Transcript Tue 4pm New_developments - PLUSweb

Exploring the Risks of
Contaminated Medical
Products
MODERATOR:
Susan R. Chmieleski, APRN, CPHRM, FASHRM, JD, Senior Vice
President, Healthcare Product Manager & Risk Management Lead,
Darwin Allied World
PANELISTS:
Clay Anselmo, President & Chief Executive Officer,
Reglera
Scott Brubaker, CTBS, Chief Policy Officer,
American Association of Tissue Banks
Robert E. Jurgel, Jr., MBA, RPLU, Senior Vice President & Head of
Healthcare Underwriting, ROCKHILL Underwriting Management
Anthony Vale, Esq., Partner,
Pepper Hamilton, LLP
Industry Overview / Case Study
Rob Jurgel, RPLU
Senior Vice President - Healthcare
ROCKHILL Underwriting Management
Chicago, Illinois ~ March 24 & 25, 2009
What is an allograft?
• A graft of tissue or an organ taken from one
individual (donor) and given to another
individual (recipient).
Organ Bank Industry
•
•
•
•
58 federally chartered banks (non profit)
Matching Network – UNOS via Unet (1999)
25,628 Transplants, 12,934 Donors
6 Products – Kidney, Heart, Lung, Liver, Pancreas,
Intestines
• Procurement - Transplant Centers – 253
• Regulation – HRSA, AOPO - voluntary
• Morphing into Tissue
Tissue Bank Industry
•
•
•
•
200+ Banks, 100 AATB Accredited
1.5 million grafts annually
Hundreds of products
Procurement– Hospitals, Universities,
Funeral Homes, Morgues
• Regulation – FDA, AATB – accreditation is
VOLUNTARY
• New Regulations- May 2005
Tissue Processing &
Distribution
•
•
•
•
•
•
Identify & Screen Donors
Obtain Informed Consent
Recover Tissue
Test, Process, Sterilize & Store Tissue
Distribute
Record Keeping
Case Study - Video
• You’ll never look at Healthcare the
same!
Claims Fallout
• 1077 bodies harvested illegally
• 13,000 people have received tissue
harvested illegally
• Recipient Cases:
• “Disease”
• “Disease Phobia”
• Donor Cases - Estate
• Multiple parties
Laws, Regulations, and
Litigation
Anthony Vale, Esq.
Partner, Pepper Hamilton, LLP
Chicago, Illinois ~ March 24 & 25, 2009
Allograft Basics
• Human bone, ligaments, valves, skin


Each donor may provide 50-100
allografts
Over 1 million musculoskeletal per year
• Obtained by “recovery agency”
• “Tissue bank” processes bone/tissue
• Distributor supplies to
hospital/surgeon
Three statutes: NOTA,
“Blood Shield” and UAGA
• National Organ Transplant Act:
human tissue may not be sold

Tissue banks may charge “reasonable
fees” for services
• Blood shield laws
• Anatomical Gift Act: who may give
consent? May rely on facially valid
documents
Federal, some state
regulations and AATB
• Federal regulations


Require testing of donor for infectious
disease and medical history
No equivalent of FDA 510k
• State regulations

May require inspection of facility
• AATB standards
Tissue Processors
• Few major players
• Role: increase donations; use
donations to maximize value; ensure
safety
• Redundant safety measures:
screening by recovery agency; blood
test; sterilization or other processing
Litigation Risks
•
•
•
•
Widespread use of allograft
High demand for donations
Supply chain extended
Processing practically eliminates
risks of disease transmission

