国外药事

美国FDA医疗器械监管科学研究项目简介(第一部分:无源医疗器械)

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  • 广东省医疗器械质量监督检验所,国家药品监督管理局体外循环器械重点实验室,广州 510080

网络出版日期: 2021-11-18

基金资助

广州市科技计划项目:高性能血液灌流器的临床应用与产业化研究(编号 201802010019);广东省食品药品监督管理局科技创新项目: 体外循环器械国家重点实验室(编号 2018ZDZ04)

A Brief Introduction to Scientific Research Project of Medical Device Regulation by FDA (Part 1: Passive Medical Devices)

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  • Guangdong Medical Devices Quality Surveillance and Test Institute, Key Laboratory of Extracorporeal Circulation Devices of National Medical Products Administration, Guangzhou 510080 , China

Online published: 2021-11-18

摘要

目的: 介绍美国FDA开展的医疗器械监管科学研究项目,为我国医疗器械监管科学研究提供参考。方法:翻译和整理美国FDA发布的各类文件资料和研究项目,梳理其正在开展的监管科学研究项目。结果与结论:美国FDA与科研机构、临床机构、其他政府机构及产业界合作开展医疗器械监管科学研究。依据临床需求和前沿研究,在骨科、心血管科、放射学、微生物学等多个领域开展专题研究, 取得的研究成果用于确保医疗器械的安全性和有效性,并促进医疗器械企业创新和高质量发展。其中在无源医疗器械领域开展的研究项目有关于产品性能及检测方法的研究,如物理机械性能研究、流体性能研究、病原菌快速检测技术等;有针对新兴技术的研究,如增材制造、新型材料与制造的研究;也有关于医疗器械安全和有效性的基础性研究,如纳米毒理学、聚合物动力学、微生物学等研究。

本文引用格式

王文荣, 徐苏华, 刘婧群, 柯军, 李杨玲 . 美国FDA医疗器械监管科学研究项目简介(第一部分:无源医疗器械)[J]. 中国药事, 2021 , 35(11) : 1283 -1290 . DOI: 10.16153/j.1002-7777.2021.11.011

Abstract

Objective: To introduce the scientific research project of medical device regulation by Food and Drug Administration (FDA) in order to provide references for the scientific researches of medical device regulation in China. Methods: Various documents and research project abstracts issued by FDA were translated and sorted out and the regulatory science research projects undergoing were reviewed. Results and Conclusion: FDA cooperates with scientific institutions, clinical institutions, other government agencies and industries to carry out scientific researches of medical device regulation. Based on current clinical needs and cutting-edge researches, FDA conducts special researches in such fields as orthopedics, cardiology, radiology and microbiology. The research results are used to ensure the safety and effectiveness of medical devices and promote high development and innovation of medical device companies. In the field of passive medical devices, the current research projects include researches on product properties and detection methods, such as physical and mechanical properties, fluid properties, rapiddetection technology of pathogens, etc. They also include researches on emerging technologies, such as additive material manufacturing and new materials and their manufacturing. There are also basic researches on the safety and effectiveness of medical devices, such as nanotoxicology, polymer dynamics, microbiology, etc.

