%0 Book %A Institute of Medicine %E Field, Marilyn J. %E Tilson, Hugh %T Safe Medical Devices for Children %@ 978-0-309-09631-7 %D 2006 %U https://nap.nationalacademies.org/catalog/11313/safe-medical-devices-for-children %> https://nap.nationalacademies.org/catalog/11313/safe-medical-devices-for-children %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 480 %X Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients. %0 Book %A Institute of Medicine %T Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years %@ 978-0-309-21242-7 %D 2011 %U https://nap.nationalacademies.org/catalog/13150/medical-devices-and-the-publics-health-the-fda-510k-clearance %> https://nap.nationalacademies.org/catalog/13150/medical-devices-and-the-publics-health-the-fda-510k-clearance %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 318 %X Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework. %0 Book %A Institute of Medicine %E Hanna, Kathi E. %E Manning, Frederick J. %E Bouxsein, Peter %E Pope, Andrew %T Innovation and Invention in Medical Devices: Workshop Summary %@ 978-0-309-08255-6 %D 2001 %U https://nap.nationalacademies.org/catalog/10225/innovation-and-invention-in-medical-devices-workshop-summary %> https://nap.nationalacademies.org/catalog/10225/innovation-and-invention-in-medical-devices-workshop-summary %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 112 %X The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs. %0 Book %A National Research Council %E Scarborough, Bonnie A. %T Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices %D 2004 %U https://nap.nationalacademies.org/catalog/11035/proceedings-from-the-workshop-on-science-based-assessment-accelerating-product %> https://nap.nationalacademies.org/catalog/11035/proceedings-from-the-workshop-on-science-based-assessment-accelerating-product %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 48 %X The Food and Drug Administration (FDA) has established testing centers for assessment of three categories of medical products; devices, biologics, and drugs. Increasingly, however, medical products are appearing that are combinations of more than one of those categories. The FDA is just beginning to develop procedures for evaluating such combination products, which pose new challenges for assessing efficacy and safety. The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is an NRC activity that brings together relevant parties to discuss R&D, applications, and regulation of biomedical materials and devices. In 2003, BEMA held a workshop to discuss science-based assessment for evaluation of combination products. This report and accompanying CD present abstracts and viewgraphs of the talks given at that workshop. The workshop focused on three specific types of combination products: orthopedic repair using morphogenetic protein, drug-eluting stents, and cell-matrix cartilage implants. In addition, context-setting discussions of science-based assessment and experimental design were presented at the workshop. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Johnson, Anne %E Bremer, Andrew %E Connell, Nancy %T Cutting-Edge Scientific Capabilities for Biological Detection: Proceedings of a Workshop–in Brief %D 2022 %U https://nap.nationalacademies.org/catalog/26553/cutting-edge-scientific-capabilities-for-biological-detection-proceedings-of-a %> https://nap.nationalacademies.org/catalog/26553/cutting-edge-scientific-capabilities-for-biological-detection-proceedings-of-a %I The National Academies Press %C Washington, DC %G English %K Biology and Life Sciences %P 11 %X Recent advances in biotechnology and the life sciences have led to new and emerging paradigms for biological detection. For instance, technologies for analyzing brain activity are advancing rapidly and may soon find their way into a multitude of consumer electronics and medical devices. Other technologies are using biological or bio-inspired methods to analyze chemicals present in air, including those of biological origin, allowing the technologies to detect and sense compounds - such as disease biomarkers or industrial pollutants - with unprecedented speed and precision. What capabilities might these technologies unlock? What economic and societal drivers are influencing their development? What ethical, legal, and social issues do they raise? The National Academies of Sciences, Engineering, and Medicine hosted a virtual workshop on Cutting Edge Scientific Capabilities for Biological Detection on January 20, 21, and 28, 2022, to explore emerging technologies for biological detection and critical issues related to their development and use. This publication summarizes the presentation and discussion of the workshop. %0 Book %A National Academy of Engineering %E Olson, Steve %T Engineering for Pandemics: Preparedness, Response, and Recovery: