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Clinical applications of biomaterials
MEDICAL DEVICES- MEASUREMENTS, C.A. Caceres, H.T. Yolken, R.J. Jones and H.R. Piehler
QUALITY ASSURANCE AND STANDARDS
American Technical Fub&shm Ltd. 1983, pp 306 $32
In 198 1 the American Medical Association, the National Bureau of Standards and the American Society for Testing and Materials sponsored a conference. The title of the conference, and presumably, much of the input to the conference have re-appeared in this book. The intention was to “provide physicians, scientists, and members of industry and government with a comprehensive overview of the role and impact of medical device standards and measurements on health care”. The book is intended to be read “selectively”, accordingly it is divided into three main sections each with an Overview, Guidelines and Case Studies. The main sections deal respectively with “The need for a Common Language”, “Systematization to arrive at a Common Language” and “The Application and Impact of Standards for Medical Devices”. Thus much of the first two parts is mainly concerned with the lack of adequate standards in fields as diverse as clinical chemistry, orthopaedic implants, computerized medical technology and monitoring devices. The section on Application and Impact was an interesting reflection of the current state of standardisation in the United States. There were six case studies. The first was concerned with Foley Catheters for which a Performance Standard has been developed. For Hydrocephalic Shunts a Performance Standard has been proposed. A “descriptive code” for Cardiac pacemakers has been proposed and become widely accepted. The fourth case study deals with standardised labelling and packaging as a device for the prevention of medication errors and makes a plea for “a national ;zdz;r still, an international labelling quality
CLINICAL APPLICATIONS AJ.C. Lee, T. Albrektsson
The chapter on “Technology Awareness: electrical safety, the clinical environment, and standards” is one of several chapters to contain absolutely no references. There is no a parent awareness that there is a vast amount o P effort being made internationally to produce electrical safety standards, no mention of the International Electrotechnical Commission or its internationally approved document IEC 601-l to which even the United States is supposed to give support. There was extremely brief reference to ANSI/MM1 Safe Current Limits for Electra-medical Devices, but no statement of those limits or discussion of the standard. Much of this chapter is a plea for some form of equipment management policy, but not developed to the extent of the DHSS Health Equipment Information No. 98 publication. The final chapter in this section deals with “Clinical environment and the law: product liability”. This chapter provides an interesting insight into American medicine. For instance it suggests that the order of priority for standard setting might be related to the proportion of alleged failures, in which case the top priority would be breast implants and silicone injections! This book provides an expensive look at American medicine, and the work needed to provide an acceptable level of standardization in medical devices. Very little of that work appears to have reached any conclusions in the United States, and there appears to be an almost total lack of awareness of any medical standards work in progress anywhere else in the world. D. Whe@n
OF BIOMATERIALS
and P.I. Branemark
Published by John Wiley G1 Sons. Advances in Biomaterials Series No. 4. 1982. Pages xiii + 335, E27.50
This is the volume from the Second European Conference on Biomaterials organised by the European Society of Biomaterials and held in Gothenberg, Sweden, August 1981. Four sections are covered, orthopaedic, dental, chemical and a general section entitled biological.
which continues to be of importance in various applications of metallic alloys, but also includes studies on biodegradable glasses and hydrogels. The biological section is a mixed collection of papers including blood interactions, uses of collagen, arterial prostheses and dressings.
The importance of ceramic materials is once again emphasised by the number of papers devoted to applications of these materials in orthopaedic and dental uses. Carbon is also represented in different forms. What is interesting is the way in which a much more systematic investigation of biomaterials is becoming apparent with the application of advanced materials science techniques. The section of papers under the chemical heading, not surprisingly include results on corrosion studies
As with all conference proceedings the book represents a cross section of work in progress, some much more complete than others. Such a book can never be regarded as a definitive guide to a subject but is always useful as a progress report. For this reason it is worth considering but may well have been overtaken by more definitive works which give a more comprehensive review of certain aspects of the subject.
