Residual ethylene oxide in medical devices and device material Lucas, Anne D.; Merritt, Katharine; Hitchins, Victoria M. ...
Journal of biomedical materials research. Part B, Applied biomaterials,
15 August 2003, Letnik:
66B, Številka:
2
Journal Article
Replacement hip arthroplasty with the use of ultrahigh molecular weight polyethylene for the cup articulating with a metal head has provided a low friction arthroplasty with years of success. ...However, the search for improved materials and designs for articulating surfaces continues. The use of metallic heads articulating with metallic cups is now being reconsidered for total hip replacements. Success will be enhanced if wear and corrosion of the articulating surfaces can be kept below that of the metal on ultrahigh molecular weight polyethylene couple. Concern has been raised about the release, and biologic fate, of metal species from corrosion and wear. Titanium alloys have been shown to have limitations as an articulating surface showing significant wear, and the alloy per se should not be considered for wear couples in total hip replacements. The cobalt chromium alloys are known to have reasonable wear and corrosion properties and continue to be evaluated. The issue of cobalt chromium wear and corrosion products and how this relates to the biologic performance of total hip replacement devices is reviewed. Under the condition of wear as currently experienced at the articulating surfaces of cobalt chromium alloys and ultrahigh molecular weight polyethylene, the amount of metallic products transferred to the tissues is sufficiently low to be well tolerated by the biologic system. Nickel and cobalt ions arc, rapidly transported from the implant site and eliminated in the urine. Chromium is stored in the tissue and eliminated more slowly. The issue of host hypersensitivity to these elements remains of concern. All 3 elements, in ionic form, are known to cause contact dermatitis. Untoward biologic reactions, including hypersensitivity, should be minimized if wear and corrosion phenomena are minimized.
As part of a method development for peel testing, an interlaboratory comparison among Food and Drug Administration-Center for Drug Evaluation and Research, Food and Drug Administration-Center for ...Devices and Radiological Health and Southwest Research Institute was conducted using medical tapes. The aim was to determine which readily available substrate stainless steel (SS), high density polyethylene (HDPE) or Vitro-Skin(R) would best distinguish among various medical tapes. Five medical tapes (3M 1523, 3M 1525L, 3M 1776, Mepiform(R) and Mediderm(R) 3505) were evaluated on four different substrates (SS, HDPE, Vitro-Skin, and human cadaver skin) using the following peel parameters: approximately 3 min dwell time, 90 degrees peel angle, and 300 mm/min peel rate. No substrate mimics cadaver skin for all five tapes. SS had the best ability to distinguish among the medical tapes. Overall, for quality control purposes (yielding good discrimination and precision), SS would be the optimal substrate.
In a previous study on peel adhesion for medical tapes, it was shown that a stainless steel (SS) substrate better discriminated among medical tapes than a high-density polyethylene (HDPE) substrate. ...The objective of this study was to determine if a SS substrate would also better distinguish among transdermal drug delivery systems (TDDSs). Five TDDSs (Vivelle Dot, Climara, Catapres-TTS, Duragesic, and Mylan Fentanyl) were evaluated on three different substrates (SS, HDPE, and human cadaver skin). All measurements were made using a dwell time of approximately 3 min, a peel angle of 90 degrees, and a peel speed of 300 mm/min. Differences among TDDSs were greater for SS than for HDPE, using the F statistic for testing for differences among TDDSs means as a measure of heterogeneity, thereby indicating greater discrimination by SS.
As a means of decontaminating instruments possibly exposed to Creutzfeldt-Jakob disease, the World Health Organization has recommended immersion and autoclaving in sodium hydroxide. However, this ...recommendation has raised concerns of possible damage to autoclaves, and hazards to operators as a result of the caustic vapors. A series of experiments has been conducted that demonstrate that there are containment pan-and-lid combinations in which instruments can be autoclaved in sodium hydroxide without risk to the autoclave or the operator. (Am J Infect Control 2003;31:257-60.)
The effect of proteins on corrosion rates of 316L stainless steel, commercially pure titanium and titanium 6-aluminium 4-vanadium was studied in the static and fretting modes. The static mode was ...studied using cylindrical specimens as per ASTM F-746, and static fracture fixation plates. The fretting mode was studied using a two-hole plate fretting machine which caused a cyclic rocking motion between the plate and the screws, as per ASTM F-897. Electrochemical techniques of polarization resistance and Tafel slope measurements were used to study effects of proteins on the anodic and cathodic corrosion reactions. It was found that proteins increased the corrosion rate of the stainless steel and C.P. titanium cylindrical specimens, but did not have an effect on the Ti-6AI-4V cylinders. In the fretting mode proteins decreased the corrosion rate of the stainless steel plates, but did not have an appreciable effect on either of the titanium alloys. The presence of proteins appeared to cause an increase in the anodic Tafel constant and a decrease in the cathodic Tafel constant of stainless steel specimens. Significant differences in the shapes of the cathodic Tafel slopes were also seen with cylinders with different surface conditions, and static versus fretting plates.
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