Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Friday, February 28, 2014
Thursday, February 27, 2014
Posted by Daniela Nuñez, Consumers Union FiDA highlight
Since last September, Consumers Union’s Safe Patient Project has been calling on the top hip and knee manufacturers to warranty their products. A warranty would cover revision surgery for patients if their implant is defective –for example, if the implant breaks, fails to adhere to the patient’s body or emits metal particles into tissue or blood. Shockingly, only one hip and knee implant part comes with a warranty, yet more and more patients are getting these implants installed in their bodies.
To help us understand what patients really need, we’ve asked thousands of people with artificial hips and knees to tell us what they expect from a good warranty. Now, we’ve started asking orthopedic surgeons who implant these hip and knee devices what they think about our warranty idea. As experts in their field, we think they’d give us some good input. A surgeon in Florida shared his thoughts on warranties in a guest blog post. Some orthopedic surgeons in Washington state had helpful comments, with several stating an interest in the idea. And a researcher who has analyzed hip and knee implants retrieved from patients over the past 30 years reached out to us with a very useful perspective on the issue.
In our newest effort to get more feedback from surgeons, our Safe Patient Project team will head to the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans March 10-14, 2014. We tried to pay the registration fee for us and several patient safety activists, but an AAOS representative told us that this is a “private meeting and not open to those outside the medical field or official exhibitors.” So, we will be outside the meeting and around New Orleans ready to talk to surgeons about why we think hip and knee manufacturers should back their products with a warranty and identifying supporters.
Unfortunately, many patients are left in the dark on how long their hip or knee implant will last — even though most people are given an estimate, there is not a solid guarantee to back that up. Patients also need a clear process to follow if their device fails unexpectedly, something that is routinely offered with warranties. And when a hip or knee implant fails, insurance companies, Medicare and patients are forced to foot the bill while the implant maker doesn’t have to pay a dime. That should change.
Surgeons play an important role in the success of a patient’s hip or knee replacement. We look forward to getting their feedback! And we hope we can enlist their support for warranties.
(If you are an orthopedic surgeon, please email us your thoughts on a warranty at email@example.com. If you’ll be at the AAOS conference, let us know!)
Tuesday, February 18, 2014
Read the ruling here.
NewJersey.com ruling article here.
NewJersey.com ruling article here.
Wednesday February 12, 2014
Trial against pelvic mesh manufacturers ongoing
Daily Mail Staff
CHARLESTON, W.Va. -- A Johnson & Johnson president of North American businesses was the latest to testify in one of several cases against the manufacturers of pelvic mesh.
Trial began Monday in the case brought by women who say the mesh used to treat stress urinary incontinence led to pain and permanent injury because of its defective design.
Carolyn Lewis, Kenneth Lewis, Augistina Brown-Singletary, Andre Singletary-Smith, Karin Harrison, Robert Harrison, Patricia Headrick, Darrell Headrick, Katie Uszler, Nick Uszler, Kelly Young and Kenneth Young originally filed the lawsuit in July 2012 in the Northern District of Texas.
Lewis received surgery in 2009, where doctors implanted the TVT, or transvaginal tape. The lawsuit alleges because of the defective design of the product, Lewis experienced pain when she emptied her bladder and during sex.
Defendants in the case are Johnson & Johnson, Ethicon Inc., Ethicon Women's Health and Urology, Gynecare and American Medical Systems Inc. This is the first case against Ethicon.
Attorneys for the companies said the plaintiffs never complained about problems from the mesh until after they filed the lawsuit and said the product was not defective.
U.S. District Judge Joseph Goodwin is overseeing the consolidation of more than 26,000 similar cases alleging injury from plastic mesh devices used to treat bladder and other organ weaknesses.
Laura Angelini, who has served in several marketing positions at Johnson & Johnson and Ethicon, appeared in a pre-recorded video deposition.
In her video testimony, Angelini agreed with the attorney, saying a Swedish company and the inventor of the TVT signed an agreement that later led to the company being the exclusive supplier of the tape. She said the inventor was a 20 percent shareholder in the company.
Angelini said the TVT initially was launched in Europe and was launched in the U.S. in late 1998. She agreed the type of mesh was used in hernia repair.
In Monday's opening statements, Lewis' attorney, Thomas Cartmell, alleged Ethicon used mesh to treat hernias but problems caused by the heavy nature of the product and small pores required surgeries to remove it.
Cartmell said a Swedish inventor later contacted Ethicon saying he used the old mesh to treat stress urinary incontinence and experienced no complications.
