medical products of human origin
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3 Patient Safety Programme
Health Systems and Innovation
Medical Products of Human Origin
Jose R. Nuñez MD, PhDMedical Officer Transplantation
4 Patient Safety Programme
Health Systems and Innovation
Clinical transfusion
Transfusion safety
Haemovigilance
5 Patient Safety Programme
Health Systems and Innovation
6 Patient Safety Programme
Health Systems and Innovation
Medical Products of Human Origin :
from human to human
7 Patient Safety Programme
Health Systems and Innovation
8 Patient Safety Programme
Health Systems and Innovation
9 Patient Safety Programme
Health Systems and Innovation
10 Patient Safety Programme
Health Systems and Innovation
11 Patient Safety Programme
Health Systems and Innovation
Medical Products of Human Origin :
from human to human
from human for humans
12 Patient Safety Programme
Health Systems and Innovation
Clinical transfuion
Transfusion safety
Haemovigilance
13 Patient Safety Programme
Health Systems and Innovation
107 millions
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Health Systems and Innovation
Kidney Liver Heart Lung Pancreas
76118 23721 5741 4278 2564
2011 GKT/ GODT
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011
≈ 112,600 organs transplanted(≈ 10% of estimated global needs)
≈ 5.1 % increase over 2010
103 countries reported to the Global Observatory on Organ Donation and TransplantationSouth Africa, India and China - are 2010 estimates
15 Patient Safety Programme
Health Systems and Innovation
Similarities• Original procurement from a human donor.
Need to meet essential ethical and safety requirements inherent to their human origin
• Living donor
16 Patient Safety Programme
Health Systems and Innovation
Kidney Liver Heart Lung Pancreas
76118 23721 5741 4278 2564
2011 GKT/ GODT
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011
≈ 112,600 organs transplanted(≈ 10% of estimated global needs)
103 countries reported to the Global Observatory on Organ Donation and TransplantationSouth Africa, India and China - are 2010 estimates
17 Patient Safety Programme
Health Systems and Innovation
Kidney Liver Heart Lung Pancreas
76118 23721 5741 4278 2564
Living Donor 32350
Living Donor
4222
42,5% 17,8%
2008 GKT/ GODT
≈ 112,600 organs transplanted(≈ 10% of estimated global needs)
103 countries reported to the Global Observatory on Organ Donation and TransplantationSouth Africa, India and China - are 2010 estimates
Global Observatory on Donation and Transplantation Organs Transplanted Globally in 2011
18 Patient Safety Programme
Health Systems and Innovation
Similarities• Original procurement from a human donor.
Need to meet essential ethical and safety requirements inherent to their human origin
• Living donor• Without alternative of comparable benefit• Often last option• “Radical” treatment• Cross border
19 Patient Safety Programme
Health Systems and Innovation
• 1.9 million tissue grafts distributed by AATB accredited tissue
banks each year
• > 200,000 tissues grafts a year in Germany
• 46,000 corneas distributed by Sri Lanka Eye Bank over 30
years
• > 100,000 tissues imported into Korea in one year
• 5,000 cornea transplants in Italy each year
• 20,000 tissue transplants in France in one year
Deirdre Fehily, Kuala Lumpur, WPR Regional Meeting 8-10 June 2009
Tissues
20 Patient Safety Programme
Health Systems and Innovation
Similarities• Original procurement from a human donor.
Need to meet essential ethical and safety requirements inherent to their human origin
• Living donor• Without alternative of comparable benefit• Often last option• “Radical” treatment• Cross border• Scanty resource
21 Patient Safety Programme
Health Systems and Innovation
22 Patient Safety Programme
Health Systems and Innovation
self-sufficiency
…. is the satisfaction of the transplantation needs of a given population, using resources obtained from within that population.
transplantation needs of a given popul blood
23 Health Systems Policies and Workforce
Health Systems and Innovation
ClinicalProcedures
Donor
Professionals
Patient Recipient
Society / Authority
To meet patients needs:
1. Government responsibility
• Organization
2. Equity
• In the burden of donation
• In allocation (UHC) WHA63.22
3. Education
• To donation
• To prevention
4. Trust of the Public
• Transparency
• Professionalism
Donation is a civic gesture, an expectation but not an exception
The Self-Sufficiency ParadigmThird Global Consultation on Organ donation and Transplantation Madrid May 2010
24 Health Systems Policies and Workforce
Health Systems and Innovation
ClinicalProcedures
24
Professionals Authorities
The Magnificent Seven, John Sturges,1960
25 Patient Safety Programme
Health Systems and Innovation
WHO Organization-wide Initiative for Medical Products of Human Origin
26 Patient Safety Programme
Health Systems and Innovation
“ Health products of an exceptional nature”
WHO Organization-wide Initiative for Medical Products of Human Origin
27 Patient Safety Programme
Health Systems and Innovation
* GUIDING PRINCIPLE 10
WHO Guiding Principles On Human Cell, Tissue And Organ Transplantation
Endorsed by the sixty-third World Health Assembly in Resolution WHA 63.22
28 Patient Safety Programme
Health Systems and Innovation
WHO Organization-wide Initiative for Medical Products of Human Origin
Why “product” ?
