The effects of use and simulated reuse on percutaneous transluminal coronary angioplasty balloons and catheters.
A series of studies was undertaken to determine the effects of single patient use and simulated reuse on percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. Catheters were retrieved from Walter Reed Army Medical Center and were low-level disinfected and cleaned at the US Food and Drug Administration. They were then tested for balloon compliance, and the results were compared against the manufacturer's specifications. Selected groups of catheters were subjected to EO-resterilization and a simulated reuse protocol. The results demonstrated that the effects of use and EO-resterilization is model specific. Furthermore, some balloons demonstrated a time-dependent behavior while others recovered from the effects of simulated reuse by compliance testing at high pressure. Testing for the slipperiness of the catheters after repeated EO-resterilization also demonstrated that changes were model specific.
Brown
S A
SA
Division of Mechanics and Materials Science, HFZ-150, US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Technology, 9200 Corporate Blvd, Rockville, MD 20850, USA.
Merritt
K
K
Woods
T O
TO
Hitchins
V M
VM
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D016507:Cardiology Service, Hospital / Q000592:standards*; D004202:Disinfectants / Q000737:chemistry; D004203:Disinfection / Q000379:methods*; D004209:Disposable Equipment; D004219:District of Columbia; D004866:Equipment Contamination; D017743:Equipment Reuse; D005027:Ethylene Oxide / Q000737:chemistry; D006772:Hospitals, Military / Q000592:standards; D006801:Humans; D008421:Materials Management, Hospital; D008422:Materials Testing; D011312:Pressure; D011356:Product Labeling; D013525:Surgical Instruments / Q000382:microbiology / Q000592:standards
D004202:Disinfectants; D005027:Ethylene Oxide