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High-Risk Devices Being Fast-Tracked?

| May 2, 2011 | Uncategorized |

Medical professionals rely upon medical devices every day when treating patients with serious injuries or illnesses. Both patients and doctors alike rely upon the devices being used, and trust that they are going to be able to solve whatever problems may be occurring. Before devices can be used, they must be approved by the Food and Drug Administration (FDA). The approval process is falling under heavy scrutiny after several high-profile issues have raised concerns over the agency’s fast-track approval process.

The FDA had pledged to give certain devices, such as replacement hips or external defibrillators, a more thorough review before they would be permitted to be used in the treatment of patients. The Government Accountability Office (GAO) recently stated that the FDA had decided to allow several products to be used while still debating whether or not the devices should receive additional testing.

Prior to a device receiving clearance, the FDA will need to decide if it is of low-risk or high-risk to patients. Those that fall into the low-risk category will generally be approved as long as they are similar to other devices on the market, since patients will not be depending upon the devices for any major needs. For those considered high-risk, the companies that manufacture the devices need to demonstrate in clinical trials that they work correctly.

However, not all high-risk products receive extra FDA scrutiny. If the product manufacturer can prove that it is similar to another product already being used, the device could be permitted without the need for clinical trials.

In 2009, the GAO requested that the FDA reclassify the products to determine the potential risk, and to require clinical tests for anything that was considered high-risk. Out of the 27 products cited in the 2009 report, 26 are still awaiting a final classification status.

One of the main reasons behind the call for further FDA review was the Johnson & Johnson artificial hip. The manufacture recalled 37,000 of the devices in the U.S. after studies in the United Kingdom showed a 13 percent failure rate. This would require patients to undergo additional surgeries to correct any problems caused by the defective product.

The industry is encouraging the FDA to continue to approve devices as soon as possible, contending that any delays could result in a negative impact to patients. If you have questions about the products being used in your treatment, discuss your concerns with your physician to understand the potential risks.