Medical Regulatory Bodies Research Articles

Attainment of competency in management and leadership

PurposeThe purpose of this paper is to provide a summary of a research and consultation project being undertaken by the NHS Institute for Innovation and Improvement and The Academy of Medical Royal Colleges to develop an integrated medical management and leadership competency framework. This will apply to all doctors in training at undergraduate and postgraduate levels and post‐registration.Design/methodology/approachA literature review and consultation approach has been adopted. By interviewing appropriate stakeholders from medical professional, educational, service and regulatory bodies, a high level of awareness and engagement has been realised. This should pay dividends at the implementation phase.FindingsWhilst some management and leadership is included within current curricula, it is highly variable both in terms of its coverage and relevance. At undergraduate level, it is often covered within professional development modules. At postgraduate level, some exciting initiatives are offered for some doctors but no integrated, systematic and coherent framework exists. Findings from the research are influencing the design and content of the emerging competency framework.Research limitations/implicationsThe approach used has provided a good range of information however, neither an exhaustive set of views or a full literature review has been obtained.Practical implicationsIntroduction of the Medical Leadership Competency Framework will have a significant impact on how doctors are trained. To be deemed an effective and safe doctor in the future, competence in both clinical and wider non‐clinical competences including management and leadership will be required.Originality/valueThis paper will raise awareness of this important initiative and offer a methodology for other clinical professional groups, nationally and internationally.

Should Caregivers Be Compelled to Disclose Patients' HIV Infection to the Patients' Sex Partners Without Consent?

The emergence of the HIV/AIDS pandemic has added to the tension between patients' private interests and public health interests regarding medical confidentiality. Many people become infected with HIV because they are unaware of the positive serostatus of their sexual partners. Informing or warning the sexual partners of HIV-positive patients of the patients'serostatus could assist in curtailing the spread of HIV/AIDS because sexual partners can thereby choose to avoid having unprotected sex with infected persons. By law, however, doctors have a duty to their patients to protect their medical confidentiality. Doctors, therefore, face a dilemma concerning which should prevail: patients' right to privacy and confidentiality or the importance to society of controlling the spread of the pandemic. Most medical regulatory bodies do not take clear-cut positions on the issue, leaving the decision to the discretion of individual doctors. The question of whether doctors should be legally empowered to breach the confidence of patients to protect the patients' sexual partners is discussed here with reference to the existing laws of Canada, the United States, and Nigeria.

Issues of patient consent: a study of paediatric high-dependency care

This article reports on the issues relating to obtaining informed, signed consent for a study of paediatric high-dependency care and provides practical guidance on confidentiality for health service researchers. Consent and confidentiality are not new concepts but recent changes to the legislation and guidance offered from nursing and medical regulatory bodies have caused concerns and confusion for researchers with respect to both issues. Balancing health service research and the development of services against the requirements of patients for confidentiality is essential yet challenging. This was a time consuming, costly exercise. Resource implications may ultimately mean that studies which are of benefit to patients in relation to the delivery of their care may not be undertaken. Health professionals need to be continually updated and made aware of the legislation and confidentiality requirements for health service research involving the collection of patient-identifiable details.

Medical device regulation for manufacturers.

Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.