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Traceability of biomedical devices What is traceability? Historical evidence of traceability can be found as far back as 5 thousand years before Jesus Christ, in the Elamite and Sumerian civilizations. Numerous donations made to the temples were marked with an attestation as a form of signature.. From a legal perspective, in France, the history of traceability begins May 6, 1969 with the publication of decree no. 69-422. This decree gave the "établissements départementaux d'élevage" (departmental breeding establishments) the responsibility of identifying and recording ovines, caprines and bovines, for the purpose of improving the races. Defined in 1987 by ISO standard 8402 as: "the ability to trace the history, application or location of an entity by means of recorded identification." Entity can designate:
When it refers to a medical device, the term "traceability" can refer to:
Traceability makes a primordial contribution to the different healthcare occupations, by solving problems of identification, authentication and geolocation of biomedical equipment. No doubt in the coming years, traceability will become increasingly valued in the management systems of healthcare institutions. In the medical sector, are there traceability obligations under the law? There is no law as yet forcing healthcare institutions to introduce a system of traceability, except in certain sensitive sectors such as pharmaceutical or blood products. On the other hand, it is in the medical sector that awareness of traceability issues is most advanced, as any error or deficiency can result in immediate and often irreversible harm. This is why traceability needs have given rise to numerous fields of "vigilance", such as Biovigilance or Cosmetovigilance, as well as Hemo, Infectio, Toxico, Reacto, Pharmaco, and Medical Device vigilance. In the form of medical device vigilance, it seeks to ensure the safety of patients, users and third parties, by indicating any incidents related to the use of medical devices. What does traceability of medical devices make possible (its objectives)? The primary objectives of medical traceability are: the identification, authentication and geolocation of medical devices and patients. It makes it possible to optimize the management and costs related to the storage and deployment of devices, while it guarantees the safety of the sick during their stay in the hospital by tracking the products administered to them. How can you introduce a traceability project in a healthcare institution? First evaluate the needs of the establishment. What types of hospital departments are making the request and for which jobs in particular? What are the medical devices to be traced, the information to be tracked and the resources required? Then, the capacity of the healthcare institution to meet this future requirement must be evaluated. What are the strengths and weaknesses of today's technologies with regard to traceability that impact the project? To conclude, note that the patient, as much as the supplier, will be part of this process. |
Newsletter IFCS - August 2009 IFCS launches its new site dedicated to the The only solution integrating the standards and references of the medical field. The new site contains documentation on computer-assisted biomedical management, our coaching services and information regarding the use of our Senergy Biomedical application. All to meet your needs for managing maintenance of biomedical devices. IFCS Event: Traceability of Biomedical Equipment: Issues and Challenges Thursday September 17, 2009, IFCS is organizing a one-day training session at Hotel Novotel Montreal. This event is designed for all managers of healthcare institutions, and addresses the question of traceability which is central to the concerns of the healthcare system.
Novotel Montreal 
A few interesting links concerning traceability in the field of biomedical engineering: Trace News Info - La traçabilité dans le domaine de la santé GS1 France - Traçabilité et santé : nouvelle réglementation Logistique.com - La très longue histoire de la traçabilité Industrie Canada - Instruments médicaux '' The incessant progress of surgery, medical science and pharmaceuticals is worrisome: what are we going to die of in twenty years?" Journal 1992-1996 Quotations of Philippe Bouvard |
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