Tissue processing

Form Approved

OMB No. 0990-

Exp. Date XX/XX/20XX

THE NATIONAL TISSUE RECOVERY

THROUGH UTILIZATION SURVEY

SECTION 4 – Tissue Processing

The Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), through a contract with the American Association of Tissue Banks, is conducting the 2016 National Tissue Recovery through Utilization Survey (NTRUS).

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Your responses will remain anonymous in the final dataset. While results of this survey will be released in aggregate form and data may be made available in the form of a de-identified dataset, no specific institutional identifiable information will be included.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990-xxxx. The time required to complete this information collection is estimated to average 60 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer

Tissue Processing

The survey provides definitions for specific donors and tissue types. To facilitate accurate totals, provide counts using the descriptions provided. Where terms are italicized, use the definitions found at AATB Standard A2.000 DEFINITIONS OF TERMS. Some terms and/or definitions are new and some have been revised. Refer to the NTRUS Definitions of Terms document provided with this survey.

The information you are reporting is for the following physical locations(s) by name, city and state:

1. name, city, state

2. name, city, state

(need capability for multiple lines/entries)

Which of the following types of tissue did your tissue bank process? (Check all that apply)

TISSUE FROM DECEASED DONORS

□ musculoskeletal (i.e., bone, cartilage, osteochondral grafts, osteoarticular grafts)

□ soft tissue (i.e., fascia lata, ligaments, tendons, pericardium, nerves, peritoneal membrane, adipose)

□ cardiac tissue

□ vascular tissue

□ skin

□ cellular tissue

□ dura mater

□ other tissue from deceased donors (specify) _______

How many total deceased donors did your tissue bank process? (count one donor only once) ______

What is the average graft yield (#) per deceased donor (for all tissue types combined)? _____

Note: Graft yield is defined as the total number of finished tissue grafts processed from one donor.

TISSUE FROM LIVING DONORS

□ living donor tissue (i.e., birth tissue, surgical bone, skin for allogeneic use, or autologous bone)

□ other tissue from living donors (specify) _______

How many total living donors did your tissue bank process? (count one donor only once) ______

What is the average graft yield (#) per living donor (for all tissue types combined)? _____

Note: Graft yield is defined as the total number of finished tissue grafts processed from one donor.

How many total donors of the following types of tissues did your tissue bank process:

TISSUE FROM DECEASED DONORS

musculoskeletal

bone _____

cartilage (e.g., costal, articular) _____

osteochondral grafts – fresh/refrigerated _____ (i.e., an allograft consisting of a section, condyle, or plug of bone with an intact articular surface)

osteochondral grafts – frozen/cryopreserved ______ (i.e., an allograft consisting of a section, condyle, or plug of bone with an intact articular surface)

osteoarticular grafts – fresh/refrigerated _____(i.e., a large weight bearing allograft with intact articular surfaces consisting of a joint with associated soft tissue and bone)

osteoarticular grafts – frozen/cryopreserved ______ (i.e., a large weight bearing allograft with intact articular surfaces consisting of a joint with associated soft tissue and bone)

soft tissue

fascia lata _____

ligaments (i.e., patellar) _____

tendons (e.g., Achilles, gracillis, anterior/posterior tibialis, semitendinosus, flexors/extensors, peroneus longus) ___

rotator cuff _____

pericardium _____

nerves _____

peritoneal membrane____

adipose _____

cardiac tissue

valved conduits _____

non-valved conduits _____

patch graft_____

aortoiliac graft _____

vascular tissue

arteries _____

vein grafts_____

skin

thin ____

thick _____

full-thickness _____

cellular tissue _____

dura mater _____

tissue as a device ______

(i.e., products and combination products requiring PMA or 510k clearance; regulated under the FD&C Act as well as under 21 CFR Part 1271 from Section 361 of the PHSA)

tissue as a biological product ______

(i.e., products requiring BLA or IND; regulated under Section 351 of the PHSA and/or the FD&C Act, as well as under 21 CFR Part 1271 from Section 361 of the PHSA)

tissue as a drug ______

(i.e., products requiring IND/NDA; regulated under Section 201 of the FD&C Act, as well as under 21 CFR 1271 from Section 361 of the PHSA)

other tissue from deceased donors (specify)_____ ; indicate number for each_____

How many donors of the following types of tissues did your tissue bank process:

