title: Current practices in corrosion, surface characterization, and nickel leach testing of cardiovascular metallic implants.
abstract: In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In addition to the above topics, best practices for these various tests were discussed, and knowledge gaps were identified. Prior to the workshop, discussants had the option to provide feedback and information on issues relating to each of the topics via a voluntary preworkshop assignment. During the workshop, the pooled responses were presented and a panel of experts discussed the results. This article summarizes the proceedings of this workshop and background information provided by workshop participants. 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, 105B: 1330-1341, 2017.
authors.affiliation: US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, Maryland.
authors.forename: Srinidhi
authors.initials: S
authors.lastname: Nagaraja
authors.affiliation: US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, Maryland.
authors.forename: Matthew
authors.initials: M
authors.lastname: Di Prima
authors.affiliation: US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, Maryland.
authors.forename: David
authors.initials: D
authors.lastname: Saylor
authors.affiliation: US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, Maryland.
authors.forename: Erica
authors.initials: E
authors.lastname: Takai
mesh_terms: D003343:Corrosion; D004493:Education; D006801:Humans; D009532:Nickel / Q000009:adverse effects / Q000493:pharmacokinetics; D011475:Prosthesis Failure; D015607:Stents / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D009532:Nickel
keywords: cardiovascular; corrosion; metal (alloys); metal ions