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Medical Advisory Board Agenda

MEDICAL ADVISORY BOARD MEETING AGENDA

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MEDICAL ADVISORY BOARD MEETING

AGENDA

Thursday, October 20, 2011

1:00 pm – 4:00 pm

Rosen Centre

Orlando, Florida

I. Call to Order

II. Approval of Minutes

III. Committee Reports

A. Medical Review Subcommittee (Lindquist, Misko)

i. EUSTITE Terminology

B. Policy and Position Research Subcommittee (Sugar)

C. Accreditation Board (Binnion, Croasdale)

i. Backup & Assistant Medical Director Subcommittee (Croasdale)

ii. Eye Bank Functions Subcommittee (Fischer)

D. Certification Board (Adler)

E. Technician Education Committee (Miller)

F. Technical Procedures Manual (Iliakis)

IV. Old Business

V. New Business

A. C3.500: Other Establishments Performing Eye Banking and C3.510 Utilization of

Services Provided by Establishments Performing Limited Eye Banking Functions

(DeMatteo)

B. M1.500: Recipient Follow-Up Information (Woody)

C. L1.200, M1.400, M1.500, Glossary: Recipient information (Glasser)

D. L2.000: Packaging, Sealing and Packing for Transport (DeMatteo)

VI. Late Additions

A. M1.500: Recipient Follow-Up Information (Mathes)

B. M1.500: Recipient Follow-Up Information (Tu, Aldave)

VII. For Information and Review

A. FDA Validation Workshop (DeMatteo)

B. Eye Bank Processing Survey (DeMatteo)

C. Cornea Donor Study (Montoya)

Call to Order

Approval of Minutes

Medical Advisory Board Minutes, EBAA, June 24, 2011, Tucson, AZ Page 1 of 9

MEDICAL ADVISORY BOARD MEETING MINUTES Eye Bank Association of America

Friday, June 24, 2011 1:00pm – 3:00pm

The Westin La Paloma Tucson, Arizona

I. Call to Order Dr. Glasser called the meeting to order at 1:00pm, and noted that only voting members will be seated at the head table, with non-voting members seated in the front rows. He recognized and thanked the members of the MAB that are rotating off of the committee. Three new members will be joining the committee at the next meeting: Jennifer Li, MD, Roni Shtein, MD and Bennie Jeng, MD. Dr. Glasser also announced a new category of membership – Lifetime Member (Ex-Officio, non-voting) – and invited those who are eligible to continue attending future MAB meetings. The following members were present: David Glasser, MD, Chair Michael Nordlund, MD, PhD, Vice Chair Marian Macsai MD, EBAA Chair, Ex-Officio Tony Bavuso, Secretary Patricia Aiken-O’Neill, EBAA President, Ex-Officio Victoria Adler Anthony Aldave, MD Sam Barone, MD, FDA Liaison, Ex-Officio Michael Belin, MD, PPR Subcommittee, Ex-Officio Beth Binnion Bruce Bodner, MD Scott Brubaker, AATB Liaison, Ex-Officio Christopher Croasdale, MD Barbara Crow Jennifer De Matteo, EBAA Director, Ex-Officio Donna Drury Paul Dubord, MD, PPR Subcommittee, Ex-Officio Linda Fraser Mary Gatien Melissa Greenwald, FDA Liaison, Ex-Officio Sadeer Hannush, MD Ellen Heck Brenda Horn Bernie Illiakis Adam Kaufman, MD, PPR Subcommittee, Ex-Officio Stephen Kaufman, MD, PhD, Scientific Programs Chair, Ex-Officio David Korroch


William Barry Lee, MD Thomas Lindquist, MD, PhD Garret Locke Jackie Malling Mark Mannis, MD Eric Meinecke Tom Miller Jachin Misko Brian Philippy, Ex-Officio Graeme Pollack, MD George Rosenwasser, MD Kevin Ross Robert Schultze, MD, PPR Subcommittee, Ex-Officio Naoshi Shinozaki, MD Doyle Stulting, MD, PhD Alan Sugar, MD Joel Sugar, MD Donald Tan, MD Joseph Tauber, MD Bradley Tennant Mark Terry, MD Carrie Thomas Woodford Van Meter, MD Bruce Varnum, EBAA Immediate Past Chair, Ex-Officio David Verdier, MD Jason Woody II. Approval of Minutes

Dr. Glasser requested that the minutes from the last meeting be accepted. ACTION: A motion was made and seconded to accept the minutes as

presented in the agenda book. Motion passed. III. Committee Reports A. Medical Review Subcommittee – Thomas Lindquist, MD, PhD, Jachin Misko

Dr. Lindquist reviewed the reports in the agenda book. He noted that the Primary Graft Failures (PGF) in the OARRS report are reported to be due to donor tissue. The subcommittee will be discussing the possibility of reporting a figure that includes all PGFs regardless of whether they were due to donor tissue. There were two reported cases of endophthalmitis to date in 2011. Both tissues were


prepared by surgeons – one for DSAEK, and the other for DMAEK. One case was Candida and the other was Streptococcus. Jachin Misko gave a report on the European Standards and Training in the Inspection of Tissue Establishments (EUSTITE) definitions of serious adverse reactions (SAR) and serious adverse events (SAE). The subcommittee was asked to review them and consider creating internationally common terminology. He noted that the EBAA definitions and EUSTITE definitions are currently very similar. The subcommittee has two recommendations: 1) create a crosswalk document showing the equivalence of language between EBAA and EUSTITE definitions, and 2) survey the EBAA membership about creating additional categories in OARRS for reporting incidents that are currently not required to be reported in OARRS. These recommendations will be carried out by the Medical Review Subcommittee.

