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1 or How did we get here? Symposium info.ainslie.com
2 Why does our organization exist? We are manufacturers, users, researchers and people with an interest in Ultrasonics. As such we need to be knowledgeable about the capabilities and effects of this special energy form. Our organization has developed over the years to help in this endeavor. Note: On subsequent slides the symbol indicates that a source document has been provided in the list of references. Symposium info.ainslie.com
3 The UMA (Ultrasonic Manufacturers Association) was established in 1956: To collect and to disseminate sound and accurate information relating to ultrasonic equipment and its application. To collect and disseminate information and statistics to interest and value to the membership so as to promote the development and applications of ultrasonic products and to improve the usefulness and quality of such products manufactured by or supplied by the membership To assist and cooperate with the members in their relations with governmental administrative agencies concerned with the field of ultrasonics. Symposium info.ainslie.com
4 The UIA (Ultrasonic Industry Association) was established in 1975: To consider and deal with intra-industry problems and to foster and further, in every lawful manner, the interests of the manufacturers of ultrasonic materials, products and supplies; and in furtherance of these objectives:. To promote the growth of the industry on a firm and lasting basis. To collect and disseminate information of interest and value to the membership, so as to promote the development and application of ultrasonic products. Symposium info.ainslie.com
5 Over the years, the UIA has evolved into an organization dedicated to the advancement of the technology and applications of ultrasonics used to create changes in materials. As such, we now include as members: A Manufacturer or purchaser of ultrasonic equipment and related items for sale or use. A Company or institution that uses ultrasonic equipment, does research, or provides services, in the field of ultrasonics. Persons with an interest in the field of ultrasonics. Professional or trade organizations sharing common interests with the UIA. Students enrolled at an academic institution in a degree program in science, engineering, or technology. Symposium info.ainslie.com
6 In the 1960 s The UMA zealously protected their proprietary knowledge of the mechanisms of interaction. Never the less they published: A List of Standard Definitions A System of Standard Ratings Covering Ultrasonic Electrical Generators A Bibliography of Ultrasonics in Medicine (November 1963) A Recommended Standard Cavitation Activity Measuring Procedure (Copyright August 1964) Symposium info.ainslie.com
7 Cavitron Corporation, a sustaining member of the UMA and UIA had an business philosophy. Participation in the industry association. Sponsorship of its personnel in the cross disciplinary activities of in the industry. Participation in the formulation of voluntary and governmental standards. Symposium info.ainslie.com
8 In 1969, Alan Broadwin joined Cavitron to participate in the ground breaking development of the Phaco Emulsifier for cataract surgery. He was encouraged to: Become an active member of the association. Take a leadership role in the industry association activities. Help to develop the company strategy to address the new governmental requirements being promulgated for medical device manufacturers. Symposium info.ainslie.com
9 During those early years with Cavitron, your speaker: Was exposed to a broad spectrum of applications in the ultrasonic field from power ultrasonic welding to various ultrasonic surgical modalities. Did some initial experimentation on the effects of ultrasonic vibrations in the eye. Helped bring the Phaco Emulsifier to the market. Evaluated the application of ultrasonic vibration to other surgical modalities. Participated in the development, clinical trials and marketing of the CUSA (Cavitron Ultrasonic Surgical Aspirator). Symposium info.ainslie.com
