Effect of processing on silk‐based biomaterials: Reproducibility and biocompatibility

Wray, Lindsay S.; Hu, Xiao; Gallego, J.-I. Andrés; Georgakoudi, Irene; Omenetto, Fiorenzo G.; Schmidt, Daniel F.; Kaplan, David L.

doi:10.1002/jbm.b.31875

Cited by 291 publications

(316 citation statements)

References 49 publications

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“…Materials should also be evaluated for their capacity to retain unacceptable levels of reprocessing chemical residuals as a result of any recommended cleaning, disinfection, or sterilization procedures [138]. If there is a potential for toxic byproducts or residuals, then manufacturers of both critical and semi-critical devices should perform extra biocompatibility testing on these potential threats [139].…”

Section: Effect Of Different Materials On a Device's Biocompatibilitymentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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Section: Effect Of Different Materials On a Device's Biocompatibilitymentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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“…Ham ipeğin yapısının yaklaşık %70-80'ini ipeğin ana yapısını oluşturan fibril yapıdaki bir protein olan fibroin, %20-30'unu fibroinleri bir arada tutmaya yarayan zamksı bir protein olan serisin, %1,5-3,3 civarında ise inorganik tuzlar ve renklendirici maddeler gibi doğal safsızlıklar oluşturur [28,34,[45][46][47][48]. İpek fibroini, insan vücuduna yabancı bir protein olmasına rağmen, hücre çoğalmasını desteklemesi, biyouyumluluk, oksijen ve su buharı geçirgenliği, biyolojik çözünürlük ve minimal yangı gibi özellikleri nedeni ile birçok biyomedikal kullanım alanı için uygundur.…”

Section: Serisin Gidermeunclassified

İpek Ameliyat İplikleri ve Türkiye’de Üretim Olanakları

Coşkun¹,

Karaca²,

Hockenberger³

et al. 2016

Tekstil ve Mühendis

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Tıbbi tekstiller, teknik tekstiller içinde hızla ilerleyen alanlardan birisidir. Özellikle ameliyat iplikleri, tıbbi tekstiller içinde önemli bir pazar hacmine sahiptir. İpek, mukavemeti, inceliği, esnekliği, biyouyumluluğu, kullanım ve düğüm kolaylığı ile vazgeçilmez bir ameliyat ipliği malzemesidir. İpek ameliyat ipliği tüketiminde, özellikle ülkemizdeki geleneksel yaş koza üretimi ve son yıllarda gerçekleştirilen girişimlerle başlatılan ham ipek üretimine rağmen, ithal ürünlerden henüz vazgeçilmemiştir. Önemli bir pazar payına sahip ipek ameliyat ipliklerinin ülkemizde üretilebilmesi, hem ipeğin kullanım alanlarını çeşitlendirilmek hem de ameliyat ipliği kullanımında dışa bağımlılıktan kurtulmak açısından önem arz etmektedir. Bu çalışmada, ipek ameliyat ipliklerinin üretim sürecine yer verilmiş ve yerli üretim olanakları tartışılmıştır.

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“…Bombyx mori is a main source of fibroin and sericintwo proteins of silk fibre, which are used in medicine for producing a biocompatible biopolymers for tissue engineering, biomedical and biotechnological applications and regenerative therapy [7][8][9][10]. Fibroin is a heterodimeric protein with a heavy chain (395 kDa) and two small subunits, P25 and L-chain of 25 kDa [8,11]. The amino acid composition of silk fibroin from Bombyx mori consists primarily of glycine (43%), alanine (30%) and serine (12%) [8,12].…”

Section: Silk Fibre Proteinsmentioning

confidence: 99%

“…The amino acid composition of silk fibroin from Bombyx mori consists primarily of glycine (43%), alanine (30%) and serine (12%) [8,12]. Sericin comprises different polypeptides ranging in weight from 24 kDa to 400 kDa and is characterized by unusually high serine content (40%) along with significant amounts of glycine (16%) [8,11].…”

Section: Silk Fibre Proteinsmentioning

confidence: 99%

The Mulberry Silkworm—A New Source of Bioactive Proteins

Łochyńska¹

2015

JAST-A

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Abstract:Beyond the commonly known proteins built silk fibres-fibroin and sericin, there are almost 300 bioactive proteins in the silkworm haemolymph. The aim of this work was to present bioactive compounds obtained from the silk fibre and isolated from the body of this insect, which may be used in medical and pharmacological applications. The most important are bioactive proteins. However, the juvenile stages of mulberry silkworm possess other very valuable active substances.

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Effect of processing on silk‐based biomaterials: Reproducibility and biocompatibility

Cited by 291 publications

References 49 publications

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

İpek Ameliyat İplikleri ve Türkiye’de Üretim Olanakları

The Mulberry Silkworm—A New Source of Bioactive Proteins

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