Fear of disease?
• Potential claims by donors’ families
Are Practices Safe?
Scott Brubaker, CTBS
Chief Policy Officer
Chicago, Illinois ~ March 24 & 25, 2009
How many Tissue Banks
are there?
• Depends on what your definition is FDA’s eHCTERs database for registered “Tissue
Establishments”
• Query capabilities are flawed in some ways
but it can be useful….depends what you need
 Expectations probably include Tissue Banks
involved in the chain (consent/recovery,
processing, distribution) leading to the most
commonly distributed tissues
Examples of Who Must
Register - by Function
• Recover HCT/Ps, Screen HCT/P Donors
• Test Donors
• Process
• Package, Label, Store
• Distribute
FDA’s HCT/P List*
• Bone (including demineralized bone), cartilage
• Ligaments, tendons, fascia, pericardium, dura mater
• Skin, amniotic membrane (when used alone, not for ocular
repair)
• Arteries and veins (except umbilical cord veins, etc.)
• Heart valve allografts
• Semen, oocytes, embryos
• Ocular tissue (corneas and sclera)
• Hematopoietic stem/progenitor cells derived from cord blood
*grouped by me
Recover
(active registrations, query 4-17-08)
eHCTERs
Query
Result
(minus search
flaws and
satellites)
Bone
140
98
50
Skin
136
103
49
Actual
Accredited
by AATB
Process
(active registrations, query 4-17-08)
eHCTERs
Query
Result
Actual
(minus search flaws
and those w/limited
processing activities,
satellites)
Bone
93
32
23
Skin
71
26
17
Accredited
by AATB
Process
(active registrations, query 4-17-08)
eHCTERs
Query
Result
Actual
(minus search flaws
and those w/limited
activities, satellites)
Accredited
by AATB
Heart
Valves
45
4
4
Vascular
45
5
4
Distribute
(active registrations, query 4-17-08)
Bone
eHCTERs
Query
Result
(minus search
flaws and
satellites)
378
283
Actual
Accredited
by AATB
46
2007 AATB Survey of
Accredited Tissue Banks
- Distribution
Graft Type
# of Grafts
Musculoskeletal
1,281,259
Tissue Devices
419,418
Soft Tissue (tendons, ligaments)
160,800
Skin
88,249 (21,825 sq ft)
Cardiac
5,399
Vascular
3,814
Dura
331
1,959,270
State Requirements for
Tissue Banks
(Data circa 2007)
• New York State Department of Health
 811 TBs licensed;191 located outside of NY
• Florida Agency for Health Care Administration
 76 TBs licensed; 56 located outside of FL
• California Health and Safety Code
 496 TBs licensed; 118 hold outside of licenses
• Other permit, licensing, certification, programs
 DE, DC, GA, IL, LA, MD, MI, OK, OR
AATB Bulletin No. 08-55
13 States listed & requirements
differ
http://www.aatb.org/files/staterequirementsforlicensure.pdf
AATB & State Laws
• AATB accreditation or certification of personnel
is referenced in statutes/laws in >20 states
Recommendations &
AATB Accreditation
• American Academy of Orthopaedic Surgeons
 Policy: use tissue only from banks accredited by AATB.
• American Burn Association
 Require compliance with all federal, state, and JCAHO
requirements, and recommend standards of the AATB.
• Philadelphia Grand Jury Report (BTS investigation)
 Recommendation requires all tissue agencies to be
licensed by the state and accredited by the AATB
should be required for a license
• FDA’s Inspection Program
 Tiered approach; use professional accreditation as a
factor when stratifying TEs to inspect
AATB’s Standards
•
•
1st published in 1984
AATB’s Standards have
served as a model for:

FDA’s CGTP regulations

Health Canada’s Safety of Cells,
Tissues and Organs Regulations &
draft Guidance

New York DOH’s Tissue & Cell
Standards

European Union Commission
Directives

European Association of Tissue
Banks Standards

British Association for Tissue Banking
Standards

Spanish Association of Tissue Banks’
Standards

(ALaBaT) Latin American Association
for Tissue Banks Standards (in
development)
AATB’s Standards are More
Detailed than FDA
Regulations
• Standards require:





Medical Director makes all donor suitability
(eligibility) determinations
Detailed consent requirements
Donor screening for risk/quality
Specific “quality” screening requirements
Detailed tissue recovery requirements
• time limitations for recovery
• technical recovery methods
AATB’s StandardsMore Detailed than FDA
Regulations
• Standards:







Donor reconstruction requirements
Archiving of a serum or plasma sample from
every donor if any remains after testing
Process control endpoints related to quality
Specific tissue release criteria
More labeling & package insert controls, content
More personnel-related safety concerns
Must establish recipient follow-up data collection
protocols
3rd Party Inspections
AATB
EBAA
In general, state licensing & voluntary
accreditation offers an enhanced level
of satisfaction and safety since there
exists 3rd-party scrutiny of the tissue
and/or eye bank’s operations.
New York
Florida
California
Standards for End Users
“Tissue Services”
• The Joint Commission

Transplant Safety Chapter - Transplanting Tissues
• Hospitals, Critical Access Hospitals, Ambulatory Care, Office-
based Surgery, Laboratory
• AABB

Standards for Blood Banks & Transfusion Services
• College of American Pathologists

