1 27th October 2011 Medical Devices Training Journey in Portuguese Hospitals: Impact Assessment

Medical Devices Regulators Necessity: Approximation Interaction Communication Cooperation Exchange of Experiences Medical Devices Users Users vs Regulators

a) What to buy? Is it conform? Requirements for verification of conformity ▪ Labelling/IFU ▪ Declaration and Certificates of Conformity b) Sometimes in Portuguese newspapers there are news on the development of a national medical device, which included clinical investigations taking place on a Portuguese Hospital. Infarmed was not notified on these clinical investigations. Clinical investigation c) Incident underreporting Vigilance Issues to be presented Training Journey

1- Where In Infarmed or In each Hospital Decision: Decision: In each Hospital in order to facilitate the participation and to reduce costs. 2- Contact point a) Supply Department, Hospital Pharmacy, Ethics Commitee, investigators, nurses, physicians and … or b) Management Board Decision: Decision: Management Boards – to promote participation and to avoid the existence of different contact points in the same Institution, considering the diversity of themes and target audience. Discussion of Logistics

 60 letters sent – April 2010  26 spontaneous answers Second contact: Second contact: - New contact points: Training centers - Arranging training sessions scheduling (day; morning/afternoon) vs availability - Trying to schedule sessions for the same geographic area, so as to visit nearby Hospitals Logistics

 May 2010 to January 2011  North to South of Portugal  Travels arrangements ▪ 17 sessions took place (including 21 Hospitals) ▪ 2 sessions did not take place due to lack of participants Logistics On the road …

Distribution of an enquiry on the 3 themes: - before - after Traning Performance Enquiry purpose: - Evaluate if the information clear enough - Evaluate the previous knowledge of health profissionals on MDs legislation - Requirements for verification of conformity - Clinical Investigation - Vigilance

Percentage of correct answers per Hospital (before) Enquiry Results (1)

Percentage of correct answers per hospital (after) Enquiry Results (2) - The greater improvement was registered in the lowest (prior) ranking Hospitals. - Uniform level of knowledge - 80% average of correct responses.

Average of correct answers (standard deviation = 6,27) (standard deviation = 4,62) beforeafter Enquiry Results (3) Correct Incorrect / No answer

Most frequent wrong answer: Infarmed authorizes the market placement of medical devices Great diversity of professionals Great diversity of issues Enquiry – before - % correct answers varies between 59,4% and 81,3% Enquiry – after - % correct answers varies between 71,7% and 89,3% Difference between after and before - average 10,5%, varies between 2,4% e 26% Generally and considering each Hospital the session was profitable (11 Hospitals had a difference  5%) Enquiry Conclusions

Training Sessions Conclusions (1) Hospitals In general, the program was considered good More training sessions are needed Too much information in a short time More specific training sessions are needed More examples and case studies should be presented Concern: Reprocessing of single-use medical devices

Some lack of information on Infarmed’s role in regulating medical devices, on the level of information available at the website and on the possibility of directly contacting, at any time, by phone or e- mail our services Lack of knowledge on medical devices specific terminology In general, the nursing staff is most concerned with medical devices Physicians are less receptive In most situations, in case of problems, professionals contact directly with the distributor, and do not notify Infarmed There were cases where professionals felt that they had contributed to the improvement/development of medical devices by reporting problems Training Sessions Conclusions (2) Hospitals

Opportunity of learning/seeing in loco the Hospital’s reality (concerns/problems) Visited Hospitals Visited Sterilisation Facilities Exchange of Experiences Good and bad Training Sessions Conclusions (3) Hospitals

Opportuniy to adapt existing national legislation considering some critical points identified by health professionals (ex: loan of reusable MDs by distributors to Hospitals – surgical instruments) Established new contact points with Hospitals Participation in other sessions by invitation and in collaboration with Hospitals Increase the number of complaints related to medical devices Increase the number of requests for information Increase the number of incident notifications Training Sessions - Practical Results

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