TISSUE FROM LIVING DONORS

birth tissue

amniotic membrane (only)_____

chorionic membrane (only) _____

amniotic + chorionic membrane _____

amniotic fluid _____

Wharton’s jelly _____

placental/chorionic disc _____

umbilical cord tissue _____

umbilical vein _____

other birth tissue (specify)______________; indicate number for each _____

surgical bone _____

skin for allogeneic use _____

autologous bone _____

autologous parathyroid _____

tissue as a device ______

(i.e., products and combination products requiring PMA or 510k clearance; regulated under the FD&C Act as well as under 21 CFR Part 1271 from Section 361 of the PHSA)

tissue as a biological product ______

(i.e., products requiring BLA or IND; regulated under Section 351 of the PHSA and/or the FD&C Act, as well as under 21 CFR Part 1271 from Section 361 of the PHSA)

tissue as a drug ______

(i.e., products requiring IND/NDA; regulated under Section 201 of the FD&C Act, as well as under 21 CFR 1271 from Section 361 of the PHSA)

other tissue from living donors (specify) _____; indicate number for each _____

How does your tissue bank treat tissues with radiation PRIOR to processing (non-terminal irradiation)? Check all that apply.

□ we do not treat tissues with radiation prior to processing

□ electron beam radiation only; indicate dose: ___________________

□ gamma radiation only, below 1.5 Mrads (15 kGy)

□ gamma radiation only, 1.5 - 2.5 Mrads (15-25 kGy)

□ gamma radiation only, above 2.5 Mrads (25 kGy)

How does your tissue bank treat tissues with radiation to reduce/eliminate microorganisms as a FINAL treatment (terminal irradiation)? Check all that apply.

□ we do not treat tissues with radiation as a final treatment

□ electron beam radiation only; indicate dose: ___________________

□ gamma radiation only, below 1.5 Mrads (15 kGy)

□ gamma radiation only, 1.5 - 2.5 Mrads (15-25 kGy)

□ gamma radiation only, above 2.5 Mrads (25 kGy)

Indicate how many musculoskeletal GRAFTS were processed using the following methods (if none, enter zero):

electron beam radiation (only)_____

gamma radiation (only)_____

ethylene oxide (only) ______

antibiotics (only) _____

Types of proprietary/patented processing (only)

Allowash® _____

ATP _____

BioCleanse ® Process _____

Clearant Process® _____

Tutoplast® Process_____

NovaSterilis (supercritical CO2) _____

Other proprietary methods (specify) _____; indicate number _____

Combinations of Antibiotics and Radiation – Musculoskeletal

For each combination used specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Antibiotic(s) (specify) Radiation Target Dose # grafts

_______________________ __________________ _______

_______________________ ___________________ _______

Combinations of Proprietary/Patented Processing then Radiation – Musculoskeletal

For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Proprietary/Patented Method (specify) Radiation Target Dose # grafts

_______________________ _________________ _______

_______________________ _________________ _______

Report any other combinations of methods used: ________________________________________________

Indicate how many soft tissue GRAFTS (i.e., fascia lata, ligaments, tendons, pericardium, nerves, peritoneal membrane, adipose) were processed using the following methods (if none, enter zero):

electron beam radiation (only) _____

gamma radiation (only)_____

ethylene oxide (only) ______

antibiotics (only) _____

Types of Proprietary/Patented Processing (only)

Allowash® _____

ATP _____

BioCleanse ® Process _____

Clearant Process® _____

Tutoplast® Process_____

NovaSterilis (supercritical CO2) _____

other proprietary methods (specify) _____; indicate number _____

Combinations of Antibiotics and Radiation – Soft Tissue Grafts

For each combination used please specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Antibiotic(s) (specify) Radiation Target Dose # grafts

