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Post-marketing Vigilance on Medical Devices

Post-marketing Vigilance on Medical Devices. Milan, dd-mon-2011. Ilaria Bonari Manager for Pharmacovigilance and Vigilance for Medical Devices. Agenda. Vigilance: what & why Vigilance: how & when Some “NOTES”. Agenda. Vigilance: what & why Vigilance: how & when Some “NOTES”.

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Post-marketing Vigilance on Medical Devices

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  1. Post-marketing Vigilance on Medical Devices Milan, dd-mon-2011 IlariaBonari Manager for Pharmacovigilance and Vigilance for Medical Devices

  2. Agenda • Vigilance: what & why • Vigilance: how & when • Some “NOTES”

  3. Agenda • Vigilance: what & why • Vigilance: how & when • Some “NOTES”

  4. Vigilanza: cosa & perché Group of the activities aimed at ensuring that all the information relating to quality, safety, efficacy shortfalls of Alcon products sold in Italy, received in writing, electronically, or verbally, are collected, investigated, assessed and, if required, notified to the Competent Authorities

  5. Vigilance: what & why  Compliance Alcon quality policy / procedures * supply information and support to customers better knowledge of our products improve our image *IO-RA-09 Rev 10 “Post-marketing Vigilance” *IO-RA-07 Rev 03 “Handling product complaints”

  6. Vigilance: what & why  Legal requirement undermining all the efforts of the company to keep a product on the market failure to comply with the relevant law* * Legislative decree no. 37 of 25/01/2010 “Implementation of the 2007/47/EC Directive relating to medical devices” * MEDDEV 2.12-1 rev 6 “Guidelines on a medical devices vigilance system” in force since 20/03/2010

  7. Vigilance: what & why  Compliance Alcon quality policy/procedures  Legal requirement safeguard of public health assessment Risk/Benefit of our products

  8. Vigilance: what & why Group of the activities aimed at ensuring that all the information relating to quality, safety, efficacy shortfalls, of Alcon products sold in Italy received in writing, electronically, or verbally, are collected, investigated, assessed and, if required, notified to the Competent Authorities

  9. Vigilance: what & why Group of the activities aimed at ensuring that all the information relating to quality, safety, efficacy shortfalls, of Alcon products sold in Italy received in writing, electronically, or verbally, are collected, investigated, assessed and, if required, notified to the Competent Authorities COMPLAINTS

  10. Vigilance: what & why Some examples.... “2 INFINITI CASSETTES have given suction problems during the priming test procedure” “After implantation of a RESTOR lens the patient complained about fuzzy vision” “After using DISCOVISC microscopic particles have been found near the incision tunnel of the operated eye” “Upon opening of the container a MA60AC lens with broken haptic was found”

  11. Vigilance: what & why Among all the ... COMPLAINTS

  12. Vigilance: what & why (*)those that have an impact on the health of the patient are called COMPLAINTS (*) incidents … and must be reported to the Competent Authority

  13. Vigilance: what & why … returning to the examples … “After implantation of a RESTOR lens the patient complained about fuzzy vision” “2 INFINITI CASSETTES have given suction problems during the priming test procedure” “After using DISCOVISC microscopic particles have been found near the incision tunnel of the operated eye” “Upon opening of the container a MA60AC lens with broken haptic was found”

  14. Vigilance: what & why incidents Any dysfunction or deterioration of the characteristics and/or performance, as well as any shortfall in labelling or in the directions for use, directly or indirectly, of a device, which may cause or have caused the death, or a serious worsening of the health of the patient, an user or of anyone else. OBLIGATION to NOTIFY the Competent Authority

  15. Vigilance: what & why Notification times * Manufacturer Physical or corporate individual responsible for the design, manufacturing, packaging, labelling of a device for the purpose of introduction in the market under their own name.