B. Policy and Position Research Subcommittee – Alan Sugar, MD

Dr. Sugar submitted and presented the Subcommittee’s report on tissue from donors who were taking Amantidine. The subcommittee recommended no changes to the Medical Standards, which should sufficiently allow for screening out donors taking Amantidine.

C. Accreditation Board – Beth Binnion, Christopher Croasdale, MD

Beth Binnion reported that thirteen (13) banks had applied for inspection this past cycle, and twelve (12) of them received three (3) year accreditation status, while one bank was denied. Ms. Binnion also gave a report from an ad hoc committee that was formed to review the Accreditation Board’s (AB) current definition of “processing” to ensure that it is being applied by the AB as intended by the MAB and to review the impact it is having on banks performing all eye bank services vs banks performing only specific services. The committee concluded that if a bank is not performing at least 25 processing procedures in a flow hood, clean room, etc., after recovery, then for the purposes of accreditation they are not considered a processing bank. The committee also concluded that this interpretation is compatible with the MAB’s original intent of the definition of processing. The committee had three recommendations: 1) the six eye bank functions should be clearly and consistently defined in the Medical Standards, 2) form a working group to review and clarify the language in the Medical Standards and present their work at the MAB meeting in October, and 3) once the definitions are clearly reflected in the Medical Standards then have them removed from the AB Policies and Procedures document. An ad hoc working group was formed consisting of the following members:


Tim Fischer, Bess Beliveaux, Brian Philippy, Garret Locke, Kevin Ross, and Jennifer DeMatteo

Ms. Binnion proposed the following change to the Medical Standards: C1.200 Medical Director (Paragraph 3) Any physician Each Medical Director and co-directors of each

member eye bank or physician of a non-member bank who provides verification of competency for tissue recovery and preservations, shall attend the Medical Directors’ Symposium at the annual meeting of the EBAA at least once every three years and a Medical Advisory Board meeting once every three years. A newly appointed Medical Director shall attend a Medical Directors’ Symposium and a Medical Advisory Board Meeting within one year of appointment, unless a Co-Medical Director has fulfilled the requirement. The eye bank shall provide written documentation of such attendance at the time of the eye bank site inspection.

ACTION: A motion was made and seconded to accept the changes to C1.200. Motion passed.

Dr. Croasdale requested that an ad hoc committee be created to review the role and functions of backup and assistant medical directors. A committee was formed consisting of the following members: Chris Croasdale, MD (Chair), Bruce Bodner, MD, Paul DuBord, MD, Tom

Lindquist, MD, PhD, Brad Tennant, Mary Gatien and Jennifer DeMatteo Dr. Croasdale reported that after further discussion of the response to the refrigerator temperature probes white paper distributed by the AB in November 2010, the AB will further communicate to banks that the white paper is a concept explanation of what is currently in the Medical Standards and recommends no change to the Medical Standards. Dr. Croasdale proposed the addition of language to the Medical Standards to clarify that banks are not required to review a printed or paper copy of infectious disease testing results, and that any written form of results, electronic or otherwise, is sufficient. Changes to the Medical Standards were proposed as follows: D1.200 Donor Testing The eye donor must be tested according to:

• EBAA testing requirements (D1.210) • FDA testing requirements (D1.220) • State requirements


• Other testing requirements of the country of import, if exported outside of the United States

A review of written results of infectious disease testing shall be received by the eye bank prior to releasing tissue designated for surgical use. The infectious disease testing laboratory and test kits used must meet FDA regulatory requirements (Ref. Appendix IV). Eye banks outside the U.S. must use a laboratory that is accredited by, and whose tests are approved by their own countries’ regulatory agencies.

If plasma dilution sufficient to affect the results of communicable disease testing is suspected, the donor should be considered ineligible, unless a pre- transfusion or infusion sample drawn up to 7 days before recovery is tested; or an algorithm designed to evaluate volumes administered in the 48 hours before specimen collection is used, showing that plasma dilution sufficient to affect the results has not occurred (Ref. Appendix IV). Eye banks outside of the U.S.A. shall use a plasma dilution algorithm which meets the requirements of their own countries’ regulatory agencies. If no such requirements exist, they shall use an algorithm which meets FDA requirements.

ACTION: A motion was made and seconded to accept the changes to D1.200. Motion passed.

D. Certification Board – Victoria Adler

Ms. Adler reported that there were 42 CEBT examinees for the March 2011 testing period; thirty-one (31) of the applicants passed the exam and eleven (11) failed, resulting in a seventy-four percent (74%) pass rate. The Certification Board will do an item review in July 2011 and full exam review in August 2011. The next exam period will be October 1-15, 2011. The exam consists of 250 questions, requiring a score of 187 to pass. The highest reported score to date is 241. The committee has one recommendation to be considered by the EBAA Board of Directors in October 2011, which would change the current requirement to sit for the exam from a high school diploma and six months relevant experience in the past 12 months to a baccalaureate degree and six months experience or a high school diploma and 12 months experience. This recommendation comes after a statistical review of pass rates based on education/experience levels, with the intent to improve pass rates for the exam.


E. Technician Education Committee – Tom Miller Mr. Miller reported that there have been three (3) technical EBAA Educational Institutes (EEI) over the past year: on donor case studies, DSAEK tissue preparation, and sepsis and shock. He reported that there was a successful Technician Education Seminar in February with 45 attendees. The committee also facilitated the Technician Skills Workshop for the June 2011 EBAA meeting. For the upcoming year, the committee will focus on increasing the number of EEIs from four to six per year.

F. Technical Procedures Manual – Bernie Iliakis

Bernie Iliakis reported that the committee made three types of changes to the manual: 1) technical procedures currently being performed that are not reflected in the manual, 2) current best practices not reflected in the manual, and 3) addition of missing references to the current manual. ACTION: A motion was made and seconded to accept the changes to

the Technical Procedures Manual as presented. Motion passed.

