Surface evaluation of cardiac angiographic catheters after simulated use and reprocessing
Source abstract
Abstract
Abstract Reprocessing of single-use intravascular catheters is a common practice in public health services and hospitals. The determination of safe number of reprocessing cycles before the catheter integrity becomes compromised has been a priority issue. The present paper addresses the evaluating molecular and micro-structural integrity of reprocessed cardiac angiographic catheters. The Fourier Transform Infrared Spectroscopy and Scanning Electron Microscopy were carried out to elucidate morphological changes. The tensile test was performed on catheters to examine changes in bulk characteristics. In this work, samples of catheters were reprocessed until nine times and sterilized by hydrogen peroxide plasma. It was observed that the number of hydrogen-bonded carbonyls groups increased in 0.05 u.a. ( p p = 0.0003) at increasing number of reprocessing cycles, also suggestive of crosslinking in this material.
Source: openaire · Quality: candidate unverified · Source record ↗
Research context
OpenAlex topics: Medical Device Sterilization and Disinfection
SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.
References (20)
Show source-provided references
1. Food and Drug Administration/FDA, Center for Devices and Radiological Health/CDRH, Coronary and peripheral arterial diagnostic catheters, 2003 (cited, Available from: http://www.fda.gov/cdrh/ode/guidance/1216.html).
2. Food And Drug Administration/FDA, Medical Device User Fee and Modernization Act/MDUFMA, Medical devices, reprocessed single-use devices, termination of exemptions from premarket notification, requirement for submission of validation data, 2005 (cited, Available from: http://www.fda.gov/cdrh/mdufma).
3. Food and Drug Administration/FDA, Center for Devices and Radiological Health/CDRH, Class II special controls guidance document for certain percutaneous transluminal coronary angioplasty (PTCA) catheters, 2008 (cited, Available from: http://www.fda.gov/cdrh/ode/guidance/1608.pdf).
4. The effect of sterilization on a poly (dimetilsiloxane)/poly (hexamethylene oxide) mixed macrodiol-based polyurethane elastomer10.1016/j.biomaterials.2006.04.017 ↗
5. Food and Drug Administration/FDA, Center for Devices and Radiological Health/CDRH, Non-clinical tests and recommended labeling for intravascular stents and associated delivery systems, 2005 (cited, Available from: http://www.fda.gov/cdrh/ode/guidance/1545.pdf).
6. Hydrogen plasma treatment of poly(ethylene terephthalate) surfaces10.1016/S0257-8972(00)01164-6 ↗
7. Photooxidation and stabilization of silanised poly(ether-urethane) hybrid systems10.1016/j.polymdegradstab.2007.01.034 ↗
8. Evaluation and qualification of reprocessing modification in single-use devices in interventional cardiology10.1016/j.apsusc.2004.05.223 ↗
9. Curr. Biofilms on central catheters: is eradication is possible?
10. Efficiency in endotoxin removal by a reprocessing protocol for electrophysiology catheters based on hydrogen peroxide plasma sterilization10.1016/j.ijheh.2006.05.001 ↗
11. Comparison of performance characteristics between new and reprocessed electrophysiology catheters10.1007/s10840-006-9055-z ↗
12. BS/EN/ISO, ISO 10555-1:2003, sterile, single-use intravascular catheters. Part 1. General requirements, European Committee for Standardization (CEN), Brussels, Belgium, 2003, pp. 1–10.
13. Infrared microspectroscopic study of the thermo-oxidative degradation of hydroxyl-terminated polybutadiene/isophorone diisocyanate polyurethane rubber10.1016/j.polymdegradstab.2007.05.010 ↗
14. Degradation of pré-aged polymers exposed to simulated recycling: properties and thermal stability10.1016/j.polymdegradstab.2005.09.004 ↗
15. Synthesis and properties of poly (urethane-imide) interpenetrating network, membranes10.1016/j.desal.2007.09.042 ↗
16. Synthesis, characterization and biodegradation studies of poly(ester urethane)s10.1016/j.cej.2007.11.017 ↗
17. Plasma-based sterilization: effect on surface and bulk properties and hydrolytic stability of reprocessed polyurethane electrophysiology catheters10.1002/1097-4636(20001215)52:4<774::AID-JBM23>3.0.CO;2-O ↗
18. Hydrolytic degradation and functional stability of a segmented shape memory poly(ester urethane)10.1016/j.polymdegradstab.2008.10.012 ↗
19. Mechanistic implications of plastic degradation10.1016/j.polymdegradstab.2007.11.008 ↗
20. Thermo-oxidative behavior of high-temperature PMR-15 resin and composites10.1016/j.msea.2007.09.103 ↗