C37 NEW INSIGHTS IN THE EPIDEMIOLOGY, MANAGEMENT, AND OUTCOMES OF CYSTIC FIBROSIS, ILD, AND RESPIRATORY DISEASE: Review Of Instructions For Use (ifus) Of Intravascular Medical Devices (imds) After An Fda Safety Warning Using A Human Factors Engineering Heuristic

Rationale Since January 2014, the FDA has received approximately 500 medical device reports on detached hydrophilic and/or hydrophobic coatings (e.g., polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone ) from intravascular medical devices (IMDs) such as guidewires, catheters, and introducers used for intravascular procedures. Problems with inconsistent, nonstandard terms that varied between manufacturers and with products produced by the same manufacturer; nonspecific IFUs that applied to multiple products but lacked specific information for any one single product; lack of figures to support and explain text instructions; illegible font; lack of available IFUs for all products; inconsistent location of specific information; lack of storage instructions and operating range, such as temperature, flow rates, and duration of use; lack of URL or websites for further information.