Description of Event or Problem · 1
THE SADMERC WHICH IS AN EXTENSION OF MEDICARE HAS RECEIVED SEVERAL CONCERNS ABOUT SURGICAL DRESSINGS THAT CONTAIN SILVER IONS. MULTIPLE COMPANIES HAVE APPROACHED THE SADMERC WITH CLAIMS THAT SILVER IS AND ANTIMICROBIAL. ONE COMPAY IN PARTICULAR DR LAN'S MEDICAL PRODUCTS CLAIMS ON THEIR WEBISTE "SINCE ITS START, THE COMPANY HAS AGGRESSIVELY AND SUCCESSFULLY SUBMITTED AND HAS HAD APPROVED TWO 510 K CERTIFICATIONS FOR ITS WOUND CARE PRODUCTS. WE ARE PARTICULARY PROUD OF ONE OF THESE PRODUCTS. NEWLY APPROVED BY THE FDA. IT IS AN ABRAMS SUGICAL DRESSING IMPREGNATED WITH 8.5% SILVER SODIUM HYDROGEN ZIRCONIUM PHOSPHATE THAT WILL PROVIDE EFFECTIVE ANTI MICROBIAL PROTECTION TO A WOUND FOR UP TO THREE DAYS 510K# K033164- TYCO HEALTHCARE IS ANOTHER CO 510K K033453. THE SADMERC IS NOW BEING BOMBARDED BY THESE CLAIMS BY MULTIPLE COMPANIES. THE CLAIM THAT FDA HAS APPROVED THEIR SILVER IMPREGNATED SURGICAL DRESSINGS WITH CLAIMS THAT THEY GIVE ANTIMICROBIAL PROTECTION TO A WOUND. I SPOKE WITH A FDA CONSUMER SAFETY OFFICER, ON AUGUST 12, 2004 WHO STATED THAT THE PURPOSE OF THE SILVER IONS IN THE BANDAGES OF THESE PRODUCTS IS TO REDUCE BACTERIAL GROWTH IN THE WOUND PAD BUT HAS NO EFFECT ON THE WOUND OR THE HEALING OF THE WOUND. I WOULD LIKE CONFIRMATION OF THE ABOVE STATEMENT.