Transfusion Medicine Checklist
• American Association of Tissue Banks

Section L - Tissue Dispensing Services
Tissue handling oversight unknown if not under these umbrellas
Disease Transmission by
Tissue Since 2000
HCV
Frozen
tendons, cryo
vein
Inadequate Infectious Disease Test
Methodology (HCV NAT not in use)
AATB required NAT in 2005; FDA
required NAT in 2008
Clostridium
Fresh
bone/cartilage
Violated Standards; Inadequate
microbial detection methods; a
death occurred
2002
Clostridium
Fresh/frozen
tendon,
meniscus
Inadequate microbial detection
methods
2003
Strep. pyogenes
Frozen
tendons
Inadequate microbial detection
methods; lack of sharing of records
2006
Chryseobacterium
meningosepticum
Frozen
tendons
Contamination from processing
environment
2000
(2002)
2001
CDC in 2005: Estimated incidence = 0.0004% per 900,000 implants/yr
Largest Recalls
• 2005-2006


BTS-related
≈ 28,000 allografts from 6 tissue banks made available
• TBs verified where all grafts were sent
7.1%
• ≈ 700 tissue grafts unaccounted for by end users
 500 US + 200 International
• ≈ 1,300 tissue devices unaccounted for by distributors & end
•
•
•
•
users
≈ 8,000 returned or destroyed by end users
≈ 15,800 implanted
The rest were not distributed and quarantined at TBs
No disease transmission proven
Largest Recalls
• 2006
 Chryseobacterium meningosepticum
 2 infections reported; resolved, grafts remain in place and
functional
 ≈ 4,800 frozen tendons/ligaments recalled
• TB verified where all grafts were sent
• Disposition of 99% of the grafts known within 30 days

Will some help from FDA, 100% reached
• ≈ 750 hospitals in Canada, Mexico, and the US
 ≈ 1,000 grafts returned by end users
 ≈ 3,800 grafts implanted
A Sentinel Event
?
•
•
•
•
Recovery agency and tissue processor were not accredited by AATB
AATB Standards were violated (body not cooled within 12 hrs of
death for recovery up to 24 hrs after death; not until 19 hrs)
Death event should not have occurred
Processor has since attained AATB accreditation but recovery
agency has not
A., Matthew. "Photo Cited" somaweb.org. 1995-2008;
photographer unknown
Aldous Huxley 1894-1963
“That men do not
learn very much
from the lessons of
history is the most
important of all the
lessons of history.”
Thank you!
ENSURING PATIENT SAFETY
THROUGH APPLICATION OF
QUALITY ASSURANCE SYSTEMS IN
TISSUE BANKING
Presented by
Clay Anselmo, RAC
President and CEO
Reglera LLC
Denver, CO
Chicago, Illinois ~ March 24 & 25, 2009
Key Risk Elements
• Donors
• Tissue Handling
• Processing
• Storage and Distribution
• Regulatory
Quality Management
Systems (QMS)
• PURPOSE
 FDA/Regulatory – Prevent Disease Transmission
 General – Ensure Safety of Tissue Products
• GENERAL CONCEPT- Procedure-Based Controls to
Detect, Correct, Prevent Sources of Product Problems
• Systematic
• Self-Correcting
• Continuously Improving
• Addressing Each Risk Area
• Provide Structure for Regulatory / Standards
Compliance
• Operational Stability
Quality Management
Systems
(QMS)
Diagram
QUALITY
MANAGEMENT
SYSTEMS DIAGRAM
Management Review
Returned Product
e
ag
an
In
Non-Conforming
Product
M
Complaints / Adverse
Event Reporting /
HCTP Deviations
ng
Supplier
Quality Assurance
i
in
ra
/T
te
rn
l
ro
al
A
ud
it
Corrective and Preventive Action
t
on
tC
en
um
oc
D
Quality Data Analysis
t
en
m
Statistical Techniques
Equipment
Controls and
Process Validation
Supplies and
Reagent Controls
Labeling and
Packaging
Tracking
Receiving, InProcess and Final
Inspection
Processing and Process Controls
Recovery and Donor Eligibiltity
Product Release
Handling,
Storage and
Distribution
Tissue Regulations,
Standards and Guidance
• Important Regulations
 21 CFR 1271
 State Specific Regulations
• Important Standards
 AATB Standards For Tissue Banking
 EBAA Medical Standards
• What Are These and Why Are They Important?
 Establish SPECIFIC Requirements for Tissue
Banking
 Provide QMS Implementation Framework
 Establish Inspectional / Certification Criteria
Important Risk Reduction
Activities
• Donor Eligibility Determination
• Processing, Storage & Handling Controls
• Audits
• Post Market Monitoring Activities
• Overall QMS Adoption
Measuring Performance
• Accreditation
• Regulatory History
• Assessment
• Post-Market Monitoring
Thank You