Proceedings of a Forum %@ 978-0-309-15046-0 %D 2021 %U https://nap.nationalacademies.org/catalog/26093/engineering-for-pandemics-preparedness-response-and-recovery-proceedings-of-a %> https://nap.nationalacademies.org/catalog/26093/engineering-for-pandemics-preparedness-response-and-recovery-proceedings-of-a %I The National Academies Press %C Washington, DC %G English %K Engineering and Technology %P 48 %X The 2020 Annual Meeting of the National Academy of Engineering took place under the most unusual circumstances in the Academy's 56-year history. In January 2020 the first few cases of a respiratory illness caused by a newly identified coronavirus were reported in the United States. By March, COVID-19 had become a global pandemic. As soon as the first few cases were reported, engineers began working wiith scientists, medical professionals, and others in the public and private sector to address needs generated by the pandemic. They brought automation, process control, and artificial intelligence to the production of protective equipment, diagnostics, and therapeutics. They established robust supply chains of critical materials. They strengthened the communication technologies and platforms that allowed people to telework and keep in touch with friends and family members. The 2020 annual meeting was held virtually. The two main plenary presentations, delivered by David Walt, the Hansjörg Wyss Professor of Biologically Inspired Engineering at Harvard Medical School, and Pam Cheng, executive vice president of global operations and information technology for AstraZeneca, focused on the critical role of engineers in responding to the epidemic. Similarly, the annual forum, held the next day and organized by NAE executive officer Al Romig, Jr., and a distinguished organizing committee, was entitled "Engineering for Pandemics: Preparedness, Response, and Recovery". The plenary and forum presentations, which are summarized in this volume, abundantly demonstrate the essential functions that engineers have performed in responding to the virus. They also reveal the lessons derived from engineering that must be absorbed to prepare effectively for future pandemics and for other disasters, expected and unexpected, that will certainly occur in the future. %0 Book %A Institute of Medicine %E Wizemann, Theresa %T Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report %@ 978-0-309-16206-7 %D 2011 %U https://nap.nationalacademies.org/catalog/13020/public-health-effectiveness-of-the-fda-510k-clearance-process-measuring %> https://nap.nationalacademies.org/catalog/13020/public-health-effectiveness-of-the-fda-510k-clearance-process-measuring %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 132 %X The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Whitacre, Paula %T The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: Proceedings of a Workshop–in Brief %D 2021 %U https://nap.nationalacademies.org/catalog/26441/the-food-and-drug-administrations-emergency-use-authorization-lessons-learned-from-the-past-to-guide-the-future %> https://nap.nationalacademies.org/catalog/26441/the-food-and-drug-administrations-emergency-use-authorization-lessons-learned-from-the-past-to-guide-the-future %I The National Academies Press %C Washington, DC %G English %K Policy for Science and Technology %P 13 %X The U.S. Food and Drug Administration (FDA) has responsibility for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. In certain declared emergencies, FDA has the option to authorize use of a new product or a new use of an approved product - an authority known as Emergency Use Authorization (EUA)- if it has reason to believe that the product may be effective and that its known benefits outweigh its known risks. By contrast, in non-emergency situations, applicants must demonstrate a product's safety and effectiveness through a lengthier, more extensive process. On October 5-6, 2021, the Committee on Science, Technology, and Law of the National Academies of Sciences, Engineering, and Medicine convened a virtual workshop on the EUA process. At the workshop, presenters and participants examined FDA's recent and historic use of EUAs, discussed lessons learned during the COVID-19 pandemic, and considered how those lessons might inform future efforts. The workshop also highlighted emergency mechanisms used by other health regulators and considered how U.S. and global regulatory partners can strengthen cooperation in responding to global health emergencies. This publication summarizes the presentation and discussion of the workshop. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Babik, Kelsey R. %E Downey, Autumn %E Alper, Joe %T Personal Protective Equipment and Personal Protective Technology Product Standardization for a Resilient Public Health Supply Chain: Proceedings of a Workshop %@ 978-0-309-70450-2 %D 2023 %U https://nap.nationalacademies.org/catalog/27094/personal-protective-equipment-and-personal-protective-technology-product-standardization-for-a-resilient-public-health-supply-chain %> https://nap.nationalacademies.org/catalog/27094/personal-protective-equipment-and-personal-protective-technology-product-standardization-for-a-resilient-public-health-supply-chain %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 166 %X The National Strategy for a Resilient Public Health Supply Chain lays out the U.S. government vision to protect the health and security of Americans by ensuring a supply chain for personal protective equipment (PPE) and technology (PPT), medical devices, medicines, and other public health supplies that is resilient against disruptions from pandemics and other biological threats. Additional forethought and collaboration amongst policy makers, manufacturers, and users is needed to make PPE and PPT innovation, standardization, stockpiling, and use more resilient. The National Academies convened a public workshop in March 2023 to explore innovative approaches and technologies needed to update and streamline the U.S. standardization system for PPE and PPT in support of supply chain resiliency. Discussions included ways to improve the effectiveness, safety, supply stability, and accessibility of PPE and PPT designed for use in health care settings, by critical infrastructure workers, and by the general public. This Proceedings of a Workshop summarizes the discussions held during the workshop. %0 Book %A National Academy of Engineering %A National Academies of Sciences, Engineering, and Medicine %T New Directions for Chemical Engineering %@ 978-0-309-26842-4 %D 2022 %U https://nap.nationalacademies.org/catalog/26342/new-directions-for-chemical-engineering %> https://nap.nationalacademies.org/catalog/26342/new-directions-for-chemical-engineering %I The National Academies Press %C Washington, DC %G English %K Engineering and Technology %P 368 %X Over the past century, the work of chemical engineers has helped transform societies and the lives of individuals, from the synthetic fertilizers that helped feed the world to the development of novel materials used in fuels, electronics, medical devices, and other products. Chemical engineers' ability to apply systems-level thinking from molecular to manufacturing scales uniquely positions them to address today’s most pressing problems, including climate change and the overuse of resources by a growing population. New Directions for Chemical Engineering details a vision to guide chemical engineering research, innovation, and education over the next few decades. This report calls for new investments in U.S. chemical engineering and the interdisciplinary, cross-sector collaborations necessary to advance the societal goals of transitioning to a low-carbon energy system, ensuring our production and use of food and water is sustainable, developing medical advances and engineering solutions to health equity, and manufacturing with less waste and pollution. The report also calls for changes in chemical engineering education to ensure the next generation of chemical engineers is more diverse and equipped with the skills necessary to address the challenges ahead. %0 Book %A Institute of Medicine %E Yaffe, Sumner, M.D. %E Estabrook, Ronald W. %E Bouxsein, Peter %E Pitluck, Sarah %E Davis, Jonathan R. %T Rational Therapeutics for Infants and Children: Workshop Summary %@ 978-0-309-06937-3 %D 2000 %U https://nap.nationalacademies.org/catalog/9816/rational-therapeutics-for-infants-and-children-workshop-summary %> https://nap.nationalacademies.org/catalog/9816/rational-therapeutics-for-infants-and-children-workshop-summary %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 136 %X The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development. %0 Book %A Institute of Medicine %E Wizemann, Theresa %T Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report %@ 978-0-309-15849-7 %D 2010 %U https://nap.nationalacademies.org/catalog/12960/public-health-effectiveness-of-the-fda-510k-clearance-process-balancing %> https://nap.nationalacademies.org/catalog/12960/public-health-effectiveness-of-the-fda-510k-clearance-process-balancing %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 140 %X The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Artificial Intelligence and Machine Learning to Accelerate Translational Research: Proceedings of a Workshop—in Brief %D 2018 %U https://nap.nationalacademies.org/catalog/25197/artificial-intelligence-and-machine-learning-to-accelerate-translational-research-proceedings %> https://nap.nationalacademies.org/catalog/25197/artificial-intelligence-and-machine-learning-to-accelerate-translational-research-proceedings %I The National Academies Press %C