参考文献

[1] 刘昌孝.国际药品监管科学发展概况[J].药物评价研究,2017,40(8):1029-1043.
[2] 刘文博.浅谈器械审评科学的应用[N].北京:中国医药报,2018-3-20(003).
[3] DP Matthew,C James,H David,et al.Additively Manufactured Medical Products-the FDA Perspective[J].3D Printing in Medicine,2016,2(1):1-6.
[4] Lucas AD,Forrey C,Saylor DM,et al.Solvent or Thermal Extraction of Ethylene Oxide from Polymeric Materials:Medical Device Considerations[J].Journal of BiomedicalMaterials Research:Part B Applied Biomaterials,2018,106(6):2455-2463.
[5] Vorvolakos K,Coburn JC,Saylor DM.Dynamic Interfacial Behavior of Viscoelastic Aqueous Hyaluronic Acid:Effects of Molecular Weight,Concentration and Interfacial Velocity [J].Soft Matter,2014,10(13):2304-2312.
[6] Sudhanva R,Govindarajan,Tanmay,et al.A Hydrophilic Coumarin-based Polyester for Ambient-Temperature Initiator-Free 3D Printing:Chemistry,Rheology and Interface Formation[J].Polymer,2018,152(12):9-17.
[7] Dianne E Godar.3D Bioprinting:Surviving under Pressure,Tissue Regeneration[M].London:IntechOpen,2018:185-196.
[8] Zhang L,Casey B,Galanakis DK,et al.The Influence of Surface Chemistry on Adsorbed Fibrinogen Conformation,Orientation,Fiber Formation and Platelet Adhesion[J].Acta Biomaterialia,2017(54):164-174.
[9] ASTM D7661-10(Reapproved 2017)Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms[S].2017.
[10] Martin M,Sharmista C,Xiaoli H,et al.Application of Quality by Design(Qbd)Approach to Ultrasonic Atomization Spray Coating of Drug-Eluting Stents[J].AAPS Pharmscitech,2015,16(4):811-823.
[11] Sarkar DS,Lucas AD,Carlin AS,et al.Controlled Initial Surge Despite High Drug Fraction and High Solubility[J].Pharmaceutical Development and Technology,2017,22(1):35-44.
[12] JD Weaver,L Ramirez,S Sivan,et al.Characterizing Fretting Damage in Different Test Media for Cardiovascular Device Durability Testing[J].Journal of the Mechanical Behavior of Biomedical Materials,2018(82):338-344.
[13] R Marrey,B Baillargeon,M Dreher,et al.Validating Fatigue Safety Factor Calculation Methods for Cardiovascular Stents[J].Journal of Biomechanical Engineering,2018,140(6):061001.
[14] Palepu V,Helgeson MD,MF Michael,et al.Impact of Bone Quality on the Performance of Integrated Fixation Cage Screws[J].The Spine Journal:Official Journal of The North American Spine Society,2018,18(2):321-329.
[15] P Vivek,Peck JH,Simon DD,et al.Biomechanical Evaluation of an Integrated Fixation Cage During Fatigue Loading:a Human Cadaver Study[J].Journal of Neurosurgery Spine,2017,26(4):1-8.
[16] Srinidhi N,SJL Sullivan,Philip R,et al.Impact of Nitinol Stent Surface Processing on In-vivo Nickel Release and Biological Response[J].Acta Biomaterialia,2018(72):424-433.
[17] SJL Sullivan,D Madamba,S Sivan,et al.The Effects of Surface Processing on In-vivo Corrosion of Nitinol Stents in a Porcine Model[J].Acta Biomaterialia,2017(62):385-396.
[18] SJL Sullivan,Philip Stafford,E Malkin,et al.Effects of Tissue Digestion Solutions on Surface Properties of Nitinol Stents[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2018,106(1):331-339.
[19] Sritharan D,Fathi P,Weaver JD,et al.Impact of Clinically Relevant Elliptical Deformations on the Damage Patterns of Sagging and Stretched Leaflets in A Bioprosthetic Heart Valve[J].BMES's Cardiovascular Engineering and Technology,2018,9(4):1-14.
[20] Malinauskas RA,Hariharan P,Day SW,et al.FDA Benchmark Medical Device Flow Models for CFD Validation[J].ASAIO Journal(American Society for Artificial Internal Organs:1992),2017,63(2):150-160.
[21] KI Aycock,Robert L,FC Lynch,et al.The Importance of Hemorheology and Patient Anatomy on the Hemodynamics in the Inferior Vena Cava[J].Annals of Biomedical Engineering,2016,44(12):1-15.
[22] Herbertson LH,Olia SE,Daly A,et al.Multilaboratory Study of Flow-Induced Hemolysis Using the FDA Benchmark Nozzle Model[J].Artificial Organs,2015,39(3):237-248.
[23] Q Lu,BV Hofferbert,G Koo,et al.In Vitro Shear Stress‐ induced Platelet Activation:Sensitivity of Human and Bovine Blood[J].Artificial Organs,2013,37(10):894-903.
