View
213
Download
1
Category
Preview:
Citation preview
1
The role of competent authorities in Bio Vigilance
M. Jesus Felix (mjfelix@catsalut.cat)Medical Coordinator of Tissues and Cells
Catalan Transplant Organization on behalf of Catalan Health Services .
Health Department. Government of Catalonia
2
SURVEILLANCE(BIO VIGILANCE)
3
Catalonian reporting circuit
Urgentevents:
before 24 h
Non urgent events:
before 36 h
4
Reporting Circuit
CatalonianHospitals
Other SpanishHospitals
EuropeanHospitals
5
6
SAR in recipients
7
SAR in living donor
8
Incident
9
SAE
10
Serious adverse effect: affects the product and /or
the process
Serious adverse reaction: affects the person (the donor
or the recipient)
DEFINITIONS
11
Evaluation of the event
Case investigation Risk evaluation
Notification: Clinical Report
Corrective implementing measures if required
Solving the case to prevent and register it
12
The role of Competent authorities (CA)
Clinical notification report sent to CA
Analyzing
and investigating
Ask for more /new data (if necessary)
To TE To Transplant Responsible
Donor data Tissue data
Contralateral cornea : Transplanted and results
or not transplanted. Wy?
- SAE/SAR explanation - Intervention data
- First measures applied -Recipient status
- Consequences for recipient
13
Implementing Measures
• With all data and documents available, it becomes:
An evaluation of possible damage is made
Appropriate measures are taken
Disseminating information to all involved areas
and responsible
Close the case
And introduced SAE/SAR in BV Register
An evaluation of possible damage is made
Appropriate measures are taken
Disseminating information to all involved areas
and responsible
Close the case
And introduced SAE/SAR in BV Register
14
CLINICAL CASES
15
Avaluation of an Event
• Every event should be analyzed in: – Severity.– Imputability.– Impact.
16
Severity
17
Imputability
18
Impact Assessment• Step 1: assessing likelihood of occurrence/
recurrence of SAR/E:
19
Impact Assessment• Step 2: assessing Impact /Consequences of
SAR/E should it recur.
20
Impact Assessment• Step 3: Applying the Impact Matrix.
21
Impact Assessment• Step 4:• The response of a tissue or cell bank or a health authority to a specific
SAE/SAR should be proportionate to the potential impact as assessed by the matrix described.
• GREEN: The tissue or cell bank to manage the corrective and preventive actions and the health authority to file the report and keep a ‘watching brief’.
• YELLOW: Requires interaction between the tissue or cell bank and the health authority which may request an inspection that focuses on the SAE/SAR and corrective and preventive actions to be followed up, including evidence of effective recall, where necessary. Written communication to professionals working in the field might be appropriate.
• RED: Health authority will generally designate representatives to participate in developing or approving the corrective and preventive action plan, possibly a task force to address broader implications. Inspection, follow up and written comm
22
MADE-UP EXAMPLE
23
• A cornea recipient from United Kingdom developed vCJD symptoms five years after the graft. SAE or SAR??
• Do you need to measure severity and imputability?
• And the impact assessment tool?
24
• A cornea recipient from United Kingdom developed CJD symtomes five years after the graft. SAE or SAR?? SAR
• Do you need to measure severity and imputabilily? YES
• And the impact assessment tool? YES
25
Severity
26
Imputability
27
Impact Assessment• Step 1: assessing likelihood of occurrence/
recurrence of SAR/E:
28
Impact Assessment• Step 2: assessing Impact /Consequences of
SAR/E should it recur.
29
Impact Assessment• Step 3: Applying the Impact Matrix.
30
CASE 1
31
• A piece of bone identified as distal femur was sent to a hospital to be grafted. When the professionals opened the graft they discovered it was a proximal femur.
• What would you do?
• Is it a SAE or SAR?
32
• The tissue was grafted without any complication for the recipient.
• The label and package procedure of the tissue establishment was revised.
33
CASE 2
34
• Donor of heart valves and corneas. The first determination RPR was negative. But in a second determination, it was TPHA + (IgG +, IgM-). One cornea was already grafted.
• What would you do?
• SAE or SAR?
35
• Another analysis was performed, and it was also positive.
• It was a past infection.
36
• The corneas were kept in Optisol®
• No complication in the recipient.
37
CASE 3
38
• An haematologist reported a neumothorax while setting a central catheter in the subclavian for obtaining peripheral blood for an autologous HSCT.
• What would you do?
• SAE or SAR?
• Can the event be imputed to the procedure?
39
• The patient stayed in hospital where he received medical treatment and he recovered completely. The transplant was performed.
40
CASE 4
41
• Two tissue recipients presented a positive culture to Enterobacter cloacae in the exudate of the surgical wound.
• What would you do?
42
• In both cases the antiobiogramme was the same, and it was sensible to Gentamicina (an antibiotic used for cleaning the bones at the tissue bank).
• In one recipient the tissue culture was negative but the site culture wasn’t performed.
• In the other recipient no culture was performed.
• What else would you do?? SAE or SAR?
43
• They contacted the other professionals that had grafted tissues from the same donor. The cultures in all cases were negative.
• A bone piece stayed at the tissue establishment and it was sent to be analyzed. The result was also negative.
• They concluded that it was a surgery contamination.
44
• They concluded that it was a surgery contamination.
• Both recipients got antibiotic treatment and they recovered completely.
45
CASE 5
46
• The results of the anatomical pathology informed that a tissue donor had an adenocarcinoma.
• It was a heart valve and ocular donor.
• One cornea was grafted, the other was discarded due to quality reasons. Heart valves were stored at the bank.
• What would you do? SAE or SAR?
47
• Follow up of the recipient. He hasn’t developed any reaction.
48
CLINICAL CASES
Recommended