The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
It was a case of good and bad — last week the Senate passed legislation to oversee medical device safety, and while Senators agreed to increase fees to help fund some safety oversight, they missed the opportunity to include important medical device safety provisions that thousands of activists helped support.
This week, the House passed their own version of the legislation, which also failed to include these critical patient safety provisions that Consumers Union has urged Congress to adopt. To make matters worse, the House bill left out some of the good provisions included in the Senate package.
The debate over FDA oversight has been the subject of intense industry lobbying, and the lobbyists managed to block efforts to require device makers to make sure high-risk devices undergo clinical safety testing before they’re put on the market. Given high profile safety failures with complex medical implants, Congress should be strengthening the FDA’s ability to oversee this industry.
Naturally, we are disappointed that these bills failed to include the patient safety measures we think are essential. But we are grateful that Senator Harkin, Chairman of the Senate Health, Education, Labor and Pensions Committee, and his staff, worked diligently to keep the Senate bill from including things that are outright offensive to consumers – a tall order given the money and omnipresence of the medical device lobby in Congress over the past year.
It’s clear that our current system for approving medical devices has significant safety gaps. More than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale. Instead, the FDA clears these devices through its fast track 510(k) process based on whether they are “substantially equivalent” to devices that are already on the market.
By law, the FDA can only consider whether the new device is similar to one already being sold and no evidence of clinical testing is required – even when the device it is based on has been recalled by the manufacturer due to safety problems. We thought this practice was so ridiculous that we placed an ad in Politico to call attention to it.
Consumers Union and other consumer and public health organizations have pushed for an amendment that would provide FDA with the authority to reject new devices based on their similarity to devices recalled by the manufacturer for safety. At the very least, the FDA should have the authority to require manufacturers to prove they have fixed the safety flaw, which it currently does not have.
Along with other consumer groups, we have had the help of a number of patient safety activists, many who have suffered harm from a medical device. Their contribution to the debate on this issue has been invaluable.
While we have been able to raise the profile of medical device safety problems with lawmakers and the media, we still have a lot of work to do. It may take another 5 years before we can remind Congress to close the absurd safety loophole that allows new devices to be cleared for sale based on recalled devices. Do you have any ideas for how medical devices safety could be improved? Leave a comment below.
Govt oversite doesn’t work, let the legal system make it painful for these company’s
Dollars will get their attention!
Judith Buck says: “I think every memeber of Congress should be required to have at least one new device implanted in their own bodies. Perhaps that would make them more earnest about seeing to it that they actually work”
Judith, I respectfully disagree. The politicians would pay off the company to put in an inert or proven safe devise and would never be in the same danger that we as average citizens that cannot afford to pay off the company to get a safe device would be subject to!
I think every memeber of Congress should be required to have at least one new device implanted in their own bodies. Perhaps that would make them more earnest about seeing to it that they actually work!
I know that when I took Levaquin for a week and developed tendonitis
of my Achilles tendon a month later, the pharmaceutical company was required to report my problem to the FDA. Is the same true for medical devices? If that rule doesn’t now exist, why not ask the FDA to publish one for comments and hopefully bypass Congress and the lobbyists?
Of course reporting of adverse events is required for medical devices. Anything you think may have been caused by a pharmaceutical or device can be reported.
Anyone can report an adverse event to the FDA.gov site and to the manufacturer, which the MD has to respond to the information. Do it. it’s online, easy, and, it gets into your medical records, which you should all read the paper version of your medical records, and get copies, not the electronic version or the computer version at the med records depts. Medicare will not accept any CD versions of medical records, if an encrypted CD sent, the password is sent separately. But, in a letter, Medicare tells them the paper version must be sent. All this EHR, HIM, nonsense, BS. Report your adverse/allergy/medical device failures directly, The doc’s won’t do it, maybe a pharmacist will, but you could be saving the next person’s life. Do it.
Your congress at work for …. not always you. If you are planning any implants you might want to check out the device yourself just as you would prior to buying an auto or a major piece of home equipment. Where would you check not sure, perhaps Europe or other more consumer oriented countries reviews of such devices. Same thing applies to drugs, user beware.
PS. I sign over 100 petitions every month and make between 15 and 20 phone calls to my representatives in congress and President Obama every month because I am sick and tired of the wealthy and corporate America having Carte Blanche and getting ANYTHING they want any time they want it. right now the poor and middle class pay virtually all the taxes while corporate America and the wealthy pay little to no taxes!! Is this fair?? It certainly does not sound like it to me when the people that can actually afford to pay taxes without it affecting their lifestyle pay none while the people that struggle to survive every day pay all the taxes!!
Did anyone expect congress to pass ANYTHING that corporate Amreica did not put their stamp of approval on? I certainly did not! How can we expect ANY government agency or our elected representatives to do ANYTHING that will benefit the American People when the wealthy and corporate America can BUY ANY LEGISLATION THEY WANT USING POLITICAL CONTRIBUTIONS AS BRIBES. We as registered voters and American citizens MUST stand up and stop this!! One thing I have discovered is that when any corporation starts running an ad campaign professing something is true, accurate or safe, THE EXACT OPPOSITE IS ALMOST ALWAYS WHERE THE TRUTH ACTUALLY LIES!!!! Truth in advertising is whatever corporate America decides it is, even if they know that it is anything but the truth!! Are you fed up with the corruption that exists in government???? If you are, stand up and be counted, speak up and make your opinion known and above all else VOTE!! The only way the wealthy and corporate America get what they want even if it bad for America and/or the American People is because far to many of the American People have stopped paying attention and have also stopped voting! Stand up and be counted by voting and telling your representatives in congress what you want through emails, letters and telephone calls. We as American Citizens have the responsibility to know how your representatives in congress vote and to let them know when they are doing anything that is not beneficial to America and the American People. By not paying attention to how our representatives are voting we put our stamp of approval on their activites, even and especially when it is bad for America and/or the American People!!! STAND UP AND BE COUNTED, VOTE!!!!
