127th October 2011

Medical Devices Training Journey in Portuguese Hospitals: Impact Assessment

Medical Devices Regulators

Necessity:Necessity:Approximation

InteractionCommunication

CooperationExchange 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 presentedIssues to be presented

Training JourneyTraining 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 LogisticsDiscussion 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

LogisticsLogistics

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

LogisticsLogistics

On the road …

Distribution of an enquiry on the 3 themes:

- before

- after

Traning PerformanceTraning 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)Enquiry Results (1)

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0

90,0

100,0

%co

rrec

t an

swer

s

A B C D E F G H I J K L M N O P Q

Hospital

Percentage of correct answers per hospital (after)

Enquiry Results (2)Enquiry Results (2)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

% c

orr

ec

t a

ns

we

rs

A B C D E F G H I J K L M N O P Q

Hospital

- 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)

before after

Enquiry Results (3)Enquiry Results (3)

72,3%

27,7% 17,2%

82,8%

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 ConclusionsEnquiry Conclusions

Training Sessions Conclusions (1)Training Sessions Conclusions (1)Hospitals 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)Training Sessions Conclusions (2)Hospitals 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)Training Sessions Conclusions (3)Hospitals 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

Thank you for your attention