Outcome of a process,
quality management
3 Global Governance Tools for MPHO
29 Patient Safety Programme
Health Systems and Innovation
Three Global Governance Tools for MPHO
1. Global set of PRINCIPLES inherent to the Human Origin
2. Global use of coding systems for all MPHO
3. Global collaborative tools for Vigilance and Surveillance
30 Patient Safety Programme
Health Systems and Innovation
1. Global set of PRINCIPLES inherent to the Human Origin
Prohibition of financial gain on the human body and its parts as such,
recognizing that procurement through financial incentives and profit on some
human body parts as such (e.g. plasma and gametes) is not forbidden in
some countries, in which case respect of other requirements starting with
transparency is even more important;
Responsibility for the provision of MPHO placed with authorities and through
them the individual citizen and resident;
Genuine consent of donors and recipients;
Protection of the incompetent
Equity as a goal, in the burden of donation and in allocation of MPHO
Use of MPHO justified by evidence and absence of comparable alternative;
31 Patient Safety Programme
Health Systems and Innovation
Prohibition of financial gain along European requirements
Council of Europe Convention on Human Rights and Biomedicine (Oviedo 1997) and Additional Protocol concerning Transplantation of Organs and Tissues of Human Origin
Draft Council of Europe Convention against Trafficking in Human Organ (Council of Europe - CDPC)
Charter of Fundamental Rights of the European Union Citizen
1. Global set of PRINCIPLES inherent to the Human Origin
32 Patient Safety Programme
Health Systems and Innovation
Three Global Governance Tools for MPHO
1. Global set of PRINCIPLES inherent to the Human Origin
3. Global collaborative tools for Vigilance and Surveillance of MPHO
2. Global use of coding systems for all MPHO
Traceability and accountability mandated throughout the
process, from donors to recipients, including long term outcomes
and vigilance and surveillance under the oversight of national
competent authorities;
Transparency and openness to scrutiny indispensable even if
confidentiality and anonymity when required must be preserved;
33 Patient Safety Programme
Health Systems and Innovation
2. Global use of coding systems for all MPHO
Allow: easier information transfer + traceability + interoperability across MPHO, and
between countries in routine and emergency + cost containment
From the transfusion experience Coding is a priority
34 Patient Safety Programme
Health Systems and Innovation
2. Global use of coding systems for all MPHO
35 Patient Safety Programme
Health Systems and Innovation
• Terminology• Nomenclature
• Translations• Coding• Unique identifiers
• Centers
• Donations
• Recipient(s)
• Formatting standards• Delivery means• Inter-operability across
Medical Products of Human Origin
Information Standard for Blood and Transplant 128
SAFETY
ETHICS
36 Patient Safety Programme
Health Systems and Innovation
Three Global Governance Tools for MPHO
1. Global set of PRINCIPLES inherent to the Human Origin
2. Global use of coding systems for all MPHO
3. Global collaborative tools for Vigilance and Surveillance of MPHO
Duty to constantly optimize the safety, quality and efficacy of
procurement, process and clinical application of MPHO
37 Patient Safety Programme
Health Systems and Innovation
Dr Luc Noël EHT/CPR "Clinical Procedures"
Bologna Initiative for Global Vigilance and Surveillance
BIG V&S
38 Patient Safety Programme
Health Systems and Innovation
http://www.notifylibrary.org/
39 Patient Safety Programme
Health Systems and Innovation
• A database of all types of severe adverse events and reactions that have
been reported arising from procurement and processing to clinical application of
cells, tissues and organs for transplantation as well as of medical products of
human origin used in assisted reproduction technologies.
1. A reference for professionals focused on diagnostic and investigation
2. but also providing evidence for donor selection,
3. A source of information for candidate recipients and living donors
4. A database for further study
40 Patient Safety Programme
Health Systems and Innovation
• Scope: organs, tissues and cells for transplantation and
for assisted reproduction.
Blood ?
• Aim: to create and maintain a compendium of cases of
adverse reactions/events for donors and recipients of
organs, tissues or cells, noting how they were detected,
confirmed and documented and to develop guidance
based on the information collected.
41 Patient Safety Programme
Health Systems and Innovation
• Utilized Standard Definitions• Severe Adverse Reactions: An adverse response that HAS
occurred, including a communicable disease, in a recipient or in a living donor
• Serious Adverse Events: An adverse occurence that MIGHT lead to harm in a recipient or a living donor
• Uniform Definitions of Donor Derived InfectionsGarzoni C, Ison MG. Transplantation. 2011; 92: 1297 – 1300.
• Review of published reports of SARE
• Standardized summaries including:• Adverse Incident, Substance Type, Latency, Alerting
Symptoms, Frequency Data and Estimates, Demonstration of Imputability, Keywords, References
Method
42 Patient Safety Programme
Health Systems and Innovation
The NOTIFY Library
More than 900 documented case types can be searched in a structured way by organ, tissue or cell type and/or incident type associated bibliographic references and expert analyses.
Reactions Infectious transmissions of all types, malignancy transmissions, and
genetic transmissions to transplant recipients and to the offspring of children born from donated gametes.
Events caused by process failures and reactions in living donors
Site and search tools publicly available (without username and password) Language specific interface in Regions.
Objective: communicating vigilance information as widely as possible in the interests of improving the safety of MPHO worldwide
43 Patient Safety Programme
Health Systems and Innovation
The establishment of globally agreed principles for the governance of MPHO would represent significant progress towards the goal of meeting minimum standards, as well as serving:
The Human Body as the Source of Therapeutics
• to underline the cross cutting concerns regarding all MPHO, inherent to their human origin;
• to demonstrate respect for the human body and hence the dignity of persons;
• To increase safety and enhance ethical practices; • To encourage donation by generating trust in procedural safeguards such
as consent requirements and protocols for care and follow-up of donors;• To avoid distortions in practices due to the undermining effect of bad
examples, such as the justification of payment for organs by appeal to legal trade in plasma.
44 Patient Safety Programme
Health Systems and Innovation
MPHO
Health System Governanceand Service Delivery
Health Systems and Services45 Clinical
Procedures
Thank you
nunezj@who.int
noell@who.int
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