10 Pfizer Hospital Products Group purchased the Cavitron Corporation in As Director of Ultrasonic Technology for Pfizer: I was asked to take an active role in the development of the international standards under development. (I joined the US TAG for IEC TC 87 Ultrasonics) They supported my request to find out what the mechanisms were that provided such unique tissue interactions when using ultrasonic surgical devices. (I collaborated with Dr. Mark Schafer in determining the mechanism for tissue fragmentation) They encouraged me to reach out to global organizations through the UIA to develop sources of information which would benefit the company. (I reached out to the Ultrasonic & Acoustic Transducer Group at the University of Southhampton, UK and the National Physical Laboratory in Teddington, UK where I met Bajram Zeqiri) Symposium info.ainslie.com
11 During the 1988 to 1993 period, I participated in the discussions and drafting of such international standards as: IEC Ultrasonics Surgical Systems (Mark Schafer will talk to you). IEC Ultrasonics Dental Descalers IEC Investigation on Test Procedures for Ultrasonic Cleaners (Bajram Zeqiri will talk to you). IEC Characteristics and measurements of ultrasonic piezo ceramic transducers. Symposium info.ainslie.com
12 When I was retired by Pfizer I started working in both the medical device and aerospace fields. I was surprised by the similarities in these two industries. Both involve life or death products. Both require the highest level of quality assurance. Both are subject to intense regulatory scrutiny. Both rely on advanced technology for their most spectacular successes. I looked into how the organizations that contribute to the understanding and control of these industries developed and interact. Symposium info.ainslie.com
13 Year Event Reason 1902 Biologics Control 1906 Pure Food and Drugs Act 1938 Food Drug & Cosmetic Act Sulfanilamide 1962 Drug Amendments Thalidomide 1963 GMP s for Drugs 1976 Medical Device Amendments Dalkon Shield 1978 CGMP Drugs & Devices 1987 Guidelines for Process Validation Beginning of Design Controls 1990 Safe Medical Devices Act Shiley Heart Valve 1997 QSR for Medical Devices Full Quality System Required for Companies 1999 QSIT Inspection Technique Management, Design, Production & Process, CAPA Symposium info.ainslie.com
14 Year Event Reason 1903 First Powered Flight 1918 US Post Office Airmail 1926 Air Commerce Act 1934 Air Mail Act 66 Crashes 1946 Federal Airport Act 1958 Federal Aviation Act 3 Mid Air Collisions 1959 MIL-Q-9858 Quality Requirements 1997 AS9000 Application of ISO 9001 to Aerospace Requirements 2009 AS9100 Quality Management Systems for Aviation Symposium info.ainslie.com
15 Year Event Reason 1906 IEC International Electro Technical Commission Formed 1926 ISA International Federation of National Standards Associations New York & Switzerland 1946 ISO formed from ISA and UNSCC 1979 BS 5750 Issued Based on MIL-Q-9858 of ISO 9000 Issued Quality Systems Standard 1993 EEA European Economic Area created CE Marking 1993 MDD Medical Device Directives Legal Requirements for Medical Device Companies in the EU 1997 EN Issued Application of ISO 9001 to Medical Devices 2003 ISO Issued Quality Systems Requirements for Medical Companies Symposium info.ainslie.com
16 Symposium info.ainslie.com
17 Failures in the medical device and aerospace fields are unacceptable. Accidents and mistakes in other fields do happen. Companies with Quality Systems have been asked to establish Risk Management processes so that they can analyze and hopefully mitigate failure modes. Companies need to be aware of the nature of the overlapping requirements so that they can appropriately plan their actions. Symposium info.ainslie.com
18 United States Laws Pure Food & Drugs Radiation Control for Health & Safety Medical Device Amendments Etc. International Requirements EU MDD Canada Japan Etc. Company in the Ultrasonic Industry Voluntary Standards IEC ISO Etc. Symposium info.ainslie.com
19 Slide Description of Reference 3 UMA Incorporation & Minutes of Meeting 4 UIA Incorporation List of Standard Definitions 6 Bibliography of Ultrasonics in Medicine 6 Cavitation Activity Measurement Procedure 10 Bajram Zeqiri Cleaning Systems 10 Matk Schafer Acoustical Characterization 10 Ultrasonic & Acoustic Transducer Group Symposium info.ainslie.com
20 Slide Description of Reference 12 Introduction to ISO 13 Introduction to QSR by Troutman 13 Medical Device Regulations Come of Age 14 Aerospace Standardization & History 15 Why Was the IEC Created? 15 The ISO Story Friendship among Equals Symposium info.ainslie.com
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