Exploring the Risks of Exploring the Risks of Contaminated Medical Contaminated Medical
ProductsProductsMODERATOR:
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
Chicago, Illinois ~ March 24 & 25, 2009
Industry Overview / Case Study
Rob Jurgel, RPLURob Jurgel, RPLUSenior Vice President - HealthcareSenior Vice President - Healthcare
ROCKHILL Underwriting ManagementROCKHILL Underwriting Management
What is an allograft?
• A graft of tissue or an organ taken from one individual (donor) and given to another individual (recipient).
Organ Bank IndustryOrgan 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
Chicago, Illinois ~ March 24 & 25, 2009
Laws, Regulations, and LitigationLaws, Regulations, and Litigation
Anthony Vale, Esq.
Partner, Pepper Hamilton, LLP
Allograft BasicsAllograft 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
Chicago, Illinois ~ March 24 & 25, 2009
Are Practices Safe?Are Practices Safe?
Scott Brubaker, CTBS
Chief Policy Officer
How many Tissue Banks are How many Tissue Banks are there?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 Examples of Who Must Register - by FunctionRegister - by Function
• Recover HCT/Ps, Screen HCT/P Donors
• Test Donors
• Process
• Package, Label, Store
• Distribute
FDA’s HCT/P List*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
RecoverRecover (active registrations, query 4-17-08)
eHCTERs Query Result
Actual (minus search
flaws and satellites)
Accredited by AATB
Bone 140 98 50
Skin 136 103 49
ProcessProcess (active registrations, query 4-17-08)
eHCTERs Query Result
Actual (minus search flaws and those w/limited
processing activities, satellites)
Accredited by AATB
Bone 93 32 23
Skin 71 26 17
ProcessProcess (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
DistributeDistribute (active registrations, query 4-17-08)
eHCTERs Query Result
Actual (minus search
flaws and satellites)
Accredited by AATB
Bone 378 283 46
2007 AATB Survey of 2007 AATB Survey of Accredited Tissue BanksAccredited Tissue Banks
- Distribution- 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 State Requirements for Tissue BanksTissue Banks(Data circa 2007)(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. 08-55AATB Bulletin No. 08-5513 States listed & requirements differ13 States listed & requirements differ
http://www.aatb.org/files/staterequirementsforlicensure.pdf
AATB & State LawsAATB & State Laws
• AATB accreditation or certification of personnel is referenced in statutes/laws in >20 states
Recommendations & AATB Recommendations & AATB AccreditationAccreditation
• 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 StandardsAATB’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 AATB’s Standards are More Detailed than FDA RegulationsDetailed 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 Standards-AATB’s Standards-More Detailed than FDA More Detailed than FDA
RegulationsRegulations
• 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 Inspections3rd Party Inspections
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.
AATBAATB EBAAEBAA
New YorkNew York CaliforniCaliforniaa
FloridFloridaa
Standards for End Users Standards for End Users “Tissue Services”“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 Disease Transmission by Tissue Since 2000Tissue Since 2000
2000 (2002)
HCVFrozen
tendons, cryo vein
Inadequate Infectious Disease Test Methodology (HCV NAT not in use)
AATB required NAT in 2005; FDA required NAT in 2008
2001 ClostridiumFresh
bone/cartilage
Violated Standards; Inadequate microbial detection methods; a
death occurred
2002 ClostridiumFresh/frozen
tendon, meniscus
Inadequate microbial detection methods
2003 Strep. pyogenes Frozen tendons
Inadequate microbial detection methods; lack of sharing of records
2006Chryseobacterium meningosepticum
Frozen tendons
Contamination from processing environment
CDC in 2005: Estimated incidence = 0.0004% per 900,000 implants/yr
Largest RecallsLargest Recalls
• 2005-2006 BTS-related ≈ 28,000 allografts from 6 tissue banks made available
• TBs verified where all grafts were sent• ≈ 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
7.1%
Largest RecallsLargest 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 EventA 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
?
“That men do not learn very much from the lessons of history is the most important of all the lessons of history.”
A.,
Mat
thew
. "P
hoto
Cite
d" s
omaw
eb.o
rg.
1995
-200
8;
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Aldous Huxley 1894-1963Aldous Huxley 1894-1963
Thank you!
Chicago, Illinois ~ March 24 & 25, 2009
ENSURING PATIENT SAFETY THROUGH APPLICATION OF QUALITY ASSURANCE
SYSTEMS IN TISSUE BANKING
Presented byClay Anselmo, RACPresident and CEO
Reglera LLCDenver, CO
Key Risk ElementsKey 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
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
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