[24] Morrison TM,Dreher ML,Nagaraja S,et al.The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices[J].Journal of Medical Devices,2017,11(2):024503.
[25] H Prasanna,DS Gavin,M Horner,et al.VerificationB e n c h m a r k s t o A s s e s s T h e I m p l e m e n t a t i o n o f Computational Fluid Dynamics Based Hemolysis Prediction Models[J].Journal of Biomechanical Engineering,2015,137(9):094501.
[26] S Guha,AM Alfaro,P Hariharan,et al.Effectiveness of Facemasks for Pediatric Populations Against SubmicronSized Aerosols[J].AJIC:American Journal of Infection Control,2015,43(8):871-877.
[27] KL Dearfield,BB Gollapudi,JC Bemis,et al.Next Generation Testing Strategy for Assessment of Genomic Damage:a Conceptual Framework and Considerations[J].Environmental and Molecular Mutagenesis,2017,58(5):264-283.
[28] V Chandrasekar,DW Janes,DM Saylor,et al.Conservative Exposure Predictions for Rapid Risk Assessment of PhaseSeparated Additives in Medical Device Polymers[J].Annals of Biomedical Engineering,2018,46(1):14-24.
[29] LC Savery,R Vi?as,Amber M et al.Deriving a Provisional Tolerable Intake for Intravenous Exposure to Silver Nanoparticles Released from Medical Devices[J].Regulatory Toxicology and Pharmacology,2017,85:108-118.
[30] SA Skoog,Q Lu,RA Malinauskas,et al.Effects of Nanotopography on the In Vitro Hemocompatibility of Nanocrystalline Diamond Coatings[J].Journal of Biomedical Materials Research Part A,2017,105(1):253-264.
[31] WH DeJong,S Hoffmann,M Lee,et al.Round Robin Study to Evaluate the Reconstructed Human Epidermis(Rhe)Model as an in Vitro Skin Irritation Test for Detection of Irritant Activity in Medical Device Extracts[J].Toxicology in Vitro,2018(50):439-449.
[32] Y Wang,A Guan,Samanthi WK.et al.Analytical Chemistry in the Regulatory Science of Medical Devices[J].Annual Review of Analytical Chemistry,2018,11(1):307-327.
[33] Ludwig Kyle B,Chandrasekar Vaishnavi,Saylor David M,et al.Characterizing the Free Volume of Ultrahigh Molecular Weight Polyethylene to Predict Diffusion Coefficients in Orthopedic Liners[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2018,106(6):2393-2402.
[34] Lucas AD,F Christopher,Saylor DM,et al.Solvent or Thermal Extraction of Ethylene Oxide from Polymeric Materials:Medical Device Considerations[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2018,106(6):2455-2463.
[35] H Li,VM Hitchins,S Wickramasekara,et al.Rapid Detection of Bacterial Endotoxins in Ophthalmic Viscosurgical Device Materials by Direct Analysis of Endotoxin in Real Time by Mass Spectrometry[J].Analytica Chimica Acta,2016,943:98-105.
[36] H Li,S Wickramasekara,P Nemes.One-hour Screening of Adulterated Heparin by Simplified Peroxide Digestion and Fast RPIP-LC-MS[J].Analytical Chemistry,2015,87(16):8424-8432.
[37] N Peter,Hoover WJ,Keire DA.High-throughput Differentiation of Heparin from Other Glycosaminoglycans by Pyrolysis Mass Spectrometry[J].Analytical Chemistry,2013,85(15):7405-7412.
[38] Zhang,Qin,Malghan,et al.Silver Nanoparticles:Significance of Physicochemical Properties and Assay Interference on the Interpretation of in Vitro Cytotoxicity Studies[J].Toxicology in Vitro,2017(38):179-192.
[39] Austin CA,Hinkley GK,Mishra AR,et al.Distribution and Accumulation of 10 Nm Silver Nanoparticles in Maternal Tissues and Visceral Yolk Sac of Pregnant Mice,and A Potential Effect on Embryo Growth[J].Nanotoxicology,2016,10(6):654-661.
[40] Mishra AR,Zheng J,T Xing,et al.Silver Nanoparticleinduced Autophagic-lysosomal Disruption and NLRP3-Inflammasome Activation in Hepg2 Cells Is Sizedependent[J].Toxicological Sciences,2016,150(2):473-487.
[41] Skoog SA,K Girish,Narayan RJ,et al.Biological Responses to Immobilized Microscale and Nanoscale Surface Topographies[J].Pharmacology & Therapeutics,2018,182:33-55.
[42] PE Petrochenko,J Zheng,Brendan JC,et al.NanosilverPMMA Composite Coating Optimized to Provide Robust Antibacterial Efficacy While Minimizing Human Bone Marrow Stromal Cell Toxicity[J].Toxicology in Vitro,2017(44):248-255.
