Sterilization of implantable polymer-based medical devices: A review

Tipnis, Namita; Burgess, Diane J.

doi:10.1016/j.ijpharm.2017.12.003

Cited by 171 publications

(177 citation statements)

References 28 publications

Supporting

Mentioning

173

Contrasting

Unclassified

Order By: Relevance

“…Prior any biological testing of the sample, an appropriate sterilization technique has to be selected. To exclude that the latter has an influence on the functional properties of the final product, physical and chemical characteristics have to be characterized thoroughly before and after the sterilization …”

Section: Prerequisites For a Reproducible In Vitro Testingmentioning

confidence: 99%

In Vitro Thrombogenicity Testing of Biomaterials

Braune

Latour

Reinthaler

et al. 2019

Adv Healthcare Materials

View full text Add to dashboard Cite

reliable, and reproducible. [20][21][22] This is, not least, important for realizing interstudy comparisons of the thrombogenicity of different materials. According, e.g., to the regulation (EU) 2017/745 of the European parliament and of the council on medical devices, in vitro and in vivo tests are a mandatory parts within the preclinical product verification and validation (see Annex II: Technical documentation, 6.1 Preclinical and clinical data). [23] Beyond the results of these tests, also detailed information concerning the test design, respective protocols and data analysis are obligatory to meet the requirements of the regulation, particularly those formulated in the ISO standard 10993 Part 4. [24,25] Since the regulatory agencies provide recommendations rather than protocols or standard operation procedures, accepted standardizations regarding the preanalytical handling of the blood, test conditions, test parameters, reference materials, static or dynamic conditions, flow conditions, and finally, which type of cells and donors should be included is lacking. Also, standard operating procedures how the testing should be performed are lacking. [9] This has led to a situation that laboratories perform in vitro assays under substantially different test conditions, including the preanalytical characterization of blood samples, the application of blood from different species, varying anticoagulation and stabilization or storage times as well as test setups. Taking these variations into account, interlaboratory or interstudy comparisons are impossible. [8,[26][27][28] Here, we review described test methods and procedures for the assessment of the thrombogenicity of materials, prerequisites for a reproducible in vitro testing, applied test system and test parameters for the characterization of the interaction of blood components/cells and the implant. We further review and outline recent approaches that may support realizing reliable, reproducible, and laboratory independent tests.

show abstract

Section: Prerequisites For a Reproducible In Vitro Testingmentioning

confidence: 99%

In Vitro Thrombogenicity Testing of Biomaterials

Braune

Latour

Reinthaler

et al. 2019

Adv Healthcare Materials

View full text Add to dashboard Cite

show abstract

“…For chronic applications, which is expected for long-term prosthetic use, the overall design should be suited for sterilization to destroy any biological agents on the surface of the implants, to prevent infections. These may include established methods such as dry heat, electron beam-and gammairradiation, ethylene oxide, steam (autoclave), hydrogen peroxide, formaldehyde sterilization and ozone, as well as new methods such as vaporized peracetic acid, high intensity or pulsed light and microwave radiation (Joung 2013;Tipnis and Burgess 2018). The selection of the sterilization method reflects material choice of the implants with polymers; e.g.…”

Section: Electrode Designmentioning

confidence: 99%

“…Of the commercial electrodes listed in Table 1, of which a majority are US based suppliers, none of the products are FDA approved preventing clinical application of these technologies, thus affecting development of clinically suited prosthetic limb 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).…”

Section: Commercial Extra-neural Electrodes For Pnsmentioning

confidence: 99%

Peripheral nerve bionic interface: a review of electrodes

Russell

Roche

Chakrabarty

2019

Int J Intell Robot Appl

View full text Add to dashboard Cite

show abstract

“…Secondly, this study did not consider the impact of sterilisation. The high temperatures associated with steam sterilization and the high-energy of gamma irradiation may accelerate the degradation of the PLC coating and reduce the efficacy of the drugs embedded in the coating [33]. As such, the preferred sterilization method for the device in this study is ethylene oxide [34].…”

Section: Degradation and Antibiotic Release Rate Of Double Coatingsmentioning

confidence: 99%

Implant Coating Manufactured by Micro-Arc Oxidation and Dip Coating in Resorbable Polylactide for Antimicrobial Applications in Orthopedics

Cao

Tian²,

Dong³

et al. 2019

Coatings

View full text Add to dashboard Cite

Prophylaxis and the treatment of implant-related infections has become a key focus area for research into improving the outcome of orthopedic implants. Functional resorbable coatings have been developed to provide an antimicrobial surface on the implant and reduce the risk of infection. However, resorbable coatings developed to date still suffer from low adhesive strength and an inadequate release rate of antibiotics. This study presents a novel double-coating of micro-arc oxidation and resorbable polylactide copolymer on a Ti-6Al-4V implant with the aim of reducing the risk of infection post-implantation. The adhesive strength, rate of coating degradation, and antibiotic release rate were investigated. A key finding was that the micro-arc oxidation coating with the addition of antibiotics increased the adhesive strength of the poly-l-lactide-co-ε-caprolactone (PLC) coatings. The adhesive strength was influenced by the concentration of the PLC solution, the surface structure of the titanium substrate, and the composition of the coatings. The antibiotics blended into the PLC coating had a release cycle of approximately 10 days, which would be long enough to reduce the risk of developing an infection after implantation. The double coatings presented in this study have an excellent potential for reducing the incidence and severity of implants-related early infections.

show abstract

Sterilization of implantable polymer-based medical devices: A review

Cited by 171 publications

References 28 publications

In Vitro Thrombogenicity Testing of Biomaterials

In Vitro Thrombogenicity Testing of Biomaterials

Peripheral nerve bionic interface: a review of electrodes

Implant Coating Manufactured by Micro-Arc Oxidation and Dip Coating in Resorbable Polylactide for Antimicrobial Applications in Orthopedics

Contact Info

Product

Resources

About