Safety of Medical Devices
A manufacturer of a nebulizer used to deliver drugs via inhalation found that the metal aerosolizing disc would fragment a little over a long period of use. An assessment of the human health risks of inhaling micron-sized metallic airborne particles unintentionally released by the nebulizer was performed. The device delivered drugs via inhalation by forcing the drug through a series of metal orifices which dispersed the liquid into a mist. It was shown through radiography that the orifice opening would degrade over time and micron sized chips of the metal were dispersed into the aerosol. The company was advised of these findings, and modified their production process accordingly.
Phthalates Released from Tubing of Fluid Delivery Pumps
A medical device firm had developed a "finger pump" designed to introduce moderate quantities of blood or chemotherapy drugs into the human bloodstream. The repetitive flexing of the plastic tubing performed during the pumping process was alleged to increase the leaching of Bis(2-ethylhexyl)phthalate (DEHP) and other phthalates from the tubing. Cardno ChemRisk conducted a study using human blood and various pharmaceutical agents, measured the percentage loss of phthalates from the tubing over time, and provided an overall human risk assessment of the possible health hazard from the device.
Safety of Silicone Breast Implants
Silicone breast implants were used by cosmetic surgeons throughout the world for physical enhancement from about 1964 to 1984. However, concerns regarding the potential toxicity associated with chemicals leaching from the implants were raised and the manufacturers of the product were sued. Cardno ChemRisk scientists conducted an evaluation of the toxicology data, medical literature, epidemiology, case reports, biomaterials information, and related materials to help assess the safety of humans who use silicone breast implants.