the restraints applicable in care of them. The legal problems of the admission and its connection with the restraints and with the judicial review are summed up. Aspects for interpretation are given for the regulations of the decree which supposedly can prove to be most problematic in practice. Suggestions are made for the standpoints of legislative objectives which may seem necessary in the future.

Attitudes to restraint for the prevention of falls in hospital.

INTRODUCTION: Fall prevention measures in hospital are often considered to be restraint and unsuitable for clinical practice. The aim of the study was to explore attitudes to restraint and what are acceptable fall prevention measures in hospital. METHODS: A structured questionnaire was completed by 200 subjects (100 patients/relatives and 100 care professionals) in a British hospital. RESULTS: Ninety-nine percent agreed that fall prevention was important. There was 84.5% agreement that restraint is justified to prevent harm and 81.5% disagreement that restraint should never be used if the patient is at risk of falling. Disagreement was stronger among patients/relatives (91 vs. 72%; p = 0.001). Seventy seven percent disagreed that restraint is not acceptable even if discussed with patients and relatives. Significant differences in agreement were identified between patients/relatives and care professionals for the following statements: 'restraint should always be an option in patients if the patient is at risk of falling' (82 vs. 45%; p < 0.0001), 'restraining methods are acceptable at the discretion of care professionals' (91 vs. 43%; p < 0.0001), 'restraint is an infringement of personal freedom' (35 vs. 66%; p < 0.0001) and 'restraint is necessary if it frees staff to do more clinical work' (51 vs. 10%; p < 0.0001). A wide range of acceptability was identified for various measures of restraint: observation beds (95%), bed/chair alarms (80%), bed rails (77%), identification bracelets (95%) and risk labels at the head of the bed (75.5%). Direct binding (5.5%) or tranquilliser use (9%) was considered highly unacceptable. CONCLUSIONS: When there is a lack of evidence of effectiveness, fall prevention guidelines are formulated on the basis of expert opinion influenced by ethical considerations, cultural attitudes and society's values. Such information is important to formulate informed fall prevention policies.