When your health care provider treats you with a drug or medical device, you expect it to be safe. Unfortunately, there are many dangerous medical devices and pharmaceutical drugs. In fact, the number of recalls for medical products is steadily increasing. In 2013, the number of recalls was 2,303, compared to 3,202 in 2017.
Half-a-million pacemakers with hazardous software errors and contaminated valsartan blood pressure drugs exposed thousands of people to impurities that cause cancer. Dangerous medical products are not only life-threatening, but they also cost millions of dollars for the health care industry. Here are some of the main contributing factors to the steady increase in recalls reported to the FDA.
The FDA inspects plants every two years to ensure quality. While this may sound like a good practice, it does not always go according to plan. When inspectors become familiar with plants, their inspections are more likely to be inaccurate. This is because repeat inspections can result in complacency. The FDA should use new inspectors to improve this problem.
Competitiveness in the health care industry can lead to good outcomes, such as lower costs, better quality and increased access. Unfortunately, too much competition can backfire. Competition can result in firms cutting corners in quality control practices to be as profitable as possible. This leads to an increase in dangerous drug defects and recalls.
Of course, one of the main issues is with who makes recall decisions. Interestingly, managers at firms make almost all recall decisions voluntarily. Without the FDA mandating recalls, things can go wrong. The fact that most recalls are voluntary gives managers too much discretion.
There are plenty of other reasons why recalls are an ongoing issue, but these are some of the clearest ones. More research is necessary to ensure consumers are not exposed to harmful products.