IV. Old Business A. M1.500 Recipient Follow-Up Information – Gerald Cole and Doyce Williams

Mr. Cole proposed the following changes with amendments to the Medical Standards as follows:

M1.500 Recipient Follow-Up Information

3. Corneas and Sscleral tissue that can be used beyond 14 days post-mortem may be stocked at an institution only if it is for single patient use; the distributing eye bank must be notified of the recipient information when tissue is used and must be able to track the tissue. to the consignee.

ACTION: A motion was made and seconded to accept the changes to

M1.500. Motion passed.

B. Antifungal Subcommittee/Povidone-Iodine Survey – Tony Aldave, MD


Dr. Aldave reviewed the written report of the committee. The committee concluded that: 1) data shows fungal infections occur more frequently after EK than after PK, but there is no association between fungal infection after EK and whether the tissue is prepared by the surgeon or the eye bank technician, 2) none of the donor and donor cornea characteristics can be considered to be associated with an increased risk of transmitting fungal infection to the recipient, 3) a review of the source bank(s) policies and procedures should be conducted to identify potential gaps that could result in fungal contamination, 4) it is of utmost importance that the surgeon who transplants the mate of a donor cornea that is fungal culture positive be notified immediately, and 5) it was not clear that adding an antifungal agent to corneal storage media would be of benefit, based on many factors including cost and efficacy, and data suggesting that the incidence of post-keratoplasty fungal infection has not increased over the last six (6) years.

V. New Business A. M1.400 Minimum Information To Be Retained – Chris Stoeger Chris Stoeger proposed the following amendment to the Medical Standards: M1.400 Minimum Information to be Retained Forms for retaining donor and recipient information shall be established for permanent record and shall be readily accessible for inspection by the EBAA Accreditation Board.

ACTION: A motion was made and seconded to accept the proposed

amendments. Motion passed.

B. D1.600 Interval Between Death, Enucleation, Excision, Preservation, and Processing – Garret Locke

Garret Locke proposed the following amendment to the Medical Standards:

D1.600 Interval Between Death, Enucleation, Excision, Preservation, and Processing Acceptable time intervals from death, enucleation or excision to preservation may vary according to the circumstances of death and interim means of storage of the body. It is generally recommended that corneal preservation occur as soon as possible after death. All time intervals for each donor, i.e., the time of death to the time of enucleation and preservation and/or the time to corneal excision, and/or the time to additional tissue processing, shall be recorded. The


time that cooling of ocular tissues and/or refrigeration of the body was begun shall be recorded, if applicable. The time that cooling of ocular tissues and/or refrigeration of the body was begun and the duration of cooling and/or refrigeration shall be recorded, if applicable.

ACTION: A motion was made and seconded to accept the proposed amendment. Motion defeated.

C. M1.600 Statistical Reporting – Patricia Dahl and Wing Chu, MD Dr. Chu introduced a proposal to delete M1.600 from the Medical Standards.

ACTION: A motion was made and seconded to accept the proposed amendment. Motion defeated. D. Predictive Modeling – Brad Tennant

Brad Tennant described the concept of using eye bank data to prospectively forecast and assess operational needs of eye banking, and asked for the support of the MAB in forming a subcommittee to pursue this project. Dr. Glasser suggested that this could be done within the Statistical Reporting Subcommittee. An ad hoc subcommittee was formed consisting of the following members:

Chris Stoeger, Brian Philippy, Jennifer DeMatteo, Brad Tennant, and Woody VanMeter, MD

E. D1.000 Prior Organ Transplant – Patricia Dahl, Wing Chu, MD and Edwin

Roberts Dr. Chu introduced a proposal with amendments to add the following as a new

Medical Standard: D1.000 Prior Organ Transplant

The source eye bank must investigate whether there is an increased risk of relevant communicable diseases from a donated organ(s) that has been transplanted into an ocular tissue donor that dies within 8 weeks after receiving such transplant.

ACTION: A motion was made and seconded to accept the proposed amendment. Motion defeated.

VI. Late Additions There were no late additions to the agenda.


VII. For Information and Review

A. Ocular Tissue Nomenclature – Jennifer DeMatteo

Jennifer DeMatteo reported that the Eye Bank Technical Advisory Group (EBTAG) published their draft ocular tissue nomenclature and distributed it to the MAB and membership for comments. Comments are currently under review. This work is being done in order to develop a global standard for terminology that could facilitate a global coding system.

B. FDA Validation Workshop – Jennifer DeMatteo

Jennifer DeMatteo reported that the EBAA is planning a validation workshop for members as a response to recent discussions with the FDA and several FDA issuances of Form 483’s to members. The focus will be to provide guidance to members on issues of concern, such as process validation and environmental monitoring. It will be held on Thursday, October 6th, 2011. The location is yet to be determined. A draft preliminary agenda has been created.

VIII. Adjournment

ACTION: A motion was made and seconded to adjourn the Medical Advisory Board meeting at 2:35pm. Motion passed.