  16. Agenda • Vigilance: what & why • Vigilance: how & when • Some “NOTES”

  17. Vigilance: how & when (e.g. SSP, Customer Service, ...) Customer COMPLAINT What information should be acquired during the 1st contact with the customer? • product name, lot number, availability of the sample* • accurate description of the event (who, what, where, when, why) • notification date • notifier details (surname and name, telephone number) • patient details (initials, sex, age), if the case • status of health and prognosis of the patient, if the case * NOTE 1

  18. Vigilance: how & when (e.g. SSP, Customer Service, ...) Customer 1 gl COMPLAINT Vigilance Manager Who should this information be forwarded to? toIlaria Bonari Vigilance Manager by telephone 02 81803250 – 346 8485362 by e-mail TO ilaria.bonari@alconlabs.com Cc regulatory.italia@alconlabs.com shared by all members of Regulatory Affairs … and by when? within 1 working day from the date one becomes aware of the issue

  19. Vigilance: how & when (e.g. SSP, Customer Service, ...) Customer 1 gl COMPLAINT Vigilance Manager 1/5 gl Opening of complaint (Trackwise system) Complaint monitor Product Safety Department Quality Assurance c/o production site • review of lot documentation • sample analysis • possible corrective actions decides: • if the complaint is and the notification times • possible FOLLOW UP * Incident 2/10/30 dd * NOTES 2 and 3

  20. Agenda • Vigilance: what & why • Vigilance: how & when • Some “NOTES”

  21. NOTE 1: how to forward the sample • Used Medical Devices • Wear gloves, protective goggles, and repeatedly wash hands and other body parts exposed to contamination; • Insert the product in a primary sealed packaging, and affix a label stating “Risk of contamination”; • Place absorbent material between the primary and secondary packaging (e.g. blotting paper); • Place the first sealed container inside the second sealed container; affix a label stating “Risk of contamination”, wrap everything in padded or corrugated cardboard.

  22. NOTE 1: how to forward the sample • Sharp tools(e.g. probes, handpieces, micro-scalpels and cannulas) • Line and protect all the sharp parts, particularly the tips; • Place in a cut and perforation proof container to avoid that the tips may pierce and protrude from the container during shipment and handling. • If the devices have been used, also follow the instructions of paragraph "Used Medical Devices".

  23. NOTE 1: how to forward the sample BSS, large sizes Already used BSS containers: remove the installed administering device; when preparing the administering device also follow the instructions for paragraph “Sharp tools”. • Glass containers not returned in the appropriate Alcon container • Wrap in protective material (packaging film) • Place the container in another sealed container (pressure sealed, or thermo-welded plastic container, tied plastic bag) • Wrap everything in padded or corrugated cardboard and Affix a label stating “Fragile”.

  24. NOTE 2: HealthMin & health operator Also public and private HEALTH OPERATORS must notify the Ministry of Health of any incidents involving a device, implementing the same procedures applicable to the manufacturer (notification criteria, times, etc.). The Ministry of Health communicates to the MANUFACTURER the notifications of incidents from HEALTH OPERATORS, should these have not yet done so, ticking the appropriate box on the relevant form. Art. 9 Legislative Decree 46/97 “Implementation of the 2007/47/EC directive relating to medical devices” Information on incidents occurring after the introduction in the market

  25. NOTE 3: FOLLOW UP & Q activities • It is possible that the Product Safety Department • may require further information • (FOLLOW UP activities) from the involved health personnel • Investigation questionnaires • Medical Device • Delivery Systems • IOL • ACRYSOF Phakic • ACRYSOF ReSTOR • ACRYSOF TORIC • PARTICLES SSP COLLABORATION filling of COMPLAINT FOLLOW-UP QUESTIONNAIRE

  26. NOTE 4: particular cases requiring notification Also CASES of: • ERRORS OF USE • Action, omission of an action, producing results different from those indicated by the MANUFACTURER or expected by the Operator of the MEDICAL DEVICE. • ABNORMAL USE • Action, or omission of an action, by an OPERATOR or USER of a MEDICAL DEVICES, resulting from a conduct that goes beyond any possibility of control of the risk by the MANUFACTURER. involving Alcon medical devices must be notified inside the company following the same procedures of complaints.

  27. Thanks for your attention … keep up the good work!!!

  28. Questions ????

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