1. SURVEILLANCE OF QUALITY, SAFETY AND EFFECTIVENESS OF ORTHOPEDIC IMPLANT Autors: Sergio Antonio Sirena, Maria da Graça Sant Anna Hofmeister, Ary Hungaretti Neto, Airton Tetelbom Stein, Mario Roberto Garcia Tavares. 3rd International Congress of Arthroplasty Registries Hyatt Regency Cambridge

2. Brazil: essentials Brazil is the largest country in South America It is the World’s fifth largest country (geographical and populational) Population: more than 190 milions Unified Health System with universal acess Brazilian National Health System spent US$ 64 million (1.4% of hospital expenditure) on products of osteosintesis and arthroplasty

3. OBJECTIVE The objective of the present study is to evaluate the implementation of surveillance of hip and knee arthroplasties in a public hospital as a proposal to a national registry. METHODS A systematic registry of arthroplasty of hip and knee has been carried out, as well as, the laboratory evaluation of the devices quality. Data collection has included a standard clinical form, the surgery briefing, in which consist information about the implanted products, labels to be able to screen according to the national legislation that includes the name and reference number of the product, the maker identification and/or dealer, lot and registry at ANVISA. The Brazilian Health Surveillance Agency (ANVISA) is the financial support.

4. RESULTS Arthroplasty Hip Primaries318 Revisions57 Reasons for Primary Femoral Neck Facture48% Primary Osteoarthrosis44% Type of Arthroplasty Total89% Partial10,4%

5. RESULTS Arthroplasty Knee Primaries71 Revisions10 Reasons for Primary Primary Osteoarthrosis94% Articular Post Fracture2,8% Type of Arthroplasty Without Patellar Substitution 80,7% Tricompartimental19,3%

6. CONCLUSION This research in a public hospital has demonstrated the factibility of a national registry of knee and hip arthroplasty. PROPOUSE A NATIONAL PROGRAM ASSESSMENT AND MONITORING OF MEDICAL DEVICES Systematize the assessment and monitoring of medical devices, improving processes and practices in the sanitary control of medical devices: –Orthopedic implant (hip and knee) –Pacemaker –stent –cochlear implant –Breast Implant

7. National registry of knee and hip arthroplasty

8. NATIONAL PROGRAM ASSESSMENT AND MONITORING OF MEDICAL DEVICES Registry of information pre and post surgical in hip and knee implants. Data of the institution and the healthcare professional. Identification of the patient. Demographic data. Characterization of preoperative patient history. Characterization of surgery in progress in their respective procedures and orthopedic implants. Traceability of orthopedic implants.

9. EXPECTED RESULTS In the pilot phase of RNA WEB obtain set of information that facilitate the construction of a computer system capable of being deployed on a national scale Enable traceability of orthopedic implants hip and knee Information about the life cycle of orthopedic implants Provide an important research tool for managers and health professionals Strengthen the system of pre-market controls, deployment and implementation of the control model aftermarket Improve and expand the capacity assessment of medical technologies in the country, thus contributing to the restructuring and consolidation of the Health Industrial Complex in Brazil and decision-making of the country health sectors process Optimize the actions that result in better quality products on the market, aimed at protecting and promoting the health of the population Giving greater articulation between the public entities involved in the development, production, marketing and use of health products through its sanitary control Increase the competitiveness of Brazilian industry

10. Agenda – and potential Agenda – future and potential Revision and adaptation of the RNA system, to implement the RNI of other strategic technologies: –Pacemaker; Stent; Breast Implant; Hearing Aids Thanks and contacts sergiosirena@hotmail.com graca.hofmeister@hotmail.com ungar@via-rs.net airton.stein@gmail.com mgtavares@gmail.com