Committee Reports:

Medical Review Subcommittee

Eye Bank Association of America

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Adverse Reactions Reasonably Likely/ Proven to beDue to Donor TissueReport Date: September 13, 2011 9:55am

Surgery Date 2006 2007 2008 2009 2010 2011 MeanPrimary Graft Failures 4 36 54 53 40 28 –

Recipient Age (mean) 65.5 63.4 67.9 67 72.5 68.2 67.8Donor Age (mean) 60.8 53.7 55.5 56.9 55.4 59.3 56.1Donor Cause of Death

Cancer 1 (25%) 9 (25%) 11 (20%) 16 (30%) 9 (23%) 6 (21%) 8.7 (24%)Cerebrovascular accident 1 (25%) 2 (6%) 3 (6%) 3 (6%) 4 (10%) 4 (14%) 2.8 (8%)Heart disease 2 (50%) 13 (36%) 16 (30%) 19 (36%) 14 (35%) 13 (46%) 12.8 (36%)Respiratory disease 0 (0%) 0 (0%) 6 (11%) 4 (8%) 3 (8%) 2 (7%) 2.5 (7%)Toxic / Accident 0 (0%) 1 (3%) 3 (6%) 1 (2%) 1 (3%) 0 (0%) 1 (3%)Trauma 0 (0%) 3 (8%) 7 (13%) 6 (11%) 5 (13%) 1 (4%) 3.7 (10%)Other 0 (0%) 8 (22%) 8 (15%) 4 (8%) 4 (10%) 2 (7%) 4.3 (12%)

Mated Cases 0 (0%) 7 (19%) 8 (15%) 7 (13%) 5 (13%) 6 (21%) 5.5 (15%)Procedure Type

Anterior lamellar procedure 0 (0%) 1 (3%) 1 (2%) 1 (2%) 0 (0%) 0 (0%) 0.5 (1%)Limbal or epithelial (stem cell) graft 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Penetrating keratoplasty 3 (75%) 20 (56%) 23 (43%) 27 (51%) 11 (28%) 9 (32%) 15.5 (43%)Posterior lamellar procedure (endothelial graft) 1 (25%) 15 (42%) 30 (56%) 23 (43%) 24 (60%) 18 (64%) 18.5 (52%)Scleral graft 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Other 0 (0%) 0 (0%) 0 (0%) 2 (4%) 5 (13%) 1 (4%) 1.3 (4%)

Source of Lamellar Cut Processing establishment 1 (100%) 9 (56%) 28 (90%) 24 (100%) 22 (92%) 16 (89%) 16.7 (88%)Surgeon 0 (0%) 7 (44%) 3 (10%) 3 (13%) 2 (8%) 3 (17%) 3 (16%)

Type of Lamellar Cut Laser 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Manual 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Microkeratome 1 (100%) 15 (94%) 31 (100%) 27 (113%) 24 (100%) 18 (100%) 19.3 (102%)

Preoperative Diagnosis Congenital corneal condition 0 (0%) 0 (0%) 2 (4%) 0 (0%) 0 (0%) 0 (0%) 0.3 (1%)Fuchs corneal dystrophy 1 (25%) 9 (25%) 18 (33%) 22 (42%) 15 (38%) 11 (39%) 12.7 (35%)Keratoconus 1 (25%) 5 (14%) 3 (6%) 8 (15%) 2 (5%) 2 (7%) 3.5 (10%)Mechanical or chemical trauma 0 (0%) 0 (0%) 1 (2%) 0 (0%) 1 (3%) 0 (0%) 0.3 (1%)Microbial or viral corneal change 0 (0%) 0 (0%) 1 (2%) 0 (0%) 0 (0%) 1 (4%) 0.3 (1%)Non-corneal condition 0 (0%) 1 (3%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0.2 (0%)Post-cataract surgery edema 0 (0%) 7 (19%) 10 (19%) 6 (11%) 12 (30%) 5 (18%) 6.7 (19%)Post-refractive surgery 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (3%) 0 (0%) 0.2 (0%)Repeat corneal transplant 2 (50%) 9 (25%) 6 (11%) 6 (11%) 3 (8%) 3 (11%) 4.8 (13%)Stromal dystrophy or degeneration 0 (0%) 1 (3%) 0 (0%) 2 (4%) 1 (3%) 0 (0%) 0.7 (2%)Other cause of corneal opacification or distortion 0 (0%) 4 (11%) 13 (24%) 9 (17%) 5 (13%) 6 (21%) 6.2 (17%)Other 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)

Endothelial Density (mean) 2844.8 2993.8 2773.1 2740.7 2790 2802.6 2811.2Death to Cooling (mean hrs) 2.5 3.57 3.64 3.71 2.55 3.97 3.48

Range 1–4 0–16 1–16.17 1–12 0–8.5 0–12 0–16.17Death to Preservation (mean hrs) 8.93 10 9.51 9.76 9.75 9.89 9.74

Range 6.7–15 3.5–24 1–23 3–23.5 2–18.22 4–22.38 1–24Death to Surgery (mean days) 6 5.67 6.46 6.09 5.53 6.57 6.07

Range 3–10 2–11 2–14 2–14 3–12 3–13 2–14

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Endophthalmitis 0 5 6 7 10 4 –Recipient Age (mean) 63 78 73 68 57 68.5Donor Age (mean) 59 57 55 56 58 56.7Donor Cause of Death

Cancer 0 (0%) 0 (0%) 0 (0%) 1 (14%) 1 (10%) 1 (25%) 0.5 (9%)Cerebrovascular accident 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Heart disease 0 (0%) 3 (60%) 1 (17%) 3 (43%) 3 (30%) 1 (25%) 1.8 (34%)Respiratory disease 0 (0%) 2 (40%) 0 (0%) 0 (0%) 1 (10%) 0 (0%) 0.5 (9%)Toxic / Accident 0 (0%) 0 (0%) 2 (33%) 0 (0%) 0 (0%) 0 (0%) 0.3 (6%)Trauma 0 (0%) 0 (0%) 0 (0%) 1 (14%) 1 (10%) 0 (0%) 0.3 (6%)Other 0 (0%) 0 (0%) 3 (50%) 2 (29%) 4 (40%) 2 (50%) 1.8 (34%)

