1 27th October 2011 Medical Devices Training Journey in Portuguese Hospitals: Impact Assessment
Dec 16, 2015
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