Washington, DC %G English %K Policy for Science and Technology %P 9 %X The big data revolution, accompanied by the development and deployment of wearable medical devices and mobile health applications, has enabled the biomedical community to apply artificial intelligence (AI) and machine learning algorithms to vast amounts of data. This shift has created new research opportunities in predictive analytics, precision medicine, virtual diagnosis, patient monitoring, and drug discovery and delivery, which has garnered the interests of government, academic, and industry researchers alike and is already putting new tools in the hands of practitioners. This boom in digital health opportunities has also raised numerous questions concerning the future of biomedical research and healthcare practices. How reliable are deployed AI-driven diagnostic tools, and what is the impact of these tools on doctors and patients? How vulnerable are algorithms to bias and unfairness? How can research improve the process of detecting unfairness in machine learning algorithms? How are other fields simultaneously advancing AI applications? How will academia prepare scientists with the skills to meet the demands of the newly transformed industry? Informed answers to these and other questions require interdisciplinary discussion and collaboration. On February 13 and 14, 2018, the National Academies of Sciences, Engineering, and Medicine convened a workshop to explore these and other questions related to the emerging use of AI and machine learning technologies in translational research. This publication summarizes the presentations and discussions from the workshop. %0 Book %A National Research Council %E Olson, Steve %T The Role of Human Factors in Home Health Care: Workshop Summary %@ 978-0-309-15629-5 %D 2010 %U https://nap.nationalacademies.org/catalog/12927/the-role-of-human-factors-in-home-health-care-workshop %> https://nap.nationalacademies.org/catalog/12927/the-role-of-human-factors-in-home-health-care-workshop %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %K Behavioral and Social Sciences %P 322 %X The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research—the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study. %0 Book %A National Academy of Engineering %T The Impact of Academic Research on Industrial Performance %@ 978-0-309-08973-9 %D 2003 %U https://nap.nationalacademies.org/catalog/10805/the-impact-of-academic-research-on-industrial-performance %> https://nap.nationalacademies.org/catalog/10805/the-impact-of-academic-research-on-industrial-performance %I The National Academies Press %C Washington, DC %G English %K Industry and Labor %K Computers and Information Technology %K Policy for Science and Technology %P 264 %X Drawing on the findings of sector-specific workshops, e-mail surveys, research literature, expert testimony, and committee and panel members’ expertise, this National Academy of Engineering study assesses the qualitative impact of academic research on five industries—network systems and communications; medical devices and equipment; aerospace; transportation, distribution, and logistics services; and financial services. The book documents the range and significance of academic research contributions to the five industries—comparing the importance of different types of contributions, the multi- and interdisciplinary nature of these contributions, and the multiple vectors by which academic research is linked to each industry. The book calls for action to address six cross-cutting challenges to university-industry interactions: the growing disciplinary and time-horizon-related imbalances in federal R&D funding, barriers to university-industry interaction in service industries, the critical role of academic research in the advancement of information technology, the role of academic research in the regulation of industry, the impact of technology transfer activities on core university research and education missions, and the search for new pathways and mechanisms to enhance the contributions of academic research to industry. The book also includes findings and recommendations specific to each industry. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Airport Passenger Screening Using Millimeter Wave Machines: Compliance with Guidelines %@ 978-0-309-46744-5 %D 2017 %U https://nap.nationalacademies.org/catalog/24936/airport-passenger-screening-using-millimeter-wave-machines-compliance-with-guidelines %> https://nap.nationalacademies.org/catalog/24936/airport-passenger-screening-using-millimeter-wave-machines-compliance-with-guidelines %I The National Academies Press %C Washington, DC %G English %K Engineering and Technology %K Transportation and Infrastructure %P 200 %X The Transportation Security Administration requested a study by the National Research Council (NRC) to establish the Committee on Airport Passenger Screening: Millimeter Wave Machines to evaluate two models of active millimeter wave scanners: the L3 ProVision 1 and L3 ProVision 2. Airport Passenger Screening Using Millimeter Wave Machines provides findings and recommendations on compliance with applicable health and safety guidelines and appropriateness of system design and procedures for preventing over exposure. This study addresses the issue of whether millimeter wave machines used at airports comply with existing guidelines and whether it would be possible for anything to go wrong with the machines so that, by mistake, it exposes a person to more than 10 W/m2. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Anderson, Karen M. %E Olson, Steve %T Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop %@ 978-0-309-44357-9 %D 2016 %U https://nap.nationalacademies.org/catalog/23530/strategies-for-ensuring-diversity-inclusion-and-meaningful-participation-in-clinical-trials %> https://nap.nationalacademies.org/catalog/23530/strategies-for-ensuring-diversity-inclusion-and-meaningful-participation-in-clinical-trials %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 84 %X Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop. %0 Book %A Institute of Medicine %E Field, Marilyn J. %E Boat, Thomas F. %T Rare Diseases and Orphan Products: Accelerating Research and Development %@ 978-0-309-15806-0 %D 2010 %U https://nap.nationalacademies.org/catalog/12953/rare-diseases-and-orphan-products-accelerating-research-and-development %> https://nap.nationalacademies.org/catalog/12953/rare-diseases-and-orphan-products-accelerating-research-and-development %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 442 %X Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. %0 Book %A Institute of Medicine %T Health IT and Patient Safety: Building Safer Systems for Better Care %@ 978-0-309-22112-2 %D 2012 %U https://nap.nationalacademies.org/catalog/13269/health-it-and-patient-safety-building-safer-systems-for-better %> https://nap.nationalacademies.org/catalog/13269/health-it-and-patient-safety-building-safer-systems-for-better %I The National Academies Press %C Washington, DC %G English %K Computers and Information Technology %K Health and Medicine %P 234 %X IOM's 1999 landmark study To Err is Human estimated that between 44,000 and 98,000 lives are lost every year due to medical errors. This call to action has led to a number of efforts to reduce errors and provide safe and effective health care. Information technology (IT) has been identified as a way to enhance the safety and effectiveness of care. In an effort to catalyze its implementation, the U.S. government has invested billions of dollars toward the development and meaningful use of effective health IT. Designed and properly applied, health IT can be a positive transformative force for delivering safe health care, particularly with computerized prescribing and medication safety. However, if it is designed and applied inappropriately, health IT can add an additional layer of complexity to the already complex delivery of health care. Poorly designed IT can introduce risks that may lead to unsafe conditions, serious injury, or even death. Poor human-computer interactions could result in wrong dosing decisions and wrong diagnoses. Safe implementation of health IT is a complex, dynamic process that requires a shared responsibility between vendors and health care organizations. Health IT and Patient Safety makes recommendations for developing a framework for patient safety and health IT. This book focuses on finding ways to mitigate the risks of health IT-assisted care and identifies areas of concern so that the nation is in a better position to realize the potential benefits of health IT. Health IT and Patient Safety is both comprehensive and specific in terms of recommended options and opportunities for public and private interventions that may improve the safety of care that incorporates the use of health IT. This book will be of interest to the health IT industry, the federal government, healthcare providers and other users of health IT, and patient advocacy groups. %0 Book %A Institute of Medicine %E Pray, Leslie %E Robinson, Sally %T Challenges for the FDA: The Future of Drug Safety: Workshop Summary %@ 978-0-309-10986-4 %D 2007 %U https://nap.nationalacademies.org/catalog/11969/challenges-for-the-fda-the-future-of-drug-safety-workshop %> https://nap.nationalacademies.org/catalog/11969/challenges-for-the-fda-the-future-of-drug-safety-workshop %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 128 %X As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report—The Future of Drug Safety: Promoting and Protecting the Health of the Public—which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.