Mated Cases 0 (0%) 0 (0%) 2 (33%) 1 (14%) 2 (20%) 1 (25%) 1 (19%)Procedure Type

Anterior lamellar procedure 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Limbal or epithelial (stem cell) graft 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Penetrating keratoplasty 0 (0%) 4 (80%) 4 (67%) 4 (57%) 3 (30%) 1 (25%) 2.7 (50%)Posterior lamellar procedure (endothelial graft) 0 (0%) 1 (20%) 2 (33%) 3 (43%) 6 (60%) 1 (25%) 2.2 (41%)Scleral graft 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (10%) 0 (0%) 0.2 (3%)Other 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 2 (50%) 0.3 (6%)

Source of Lamellar Cut Processing establishment 0 (0%) 0 (0%) 2 (100%) 2 (67%) 6 (100%) 0 (0%) 1.7 (77%)Surgeon 0 (0%) 1 (100%) 0 (0%) 1 (33%) 0 (0%) 2 (200%) 0.7 (31%)

Type of Lamellar Cut Laser 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Manual 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Microkeratome 0 (0%) 1 (100%) 2 (100%) 3 (100%) 6 (100%) 1 (100%) 2.2 (100%)

Concordant Positive Cultures 0 (0%) 1 (20%) 2 (33%) 6 (86%) 3 (30%) 2 (50%) 2.3 (44%)Recipient Culture Results

Alcaligenes 0 0 0 0 0 0 0Candida 0 2 6 4 3 3 3Cephalosporium 0 0 0 0 0 0 0Citrobacter 0 0 0 0 0 0 0Clostridium 0 0 0 0 0 0 0Corynebacterium 0 0 0 0 0 0 0Enterococcus 0 0 0 0 0 0 0Escherichia 0 0 0 0 0 0 0Flavobacterium 0 0 0 0 0 0 0Haemophilus 0 0 0 0 1 0 0.2Propionibacterium 0 0 0 0 0 0 0Pseudomonas 0 0 0 0 0 0 0Serratia 0 0 0 0 0 0 0Simplexvirus 0 0 0 0 0 0 0Staphylococcus 0 0 0 0 0 0 0Streptococcus 0 1 0 2 2 1 1Not Done 0 2 0 0 1 0 0.5No Growth 0 0 0 0 2 0 0.3

Death to Cooling (mean hrs) 3.46 4.68 4.38 3.2 3.5 3.77Range 1–5.04 1–19 0–7 1–5 2–5 0–19

Death to Preservation (mean hrs) 12.24 15.41 9.04 8.34 9.63 10.59Range 8–16.19 10–20 4–19 3.5–15.75 7–16 3.5–20

Death to Surgery (mean days) 4.8 5.33 4.57 17.1 6 8.84Range 4–6 3–6 3–6 2–128 3–8 2–128

Keratitis 1 3 4 10 5 0 –Recipient Age (mean) 67 81 74 59 55 64.1Donor Age (mean) 49 52 56 45 59 51.1Donor Cause of Death

Cancer 0 (0%) 1 (33%) 0 (0%) 0 (0%) 2 (40%) 0 (0%) 0.5 (13%)Cerebrovascular accident 0 (0%) 0 (0%) 0 (0%) 1 (10%) 0 (0%) 0 (0%) 0.2 (4%)Heart disease 1 (100%) 1 (33%) 3 (75%) 5 (50%) 3 (60%) 0 (0%) 2.2 (57%)Respiratory disease 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Toxic / Accident 0 (0%) 0 (0%) 0 (0%) 1 (10%) 0 (0%) 0 (0%) 0.2 (4%)



Trauma 0 (0%) 0 (0%) 1 (25%) 1 (10%) 0 (0%) 0 (0%) 0.3 (9%)Other 0 (0%) 1 (33%) 0 (0%) 2 (20%) 0 (0%) 0 (0%) 0.5 (13%)

Mated Cases 0 (0%) 1 (33%) 0 (0%) 2 (20%) 2 (40%) 0.8 (22%)Procedure Type

Anterior lamellar procedure 0 (0%) 0 (0%) 0 (0%) 1 (10%) 1 (20%) 0 (0%) 0.3 (9%)Limbal or epithelial (stem cell) graft 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Penetrating keratoplasty 1 (100%) 2 (67%) 2 (50%) 5 (50%) 2 (40%) 0 (0%) 2 (52%)Posterior lamellar procedure (endothelial graft) 0 (0%) 1 (33%) 2 (50%) 4 (40%) 2 (40%) 0 (0%) 1.5 (39%)Scleral graft 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Other 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)

Source of Lamellar Cut Processing establishment 0 (0%) 1 (100%) 1 (50%) 2 (40%) 2 (67%) 0 (0%) 1 (55%)Surgeon 0 (0%) 0 (0%) 1 (50%) 3 (60%) 1 (33%) 0 (0%) 0.8 (45%)

Type of Lamellar Cut Laser 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)Manual 0 (0%) 0 (0%) 0 (0%) 1 (20%) 0 (0%) 0 (0%) 0.2 (9%)Microkeratome 0 (0%) 1 (100%) 2 (100%) 4 (80%) 3 (100%) 0 (0%) 1.7 (91%)

Concordant Positive Cultures 0 (0%) 1 (33%) 2 (50%) 2 (20%) 0 (0%) 0 (0%) 0.8 (22%)Recipient Culture Results

