In the past five years, several contaminated
products have led to patient and end-user
injuries and death globally.
In 2007, there was diethylene-glycol contaminated toothpaste, and millions of toys were recalled due to lead contamination. In 2008, contaminated heparin (a blood thinner that is widely used by kidney dialysis and post-surgical patients to prevent blood clots) was recalled by the US FDA, and melamine-contaminated milk caused thousands of adverse events and several infant deaths.
In 2009, peanut-flavored foods containing contaminated peanut butter products made several people sick. Investigations into the
causes of these adverse events found that, among other reasons, inadequate or poor supplier controls were a factor. US FDA observations and warning letters for medical device manufacturers increased from 19 in 2006 to 25 in 2007 and 35 in 2008.
These incidents have triggered US and European regulatory bodies to increase their vigilance on supplier controls for the medical device and pharmaceutical industries. In December 2008, the Global Harmonization Task Force (GHTF) issued a guidance document that outlines the steps medical device manufacturers should include in their supplier control process. A second document issued in November 2009 (in draft form) describes the techniques for inspecting a medical device manufacturer’s supplier controls . At
an AdvaMed Conference in 2009, Kim Trautman from the US FDA said, "Supplier control is a much bigger issue now than it was in 2007. Even though issues with toothpaste and nuts are not directly in the device sector, these events still greatly
affect FDA thinking and controls. The emphasis on the linkage between supplier control and risk management will continue to increase."