[43] Z Qin,Rajan SS,Tyner KM,et al.Effects of Iron OxideNanoparticles on Biological Responses and MR ImagingProperties in Human Mammary Healthy and Breast Cancer Epithelial Cells[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2016,104(5):1032-1042.
[44] Shelby AS,Q Lu,Richard AM,et al.Effects of Nanotopography on the In Vitro Hemocompatibility of Nanocrystalline Diamond Coatings[J].Journal of Biomedical Materials Research Part A,2017,105(1):253-264.
[45] Yang KH,Nguyen AK,Goering PL,et al.Ultrananocrystalline Diamond-Coated Nanoporous Membranes Support SK-N-SH Neuroblastoma Epithelial [Corrected] Cell Attachment[J].Interface Focus,2018,8(3):20170063.
[46] E Rosalie,P Stefan,Aardema MJ,et al.Genotoxicity Assessment of Nanomaterials:Recommendations on Best Practices,Assays,and Methods[J].Toxicological Sciences:an Official Journal of The Society of Toxicology,2018,164(2):391-416.
[47] V Chandrasekar,DW Janes,DM Saylor,et al.Conservative Exposure Predictions for Rapid Risk Assessment of PhaseSeparated Additives in Medical Device Polymers[J].Annals of Biomedical Engineering,2018,46(1):14-24
[48] C Vaishnavi,J Dustin,F Christopher,et al.Improving Risk Assessment of Color Additives in Medical Device Polymers[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2018,106(1):310-319.
[49] DM Saylor,BA Craven,V Chandrasekar,et al.Predicting Patient Exposure to Nickel Released from Cardiovascular D e v i c e s U s i n g M u l t i-S c a l e M o d e l i n g [J].A c t a Biomaterialia,2018(70):1-11.
[50] S Nagaraja,MD Prima,D Saylor,et al.Current Practices in Corrosion,Surface Characterization,and Nickel Leach Testing of Cardiovascular Metallic Implants[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2017,105(6):1330-1341.
[51] DM Saylor,L Adidharma,JW Fisher,et al.A Biokinetic Model for Nickel Released from Cardiovascular Devices[J].Regulatory Toxicology and Pharmacology,2016(80):1-8.
[52] Xu Y,Kim CS,Saylor DM,et al.Polymer Degradation and Drug Delivery in PLGA-Based Drug-Polymer Applications:A Review of Experiments and Theories[J].Journal of Biomedical Materials Research:Part B Applied Biomaterials,2017,105(6):1692-1716.
[53] Saylor DM,J Sudi,Silverstein JS,et al.Communication:Relationship Between Solute Localization and Diffusion in a Dynamically Constrained Polymer System[J].The Journal of Chemical Physics,2016,145(3):031106.
[54] Saylor DM,F Christopher,Kim Chang-Soo,et al.Diffuse Interface Methods for Modeling Drug-Eluting Stent Coatings[J].Annals of Biomedical Engineering,2016,44(2):548-559.
[55] Y Wang,G Jayan,D Patwardhan,et al,Antimicrobial and Anti-Biofilm Medical Devices-Public Health and Regulatory Science Challenges[J].Springer,2017(5):37-65.
[56] Y Wang,A Guan,I Isayeva,et al.Interactions of Staphylococcus Aureus with Ultrasoft Hydrogel Biomaterials [J].Biomaterials,2016(95):74-85.
[57] G Allan,W Yi,Phillips KS,et al.A Contact-Lens-on-AChip Companion Diagnostic Tool for Personalized Medicine [J].Lab on A Chip,2016,16(7):1152-1156.
[58] Y Wang,V Leng,V Patel,et al.Injections Through Skin Colonized with Staphylococcus Aureus Biofilm Introduce Contamination Despite Standard Antimicrobial Preparation Procedures[J].Scientific Reports,2017,doi:10.1038/srep45070.
[59] P Nandy,Anne DL,EA Gonzalez,et al.Efficacy of Commercially Available Wipes for Disinfection of Pulse Oximeter Sensors[J].AJIC:American Journal of Infection Control,2016,44(3):304-310.
[60] Gonzalez EA,N Poulomi,Lucas AD,et al.Designing for Cleanability:The Effects of Material,Surface Roughness,and the Presence of Blood Test Soil and Bacteria on Devices[J].American Journal of Infection Control,2017,45(2):194-195.
[61] N Poulomi,Y Megan,Haugen SP,et al.Evaluation of OneWay Valves Used in Medical Devices for Prevention of Cross-Contamination[J].American Journal of Infection Control,2017,45(7):793-798.
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