Alcaligenes 0 0 0 0 0 0 0Candida 0 2 3 2 2 0 1.5Cephalosporium 0 0 0 0 0 0 0Citrobacter 0 0 0 0 0 0 0Clostridium 0 0 0 0 0 0 0Corynebacterium 0 0 0 0 0 0 0Enterococcus 0 0 0 0 0 0 0Escherichia 0 0 0 1 0 0 0.2Flavobacterium 0 0 0 0 0 0 0Haemophilus 0 0 0 0 0 0 0Propionibacterium 0 0 0 0 0 0 0Pseudomonas 0 0 0 0 0 0 0Serratia 0 0 0 0 0 0 0Simplexvirus 0 0 0 1 0 0 0.2Staphylococcus 0 1 0 0 0 0 0.2Streptococcus 0 0 0 0 0 0 0Not Done 0 0 0 3 2 0 0.8No Growth 1 0 0 1 1 0 0.5

Death to Cooling (mean hrs) 2 2.65 3.35 2.6 2.7 2.77Range 2–2 1.5–4.45 2.0–4.4 0–10 1–4 0–10

Death to Preservation (mean hrs) 13 10.07 11.93 7.32 8.91 9.07Range 13–13 5–13 10–16.90 1.7–14 3–19 1.7–19

Death to Surgery (mean days) 5 3.33 7.5 4.2 4.4 4.74Range 5–5 3–4 5–10 2–8 3–6 2–10

Corneal Dystrophy/Degeneration 2 1 0 0 0 0 –Mated Cases 2 (100%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0.3 (66.7%)

Scleral Graft Infection 0 0 0 0 0 0 –

Reactions reported to EBAA after 8/17/07.

Questions? Contact Jennifer DeMatteo at [email protected] or 202-775-4999 ext. 17.

mailto:[email protected]

Date: September 20, 2001

Subject: Equivalency of terminology between EUSTITE Serious Adverse Event / Serious Adverse

Reaction definitions and the Eye Bank Association of America Adverse Reaction Reporting Guidance

The Medical Review Subcommittee of the Medical Advisory Board of the EBAA has reviewed the

EUSTITE definitions for Serious Adverse Events (SAEs) and Serious Adverse Reactions (SARs) and

compared them with the definitions in the EBAA Adverse Reaction Reporting Guidance.

EUSTITE Definitions

Serious Adverse Event (SAE): any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity. Serious Adverse Reaction (SAR): an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, lifethreatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.

The EBAA’s definitions for “Adverse Reactions” and “Deviations” both meet the EUSTITE definition for

Serious Adverse Events (SAEs). “Adverse Reactions” include tissue-transmitted ocular infections, and

Primary Graft Failure or graft-associated biologic dysfunction. The EBAA refers to other types of SAEs as

“Deviations.”

EUSTITE also offers scales to assign each SAR ratings for “Severity,” “Imputability,” and “Impact.” While

Adverse Reactions and Deviations are not assigned ratings for severity or impact, graft-transmitted

ocular infections are classified as “Not Reasonably Likely,” “Reasonably Likely,” or “Proven” and Primary

Graft Failure or graft-associated biologic dysfunction is classified as “Not Reasonably Likely” or

“Reasonably Likely.” The below table shows the equivalency of EUSTITE SAR Imputability ratings and

EBAA Adverse Reaction Reporting Guidance definitions:

EUSTITE Serious Adverse Reaction Imputability Rating Equivalent EBAA Adverse Reaction Reporting Guidance Definition

“Definite, Certain” (“Conclusive evidence beyond reasonable doubt for attributing to the tissues/cells.”)

“Proven”

“Likely, Probable” (“Evidence in favour of attributing to the tissues/cells.”)

“Reasonably Likely”

“Possible” (“Evidence is indeterminate.”)

“Not Reasonably Likely”

“Unlikely” (“Evidence clearly in favour of attributing to other causes.”)


“Excluded” (“Conclusive evidence beyond reasonable doubt for attributing to alternative causes.”)


“Proven” and “Reasonably Likely” adverse reactions are reported to the EBAA and tracked via OARRS.

“Deviations” are reported to the EBAA via email or letter and reviewed by the Medial Review

Subcommittee but are not tracked via OARRS.

Committee Reports:

Policy & Position Research

Subcommittee

Committee Reports:

Accreditation Board

Committee Reports:

Certification Board

Committee Reports:

Technician Education Committee

Committee Reports:

Technical Procedures Manual

Old Business

New Business:

C3.500 Other Establishments

Performing Eye Banking and

C3.510 Utilization of Services

Provided by Establishments

Performing Limited Eye

Banking Functions

September 9, 2011

Dear Dr. Glasser:

I would like to propose the following changes to the Medical Standards:

C3.500 Other Establishments Performing Eye Banking

Any establishment performing any of the following functions: recovery, processing,

evaluation, storage, donor eligibility determination, and final distribution, must employ a

CEBT. A recovery and/or a storage-only establishment may meet this requirement by having

a documented consultative relationship with a CEBT and the EBAA accredited organization

in which the CEBT is employed.

All establishments performing specialized or specificlimited eye banking functionsservices

must have a Medical Director or access to a Medical Director through a documented

consultative relationship with an EBAA accredited organization. This Medical Director must

meet the requirements of Medical Director as outlined in section C1.200 of these standards.

Establishments performing specificlimited eye banking servicesfunctions may be inspected

as part of the EBAA accreditation process of an organization in which they provide services.

C3.510 Utilization of Services Provided by Establishments Performing LimitedSpecialized or

Specific Eye Banking FunctionsServices

Any EBAA accredited organization using eye banking services provided by another

establishment must either:

1.) obtain and document the establishment’s current EBAA accreditation certificate and

status; or

2.) document that the establishment is in compliance with EBAA medical standards, state and

federal regulations appropriate to their function(s). This option requires a written agreement

and the EBAA accredited organization is responsible for performing compliance audits.

Policies and procedures shall describe the audit plan, scope, and frequency.

This simple change in verbiage would more accurately reflect those eye banks who perform

specialized eye banking functions. I respectfully submit these changes for the consideration of the

Medical Advisory Board.

