When Are "Paraphernalia" Critical Medical Supplies?

Evidence of harm reduction interventions' morbidity and mortality benefits is abundant and of high quality, so there are good reasons for regional and national groups to advocate for more widespread distribution of legally regulated "drug paraphernalia," including needles, syringes, and fentanyl test strips. But lack of consistency among states' laws means that patients' interstate travel can subject them to being charged with possession of illegal items. This commentary on a case offers guidance to clinicians looking to help patients understand legal risks of interstate travel with supplies that are prescribed or recommended to reduce harms of their drug use and explores the ethical responsibilities of physicians in jurisdictions that legally prohibit these harm reduction interventions.

Conflicts of interest in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: associations with recommendations.

BACKGROUND: Treatment and diagnostic recommendations are often made in clinical guidelines, reports from advisory committee meetings, opinion pieces such as editorials, and narrative reviews. Quite often, the authors or members of advisory committees have industry ties or particular specialty interests which may impact on which interventions are recommended. Similarly, clinical guidelines and narrative reviews may be funded by industry sources resulting in conflicts of interest. OBJECTIVES: To investigate to what degree financial and non-financial conflicts of interest are associated with favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. SEARCH METHODS: We searched PubMed, Embase, and the Cochrane Methodology Register for studies published up to February 2020. We also searched reference lists of included studies, Web of Science for studies citing the included studies, and grey literature sources. SELECTION CRITERIA: We included studies comparing the association between conflicts of interest and favourable recommendations of drugs or devices (e.g. recommending a particular drug) in clinical guidelines, advisory committee reports, opinion pieces, or narrative reviews. DATA COLLECTION AND ANALYSIS: Two review authors independently included studies, extracted data, and assessed risk of bias. When a meta-analysis was considered meaningful to synthesise our findings, we used random-effects models to estimate risk ratios (RRs) with 95% confidence intervals (CIs), with RR > 1 indicating that documents (e.g. clinical guidelines) with conflicts of interest more often had favourable recommendations. We analysed associations for financial and non-financial conflicts of interest separately, and analysed the four types of documents both separately (pre-planned analyses) and combined (post hoc analysis). MAIN RESULTS: We included 21 studies analysing 106 clinical guidelines, 1809 advisory committee reports, 340 opinion pieces, and 497 narrative reviews. We received unpublished data from 11 studies; eight full data sets and three summary data sets. Fifteen studies had a risk of confounding, as they compared documents that may differ in other aspects than conflicts of interest (e.g. documents on different drugs used for different populations). The associations between financial conflicts of interest and favourable recommendations were: clinical guidelines, RR: 1.26, 95% CI: 0.93 to 1.69 (four studies of 86 clinical guidelines); advisory committee reports, RR: 1.20, 95% CI: 0.99 to 1.45 (four studies of 629 advisory committee reports); opinion pieces, RR: 2.62, 95% CI: 0.91 to 7.55 (four studies of 284 opinion pieces); and narrative reviews, RR: 1.20, 95% CI: 0.97 to 1.49 (four studies of 457 narrative reviews). An analysis combining all four document types supported these findings (RR: 1.26, 95% CI: 1.09 to 1.44). One study investigating specialty interests found that the association between including radiologist guideline authors and recommending routine breast cancer screening was RR: 2.10, 95% CI: 0.92 to 4.77 (12 clinical guidelines). AUTHORS' CONCLUSIONS: We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. However, we also stress risk of confounding in the included studies and the statistical imprecision of individual analyses of each document type. It is not certain whether non-financial conflicts of interest impact on recommendations.

Medical, pharmacy and nursing students in the Baltic countries: interactions with the pharmaceutical and medical device industries.

