Biomecanica's PostMarket Surveillance
Biomecanica is the first industry of orthopedic implants in Brazil that has a post marketing surveillance department. The surveillance system used is an adaptation of the concept proposed by ANVISA, however its focus is directed to the distribution network, and the continuous improvement of products and processes (see picture bellow).
Management of adverse events and complaints reports
The department has established procedures to attend complains and receive the notification of adverse events, so that the investigation of the causes of the occurrence could be done quickly and efficiently.
Thus, after receiving the complaint, all stages of the manufacturing process are investigated so that specific points are then discussed by the Technical Board, which evaluates and implements corrective actions in each case.
Corrective Action Management
The Technical Board is responsible for establishing strategies to prevent or minimize the possible risks that endanger the patient’s safety, and avoid similar risks that may occur in other places that are under the same conditions.
Currently, the Technical Board of the Post-Marketing Surveillance Department consists of the following members:
Coordinator of the Post Marketing Surveillance
Responsible Technician
Commercial Director
Production Director
Person in charge for the Quality Control System
Marketing Manager
Production Manager
Process Engineer Manager
Product Manager
Quality Control System Manager
Shipment Manager
Departamento Jurídico
Medical Consultants
The corrective actions taken by the technical board has been an efficient tool for continuous improvement.
Statistical Analysis
The management of complaints and adverse events led to the creation of a statistical database. With this database, it is possible to:
Evaluate the urgency of corrective and preventive actions
Evaluate the impact of corrective and preventive actions
Evaluate the incidence of complaints per client
Evaluate the incidence of complaints per application
Evaluate the incidence of complaints per product
Patient’s Card – Access to Information and Monitoring
In Brazil, doctor low salaries, and the inefficient monitoring of ANVISA created conditions for the use of unethical trade between distributors and doctors as well as the emergence of illegal companies.
Thus, it is common to see newspapers and TV news about the corruption schemes, and information about the low quality prostheses; as it happened in October 2007, after an operation triggered by the Federal Police.
The major consequences were the distrust in the population toward the national products, an increase in litigations against doctors, and an increase in the manufacturers, distributors and hospitals inspection conducted by ANVISA.
Therefore, in February 2008, Biomecânica the “Patient´s Card”, reiterating its commitment to ethics and the quality of products produced.
The patient´s card allows the patients to get in touch with Biomecânica, and obtain the following information about the products:
Registration in ANVISA
Product Certification
Biomecânica´s Certifications
Raw Material
Product Features
Leaflet information
Post Marketing Studies
The post marketing studies are important for the registration revalidations, and fundamental to the analysis of product obsolescence. Currently, the post-marketing surveillance department is working with the Project & Development department, to defined the goals of the coming years, and thus enhance the production of post-marketing studies.
Recalls
The company has well-defined structure and procedures for performing recalls, based on existing standards and requirements in Brazil. |
