Demand Stronger Regulations for Medical Devices!
- by: Consumers Union
- recipient: U.S. Congress
Over 90 percent of medical devices do not have to undergo testing on humans before they are sold to, or implanted in, us. This puts people at risk of preventable harm, permanent disability or even death!
There is also no consistent way to find out whether one's medical device is failing and needs to be removed. Simply put, there is nowhere near enough accountability of medical devices today.
Safety standards for medical devices need to be brought up to par immediately. We should be able to trust the devices we put in our bodies! Tell your Congressman that you want stronger regulations for medical devices now!
There is also no consistent way to find out whether one's medical device is failing and needs to be removed. Simply put, there is nowhere near enough accountability of medical devices today.
Safety standards for medical devices need to be brought up to par immediately. We should be able to trust the devices we put in our bodies! Tell your Congressman that you want stronger regulations for medical devices now!
Dear Member,
Rarely does Congress have the chance to save countless lives and dollars with some common-sense rules, but you have that unique opportunity as you reauthorize the Medical Device User Fee Act (MDUFA) this year. I urge you to improve the quality, safety and effectiveness of these products by demanding standards for most medical devices be brought in line with prescription drugs.
Allowing ground-breaking medical devices to be sold is one of the Food and Drug Administration's important jobs. But it's also vital that these devices don't end up hurting or killing those they intend to help. For high risk devices that are permanently implanted or help to sustain life, this requires safety testing on humans before being sold and then tracking the devices so those that break or cause harm can be quickly identified, patients can be notified and dangerous products can be removed from the market.
An average of 700 different medical devices are recalled every year since 2005 because of safety and efficacy problems, affecting millions of people. And it is estimated medical devices are associated with almost 5,000 American deaths in 2009!
Unlike prescription drugs, more than 90 percent of medical devices do not have to undergo pre-market safety and efficacy tests, inspections, or even safety monitoring once they are being used. Rather, to get FDA approval device makers only have to show that their new product is "substantially equivalent" to another already being sold. That means something as potentially risky as a heart valve may get less scrutiny and testing than a drug that treats an upset stomach.
With more and more Americans aging and using these products, innovation is important, but it should not trump safety. As you update the medical device law, I strongly urge you to support the following:
*Improve the process used to approve devices: Raise approval standards from "reasonable assurance" of safety to "substantial evidence" of safety to bring it in line with drug standards. Ensure that implantable or life-sustaining devices go through the pre-market approval process requiring clinical trials, rather than the fast track "substantially equivalent" 510(k) process. A recalled device should not be used as a "predicate" or a device that is used to compare for similarity. And any products previously approved based on that recalled device should be reviewed for safety.
*Improve monitoring of devices being used by patients, especially those that are high risk: Require the FDA to implement a national unique-identifier system for implanted devices so patients and doctors can be contacted when problems arise. Currently, there is no universal way to find out which devices went into which patients. Give the FDA adequate resources to fully implement existing programs for patient monitoring and reporting of harm to identify problems sooner. Give the FDA the authority to require device makers to do sufficient post-market studies.
*Registries: Establish registries to be used to notify all patients who have surgically installed a recalled device as opposed to just notifying the manufacturer and doctor. The Institute of Medicine's study on the 510k process estimates that if the United States had in place a registry for hip-replacement surgery, it would avoid some $2 billion of an expected $24 billion in total costs for these surgeries in 2015.
*Retain current strong conflict of interest standards: Members serving on federal advisory committees should not have conflicts of interest so decisions regarding new and existing drugs and devices are free from bias and influence.
*Adequately fund safety improvements through user fees: It's only fair that the medical device industry share with taxpayers the cost of improving the safety and efficacy of their products, since better products ultimately lead to higher industry profits. User fees should be set at a sufficient level to support the work that the FDA must do to so that devices are safe to use in humans.
Thank you for supporting improvements to make medical devices safe and effective. With more Americans using medical devices than ever before, it's time Congress updates our laws so consumers are no longer used as guinea pigs with these products.
Sign PetitionSign PetitionRarely does Congress have the chance to save countless lives and dollars with some common-sense rules, but you have that unique opportunity as you reauthorize the Medical Device User Fee Act (MDUFA) this year. I urge you to improve the quality, safety and effectiveness of these products by demanding standards for most medical devices be brought in line with prescription drugs.
Allowing ground-breaking medical devices to be sold is one of the Food and Drug Administration's important jobs. But it's also vital that these devices don't end up hurting or killing those they intend to help. For high risk devices that are permanently implanted or help to sustain life, this requires safety testing on humans before being sold and then tracking the devices so those that break or cause harm can be quickly identified, patients can be notified and dangerous products can be removed from the market.
An average of 700 different medical devices are recalled every year since 2005 because of safety and efficacy problems, affecting millions of people. And it is estimated medical devices are associated with almost 5,000 American deaths in 2009!
Unlike prescription drugs, more than 90 percent of medical devices do not have to undergo pre-market safety and efficacy tests, inspections, or even safety monitoring once they are being used. Rather, to get FDA approval device makers only have to show that their new product is "substantially equivalent" to another already being sold. That means something as potentially risky as a heart valve may get less scrutiny and testing than a drug that treats an upset stomach.
With more and more Americans aging and using these products, innovation is important, but it should not trump safety. As you update the medical device law, I strongly urge you to support the following:
*Improve the process used to approve devices: Raise approval standards from "reasonable assurance" of safety to "substantial evidence" of safety to bring it in line with drug standards. Ensure that implantable or life-sustaining devices go through the pre-market approval process requiring clinical trials, rather than the fast track "substantially equivalent" 510(k) process. A recalled device should not be used as a "predicate" or a device that is used to compare for similarity. And any products previously approved based on that recalled device should be reviewed for safety.
*Improve monitoring of devices being used by patients, especially those that are high risk: Require the FDA to implement a national unique-identifier system for implanted devices so patients and doctors can be contacted when problems arise. Currently, there is no universal way to find out which devices went into which patients. Give the FDA adequate resources to fully implement existing programs for patient monitoring and reporting of harm to identify problems sooner. Give the FDA the authority to require device makers to do sufficient post-market studies.
*Registries: Establish registries to be used to notify all patients who have surgically installed a recalled device as opposed to just notifying the manufacturer and doctor. The Institute of Medicine's study on the 510k process estimates that if the United States had in place a registry for hip-replacement surgery, it would avoid some $2 billion of an expected $24 billion in total costs for these surgeries in 2015.
*Retain current strong conflict of interest standards: Members serving on federal advisory committees should not have conflicts of interest so decisions regarding new and existing drugs and devices are free from bias and influence.
*Adequately fund safety improvements through user fees: It's only fair that the medical device industry share with taxpayers the cost of improving the safety and efficacy of their products, since better products ultimately lead to higher industry profits. User fees should be set at a sufficient level to support the work that the FDA must do to so that devices are safe to use in humans.
Thank you for supporting improvements to make medical devices safe and effective. With more Americans using medical devices than ever before, it's time Congress updates our laws so consumers are no longer used as guinea pigs with these products.
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