Journal of Biomedical Materials Research Part B: Applied Biomaterials

Original Research Report

Bacterial endotoxin detection in hyaluronic acid-based medical devices

Larissa F. Baeva

Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, 20993

Search for more papers by this author

Srilekha Sarkar Das,

Srilekha Sarkar Das

Search for more papers by this author

Victoria M. Hitchins,

Corresponding Author

Victoria M. Hitchins

[email protected]

Correspondence to: V. M. Hitchins; e-mail: [email protected]Search for more papers by this author

Larissa F. Baeva,

Larissa F. Baeva

Search for more papers by this author

Srilekha Sarkar Das,

Srilekha Sarkar Das

Search for more papers by this author

Victoria M. Hitchins,

Corresponding Author

Victoria M. Hitchins

[email protected]

Correspondence to: V. M. Hitchins; e-mail: [email protected]Search for more papers by this author

First published: 08 April 2016

https://doi.org/10.1002/jbm.b.33659

Citations: 13

Conflict of interest statement: No financial benefit of any kind was received either directly or indirectly by the authors.

Disclaimers: The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.

Share a link

Email
Wechat
Bluesky

Abstract

A simple and rapid method has been developed for testing bacterial endotoxin in hyaluronic acid (HA)-based medical devices. High-molecular-weight HA (HMW HA) in solution or HA-based medical devices was digested by the enzyme hyaluronidase to reduce solution viscosity by truncating the long chains of HA and to test for bacterial endotoxin. The bacterial endotoxin level was detected and measured by kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay. The method was applied to two different ophthalmic viscosurgical devices (OVDs) and one dermal filler, and may easily be adapted to use with up to 3% HA solutions and other HA-based medical devices. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. J Biomed Mater Res Part B: Appl Biomater, 2016. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1210–1215, 2017.

