Tuesday, November 24, 2009

Who Has Your Back?

The Obama administration wants citizens to believe government is a capable watchdog. Consider the following data on prefilled syringes, containing either heparin or saline:

Department of Health and Human Services

FDA report to AM2PAT (dba) Salient Health Care TechnologyInc.

August 11,

You are using an unvalidated automatic filling machine to fill syringes. An appropriate installation and operation qualification could not be performed as there are no manufacturing or operating instructions for the equipment.

There was no indication of sample sizes utilized and no actual test results available for the packaging runs.
Several years later, the news reported.

FDA Recalls All Pre-filled Syringe Flushes
January 29, 2008

FDA has announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, NC.

Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL, and syringe sizes of 6mL and 12mL.

Consumers and healthcare facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Healthcare facilities should immediately quarantine the products in their inventory and return them to their distributor.

Only the producer can assure quality. AM2PAT has a short history:

The company's headquarters is in Chicago, where it was incorporated as AM2PAT in 2001, according to Illinois records. AM2PAT formed a North Carolina operation in 2003, according to state corporation records. It does business as Sierra Pre-Filled.

Government reliance on inspection regimes will not improve quality. If it catches organizations pursuing profits over people (like AM2PAT), it will be long after the damage is done.

The North Carolina plant shut down in February 2008, much like E. Coli tainted meat packers or salmonella peanut butter makers.

A year later, two AM2PAT managers were convicted for their role in "sending out improperly labeled syringes linked to hundreds of bacterial infections and some (five) deaths." Injured patients are suing the firm for almost $10 million.

AM2PAT was joined by Qualitest Pharmaceuticals, which recalled 250 million Accusure insulin syringes it distributed since 2002.

Profound knowledge is needed in our hallowed halls of government and corporate board rooms. It is sorely lacking. Quality begins in the board room, but greed keeps edging it out.

Who knew "buyer beware" would return with a vengeance? Is it a byproduct of every Gilded Age?