Sterilization of implantable polymer-based medical devices: A review

Tipnis, Namita P.; Burgess, Diane J.

doi:10.1016/j.ijpharm.2017.12.003

Cited by 233Medical Device Sterilization and DisinfectionAntimicrobial agents and applicationsHealthcare Regulation

Sterilization of implantable polymer-based medical devices: A review

Tipnis, Namita P., Burgess, Diane J.·2018·International Journal of Pharmaceutics

DOI 10.1016/j.ijpharm.2017.12.003

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Abstract

This review article is focused on the sterilization techniques used for polymer-based implantable medical devices as well as the regulatory aspects governing sterile medical devices. Polymeric materials are increasingly used in implantable devices due to their biodegradable and biocompatible nature. Patients and medical staff often prefer long-term implantable devices and these can be achieved using high molecular weight polymers. Sterilization of polymer-based implantable devices is critical. Since all implantable devices must be sterile, the effect of the sterilization method on the different device components (such as, the polymer, the drug, the electronics, etc.) has to be considered. A comprehensive summary of the established sterilization methods is provided along with the possible effects on polymers. In addition, novel sterilization methods are also discussed.

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The selection of sterilization method reflects material choice of implants with polymers; gamma irradiation is fast and efficient but can degrade polymers through cross-linking, chain scission or a combination of both.
“The selection of the sterilization method reflects material choice of the implants with polymers; e.g. gamma irradiation is fast and efficient, but can degrade polymers through 'cross-linking, chain scission or a combination of both' (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
Implantable electrodes carry the highest risk when compared with other medical technologies.
“These implantable electrodes, carry the highest risk when compared with other medical technologies, are class III devices and therefore have stringent approval process including a premarket approval to weigh the health benefits against the risk (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
Class III devices have a stringent approval process including a premarket approval to weigh the health benefits against the risk.
“These implantable electrodes, carry the highest risk when compared with other medical technologies, are class III devices and therefore have stringent approval process including a premarket approval to weigh the health benefits against the risk (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018
Implantable electrodes are class III devices.
“These implantable electrodes, carry the highest risk when compared with other medical technologies, are class III devices and therefore have stringent approval process including a premarket approval to weigh the health benefits against the risk (Tipnis and Burgess 2018).”
From Peripheral nerve bionic interface: a review of electrodes (2019) · cites this paper as Tipnis and Burgess 2018

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Authors: Tipnis, N. P., & Burgess, D. J.
Affiliations: University of Connecticut (US)
Corresponding author: Burgess, Diane J.
ORCID: Tipnis, Namita P.
Burgess, Diane J.
Venue: International Journal of Pharmaceutics
Publisher: Elsevier BV
Published: 2018-06
Volume: 544
Issue: 2
Pages: 455-460
ISSN: 0378-5173 (ISSN-L)
DOI: 10.1016/j.ijpharm.2017.12.003
OpenAlex: W2780274668
Cited by: 233
References: 39
Citations by year: 2026: 19 · 2025: 32 · 2024: 32 · 2023: 36 · 2022: 28 · 2021: 28 · 2020: 26 · 2019: 19 · 2018: 13
FWCI: 12.82
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: International Journal of Pharmaceutics (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Immunology and Microbiology › Microbiology › Medical Device Sterilization and Disinfection
Physical Sciences › Chemistry › Organic Chemistry › Antimicrobial agents and applications
Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
Keywords: sterilization, biomedical implants, sterilization methods, biodegradable polymers, biocompatibility, drug-loaded implants
MeSH terms: Biocompatible Materials, Equipment Contamination, Polymers, Sterilization, United States, United States Food and Drug Administration, Guidelines as Topic, Prostheses and Implants

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Sterilization of implantable polymer-based medical devices: A review

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