REFERENCES

1 Bissen-Miyajima H. Ophthalmic viscosurgical devices: Review. Curr Opin Ophthalmol 2008, 19: 50–54.
10.1097/ICU.0b013e3282f14db0
PubMed Web of Science® Google Scholar
2 Adams ME, Lussier AJ, Peyron JG. A risk-benefit assessment of injections of hyaluronan and its derivatives in the treatment of osteoarthritis of the knee. Drug Safety 2000; 23: 115–130.
10.2165/00002018-200023020-00003
CAS PubMed Web of Science® Google Scholar
3 Gold M. The science and art of hyaluronic acid dermal filler use in esthetic applications. Journal of Cosmetic Dermatology 2009; 8: 301–307.
10.1111/j.1473-2165.2009.00464.x
CAS PubMed Web of Science® Google Scholar
4 Al-Musawi D and Thompson JN. Adhesion prevention: State of the art. Gynaecological Endoscopy 2001; 10: 123–130.
10.1046/j.1365-2508.2001.00422.x
Web of Science® Google Scholar
5 U.S. Food and Drug Administration. Guidance for Industry: Pyrogen and Endotoxins Testing: questions and answers; June 2012. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm310098.pdf. Accessed August, 10, 2015.
Google Scholar
6 U.S. Food and Drug Administration. Guidance for Industry and Food and Drug Administration Staff: Endotoxin Testing Recommendations for Single-Use Intraocular Opthalmic Devices; August 17, 2015. Available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393376.pdf
Google Scholar
7 Cutler Peck CM, Brubaker J, MD, Clouser S, Danford C, Edelhauser HE, Mamalis N. Toxic anterior segment syndrome: Common causes. J Cataract Refract Surg 2010; 36: 1073–1080.
10.1016/j.jcrs.2010.01.030
PubMed Web of Science® Google Scholar
8 Funt D, Pavicic T. Dermal fillers in aesthetics: An overview of adverse events and treatment approaches. Clinical, Cosmetic and Investigational Dermatology 2013; 6: 295–316.
PubMed Google Scholar
9 Pandey SK, Thakur J, Werner L, Aplle DJ. Ophthalmic viscosurgical devices and anterior segment surgery: Surgical applications and complications. DOS Times 2003; 9: 264–268.
Google Scholar
10 American Academy of Ophthalmology – Guidelines – TASS resources March 2012 http://www.aao.org/clinical-statement/tass-resources–march-2012
Google Scholar
11 Food and Drug Administration. FDA – Medical device safety – Medical device recalls: accessed 05/19/2015 at: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm061978.htm
Google Scholar
12 Eydelman MB, Tarver ME, Calogero D, Buchen SY, Alexander KY. The Food and Drug Administration's proactive toxic anterior segment syndrome program. Ophthalmology 2012; 119: 1297–1302.
10.1016/j.ophtha.2012.04.008
PubMed Web of Science® Google Scholar
13 Buchen, SY, Calogero D, Hilmantel G, Eydelman MB. Detecting endotoxin contamination of ophthalmic viscosurgical devices. Ophthalmology 2012; 119: e11–e18.
10.1016/j.ophtha.2012.04.005
PubMed Web of Science® Google Scholar
14 Baeva LF, Lyle DB, Rios M, Langone JJ, Lightfoote MM. Different molecular weight hyaluronic acid effects on human macrophage interleukin 1β production. J Biomed Mater Res Part A 2014; 102A: 305–314.
10.1002/jbm.a.34704
CAS Web of Science® Google Scholar
15 Clavet CR, Chaput MP, Silverman MD, Striplin M, Shoff ME, Lucas AD, Hitchins VM, and Eydelman MB. Impact of contact lens materials on multipurpose contact lens solution disinfection activity against Fusarium solani. Eye & Contact Lens 2012; 38: 379–384.
10.1097/ICL.0b013e31826f1004
PubMed Web of Science® Google Scholar
16 Food and Drug Administration. Adverse Event Reporting News 2008; November 18: page 8: http://inside.fda.gov:9003/downloads/library/onlineandprintjournals/ucm045935.pdf
Google Scholar
17 Chabra I, Obagi S. Severe site reaction after injecting hyaluronic acid-based soft tissue filler. Cosmetic Dermatology 2011; 24: 14–21.
Google Scholar
18 Dyke SV, Hays GP, Caglia AE, Caglia M. Severe acute local reactions to a hyaluronic acid-derived dermal filler. J Clin Aesthetic Dermatol 2010; 3: 32–35.
PubMed Google Scholar
19 Cohen JL. Understanding, avoiding, and managing dermal filler complications. Dermatol Surg 2008; 34: S92–S99.
10.1111/j.1524-4725.2008.34249.x
CAS PubMed Web of Science® Google Scholar
20 Edwards, PC, Fantasia JE. Review of long-term adverse effects associated with the use of chemically modified animal and nonanimal source hyaluronic acid dermal fillers. Clinical Interventions in Aging 2007; 2: 509–519.
10.2147/CIA.S382
PubMed Web of Science® Google Scholar
21 Breger J, Baeva L, Agrawal A, Shindell E, Godar DE. UVB-induced inflammatory cytokine release, DNA damage and apoptosis of human oral compared with skin tissue equivalents. Photochem Photobiol 2013; 89: 665–670.
10.1111/php.12030
CAS PubMed Web of Science® Google Scholar
22 Huang, Z, Zhao C, Radi, A. Characterization of hyaluronan, hyaluronidase PH20, and HA synthase HAS2 in inflammation and cancer. Inflammation & Cell Signaling 2014; 1: e306.
Google Scholar
23 Novitsky, TJ, Schmidt-Gengenbach, J, Remillard, JF. Factors affecting recovery of endotoxin absorbed to container surfaces. J Parenteral Sci & Technology1986; 40: 284–286.
CAS PubMed Google Scholar

Citing Literature

Volume105, Issue5

July 2017

Pages 1210-1215

Bacterial endotoxin detection in hyaluronic acid-based medical devices

Abstract

REFERENCES

Citing Literature

References

Information

About Wiley Online Library

Help & Support

Opportunities

Connect with Wiley

Bacterial endotoxin detection in hyaluronic acid-based medical devices

Abstract

REFERENCES

Citing Literature

References

Related

Information