Medical device defects can slip through the regulatory cracks

2020-09-01T09:34:57+00:00June 27th, 2019|

The medical device industry faces some competing priorities that may be nearly impossible to resolve. These devices can make an important difference in patients’ lives, and so everyone wants them to be available quickly. However, medical devices can cause terrible problems if they are defective, and so everyone wants them to be safe. For that reason, the medical device industry is heavily regulated.

Unfortunately, sometimes the pressure to get a product to market overcomes the pressure to make sure the product is safe, and regulators are not able to discover problems until after the devices are already on the market, leading to patients getting hurt by defective products.

Recently, observers have been paying attention to the system through which regulators and the industry report potential problems with medical devices. Last year, an international team of newspaper journalists investigated worldwide problems in the reporting of problems with medical devices.

One problem it found in the United States involved the FDA’s database of incidents related to potential design defects in medical devices. The FDA maintains a system known as the Manufacturer and End User Facility Device Experience (or MAUDE) database. MAUDE is publicly available, allowing patients, doctors and others to learn about potential problems. However, until recently, the FDA also had another lesser-known system known as the alternative summary reporting database, which was available for certain medical device manufacturers. It was not publicly available.

Researchers found that hundreds of thousands of incidents were reported to the alternative database and not to MAUDE. Therefore, the public didn’t know about widespread problems involving breast implants, surgical staples and other devices. Apparently in response to the report, the FDA decided to close the alternative database this year.

When patients undergo any kind of medical procedure, they trust that they will get quality care and that the drugs and devices used will be safe. When a medical device is defective, and a patient is injured as a result, the injured can talk to an attorney with experience in product liability to learn about their options for pursuing compensation.

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