EDITORIAL
Medical Devices and the Clinical Chemist "A medical device is a n y t h i n g in a hospital except the bricks in the walls and the two-legged inhabitants within their confines". With this all encompassing statement, the F i r s t Canadian Conference on Medical Devices ended in Ottawa late on Wednesday afternoon, October 22, 1975. Your E d i t o r was part of the somewhat apprehensive gathering of 450 (mainly distributors and m a n u f a c t u r e r s ) who came to hear t h a t the following Regulations were really true and would be in effect April 1, 1976. 1. No m a n u f a c t u r e r shall sell a device unless tests have been conducted in respect thereof in accordance with an acceptable method and the tests indicate t h a t the nature of the benefits claimed to be obtainable through the use of the device and the performance characteristics claimed for the device are justified. 2. A m a n u f a c t u r e r of a device shall, before April 1, 1976, or within ten days f r o m the day on which he f i r s t sells the device, whichever is the later, furnish the Director with a notification signed by the manufacturer, or by a person authorised on his behalf, advising w h e t h e r he intends to continue sales of the device in Canada and including a quantitative statement and description of: a) The performance characteristics of the device. b) The accuracy, precision and reliability of the information set out p u r s u a n t to a). c) The conditions under which the performance characteristics of the device were measured. My " t r a n s l a t i o n " of various statements of Bureau officials is t h a t these Regulations will be acted upon. The Bureau a y e a r ago consisted of only two persons. It now contains 22, even in the face of various government job freezes, etc. F r o m this, it seems t h a t the Health Protection Branch means business. The American counterpart of our Bureau, the F.D.A., apparently is only requiring pre-market clearance of "less than 5% of medical devices and these are the hazardous ones". Dr. DasGupta, Director of the Canadian Bureau, offered no such reassurance to the somew h a t nervous gathering. As clinical chemists, through the Inter-Society Council of L a b o r a t o r y Medicine (ISCLM), we have a reasonable chance to help the Bureau develop reasonable tests and standards. This opport u n i t y should be seized. D. J. C A M P B E L L ,
Vancouver General Hospital. t
Medical Devices and the Clinical Chemist "A medical device is a n y t h i n g in a hospital except the bricks in the walls and the two-legged inhabitants within their confines". With this all encompassing statement, the F i r s t Canadian Conference on Medical Devices ended in Ottawa late on Wednesday afternoon, October 22, 1975. Your E d i t o r was part of the somewhat apprehensive gathering of 450 (mainly distributors and m a n u f a c t u r e r s ) who came to hear t h a t the following Regulations were really true and would be in effect April 1, 1976. 1. No m a n u f a c t u r e r shall sell a device unless tests have been conducted in respect thereof in accordance with an acceptable method and the tests indicate t h a t the nature of the benefits claimed to be obtainable through the use of the device and the performance characteristics claimed for the device are justified. 2. A m a n u f a c t u r e r of a device shall, before April 1, 1976, or within ten days f r o m the day on which he f i r s t sells the device, whichever is the later, furnish the Director with a notification signed by the manufacturer, or by a person authorised on his behalf, advising w h e t h e r he intends to continue sales of the device in Canada and including a quantitative statement and description of: a) The performance characteristics of the device. b) The accuracy, precision and reliability of the information set out p u r s u a n t to a). c) The conditions under which the performance characteristics of the device were measured. My " t r a n s l a t i o n " of various statements of Bureau officials is t h a t these Regulations will be acted upon. The Bureau a y e a r ago consisted of only two persons. It now contains 22, even in the face of various government job freezes, etc. F r o m this, it seems t h a t the Health Protection Branch means business. The American counterpart of our Bureau, the F.D.A., apparently is only requiring pre-market clearance of "less than 5% of medical devices and these are the hazardous ones". Dr. DasGupta, Director of the Canadian Bureau, offered no such reassurance to the somew h a t nervous gathering. As clinical chemists, through the Inter-Society Council of L a b o r a t o r y Medicine (ISCLM), we have a reasonable chance to help the Bureau develop reasonable tests and standards. This opport u n i t y should be seized. D. J. C A M P B E L L ,
Vancouver General Hospital. t