_______________________ __________________ _______

_______________________ __________________ _______

Combinations of Proprietary/Patented Processing then Radiation – Soft Tissue Grafts

For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Proprietary/Patented Method (specify) Radiation Target Dose # grafts

_______________________ _________________ _______

_______________________ _________________ _______

Report any other combinations of methods used: ________________________________________________

Indicate how many cardiac tissue GRAFTS were preserved using the following methods (if none, enter zero):

refrigerated only (i.e., provided for use as fresh) ______

controlled-rate electronic programmable freezing _____

other methods (specify) _____; indicate number _____

Indicate how many units of cardiac tissue GRAFTS were processed into finished tissue for each of the following types (enter 0 if not applicable):

acellular/decellularized: _____

NOT acellular/decellularized: _____

other type (specify) _____; indicate number _____

Indicate how many vascular tissue GRAFTS were preserved using the following methods (if none, enter zero):

refrigerated only (i.e., provided for use as fresh) ______

controlled-rate electronic programmable freezing _____

other methods (specify) _____; indicate number _____

Indicate how many units of vascular tissue GRAFTS were processed into finished tissue for each of the following types (enter 0 if not applicable):

acellular/decellularized: _____

NOT acellular/decellularized: _____

other type (specify) _____; indicate number _____

Indicate how many skin GRAFTS were processed using the following methods (if none, enter zero):

electron beam radiation (only)_____

gamma radiation (only)_____

ethylene oxide (only) ______

antibiotics (only) _____

Types of Proprietary/Patented Processing (only)

Allowash® _____

ATP _____

BioCleanse ® Process _____

Clearant Process® _____

Tutoplast® Process_____

NovaSterilis (supercritical CO2) _____

other proprietary methods (specify) _____; indicate number _____

Combinations of Antibiotics and Radiation – Skin

For each combination used please specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Antibiotic(s) (specify) Radiation Target Dose # grafts

_______________________ __________________ _______

_______________________ __________________ _______

Combinations of Proprietary/Patented Processing then Radiation – Skin

For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Proprietary/Patented Method (specify) Radiation Target Dose # grafts

_______________________ _________________ _______

_______________________ _________________ _______

Report any other combinations of methods used: ________________________________________________

Indicate how many birth tissue GRAFTS were processed using the following methods (if none, enter zero):

electron beam radiation (only) _____

gamma radiation (only)_____

ethylene oxide (only) ______

antibiotics (only) _____

filtration (only) _____

ultraviolet light (only) _____

Types of Proprietary/Patented Processing (only)

Allowash® _____

ATP _____

BioCleanse ® Process _____

Clearant Process® _____

Tutoplast® Process_____

NovaSterilis (supercritical CO2) _____

Purion® Process _____

Cryotek™ Process _____

other proprietary methods (specify) _____; indicate number for each _____

Combinations of Antibiotics and Radiation – Birth Tissue Grafts

For each combination used please specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Antibiotic(s) (specify) Radiation Target Dose # grafts

_______________________ _________________ _______

_______________________ _________________ _______

Combinations of Proprietary/Patented Processing then Radiation – Birth Tissue Grafts

For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods

Proprietary/Patented Method (specify) Radiation Target Dose # grafts

_______________________ _________________ _______

_______________________ _________________ _______

Report any other combinations of methods used: ________________________________________________

For what applications does your tissue bank process demineralized bone (check all that apply)?

□ we do not process demineralized bone

□ orthopedic surgery

□ dental/periodontal procedures

□ neurosurgery

□ other applications (specify) ____________________

Does your tissue bank process skin for use as fresh grafts (not cryopreserved)?

