The stories in Patient Profiles show something within the FDA is clearly broken, and needs to be fixed. Most blame the 510(k) process which is sort of an ‘honor system’ allowing medical device makers to market their products, while the FDA and consumers hope the devices are safe and effective. We know that many are not.
They are allowed onto the market because of a 35 year old process within the FDA - known as the 510(k), a medical device maker applies for permission to market with having to provide assurances of safety and efficacy. About 90 percent of medical devices make it to the market this way and unfortunately, we are seeing the effects of this largely unregulated industry.
Do you think that clinical trials should be conducted before medical devices are sold? Should permanently implanted devices be check for patient safety to minimize injuries before they are marketed? Should the sort of reviews required for drugs apply to devices? Want to fix what’s broken?
Here’s how to get involved:
Consumers Union – Safe Patient Project
CU is pushing for strengthened medical device oversight at a critical time. The FDA budget for the next five years is under consideration and CU believes industry should be paying more to fund medical device oversight. For example a company may pay less than $5,000 to win approval of a device that can bring in millions. At the same time, industry wants more streamlined reviews to get devices on the market faster and with less regulation. Thousands of patient every year are learning that this fast-track to approval has not provided any assurances of safety and efficacy. Multiple removal surgeries, debilitating injuries, infection, pain and death result from unproven medical devices.
CU has some get-tough suggestions to strengthen the antiquated system of medical device approval which relies on an exchange of paperwork to receive a 510(k) approval to market.
Here is a very good summary of the problem and solution:
Here is their site to send a letter to your senators and representatives (It will find them from your address!)
Americans should not
Because of intense lobbying from the medical device industry, more than 90 percent of devices do not have to undergo testing on humans before they are sold to, or implanted in, us. That means heart valves and other high-risk devices can receive less scrutiny and testing than a drug for an upset stomach.
Permanently implanted devices should never be approved under the 510(k) process without premarket approval and clinical trials to assure safety. Eliminate any device grandfathered in before 1976 to be eliminated as a predicate device, because they are not current. An unsafe device should never be used as a predicate and all of those devices that named the defective predicate as a condition of approval need to be reexamined.
Eliminate the “least burdensome” standard that reflects the FDA’s relationship with industry and a reason not to ask for more information in a review of its medical device.
Instead of a “reasonable assurance” of safety before a product is marketed, let’s have a higher patient-oriented standard making sure there is “substantial evidence” of safety.
Since medical devices are not tracked universally there is no way to notify patients that they may have a defective product that should be removed. Does this make sense? If you don’t think this makes sense, let your members of Congress know. They’re writing legislation right now that will decide how safe medical devices must be.
Tell them you want safety standards for most medical devices to be brought in line with prescription drugs.