244
J. Biomed. Ehg. 1984, Vol. 6, July
G . W. Hastings
QUALITY ASSURANCE AND STANDARDS
American Technical Fub&shm Ltd. 1983, pp 306 $32
In 198 1 the American Medical Association, the National Bureau of Standards and the American Society for Testing and Materials sponsored a conference. The title of the conference, and presumably, much of the input to the conference have re-appeared in this book. The intention was to “provide physicians, scientists, and members of industry and government with a comprehensive overview of the role and impact of medical device standards and measurements on health care”. The book is intended to be read “selectively”, accordingly it is divided into three main sections each with an Overview, Guidelines and Case Studies. The main sections deal respectively with “The need for a Common Language”, “Systematization to arrive at a Common Language” and “The Application and Impact of Standards for Medical Devices”. Thus much of the first two parts is mainly concerned with the lack of adequate standards in fields as diverse as clinical chemistry, orthopaedic implants, computerized medical technology and monitoring devices. The section on Application and Impact was an interesting reflection of the current state of standardisation in the United States. There were six case studies. The first was concerned with Foley Catheters for which a Performance Standard has been developed. For Hydrocephalic Shunts a Performance Standard has been proposed. A “descriptive code” for Cardiac pacemakers has been proposed and become widely accepted. The fourth case study deals with standardised labelling and packaging as a device for the prevention of medication errors and makes a plea for “a national ;zdz;r still, an international labelling quality
CLINICAL APPLICATIONS AJ.C. Lee, T. Albrektsson
The chapter on “Technology Awareness: electrical safety, the clinical environment, and standards” is one of several chapters to contain absolutely no references. There is no a parent awareness that there is a vast amount o P effort being made internationally to produce electrical safety standards, no mention of the International Electrotechnical Commission or its internationally approved document IEC 601-l to which even the United States is supposed to give support. There was extremely brief reference to ANSI/MM1 Safe Current Limits for Electra-medical Devices, but no statement of those limits or discussion of the standard. Much of this chapter is a plea for some form of equipment management policy, but not developed to the extent of the DHSS Health Equipment Information No. 98 publication. The final chapter in this section deals with “Clinical environment and the law: product liability”. This chapter provides an interesting insight into American medicine. For instance it suggests that the order of priority for standard setting might be related to the proportion of alleged failures, in which case the top priority would be breast implants and silicone injections! This book provides an expensive look at American medicine, and the work needed to provide an acceptable level of standardization in medical devices. Very little of that work appears to have reached any conclusions in the United States, and there appears to be an almost total lack of awareness of any medical standards work in progress anywhere else in the world. D. Whe@n
OF BIOMATERIALS
and P.I. Branemark
Published by John Wiley G1 Sons. Advances in Biomaterials Series No. 4. 1982. Pages xiii + 335, E27.50
This is the volume from the Second European Conference on Biomaterials organised by the European Society of Biomaterials and held in Gothenberg, Sweden, August 1981. Four sections are covered, orthopaedic, dental, chemical and a general section entitled biological.
which continues to be of importance in various applications of metallic alloys, but also includes studies on biodegradable glasses and hydrogels. The biological section is a mixed collection of papers including blood interactions, uses of collagen, arterial prostheses and dressings.
The importance of ceramic materials is once again emphasised by the number of papers devoted to applications of these materials in orthopaedic and dental uses. Carbon is also represented in different forms. What is interesting is the way in which a much more systematic investigation of biomaterials is becoming apparent with the application of advanced materials science techniques. The section of papers under the chemical heading, not surprisingly include results on corrosion studies
As with all conference proceedings the book represents a cross section of work in progress, some much more complete than others. Such a book can never be regarded as a definitive guide to a subject but is always useful as a progress report. For this reason it is worth considering but may well have been overtaken by more definitive works which give a more comprehensive review of certain aspects of the subject.
244
J. Biomed. Ehg. 1984, Vol. 6, July
G . W. Hastings