Sincerely,

Jennifer DeMatteo, EBAA

Director of Regulations and Standards

New Business:

M1.500 Recipient Follow‐Up

Information

August 11, 2011 David Glasser, M.D. Chairman Medical Advisory Board Dear Dr. Glasser: I am writing you and the Medical Advisory Board in regard to Medical Standard M1.500 Recipient Follow-up Information. Currently Part 4 of the standard reads: Each distributing eye bank must request postoperative outcome information between three and twelve months after transplant from the transplanting surgeon concerning possible adverse reactions on all eye tissue used for human transplantation that was distributed to the surgeon by that bank. In reviewing the most recent OARRS(Online Adverse Reaction Reporting System) dated 5/8/2011 it shows not one single scleral graft infection reported since the inception of OARRS in 8/17/2007. I think we all agree the OARRS may not be perfect I do believe it is the best and most accurate method that we have available to the association and members at the current time. During this same period there were 28,740 sclera distributed by EBAA members according to the 2010 EBAA Statistical Report. Based on the information presented above I believe the reporting clearly shows there is limited or no risk of adverse due to sclera transplantation. I would request that M1.500 be revised as follows: Each distributing eye bank must request postoperative outcome information between three and twelve months after transplant from the transplanting surgeon concerning possible adverse reactions on all cornea tissue used for human transplantation that was distributed to the surgeon by that bank. Please note I fully support the follow-up corneal tissue and believe this will allow eye banks more time and resources to focus on the adverse reaction that might be related to corneal tissue.

New Business:

L1.200, M1.400, M1.500,

Glossary

Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Final Rule. § 1271.290 Tracking. (a) General. If you perform any step in the manufacture of an HCT/P in which you handle the HCT/P, you must track each such HCT/P in accordance with this section, to facilitate the investigation of actual or suspected transmission of communicable disease and take appropriate and timely corrective action. (b) System of HCT/P tracking.

(1) You must establish and maintain a system of HCT/P tracking that enables the tracking of all HCT/Ps from:

(i) The donor to the consignee or final disposition; and (ii) The consignee or final disposition to the donor.

(2) Alternatively, if you are an establishment that performs some but not all of the steps in the manufacture of an HCT/P in which you handle the HCT/P, you may participate in a system of HCT/P tracking established and maintained by another establishment responsible for other steps in the manufacture of the same HCT/P, provided that the tracking system complies with all the requirements of this section.

(c) Distinct identification code. As part of your tracking system, you must ensure: That each HCT/P that you manufacture is assigned and labeled with a distinct identification code, e.g., alphanumeric, that relates the HCT/P to the donor and to all records pertaining to the HCT/P; and that labeling includes information designed to facilitate effective tracking, using the distinct identification code, from the donor to the recipient and from the recipient to the donor. Except in the case of autologous or directed donations, you must create such a code specifically for tracking, and it may not include an individual’s name, social security number, or medical record number. You may adopt a distinct identification code assigned by another establishment engaged in the manufacturing process, or you may assign a new code. If you assign a new code to an HCT/P, you must establish and maintain procedures for relating the new code to the old code. (d) Tracking from consignee to donor. As part of your tracking system, you must establish and maintain a method for recording the distinct identification code and type of each HCT/P distributed to a consignee to enable tracking from the consignee to the donor. (e) Tracking from donor to consignee or final disposition. As part of your tracking system, you must establish and maintain a method for documenting the disposition of each of your HCT/Ps, to enable tracking from the donor to the consignee or final disposition. The information you maintain must permit the prompt identification of the consignee of the HCT/P, if any. (f) Consignees. At or before the time of distribution of an HCT/P to a consignee, you must inform the consignee in writing of the requirements in this section and of the tracking system that you have established and are maintaining to comply with these requirements.

III. Comments on the Proposed Rule and FDA’s Responses

Tracking (§ 1271.290) Proposed § 1271.290 would require each establishment that performs any step in manufacturing to set up a system for tracking each HCT/P so that the HCT/P may be tracked from donor to recipient and recipient to donor. . . we have revised the tracking provisions to require a system that enables tracking to and from the consignee, rather than to and from the recipient, and have added that labeling includes information designed to facilitate effective tracking, using the distinct identification code, from the donor to the recipient and from the recipient to the donor. (Comment 130) One comment asked for a clarification of the term ‘‘consignee.’’ This comment asked whether a hospital that receives an HCT/P is considered the consignee, or if the surgeon who uses the HCT/P is the consignee.

(Response) Either or both parties may be the consignee, depending on the particular situation. Generally, the person and/or entity to which an HCT/P is distributed would be considered the consignee. (Comment 123) Several comments from eye banks asked for an exception for corneas that are distributed internationally, noting the difficulty of obtaining information on recipients. One of these comments asked that the consignee’s signature and intended disposition be acceptable. (Response) We decline to grant an exception for corneas that are distributed internationally. However, we note that the tracking requirements in § 1271.290 do not require tracking to the recipient level, but rather to the consignee. In the case of international distribution, obtaining the consignee’s signature and intended disposition is acceptable.

EBAA Medical Standards on Recipient Information

L1.200 Package Insert Form

6. The form shall advise the transplanting surgeon that the distributing eye bank must be notified in writing of , the tissue recipient’s name, unique identification number, age and/or date of birth, diagnosis, date of surgery, location of surgery, type of surgery, and the name of the transplanting surgeon when the tissue is transplanted. This information is needed to track the tissue from the donor to the recipient.

M1.400 Minimum Information to Be Retained

Forms for retaining donor and recipient information shall be established and shall be readily accessible for inspection by the EBAA Accreditation Board.