BACKGROUND: Interactions between pharmaceutical and medical device industries and students can lead to commercial influences on educational messages, with a potential to bias future treatment choice. This is the first study in the Baltic countries describing exposure and attitudes of medical, pharmacy and nursing students towards cooperation with industry. METHODS: A cross-sectional on-line survey of current medical, pharmacy and nursing students (n = 918) in three Baltic countries was carried out. RESULTS: We found that most students participate in events organized or sponsored by industry and accept a range of gifts and benefits. Students in the Baltic countries consider cooperation with industry important; at the same time, most do not feel that they have sufficient training on how to ethically interact with pharmaceutical and medical device companies and believe that these interactions can influence their prescribing or dispensing patterns. There is a tendency to rationalize cooperation with industry by referring to the current economic situation and patient benefits. Pharmacy students have higher rates of participation and they accept gifts and other benefits more often than nursing or medical students; therefore, they are likely to be more vulnerable to potential industry influence. CONCLUSIONS: The findings highlight the need to include topics on ethics and conflicts of interests in cooperation with industry in curriculum of health care students in Baltic countries. Without proper training, students continue to be at risk to industry influence and may develop habits for their further practice differing from evidence-based practice in prescribing and dispensing of medicines, as well as use of medical devices.

Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA's Center for Devices and Radiological Health.

Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs. The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension. The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula). Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants' comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams. CDRH investigators believe that information about ICFs' readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.

Confronting the medical devices jungle.

The report by the International Consortium of Investigative Journalists (ICIJ) on the international medical device industry adds to the growing documentation of health scandals in India in recent years. A comprehensive picture emerges of manufacturers selling untested products at usurious rates; criminally negligent doctors and medical establishments; and a regulatory system focused on the industry's growth with little regard for patient safety.

Device representatives in hospitals: are commercial imperatives driving clinical decision-making?

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: (1) impacts on healthcare costs, (2) the outsourcing of expertise and (3) issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.

HEALTH TECHNOLOGY ASSESSMENT METHODS GUIDELINES FOR MEDICAL DEVICES: HOW CAN WE ADDRESS THE GAPS? THE INTERNATIONAL FEDERATION OF MEDICAL AND BIOLOGICAL ENGINEERING PERSPECTIVE.

OBJECTIVES: Current health technology assessment (HTA) methods guidelines for medical devices may benefit from contributions by biomedical and clinical engineers. Our study aims to: (i) review and identify gaps in the current HTA guidelines on medical devices, (ii) propose recommendations to optimize the impact of HTA for medical devices, and (iii) reach a consensus among biomedical engineers on these recommendations. METHODS: A gray literature search of HTA agency Web sites for assessment methods guidelines on devices was conducted. The International Federation of Medical and Biological Engineers (IFMBE) then convened a structured focus group, with experts from different fields, to identify potential gaps in the current HTA guidelines, and to develop recommendations to fill these perceived gaps. The thirty recommendations generated from the focus group were circulated in a Delphi survey to eighty-five biomedical and clinical engineers. RESULTS: Thirty-two panelists, from seventeen countries, participated in the Delphi survey. The responses showed a strong agreement on twenty-seven of thirty recommendations. Some uncertainties remain about the methods to accurately assess the effectiveness and safety, and interoperability of a medical device with other devices or within the clinical setting. CONCLUSIONS: As medical devices differ from drug therapies, current HTA methods may not accurately reflect the conclusions of their assessment. Recommendations informed by the focus group discussions and Delphi survey responses aimed to address the perceived gaps, and to provide a more integrated approach in medical device assessments in combining engineering with other perspectives, such as clinical, economic, patient, human factors, ethical, and environmental.

[Ethical and legal problems arising from off-label use of medical devices and some solution recommendations]. / Tibbi cihazlarin endikasyon disi (off-label) kullanimindan kaynaklanan etik ve yasal sorunlar ve çözüm önerileri.

The off-label use of medical devices is becoming increasingly widespread. Though the off-label use of drugs has been controlled with the establishment of legal and ethical rules, similar regulations have not been implemented for medical devices. Legal gaps in this field, and the broad initiative granted to physicians have led to the emergence of problems in practice, and physicians are vulnerable to potential criminal sanctions that may emerge as a consequence of these off-label applications. Since the off-label use of medical devices cannot rely on scientifically proven, evidence-based information, evaluation of the risks creates critically important ethical problems that may have serious deleterious effects, despite the good intent of a physician tying to be helpful. During the process of obtaining informed consent from the patient for the off-label use of a device, the physician has crucial responsibilities. The ethical responsibilities of physicians particularly increase in vulnerable patient groups that should be protected from harm. In addition to the physician, the family members who make decisions on behalf of the patient also assume some responsibilities. The development of ethical norms and guidelines enforced by legal regulations concerning this issue, an effective role for ethics committees in the decision-making process, and collaboration between patients, scientists, nongovernmental organizations, medical device companies, specialists in the field of medical ethics, and legal authorities will be important in solving this problem.

