June 20, 2013
Why Are American Product Recalls Occurring? - Part 3
It’s a fact of life, we all get sick or injured at some point. When that time comes, we trust medical devices to help restore us to proper health. Whether it is a needle or a nebulizer, medical devices save lives and prevent illness.
According to the FDA, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory.” As the FDA website explains, medical devices are intended to diagnose disease as well as to cure, mitigate, treat or prevent disease.
Unfortunately, however, these products are not impervious to malfunctions. Medical devices are made in factories, and without the proper means of control they are subject to the same errors as any other manufactured product. And once a certain amount of tainted devices are consistently discovered in circulation throughout the general public, a recall is necessary.
A study by ExpertRecall concluded the following statistics pertaining to the fourth quarter of 2012:
In the U.S. alone, 316 medical products were recalled, or about 10 million units. Of those 316 pieces, 16 were designated as class one, which is the most dangerous level; 296 products were declared class two; and 12 were registered as class three. Internationally, 64 percent of documented recalls affected U.S. consumers as well as at least one other unspecified territory or country. Thirteen pertained to U.S. customers who were in “limited geographical regions.”
The tragedy of a medical device recall goes beyond the fact that its victims are people who are already sick. Similar to product recalls that affect infants and children, the weak and the young should be protected from such disasters—but they remain exposed. Further, those who are in good health risk harming themselves when exposed to a dangerous product. But the real tragedy is that such recalls could be prevented by performing proper manufacturing quality control procedures.
Manufacturing quality control refers to the oversight of production procedures to ensure conformity and quality products. With software such as ProFicient, which can prevent deadly product recalls, manufacturers have the ability to change these alarming statistics and stop future recalls from happening.