Organ procurement organization compliance with 21 CFR 1271: A challenge for allogeneic pancreatic islet cell transplantation programs

J. L. Winters, S. A. Tran, D. A. Gastineau, D. J. Padley, P. G. Dean, Yogish C Kudva

Research output: Contribution to journalArticle

Abstract

In order to protect tissue recipients, the Food and Drug Administration drafted Title 21, Section 1271 of the Code of Federal Regulations 1271 (21 CFR 1271) to address infectious disease risk. These regulations apply to tissues but not vascularized organs. Pancreatic islet cells are regulated under 21 CFR 1271. These regulations require qualification of suppliers of critical materials and services with regard to 21 CFR 1271 compliance. As part of supplier qualification, all organ procurement organizations (OPOs) in the United States were sent a questionnaire covering the key components of these regulations. Of the 57 OPOs, 29 (51%) were in compliance based upon survey results. Twelve (21%) were not compliant in one or more areas. All indicated plans to become compliant. The remaining 15 (27%) either failed or refused to complete the survey, some indicating 21 CFR 1271 did not apply to OPOs. Using 2006 data, OPOs compliant with 21 CFR 1271 recovered 50% of the organs procured in the United States. These findings represent a challenge for allogeneic islet cell transplant programs whose raw material must comply with 21 CFR 1271. OPOs should work toward understanding and complying with 21 CFR 1271. Regulatory agencies should work toward enhancing safety of the pancreas supply by facilitating compliance through harmonization of requirements.

Original languageEnglish (US)
Pages (from-to)1472-1476
Number of pages5
JournalAmerican Journal of Transplantation
Volume9
Issue number6
DOIs
StatePublished - Jun 2009

Fingerprint

Islets of Langerhans Transplantation
Tissue and Organ Procurement
Cell Transplantation
Islets of Langerhans
Organizations
Compliance
United States Food and Drug Administration
Communicable Diseases
Pancreas
Transplants
Safety
Surveys and Questionnaires

Keywords

  • Donor evaluation
  • Donor screening
  • Donor selection
  • Organ procurement organization
  • Pancreas and islet transplantation
  • Regulation

ASJC Scopus subject areas

  • Transplantation
  • Immunology and Allergy
  • Pharmacology (medical)

Cite this

Organ procurement organization compliance with 21 CFR 1271 : A challenge for allogeneic pancreatic islet cell transplantation programs. / Winters, J. L.; Tran, S. A.; Gastineau, D. A.; Padley, D. J.; Dean, P. G.; Kudva, Yogish C.

In: American Journal of Transplantation, Vol. 9, No. 6, 06.2009, p. 1472-1476.

Research output: Contribution to journalArticle

Winters, J. L. ; Tran, S. A. ; Gastineau, D. A. ; Padley, D. J. ; Dean, P. G. ; Kudva, Yogish C. / Organ procurement organization compliance with 21 CFR 1271 : A challenge for allogeneic pancreatic islet cell transplantation programs. In: American Journal of Transplantation. 2009 ; Vol. 9, No. 6. pp. 1472-1476.
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abstract = "In order to protect tissue recipients, the Food and Drug Administration drafted Title 21, Section 1271 of the Code of Federal Regulations 1271 (21 CFR 1271) to address infectious disease risk. These regulations apply to tissues but not vascularized organs. Pancreatic islet cells are regulated under 21 CFR 1271. These regulations require qualification of suppliers of critical materials and services with regard to 21 CFR 1271 compliance. As part of supplier qualification, all organ procurement organizations (OPOs) in the United States were sent a questionnaire covering the key components of these regulations. Of the 57 OPOs, 29 (51{\%}) were in compliance based upon survey results. Twelve (21{\%}) were not compliant in one or more areas. All indicated plans to become compliant. The remaining 15 (27{\%}) either failed or refused to complete the survey, some indicating 21 CFR 1271 did not apply to OPOs. Using 2006 data, OPOs compliant with 21 CFR 1271 recovered 50{\%} of the organs procured in the United States. These findings represent a challenge for allogeneic islet cell transplant programs whose raw material must comply with 21 CFR 1271. OPOs should work toward understanding and complying with 21 CFR 1271. Regulatory agencies should work toward enhancing safety of the pancreas supply by facilitating compliance through harmonization of requirements.",
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