The U.S. Food and Drug Administration (FDA) issued a Safety Communication regarding the use intramuscular medical devices such as guidewires, intravascular catheters, delivery sheaths, implant delivery systems, and balloon angioplasty catheters and their potential serious injury to patients. Injuries may be due to possible separation of lubricious coating (flaking or peeling) with causes including difficulty of the procedure; technique of the practitioner; or use of an incorrect device, as well as improper storage conditions.
As a result of this peeling or separation, there have been 11 recalls from different manufacturers since January 1, 2010. Most of these recalls had to do with guidewires and other devices used in vasculature.
Also, since January 1, 2014, the FDA received about 500 Medical Device Reports (MDRs) reporting separation of coatings on devices such as introducers used for cerebrovascular, cardiovascular, and peripheral vascular procedures as well as guidewires and catheters. Most of the reports involved vascular guidewires with over 75 percent of the reports citing device malfunctions.
Serious concerns reported, include pulmonary embolism or infarction, myocardial embolism or infarction, embolic stroke, tissue necrosis, and death. Other serious injuries reported in MDRs included surgical intervention that was required due to coating fragments coming lose within patients’ bodies, thrombosis, and adverse tissue reactions.
No specific brand or manufacturer has been cited with greater risks when compared to others. Many factors contribute to the cause of the coating separation, including design, manufacturing, and use.
from Parker Waichman http://www.yourlawyer.com/blog/federal-regulators-issue-safety-communication-on-intramuscular-medical-devices/
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