Forgive and Remember: Managing Medical Failure Review

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(More customer reviews)As a medical student at the University of Chicago, Forgive and Remember helped shape my view of what good, caring physicians need to do when policing their own. I am currently on the quality assurance committees at three hospitals where I practice. I am buying several copies of Forgive and Remember for my committee colleagues who have not read this book.
The temptations of money over our patient's best interest, the medical malpractice environment, and the difficulties of practicing medicine in the era of managed care have made it diffuclt for well intentioned physicians to make a difference in the quality of care provided in our communities. I think this book will help me and my colleagues fufill the responsibilities the hospitals and our commununities have given us.
I truly believe all health care providers, attorneys involved with medical malpractice cases, and people interested in the delivery of healthcare need to read this book. It brings into perspective how all health care providers, from surgeons to orderlies, are human and make mistakes. It also shows how some mistakes are hard to forgive. As physicians we have to take this into account while assuring we always keep the interest of all patients, our own and those of other physicians, are well looked after.
I hope that in my local community all people will trust that their health care providers, despite the outcome of their care, did a good, competent job. Everyone alive, including physicians and our families, will someday become a patient.
In life it is important for all of us to learn from our mistakes.

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On its initial publication, Forgive and Remember emerged as the definitive study of the training and lives of young surgeons. Now with an extensive new preface, epilogue, and appendix by the author, reflecting on the changes that have taken place since the book's original publication, this updated second edition of Charles L. Bosk's classic study is as timely as ever.

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A Not Entirely Benign Procedure Review

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(More customer reviews)I am a biology major/ pre-med student at UCLA, though it is through my English class that I found this book. Simply put, this novel made me think. I continuously wondered, "can i handle 'dog dissection'... will I be able to memorize all of the countless facts about all these rare diseases?" An entire section of the book is devoted to bioethical issues, including one essay entitled, "DNR," (do not resuscitate). I began questioning myself, "is it fair to bring someone back just so that they can suffer longer with the same disease?" If you plan on going to medical school, reading this book is a must, and a joy; it is perfect for pre-meds.

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Design, Execution, and Management of Medical Device Clinical Trials Review

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(More customer reviews)In Latinamerica it is important increasing our knowlege in Medical Devices. This book is an excelent oportunity to improve the methodology of clinical trials with this kind of products.

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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition Review

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(More customer reviews)Steep price tag but worth it because - This is a good basic reference book for 21 CFR 820. It provides an outline of each requirement of the QSR with cross reference to and comparison with ISO 13485. It contains a matrix of 820 vs. 13485 with authors' notes that describe similarities/differences. It provides reference to the guidance ISO/TR 14969 which clarifies 13485. It also contains a section on process interactions, i.e., how CAPA interacts with Risk Analysis, etc. There is a chapter on Risk Analysis and information on Design Control. The comments to the QSR preamble are included and elaborated on which is helpful in determining the intent of law, useful for interpretation and application of the QSR . The authors offer useful guidance and some interpretation. All in all a good reference for new and/or practicing Quality Assurance staff, device managers, those seeking ISO medical device certification or improving their compliance in preparation for audits.

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This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is:A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg. Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors notes giving guidance derived from the authors sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.

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A Call to Action Review

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(More customer reviews)In "A Call to Action" Pfizer chairman Hank McKinnell makes the observation that the US has a "sick care" system, not a health care system. While the entitites working within this system may be the best at what they do, the lack of a true health care system will continue to impose a growing financial, social, and quality-of-life burden on all. Additionally, the health issues facing the world, such as the HIV/AIDS pandemic, are bigger than any one organization can handle.
Through provocative observations and insightful questions, McKinnell creates a framework for the discussion of this crucial issue. The solution can not lie solely upon private enterprise, governments, NGOs, or individuals, but must be achieved through the concerted efforts of all parties, both public and private. The questions raised in this book provide a necessary framework to both get the dialogue going as well as to organize what may otherwise be considered an overwhelming task. Importantly, this industry veteran shows that there is reason to believe the goal is achievable.
Our healthcare system has profound effects throughout every fiber of our society, from the way we live our lives to the taxes we pay to the role of government in providing for a healthful place in which to pursue our dreams. As such, it is important for all concerned citizens to understand the challenges facing the establishment and maintenance of a true health care system.
"A Call to Action" is a surprising, thought-provoking, and ultimately hopeful challenge to establish a true and sustainable health care system. I strongly recommend this to anyone interested in one of the biggest issues facing the US both today and in the future.

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