The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery

Giorgio Noera

doi:doi:10.11648/j.ijcts.20210702.11

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The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery

Giorgio Noera

Published in International Journal of Cardiovascular and Thoracic Surgery (Volume 7, Issue 2)

Received: 11 April 2021 Accepted: 18 May 2021 Published: 26 May 2021

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Abstract

Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for the-patient’s informed consent.

Published in	International Journal of Cardiovascular and Thoracic Surgery (Volume 7, Issue 2)
DOI	10.11648/j.ijcts.20210702.11
Page(s)	13-15
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

Glutaraldehyde, Risk Related Reference, Open Cardiac Surgery

References

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[3]	Cavagnaro A. Preclinical safety evaluation of biotechnology-derived pharmaceuticals (2002) Nature Reviews Drug Discovery (1), 469-475.
[4]	European Commission. Medical Device Coordination Group Document (2020) MDCH 2020-12 Guidance. Available from: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020-12_guidance_transitional_provisions_en.pdf.
[5]	EMA: ICH S6 (R1) Preclinical safety evaluation of biotechnology- derived pharmaceuticals. 2011. European Medical Agency. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals-step-5_en.pdf.
[6]	Hermanson G. T. (2013) Bioconjugates Technique Third Edition Elsevier ISBN 978-0-12-382239-0.
[7]	Migneault I., Dartiguenave, C., Bertrand, M. J., Waldro, C. (2004) Glutaraldehyde: behavior in aqueous solution, reaction with proteins, and application to enzyme crosslinking. Bio. Techniques 37: 790-802.
[8]	ATSDR: Glutaraldehyde. Atlanta: Agency for Toxic Substances and Disease Registry Division of Toxicology and Human Health Sciences Environmental Toxicology Branch. ©2017. Available from: https://www.atsdr.cdc.gov/Tox Profiles/tp208-p.pd4.
[9]	ATSDR: Glutaraldehyde A-1 Appendix A Minimal Risk Level and Worksheet. The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) [42 U.S.C] [Internet]. Atlanta:Agency for Toxic Substances and Disease Registry; Available from: https://www.atsdr.cdc.gov/toxprofiles/tp208.pdf.
[10]	EU-OSHA Agency European Union Directive 98/24/EC - risks related to chemical agents at work Available from: https://osha. europa.eu/en/legislation/directives/75.
[11]	Yanoa, K., Watanabea, N., Tsuyukic, K. Ikawac, T., Kasanukib, H., Yamato, M. (2015) Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan. Regenerative Therapy 1, 45-56.
[12]	European Medical Agency. (2019) First guidance on new rules for certain medical devices Available from https://www.ema.europa.eu/en/news/first-guidance-new-rules-certain-medical-devices.
[13]	Pirola S., Mastroiacovo G., Arlati FG., Mastardini G., Bonomi A., : Penza E., Polvani G.(2020) Single Center Five Years’ Experience of Ozaki Procedure: Midterm Follow-up. Available from: https://doi.org/10.1016/j.athoracsur.2020.08.039.
[14]	Sá M. P. B. O., Perazzo Á. M., Zhigalov K., Komarov R., Kadyraliev B., Enginoev S., Ennker J., Popov A. F., Quarto C., Weymann A., Lima R. C. (2019) Aortic Valve Neocuspidalization with Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure) - A Promising Surgical Technique Braz J Cardiovasc Surg. 1; 34 (5): 610-614.
[15]	Wittich C. M., Burkle C. M., W. L. Lanier. (2012) Ten Common Questions (and Their Answers) About Off-label Drug Use Mayo Clin Proc.; 87 (10): 982-990.

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APA Style

Giorgio Noera. (2021). The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery. International Journal of Cardiovascular and Thoracic Surgery, 7(2), 13-15. https://doi.org/10.11648/j.ijcts.20210702.11

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ACS Style

Giorgio Noera. The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery. Int. J. Cardiovasc. Thorac. Surg. 2021, 7(2), 13-15. doi: 10.11648/j.ijcts.20210702.11

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AMA Style

Giorgio Noera. The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery. Int J Cardiovasc Thorac Surg. 2021;7(2):13-15. doi: 10.11648/j.ijcts.20210702.11

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@article{10.11648/j.ijcts.20210702.11,
  author = {Giorgio Noera},
  title = {The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery},
  journal = {International Journal of Cardiovascular and Thoracic Surgery},
  volume = {7},
  number = {2},
  pages = {13-15},
  doi = {10.11648/j.ijcts.20210702.11},
  url = {https://doi.org/10.11648/j.ijcts.20210702.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcts.20210702.11},
  abstract = {Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for the-patient’s informed consent.},
 year = {2021}
}

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TY  - JOUR
T1  - The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery
AU  - Giorgio Noera
Y1  - 2021/05/26
PY  - 2021
N1  - https://doi.org/10.11648/j.ijcts.20210702.11
DO  - 10.11648/j.ijcts.20210702.11
T2  - International Journal of Cardiovascular and Thoracic Surgery
JF  - International Journal of Cardiovascular and Thoracic Surgery
JO  - International Journal of Cardiovascular and Thoracic Surgery
SP  - 13
EP  - 15
PB  - Science Publishing Group
SN  - 2575-4882
UR  - https://doi.org/10.11648/j.ijcts.20210702.11
AB  - Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for the-patient’s informed consent.
VL  - 7
IS  - 2
ER  -

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Author Information

Giorgio Noera

Cardiothoracic Surgery Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola (Ra), Italy

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Plain Text BibTeX RIS

APA Style

Giorgio Noera. (2021). The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery. International Journal of Cardiovascular and Thoracic Surgery, 7(2), 13-15. https://doi.org/10.11648/j.ijcts.20210702.11

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ACS Style

Giorgio Noera. The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery. Int. J. Cardiovasc. Thorac. Surg. 2021, 7(2), 13-15. doi: 10.11648/j.ijcts.20210702.11

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AMA Style

Giorgio Noera. The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery. Int J Cardiovasc Thorac Surg. 2021;7(2):13-15. doi: 10.11648/j.ijcts.20210702.11

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@article{10.11648/j.ijcts.20210702.11,
  author = {Giorgio Noera},
  title = {The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery},
  journal = {International Journal of Cardiovascular and Thoracic Surgery},
  volume = {7},
  number = {2},
  pages = {13-15},
  doi = {10.11648/j.ijcts.20210702.11},
  url = {https://doi.org/10.11648/j.ijcts.20210702.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcts.20210702.11},
  abstract = {Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for the-patient’s informed consent.},
 year = {2021}
}

Copy | Download

TY  - JOUR
T1  - The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery
AU  - Giorgio Noera
Y1  - 2021/05/26
PY  - 2021
N1  - https://doi.org/10.11648/j.ijcts.20210702.11
DO  - 10.11648/j.ijcts.20210702.11
T2  - International Journal of Cardiovascular and Thoracic Surgery
JF  - International Journal of Cardiovascular and Thoracic Surgery
JO  - International Journal of Cardiovascular and Thoracic Surgery
SP  - 13
EP  - 15
PB  - Science Publishing Group
SN  - 2575-4882
UR  - https://doi.org/10.11648/j.ijcts.20210702.11
AB  - Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for the-patient’s informed consent.
VL  - 7
IS  - 2
ER  -

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