Analytical Methods for Implantable Medical Devices: Bioprosthetic Heart Valves and Hip Implants

C. Stephan, K. Neubauer, E. Pruszkowski, B. Yuan, K. Yadav
PerkinElmer Inc,

Keywords: Medical Devices testing, Extractables and Leachables


According to the World Health Organization, an estimated 2 million different types of medical devices are now present on the global market. As the population distribution is shifting towards older ages with the increase of chronic and age-related medical conditions, this number is expected to grow at the same pace hitting the medical device industry with unique demand. For every innovative medical device that reaches market, comes a collateral concern for that device’s safety that can be assessed by precise analytical characterization. In this poster, two of the most used implants are investigated: bioprosthetic heart valves and hip implants. In the two following sections, accurate and reliable analytical methods are presented to evaluate their biocompatibility and durability. Glutaraldehyde Analysis in Bioprosthetic Heart Valve by LC-UV (Liquid Chromatography – UV Detector) A xenograft heart valve is a type of artificial bioprosthetic valve obtained from an animal source (porcine or bovine) and largely used in the over 300,000 heart valve surgeries conducted every year. Crosslinking with glutaraldehyde (GA) renders a cardiac xenograft inert, nonbiodegradable, and non-antigenic. However, GA crosslinking does not guarantee complete biocompatibility of cardiac xenografts, and paradoxically causes dystrophic calcification due to phospholipids, free aldehyde groups and residual antigenicity. It is clear that monitoring the content of GA in the manufacturing process and marketing products is crucial. In this section, a robust and reliable LC-UV workflow method is presented for the assay determination of GA. Total and Single Particle Analysis of Titanium in Serum and Hip Aspirates by ICP-MS (Inductively Coupled Plasma – Mass Spectrometry) Titanium (Ti) is a metal of choice in all kinds of prosthetics, such as artificial hip joints, knee, dental implants. The artificial joints are made from various Ti alloys, usually with a small addition of aluminum and vanadium. Because the hip ball-and-socket joint undergoes extensive use, Ti could slowly wear away over time and enter the blood stream. Even though Ti is nontoxic, its levels can give medical providers information on the level of implant degradation. In this section, total and single particle analysis of Ti in serum and hip aspirates from a patient with artificial hip was conducted using ICP-MS showing that Ti was present in both the dissolved and particulate forms.