□ no, we do not process skin

□ no, we process skin, but not for use as fresh grafts

□ yes, we process skin for use as fresh grafts

Indicate how much skin (in square feet) was preserved by each of the following methods (enter 0 if not applicable)

refrigerated only ______

controlled-rate electronic programmable freezing _____

heat sink freezing method_____

lyophilized _____

dehydrated _____

dessicated _____

other methods (specify) _____; indicate number _____

Indicate how much skin (in square feet) was processed into finished tissue for each of the following types (enter 0 if not applicable):

acellular/decellularized: _____

NOT acellular/decellularized: _____

Indicate how many units of birth tissue were preserved using the following methods; this refers to the preservation method used only for finished tissue (enter 0 if not applicable)

refrigerated only (i.e., provided for use as fresh) ______

simple freezing _____

controlled-rate electronic programmable freezing _____

lyophilized _____

dehydrated _____

dessicated _____

other methods (specify) _____; indicate number _____

Indicate how many units of birth tissue were processed into finished tissue for each of the following types (enter 0 if not applicable):

acellular/decellularized: _____

NOT acellular/decellularized: _____

For what applications does your tissue bank process birth tissue (check all that apply)?

□ we do not process birth tissue

□ ophthalmic

□ leg/foot ulcers

□ orthopedic

□ dental/periodontal

□ neurosurgical and spine

□ burns

□ general surgical

□ other general uses (specify) ____________________

Indicate how many donors of skin were recovered by the following:

AATB-accredited OPOs/tissue banks _______

non-AATB accredited OPOs/tissue banks _____

health care facilities (e.g., hospital or surgical center) _____

Indicate how many donors of musculoskeletal tissue were recovered by the following:

AATB-accredited OPOs/tissue banks _______

non-AATB accredited OPOs/tissue banks _____

health care facilities (e.g., hospital or surgical center) _____

Indicate how many donors of soft tissue were recovered by the following:

AATB-accredited OPOs/tissue banks _______

non-AATB accredited OPOs/tissue banks _____

health care facilities (e.g., hospital or surgical center) _____

Indicate how many donors of cardiac tissue or vascular tissue were recovered by the following:

cardiac tissue

AATB-accredited OPOs/tissue banks _______

non-AATB accredited OPOs/tissue banks _____

health care facilities (e.g., hospital or surgical center) _____

vascular tissue

AATB-accredited OPOs/tissue banks _______

non-AATB accredited OPOs/tissue banks _____

health care facilities (e.g., hospital or surgical center) _____

Indicate how many donors of birth tissue were provided by the following:

hospital delivery/birth centers _______

freestanding birth centers (not at a hospital) _______

AATB-accredited OPOs/tissue banks _______

non-AATB accredited OPOs/tissue banks _____

other (specify) ___________

Indicate how many donors of birth tissue delivered by:

cesarean section_______

vaginally _______

□ Check here if your tissue bank sent any human tissue to another tissue bank for further manufacture.

What tissue was sent for further manufacture? Check all that apply:

□ demineralized bone matrix

□ cancellous bone

□ bone shafts

□ other (specify) ________

□ Check here if your tissue bank processed any human tissue from non-U.S. sources

List the non-U.S. countries: ____________________________________

□ Check here if your tissue bank imported human tissue from other countries for processing and distribution in the U.S.

List the countries from which donors were imported, the number of donors processed, the general types of tissue grafts, and the quantities distributed

Country of Origin No. of donors processed Types of tissue grafts Quantity of grafts distributed

_____________ ___________________ _________________ ________________________

(multiple lines)

□ Check here if your tissue bank processed tissue from other countries only for distribution by countries other than the U.S. (i.e., processing contract only)

Indicate the tissue received and the country of origin:

TISSUE FROM DECEASED DONORS

□ musculoskeletal (i.e., bone, cartilage, osteochondral grafts, osteoarticular grafts): _________________________________

□ soft tissue (i.e., fascia lata, ligaments, tendons, pericardium, nerves, peritoneal membrane, adipose): _________________________________

□ dura mater _________________________________

□ cardiac tissue_________________________________

□ vascular tissue _________________________________

□ skin _________________________________

TISSUE FROM LIVING DONORS

□ surgical bone _________________________________

□ skin for allogeneic use _________________________________

□ autologous bone _________________________________

□ birth tissue_________________________________