TRACEABILITY PROJECT & IMPLEMENTATION FOR MEDICAL … · of the medical product, assigning it a serial number. The system allows: - Print labels online and record the destruction

TRACEABILITY

PROJECT & IMPLEMENTATIONFOR MEDICAL DEVICESIN ARGENTINA

ANDREA RODRIGUEZAPRIL 2018

AGENDA:

Anmat organizat ion

Traceabilit y Project

All MD chain & circuit

Medt ronic and proact ive at t it ude wit hindust ry

MINISTRY OFHEALTH: ORGANIZATION

ANMAT(Administ ración Nacional

de Medicamentos, Alimentos y Tecnología

Médica)

INAME(Inst ituto Nacional de

Medicamentos)

INAL(Inst ituto Nacional de

Alimentos)

DTM(Dirección de Tecnología

Medica)

a) defibrillators/cardiovertersb) electric stimulators for cochlear hearingc) intraocular lensesd) cardiac pacemakere) breast internal prosthesis

f) vascular coronary endoprosthesis (stent) g) hip prosthesis; andh) spine prosthesis

St ep 1FEBRUARY 2015

St ep 2AUGUST 2015

Medical Product Traceability SystemProvision 2303/2014 / Application

As a world leader in medical t echnology, solut ionsand services, Medtronic improves the health andlives of millions of people each year. We believe thatour deep clinical, therapeut ic and economicknowledge can help address the complex challenges- such as rising costs, aging populat ions and theburden of chronic diseases - that families and healthcare systems face. nowadays. But we can not do italone. Therefore, we assume the commitment tofind new ways of working as a team and develop solidsolut ions that offer bet ter result s to pat ients.Founded in 1949 as a provider of medical equipmentrepair services, Medtronic is today one of the largesttechnology, solut ions and medical servicescompanies globally. It employs more than 85,000people worldwide and offers services to doctors,hospitals and pat ients in more than 155 countries.Join our commitment to take health care "Together,further." For more informat ion, visit Medtronic.com.

MEDTRONIC ( ARGENTINA OFFICE)

About the company:

• How has t he process of adopt ing t he t raceabilit y regulat ions for t he company been?

A proactive attitude towards the traceability of Medical Devices

During the last 3-4 years we have been working very act ively and in conjunct ion with thehealth authorit ies in accordance with Provision No. 2303/2014 that establishes theTraceability System for Medical Products that must be implemented by all companies /hospital / inst itut ions, etc., involved in the dist ribut ion chain. dispensing and registeringmedical products under the Nat ional Administ rat ion ( Anmat). This provision was put intoeffect in April 2014, and the understanding and scope of the first stage was worked on.Later, we offered the health authorit ies and the Chamber of MedicalProducts training withcorporate speakers to understand how they are working with the FDA (US) and otherhealth authorit ies to align with internat ionalstandards.

Trainings were taken place throughout the country, many along with the health authority, for hospitals and dist ributors, on the issues that must be taken into account throughout the ent ire dist ribut ion chain. These t rainings were very well received, mainly by the dist ributors, since they valued all the informat ion that facilitates them and st reamlines the process of receiving and delivering the products. They were also very posit ive, taking into account the primary beneficiary: the pat ient .

•What are t he sectors of t he company t hat are involved in t he t raceabilit y process?

The process begins in the area of Regulat ory Affairs, from the regist rat ion of the GTIN in GS1. The regist rat ion in the internal t raceability 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 request ing the serializat ion and labeling of all t raceable products, informs the dispatches through our t raceability system connected to the ANMAT, and sends the products to the authorized depots/ warehouses

( GLN / CUFE- Physical Locat ion Code of the Establishment). It also informs the destruct ions of products through our t raceability system, and makes the remit tances ( remitos) including the GLN of Medtronic with seal or pre established.

Consistent with our mission to bring health care closer to a greater number of people, mult iple areas are involved in the constant improvement in the quality of manufacturing and dist ribut ion of our products

A proactive attitude towards the traceability of Medical Devices

The Customer Service area is responsible for the recept ion of orders and emergency management , registers the regist rat ion 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 dist ributor to the clinic 7 Hospital or inst itut ion where the product is going to be implanted in the pat ient .

What were t he challenges encountered during t he implementat ion?

At the beginning of the implementat ion of the second stage, which involved our coronary stents, we had to move into another solut ion for the serializat ion and aggregat ion process: creat ion of serial number (numeric and alphanumeric), sequent ial and random, personalized ( external serial numbers of import ).

Also implement the required security labels, with print ing on product ion line (both linear and 2 dimensional bar codes), and be able to record their destruct ion.

And finally, implement a computer system that resolves communicat ion with the ANMAT system, record and report the release of each product with a unique code, which performs the quarant ine regist rat ion and the record of the destruct ion of the unit when it was necessary. It is not easy to determine solut ions 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 pat ients

All t his was solved wit h a computer system, univocal ident ificat ion and product t raceabilit y. The univocal ident ificat ion is done under Datamat rix (or 2D) t echnology, by means of a label t hat is incorporated int o t he secondary container of t he medical product , assigning it a serial number. The system allows: - Print labels online and record the destruct ion of them. - Group units of the Products according to codes by packs, by pallets, register the

quarant ine and / or the destruct ion of the unit . - Register the dispatch or return of units associat ing them with a certain invoice or

bill. - Register complaints of units for theft , destruct ion, loss, re call, etc. - Carry out internal or t raceability reports based on the ident ificat ion code. - Send the mandatory informat ion electronically to the ANMAT.

The main benefit obtained by the company from the implementat ion of t raceability, is the eliminat ion of unfair compet it ion that counterfeiters mean, by combat ing unlicensed dist ributors and the market ing of counterfeit products.

Another great benefit of t raceability is that it allows the monitoring of the product unt il it is implanted in the pat ient , and this informat ion is very important so that the company can monitor and work more closely and part icularly with health.

Other general benefits that we can list are:

# Recovery of medical products from the market .# Reports of adverse events and post -market ing surveillance.# Follow up, t racking and security of the supply chain and control of

illegit imate products.# Reduct ion of medical errors.

• What are the benefits of traceability that had the greatest impact within the company?

# Streamlines hospital informat ion systems and claims data.# Increases the capacity of ANMAT on data systems in search of relevant product informat ion, allows evaluat ing the comparat ive effect iveness of records.# Planning for missing products and subst itut ions.# 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 them with much dynamism and proact ivity.

• What are the benefits of traceability that had the greatest impact within the company? Cont.

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-operat ional adjustment act ivit ies were carried out and in the second stage, at a more mature stage of the implementat ion, local serializat ion arrived and start -up of processes with coronary stents.

The road was not very long but it was very hard; there is st ill a long way to go and learn, but we know that it is a great benefit for pat ients to have a robust system that provides greater certainty when consuming t raceable and quality products.

We want to thank the dedicat ion of many people who formed the work team. We hope to cont inue maturing the project and lead this change to cont inue adding value to pat ients

• What are the benefits of traceability that had the greatest impact within the company? Cont.