TRACEABILITY PROJECT & IMPLEMENTATION FOR MEDICAL DEVICES IN ARGENTINA ANDREA RODRIGUEZ APRIL 2018

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1 TRACEABILITY PROJECT & IMPLEMENTATION FOR MEDICAL DEVICES IN ARGENTINA ANDREA RODRIGUEZ APRIL 2018

2 AGENDA: Anmat organizat ion Traceabilit y Project All MD chain & circuit Medt ronic and proact ive attitudewith indust ry

3 MINISTRY OFHEALTH: ORGANIZATION ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) INAME (Instituto Nacional de Medicament os) INAL (Instituto Nacional de Aliment os) DTM (Dirección de Tecnología Medica)

4 Medical Product Traceability System Provision 2303/2014 / Application a) defibrillators/cardioverters b) electric stimulators for cochlear hearing c) intraocular lenses d) cardiac pacemaker e) breast internal prosthesis St ep 1 FEBRUARY 2015 f) vascular coronary endoprosthesis (stent) g) hip prosthesis; and h) spine prosthesis St ep 2 AUGUST 2015

5 About the company: MEDTRONIC ( ARGENTINA OFFICE) As a world leader in medical t echnology, solutions and services, Medt ronic improves t he healt h and lives of millions of people each year. We believe that our deep clinical, therapeutic and economic knowledge can help address the complex challenges - such as rising costs, aging populations and the burden of chronic diseases - that families and healt h care systems face. nowadays. But we can not do it alone. Therefore, we assume the commitment to find new ways ofworking as a team and develop solid solutions t hat offer bet ter result s to patients. Founded in 1949 as a provider of medical equipment repair services, Medt ronic is t oday one of t he largest technology, solutions and medical services companies globally. It employs more than 85,000 people worldwide and offers services to doctors, hospit als and pat ient s in more t han 155 count ries. J oin our commitment to take healt h care "Toget her, furt her." For more informat ion, visit Medt ronic.com.

6 A proactive attitude towards the traceability of Medical Devices How has t he process of adopt ing t he t raceabilit y regulat ions for t he company been? During the last 3-4 years we have been working very act ively and in conjunction with the healt h aut horit ies in accordance wit h Provision No. 2303/ 2014 t hat est ablishes t he Traceabilit y Syst em for Medical Product s t hat must be implemented by all companies / hospit al / institutions, etc., involved in the distribution chain. dispensing and registering medical product s under t he Nat ional Administ rat ion ( Anmat ). This provision was put into effect in April 2014, and the understanding and scope of the first stage was worked on. Later, we offered the he alt h authorit ies and the Chamber ofme dical Products t raining wit h corporate speakers to understand how they are working wit h the FDA (US) and other he alt h authorit ies to align wit h internationalstandards. Trainings were taken place throughout the country, many along with the health authority, for hospitals and distributors, on the issues that must be taken into account throughout the entire distribution chain. These trainings were very well received, mainly by the distributors, since they valued all the information that facilitates them and streamlines the process of receiving and delivering the products. They were also very positive, taking into account the primary beneficiary: the patient.

7 What are t he sect ors of t he company t hat are involved in t he t raceabilit y process? Consistent with our mission to bring health care closer to a greater number of people, multiple areas are involved in the constant improvement in the quality of manufacturing and distribution of our products The process begins in the area of Regulat ory Affairs, from the registration of the GTIN in GS1. The registration in the internal traceability system is confirmed and the data is confirmed in the ANMAT system. Then comes into play the area of Logist ics and Operat ions, which is responsible for requesting the serialization and labeling of all traceable products, informs the dispatches through our traceability system connected to the ANMAT, and sends the products to the authorized depots/ warehouses ( GLN / CUFE- Physical Location Code of the Establishment). It also informs the destructions of products through our traceability system, and makes the remittances ( remitos) including the GLN of Medtronic with seal or pre est ablished.

8 A proactive attitude towards the traceability of Medical Devices The Cust omer Service area is responsible for the reception of orders and emergency management, registers the registration of new clients and requests the inclusion of the Medtronic GLN in the commercial document that will be sent to the clients. The internal process is completed when the product moves into the dist ribut ion chain, from the distributor to the clinic 7 Hospital or institution where the product is going to be implanted in the patient.

9 What were t he challenges encount ered during t he implement at ion? At the beginning of the implementation of the second stage, which involved our coronary stents, we had to move into another solution for the serialization and aggregation process: creation of serial number (numeric and alphanumeric), sequential and random, personalized ( external serial numbers of import). Also implement the required security labels, with printing on production line (both linear and 2 dimensional bar codes), and be able to record their destruction. And finally, implement a computer system that resolves communication with the ANMAT system, record and report the release of each product with a unique code, which performs the quarantine registration and the record of the destruction of the unit when it was necessary. It is not easy to determine solutions when it comes to the health of people, so all this led to an arduous decision-making process thinking mainly about the effect that each of the policies implemented would have on our patients

10 All t his was solved wit h a comput er syst em, univocal ident ificat ion and product t raceabilit y. The univocal ident ificat ion is done under Dat amat rix (or 2D) t echnology, by means of a label t hat is incorporat ed int o t he secondary cont ainer of t he medical product, assigning it a serial number. The syst em allows: - Print labels online and record the destruction of them. - Group units of the Products according to codes by packs, by pallets, register the quarantine and / or the destruction of the unit. - Register the dispatch or return of units associating them with a certain invoice or bill. - Register complaints of units for theft, destruction, loss, re call, etc. - Carry out internal or traceability reports based on the identification code. - Send the mandatory information electronically to the ANMAT.

11 What are the benefits of traceability that had the greatest impact within the company? The main benefit obtained by the company from the implementation of t raceabilit y, is t he elimination of unfair compet it ion t hat counterfeit ers mean, by combating unlicensed distributors and the marketing of counterfeit products. Another great benefit of traceability is that it allows the monitoring of the product until it is implanted in t he patient, and t his information is very import ant so that the company can monitor and work more closely and particularly with health. Other general benefits that we can list are: # Recovery of medical products from the market. # Reports of adverse events and post-marketing surveillance. # Follow up, tracking and security of the supply chain and control of illegit imat e product s. # Reduction of medical errors.

12 What are the benefits of traceability that had the greatest impact within the company? Cont. # St reamlines hospit al informat ion syst ems and claims dat a. # Increases the capacity of ANMAT on data systems in search of relevant product information, allows evaluating the comparative effectiveness of records. # Planning for missing products and substitutions. # We are convinced that the Traceability of Medical Products is already part of the present, to stay, surely with much more advanced stages of the process, but to reach that future we need to take the first steps and Medtronic has given t hem wit h much dynamism and proactivit y. We were able to comply with the scheduled deadlines. The first stage with less complexity since our pacemakers and cardioverter-defibrillators are already manufactured serialized, with which less-operational adjust ment activit ies were carried out and in the second stage, at a more mature stage of the implementation, local serialization arrived and start-up of processes with coronary stents.

13 What are the benefits of traceability that had the greatest impact within the company? Cont. The road was not very long but it was very hard; there is still a long way to go and learn, but we know that it is a great benefit for patients to have a robust system that provides greater certainty when consuming traceable and quality products. We want to thank the dedication of many people who formed the work team. We hope to continue maturing the project and lead this change to continue adding value to patients

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