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.

Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745).

PURPOSE: The paper focuses on the ethical appraisal of the clinical investigations (CIs) and the informed consent within the new European Union (EU) legislation on medical devices (MDs). The Regulation (EU) 2017∕745 of the European Parliament and of the Council was adopted on 5 April 2017 and entered into force on 25 May 2017, repealing the Council Directives concerning Medical Devices 93∕42∕EEC and the Active Implantable Medical Devices 90∕385∕EEC. BACKGROUND: For the past thirty years, the EU legislation on MDs has been updated by several directives: Council Directive 90∕385∕EEC on Active Medical Devices (1990); Council Directive 93∕42∕EEC on Medical Devices (1993) and Council Directive 98∕79∕EC on In vitro Medical Devices (1998) aiming to frame the MDs market development. CONTENT: From the ethical perspective, the present article investigates the new rules concerning the CIs of the MDs for human use and accessories for such devices conducted in the EU by highlighting new regulatory aspects: (1) the framework of the clinical evaluation and CI; (2) the relevant definitions; (3) the ethical principles related to CIs; (4) the informed consent; (5) the role of the national ethics committees. CONCLUSIONS: Although the new guidelines enable an extension of the definition of "medical device" and the harmonization of the rules for "the placing on market and putting into service of the medical devices", it also regulates the MDs industry to ensure clinical benefits for patients and high standards of quality and safety.

Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.

Visions on the future of medical devices in spinal cord stimulation: what medical device is needed?

Recently burst stimulation and 10 kHz stimulation have been developed as novel stimulation designs. Both appear to be superior to classical tonic stimulation in the amount of responders and the amount of pain suppression and have as an extra advantage that they are paresthesia-free. This evolution is very important as it shifts the focus of research from better targeting by developing new lead configurations to better communication with the nervous system. It can be envisioned that this is only the start of a new trend in spinal cord, brain, and peripheral nerve stimulation and that more new stimulation designs will be developed in the near future such as pseudorandom burst stimulation, pleasure stimulation, noise stimulation and reconditioning stimulation. This evolution mandates a new approach in the development of internal pulse generators, and the most obvious approach is to develop an upgradable stimulator, on which new stimulation designs can be downloaded, analogous to the apps people download on their smartphones. This will create a shift from hardware driven products to software driven stimulators.

Implantable Smart Technologies (IST): Defining the 'Sting' in Data and Device.

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of 'smart' seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in 'implantable smart technologies', considering also whether regulation needs to respond to the autonomy that such artefacts carry within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device's ability to sense and transmit data and automate medicine can be associated with the 'sting' of autonomy being disassociated from human control as well as affecting individual, group, and social environments.

The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals.

Scientists and neuroethicists have recently drawn attention to the ethical and regulatory issues surrounding the do-it-yourself (DIY) brain stimulation community, which comprises individuals stimulating their own brains with transcranial direct current stimulation (tDCS) for self-improvement. However, to date, existing regulatory proposals and ethical discussions have been put forth without engaging those involved in the DIY tDCS community or attempting to understand the nature of their practices. I argue that to better contend with the growing ethical and safety concerns surrounding DIY tDCS, we need to understand the practices of the community. This study presents the results of a preliminary inquiry into the DIY tDCS community, with a focus on knowledge that is formed, shared and appropriated within it. I show that when making or acquiring a device, DIYers (as some members call themselves) produce a body of knowledge that is completely separate from that of the scientific community, and share it via online forums, blogs, videos and personal communications. However, when applying tDCS, DIYers draw heavily on existing scientific knowledge, posting links to academic journal articles and scientific resources and adopting the standardised electrode placement system used by scientists. Some DIYers co-opt scientific knowledge and modify it by creating their own manuals and guides based on published papers. Finally, I explore how DIYers cope with the methodological limitations inherent in self-experimentation. I conclude by discussing how a deeper understanding of the practices of DIY tDCS has important regulatory and ethical implications.

Engineering the Brain: Ethical Issues and the Introduction of Neural Devices.

Neural devices now under development stand to interact with and alter the human brain in ways that may challenge standard notions of identity, normality, authority, responsibility, privacy and justice.