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

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“That men do not learn very much from the lessons of history is the most important of all the lessons of history.”

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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