Reduce manufacturing complexities for product safety PDF Print E-mail
Written by Daniel Shin   
Sunday, 04 May 2008 07:04

Contaminated Drug

Industries should eliminate, not mitigate, potential product contamination.

Contaminated Drug

Contaminated products from China have caused a public outcry for product safety. The U.S. Government says that the agencies are doing everything in their power to inspect shipped items, but officials admit that the agencies do not have the resources to inspect all products. I guess our product safety lies on statistical luck in a game of Russian roulette.

Mr. Leroy Hubley lost his wife and his son from contaminated drugs. As he testifies in front of Congress, he had to fight tears. The tragedy resulted from a contaminated called oversulfated chondroitin sulfate in the drug heparin, which is used as a blood thinner for dialysis patients. Unfortunately, it seems the presence of these contaminate is not likely accidental. Oversulfated Chondroitin sulfate mimics the effects of heparin at a lower cost, and it would not be surprising that the Chinese supplier would substitute the chemical for greater profit as inspections in China are not fully conducted.

Mr. Hubley's situation is one of the worst possible situations from the failures of factory inspections and product testing. Peter J. Arduini, the president of medication delivery at Baxter International, apologizes for the incident, but he also endorses the FDA's finding that additional inspections could have detected and prevented the problem. Mr. Arduini points to the growth of new risks as the source of the problem due to the global-wide operation of producing the product. He argues that “new ways” of thinking as well as increasing inspection standards are the solutions.

I am very sorry and heartbroken for Mr. Hubley, but I also believe Baxter did everything in their system to mitigate the risks to the lowest ratio. I would, however, disagree with Mr. Arduini that the solution is not to come up with new ideas in mitigating the rise of new risks. The solution to product safety is to undercut the root of new risks by simplifying the manufacturing process of products. Because various factories and companies are involved in creating products, there are a lot of risks within the manufacturing process. We can step up the inspections and product testing, but these processes will not eliminate risks, only mitigate them. Companies need to rethink the manufacturing process to eliminate unnecessary risks for public safety. Products should not undergo under the hands of five different companies before it emerges in the public market. Having a single manufacturing plant in one area should eliminate unnecessary product hazards.

A clear objection to this solution is that the cost to the companies would be enormous. I admit that such solution would not be feasible for real implementations. High competition in the market place has forced many companies to spread their manufacturing process worldwide. However, my solution is a realistic solution, not some magic wand fantasy, to guarantee the safety of consumers.