17. Name of surgeon receiving tissue/consignee 18. Recipient identification readily traceable to each unique graft number (See Section M1.500)


1. Each distributing eye bank shall obtain recipient information from the transplanting surgeon on each eye tissue used for human transplantation distributed to the surgeon by the bank.

2. This information shall include the following:

• Patient’s name (if allowed by law)

• Unique identification according to the following order of preference: a. Social security number b. Driver’s license number

c. Hospital information number d. Alien identification e. Passport number f. Other unique identifier appropriate to the health care delivery system where surgery is performed

• Age and/or Date of Birth • Diagnosis • Name of surgeon receiving transplanting tissue • Date of surgery • Location of surgery • Post-operative complications (tissue related)

• Type of surgery performed, e.g. penetrating keratoplasty, anterior lamellar keratoplasty, endothelial keratoplasty, keratolimbal allograft, and/or tectonic

3. Corneas and scleral tissue that can be used beyond 14 days post-mortem may be stocked at an institution only if it is for single patient use; the distributing eye bank must be able to track the tissue to the consignee.

4. Each distributing eye bank must request postoperative outcome information between three and twelve months after transplant from the transplanting surgeon concerning possible adverse

reactions on all eye tissue used for human transplantation that was distributed to the surgeon by that bank. This request must be addressed to the transplanting surgeon and delivered separately from the documentation that accompanies the eye tissue.

Glossary Distributing Establishment. An entity that is reimbursed for or invoices for providing tissue to the end user. Responsible for obtaining recipient information, post op follow up and reporting any adverse reaction to the source establishment. Traceability. The act or ability to locate ocular tissue during any step of its recovery, processing, evaluation, testing, quarantine, labeling, storage, distribution, disposition, or recall. It includes the capacity to identify the medical facility receiving the tissue and, at the medical facility, the ability to identify the storage, recipient or final disposition of the tissue. Tracking. The act or ability to locate individual tissue during any step of its recovery, processing, evaluation, testing, quarantine, labeling, storage, distribution, disposition, and recalling. It includes the capacity to identify the consignee and recipient.

New Business:

L2.000 Packaging, Sealing and

Packing for Transport

September 15, 2011

David Glasser, M.D.

Chairman, Medical Advisory Board

Dear Dr. Glasser: I am writing to you and the Medical Advisory Board in regard to Medical Standard L2.000 Packaging, Sealing and Packing for Transport. In an effort to clarify the applicability of this standard and include predistribution shipping requirements, I would propose the following:

L2.000 Packaging, Sealing and Packing for Transport

Predistribution shipments within or between establishments, before they have met their release

criteria, shall be transported in a shipping container that is capable of maintaining the desired

temperature during transport and protect the tissue from contamination.

Each tissue for export or distribution shall be individually packaged and sealed with a tamper-

evident seal.

Each eye bank shall use a packaging method for transplantable corneal tissue designed to

maintain cool conditions where the package content demonstrates remaining coolant effect at

the time of use or removal to mechanical storage or replacement of the coolant, and to prevent

freezing. For other tissue (e.g., sclera) the packaging method shall be appropriate to the method

of preservation used. Packing shall be done so that the tissue label and documentation to

accompany the tissue do not become wet. Special instructions shall be included on a Package

Insert. See Section L1.200.

I respectfully submit these changes for the consideration of the Medical Advisory Board.

Sincerely,

Jennifer DeMatteo, EBAA

Director of Regulations and Standards

Late Additions

1

Tony Bavuso

From: Kristin Mathes <[email protected]>Sent: Monday, September 26, 2011 5:00 PMTo: [email protected]: Tony Bavuso; Chris Stoeger; Barbara CrowSubject: MAB 10/2011 Late Agenda itemAttachments: M1.500 Recip FU Info.JPG

Dear Dr. Glasser, We are updating our SOP to reflect the June 2011 Medical Standard updates. M1.500 was updated to require distributing eye banks to be able to track tissue preserved in long‐term storage media (e.g. sclera or corneas in glycerin) to the consignee instead of to recipient (sec #3). In that same Standard (sec #4) eye banks are required to seek adverse reaction information on all eye tissue used for human transplantation, which would at least imply that distributing eye banks still need to track recipient info on tissue preserved in long‐term storage media. I am going off of memory, but I remember the Standard being changed in June relieved eye banks of following up postoperatively on recipients receiving transplant tissue like sclera or glycerin‐preserved corneas. Am I remembering incorrectly? If not, could I suggest a language change to section #4 of M1.500 to say: “Each distributing eye bank must request postoperative outcome information between 3 and 12 months after transplant from the transplanting surgeon concerning possible adverse reactions on all eye tissue preserved in short‐term media storage (e.g. Optisol) used for transplantation that was distributed to the surgeon by that bank.” Thanks for your consideration on this. Kind regards, Kristin Kristin Mathes | Director of Regulatory Affairs and Quality Systems Lions VisionGift o. 503.808.7026 | f. 503.808.7027 http://VisionGift.org Give the Gift of Sight. Be an Eye Donor.


4. Each distributing eye bank must request postoperative outcome information between three and twelve months after transplant from the transplanting surgeon concerning possible adverse reactions on all eye tissue used for human transplantation that was distributed to the surgeon by that bank. This request must include a query as to whether donor rim cultures were performed, and if performed whether they were positive. The request must be addressed to the transplanting surgeon and delivered separately from the documentation that accompanies the eye tissue.

For Information &

Review

FDA Validation Workshop

Eye Bank Processing Survey

Cornea Donor Study

Medical Advisory Board Agenda - Eye Bank Association of …restoresight.org/wp-content/uploads/2011/10/MAB-Agen… · · 2017-04-28Approval of Minutes III. Committee Reports ...

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