Many heparin-flush makers did not need manufacturing inspection

摘要

The North Carolina firm that recalled its heparin lock-flush solution product in December 2007 because of Sermtia marcescens contamination did not need an inspection before legally selling the medical device.rnWhat the firm needed-and had-was a letter from FDA stating that the agency had reviewed the required paperwork and determined that the heparin catheter lock-flush solution product was "substantially equivalent" to medical devices already legally on the market.rnThe publicly available summary of the firm's paperwork states that the device is "manufactured using an aseptic process," as are the four heparin lock-flush solution devices named as predecessors.rnHeparin catheter lock-flush solution products have been available from manufacturers for years, but the inconsistent regulation of these combination drug-device products means that some likely reached the market without FDA inspecting the manufacturing facility.