Assessment of total silver and silver nanoparticle extraction from medical devices.
There is concern over the release of silver nanoparticles (AgNPs) from medical devices due to their potential toxicological consequences inside the body. Towards developing the exposure component of a risk assessment model, the purpose of this study was to determine the amount and physical form of silver released from medical devices. Scanning electron microscopy was used to confirm that three of five marketed medical devices contained nanosilver coatings (mean feature sizes 115-341 nm). Aqueous device extracts (water, saline and human plasma) were analyzed with inductively coupled plasma mass spectrometry, ultraviolet-visible spectroscopy, dynamic light scattering, transmission electron microscopy, and nanoparticle tracking analysis. The amount of silver extracted from the devices ranged from 1 × 10(-1) to 1 × 10(6) ng/cm(2) (conditions ranged from 37 to 50 °C, over one hour to seven days). The results further indicated that one of the five devices (labeled MD1) released significantly more AgNPs than the other devices. This data suggests that some but not all devices that are formulated with nanosilver may release detectable levels of AgNPs upon extraction. Further work is underway to quantitate the proportion of silver released as AgNPs and to incorporate this data into a risk assessment for AgNP exposure from medical devices.
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry, and Materials Science, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
Eric M
EM
Sussman
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry, and Materials Science, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA; Fischell Department of Bioengineering, University of Maryland, College Park, MD 20742, USA.
Priyanka
P
Jayanti
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry, and Materials Science, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
Benita J
BJ
Dair
U.S. Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Chemistry, and Materials Science, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. Electronic address: brendan.casey@fda.hhs.gov.
Brendan J
BJ
Casey
D001458:Bandages / Q000009:adverse effects*; D057785:Catheters / Q000009:adverse effects*; D006801:Humans; D008422:Materials Testing; D053768:Metal Nanoparticles / Q000032:analysis / Q000737:chemistry / Q000633:toxicity* / Q000648:ultrastructure; D008855:Microscopy, Electron, Scanning; D046529:Microscopy, Electron, Transmission; D009391:Nephelometry and Turbidimetry; D010316:Particle Size; D010949:Plasma / Q000737:chemistry; D012212:Rheology; D018570:Risk Assessment; D012834:Silver / Q000032:analysis / Q000737:chemistry / Q000633:toxicity*; D012965:Sodium Chloride / Q000737:chemistry; D012995:Solubility; D013053:Spectrophotometry; D013054:Spectrophotometry, Atomic; D013499:Surface Properties; D014481:United States; D014486:United States Food and Drug Administration; D014867:Water / Q000737:chemistry
D014867:Water; D012834:Silver; D012965:Sodium Chloride
Exposure assessment; Extraction; Medical device; Silver nanoparticle