While we’re waiting for a substantial law to be passed, perhaps someone could set up a private organization like the Better Business Bureau where manufacturers might seek a good rating, and consumers could approve/disapprove a model before their doctor’s implant it.
I know that patients with heart stents carry id which has serial number and information for each stent. Hip replacement patients must carry a card which has generic information on it with no model or serial number. Why not — recent recall sent many into a frenzy to find out if their replacement was one being recalled. It would at least be a step toward safety in a recall situation.
First hip replacement about 2004 got a card to carry only information on it says Stryker hip, only a picture. No problems with it. Second hip replacement 2011 no card, constant pain since. Dr told me he was going to use the same device. Cobalt level increased to toxic level (according to what I read on the Internet. I intend seeing hip surgeon in June 2012. I have not received recall info but see on ads by various attorneys that Stryker hip device is being recalled.
It seems simple to me: The FDA should be empowered to say “No.” until a medical device is proven to be safe and effective whether the device is a new technology or based off of a previous device.
I am a retired nurse &I want to see fast action on safe drugs &other products used by patients & staff.
It’s TIME to STOP wasting time bickering & playing politics!!! LIVES ARE AT STAKE HERE! Do what’s right!
This article is being a little disingenuous here. They state “At the very least, the FDA should have the authority to require manufacturers to prove they have fixed the safety flaw, which it currently does not have.”
Having been involved in many 510(k) submissions, the truth is that the FDA currently CAN ask for anything they want, including additional safety data. The legislation would have REQUIRED them to do so.
Currently, what is asked and how stringent the demand is is totally dependent on the depth of knowledge and work ethic of the person who is assigned to the submission. This can vary greatly and can be truly whimsical. The requested legislation, which I wholeheartedly support, would have removed that uncertainty, replacing it with a firm requirement that would be for the good of the American public.
Nonetheless, I take objection to the misleading statement.
Okay, I see your point that the FDA could request additional data. It’s up to the reviewer in the FDA. So, how do we sway these reviewers to seek assistance if they are unsure about the details of the submission or to give a rat’s …?
All hospitals do keep an implant book with the manufacturer’s stickers. In the OR, the RN does the implant sheet,for billing and tracking purposes,those Ortho implants sheets are atleast 2 pages long, of every screw, rod, pin, etc placed. A copy is sent to the hospital’s records department, the ortho or other department, the manufacturer and billing and to the patient. If the patient does not get what the OR nurse put in the chart for them, usually in a biohazard bag, or if the PACU or floor RN discarded it, the patient needs to get it. This has been done for over 25 years. Come on , this is NOT new.
Thanks Janet, will contact hospital records dept for this info.
Not only am I an RN, but I have master’s degrees in health ed and health admin. I have lots of titanium in my leg and back from an MVA. No one has ever offered the paperwork to which you refer.
I think patients should be more empowered and the FDA more transparent. Who reads the package inserts for meds IF they are included with the script?
We need to demand legible information. The health care industry is no different from any other industry.
In response to Alan, the first to post a reply here – I agree with your position, to sue and let the courts make the manufacturers pay. However, my state – Michigan – is trying to legislate away the people’s right to sue for damages. They have long ago taken away our right to sue pharmaceutical companies.
Big government is NOT the answer
I think a watchdog organization is needed to place web ads that show up when people do searches for web info on procedures such as hip replacement, hernia repair/treatment (mesh), etc. Those of us who are researching what the medical morons are recommending be done to us need to have a sporting chance on the realities of such device failures by having relevant information “pop up” or appear as margin ads in search engine results.
Excellent idea.1
When INFORMED CONSENT is ENFORCED, choices and alternatives and truthful data with much caution is exercised, websites will not be needed. We used to teach patients preoperatively and for discharge home care, this is not being done anymore. Seems the public is intentionally being ignored when it’s their body and care and money. This is immoral, unethical and dangerous “medical care”.
I say, BUYER BEWARE and don’t be first to jump on the new biomolecular, biosimilar, improved, now nuclear tracer medications(not labeled per FDA after I ratted this to the public) it’s blocked, but to allow these organizations called hospitals and clinic and teaching hospitals to operate as clandestine entities with hidden agendas under the guise of “medical care” is a disaster and threat to the public. I say, stay away from non essential care, elective surgeries and ask questions to nurses and all organizations/people who know the inside industry and those MD’s who are competent. Don’t let selfishness and greed drive these life changing decisions. read http://www.fiercebiotech.com, read rsna.org, read fda.gov and alerts, epa.gov health effects, CDC.gov, stay away from snake oil sales , phony remedies. Get the facts and make decisions, if you don’t, the new medical student or nurse may and it could be the wrong one.
Retired RN with fourty years experience. Congress really does not seem to care about the health and well being of the citizens of the USA (my opinion). They seem to care more about making them selves and families comfortible; oh, and also getting re-elected.
Just my two cents, I agree with you Jany on congress caring more about being re-elected than the health of citizens. I wonder if us(USA citizens) are just another name/statistic on a piece of paper when they make their choices.