Strip Recall Could Strengthen Calls For More FDA Oversight
Medical device recalls are never a good thing, but the last thing anyone with diabetes who uses insulin wants to see in the news is a recall of meters or glucose test strips.
The FDA announced on July 31st that Nova Diabetes Care was recalling 62 million strips that have been compromised by a flaw in the manufacturing process. The strips were exposed to a chemical that can cause them to give abnormally high blood sugar readings. Nova customers in the U.S. and 12 other countries who use the recalled strips could be at risk of giving themselves incorrect doses of insulin because of the defective strips.
Given that the strips are the first step in the medical decision-making process for most diabetics, the recall might further the argument made by the advocates behind the Strip Safety campaign that the FDA needs to change how it oversees test strip accuracy. Specifically, they argue, the agency needs to tighten its allowable standards of variance of strip readings and field-test the strips after they are on the market.
Given that news of the recall has been picked up as much by lawyer blogs as major news outlets, it seems a given that this recall is going to end up in court. For the time-being, Nova is advising customers to see if they have bought the recalled strips and to use a quality control solution test included with purchases to double-check strip accuracy.
Maybe this recall will spur the need for change and make strips safer in the future, but any change that occurs probably won’t come as quickly as the first lawsuit against Nova.
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