Begin: Receive report of suspected allograft-transmitted infection
Adverse Reaction form/Complaint database
entry (note: w/ every action rectangle this
applies but this symbol is not repeated
Enter into appropriate adverse reaction/complaint
database and contact Responsible Persons
May be
assisted by
QA personnel
Communicated to Responsible Person of Regulatory Affairs/Quality
Assurance Department
Communicated to Medical Director
In-house Donor Record
Return Graft
Authorization form
Quarantine Graft
form/database
designation
Review report information, assign eventtracking code, check for other
complaints involving same donor, ensure
any returned grafts are quarantined;
quarantine inventory not yet distributed
or released, verify w/reporting entity that
complaint was received and
investigation in process, review donor
chart (A.)
Review report information and in-house donor record (B.)
Communicate with recipient’s physician (or reporting person)
Request specific recipient
information/medical
records (C.)
In-house Donor Record
Other complaint
report(s) exist(s)
for this donor
Review information received
Determine product
type affected by
adverse report
An allograft designated as a
Biologic or a Medical Device
(351 product)
To insert on both sides: Medical
Director Review (prior to reporting)
A conventional tissue
allograft (361 product
or HCT/P)
Delayed or no
response to
requests*
Delayed or no
response to
requests*
Determination whether or not this is a
“possible” allograft-transmitted infection.
(reasonable possibility) MUST be done w/in
15 days of initial report, regardless of
delays*
All known
information is
reviewed
MedWatch entry/form.
Determine
Reporting
Requirements
MDR Scheme;
International
Communications**
Determine
Reporting
Requirements
International reporting
if distributed there:
Health Canada (see
form); EU Directive –
to competent authority
of Member State
Voluntary market
withdrawal (or
recall) may be
instituted
Determine if
“probable” allograft
transmitted infection
MedWatch entry/form
Yes
Canada Vigilance
Reporting Entry/Form
(EUSTITE is developing
a form); see Directive
2006/86/EC, Annex III
Enter into appropriate adverse event database and
initiate Responsible Person actions
No
Review
decision
history,
produce
summary
report
Action Items for Medical Director
MedWatch entry/form
Actions for Responsible Person of Regulatory
Affairs/Quality Assurance Department
**EU (MDV), Canada (TPP),
Australia (TPA), Japan (ARR)
Canada Vigilance
Reporting Entry/Form
Institute
formal recall
Immediately Contact
Appropriate Agencies (D.) This
should appear earlier
Investigation
by federal
authority
Inspect/test
returned/quarantined
grafts
CAPA (Corrective
and Preventive
Action) In-process
review/impact
Communicate
with original
reporting
entity
Delayed or no
response to
requests
Initiate Field Alert:
Investigate recipients of other
allografts from same donor
Request specific recipient
information/medical
records and/or samples
Test recipient
samples
Review decision history,
produce summary report
All known
information
is reviewed
Determine if
“proven” allograft
transmitted infection
Create and Issue
response/report letters
Close Report
Close Report
A.
Pre-processing, inprocessing, postprocessing culture
results. Reagent,
equipment, and material
records. Environmental
monitoring test results
D.
Recovery Agency(ies), other
Processing Establishment(s),
federal authority (e.g., FDA,
CDC), state authority (e.g.,
NYDOH, Florida AHCA),
AATB (Accreditation
Policies, part V), appropriate
state/county health dept.,
International competent
authority, if applicable**
B.
Donor: Medical history,
clinical course, cause of
death, autopsy, all
cultures, lab work,
trauma/physical
assessment.
Recipient: current clinical
course, lab work/cultures,
operative report
C.
Clinical course,
symptoms, all
cultures/tests, operative
report, how graft culture
was obtained at implant,
viral testing history
Glossary of Acronyms and Terms
FDA = United States Food and Drug Administration
CDC = Centers for Disease Control and Prevention
NYDOH = New York State Department of Health
Florida AHCA = State of Florida Agency for Health Care Administration
AATB = American Association of Tissue Banks
**EU Authorities (MDV – Medical Device Vigilance), Canada (TPP- Therapeutic Products Program), Australia (TGA – Therapeutic Goods
Act), Japan (ARR – Adverse Reaction Reporting).