In her video testimony, Angelini said the Swedish company and the inventor signed an agreement where his company would be the exclusive supplier of the TVT.
Under the agreement, Agenlini agreed Johnson & Johnson would pay $400,000 to the company if it received acceptable clinical trial results.
In her opening statements, Christy Jones, an attorney representing the mesh manufacturers, said there were several studies on the transvaginal tape, not just those conducted by the inventor.
She said those studies have shown the tape is effective to treat stress urinary incontinence and said it was deemed the gold standard to treat this condition.
In the video, the attorney read off the agreement, saying Johnson & Johnson would pay $20 million for the TVT and a second installment of $2 million. If 140,000 units of TVT were sold, then Johnson & Johnson would pay another $2 million to the seller.
Angelini agreed that if all payments were made, that would total more than $24 million for the TVT device.
The video also showed an email from Angelini in response to her colleagues in the U.S. The attorney asked if she wrote they should spin it to more of a safety aspect than the complications and asked if she had influenced the title of a medical presentation.
Angelini responded that she provided her perspective to provide a more balanced position to show the safety data they had.
Goodwin dismissed the jury early Wednesday and told them to come back at 9 a.m. today. According to the court calendar, the trial is scheduled to last through Feb. 25.
Contact writer Andrea Lannom at Andrea.Lan...@dailymailwv.com or 304-348-5148. Follow her at www.twitter.com/AndreaLannom.
Monday, February 17, 2014
February 17, 2014 FiDA highlight added The Gazette
A 2005 surgery meant to correct Frances Schulte’s (from Coralville, Iowa) urinary incontinence brought her pain and further embarrassment rather than relief.
Doctors implanted a medical device known as surgical mesh, which has since eroded — which means her mesh sling is poking and irritating nearby organs.
“I get stabbed thousands of times a day,” Schulte said. “People don’t understand that I’m in pain every day.”
Schulte, whose surgery was done in Illinois, said that the pain prevents her from comfortably moving around and going to the bathroom.
Surgical mesh, which is generally used to repair weakened or damaged tissue, is made from synthetic material. It is permanently implanted to reinforce a weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, which can commonly occur in older women, women who have had children and women who are obese.
However, more than 1,000 adverse events were reported to the U.S. Federal Drug Administration between 2005 and 2007, which caused the agency to issue a Public Health Notification in 2008. Since then, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse.
The most common complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, organ perforation and urinary problems.
“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” the FDA states on its website.
The FDA has stated that complications associated with the use of surgical mesh have not been linked to a single brand. But Schulte, along with thousands of other women nationwide, opted to seek legal action.
Multiple class-action lawsuits have been filed against various makers of the mesh. Cases against Johnson & Johnson, C.R. Bard, Endo Health Solutions Inc. and Boston Scientific Corp. are all winding their way through federal court in the Southern District of West Virginia.
“I don’t like that they’re still putting it (the mesh) into people,” Schulte said.
Less risky alternatives
Dr. Catherine Bradley, an OB/GYN and division director of urogynecology and reconstructive pelvic surgery at the University of Iowa Hospitals and Clinics, said that a polypropylene mesh sling was first introduced to the United States in 1998. It was developed by Scandinavian researchers and was tested with promising results.
As the medical device became more popular, other companies began developing similar products, Bradley said.
“I don’t think these were tested as much as they should have been, and the FDA approval was probably inadequate,” she said.
She added that she never used transvaginal mesh for her patients because she was uncomfortable with the studies that had been completed.
Bradley noted that the FDA since has required companies making these products to do more rigorous testing, which can be expensive — this, combined with the class-action lawsuits, has led to some companies to no longer sell the product.
Instead, she opts to treat women suffering from pelvic organ prolapse through surgery without mesh in less severe cases and, when necessary by sacral colpopexy, a less-invasive surgery in which mesh is added through an incision made in the abdomen.
Bradley said there is only about a 5 percent risk of erosion when mesh is implanted this way, compared with a 10 percent and sometimes higher risk of erosion when mesh is applied transvaginally. Removing eroded mesh is difficult, but the removal can help with the pain.
“With abdominal surgery, you are also less likely to have pain than a transvaginal surgery, even one without mesh,” she said.
“As a surgeon who treats women and uses mesh, we complain about how much time we spend talking about it,” she said. “But it’s better that we’re spending more time talking with patients and counseling patients that we can’t always cure (their problems) without complications arising.”
Sunday, February 16, 2014
by Marshall Allen ProPublica, Feb. 12, 2014, 1:34 p.m.
The top executive at the country’s pre-eminent health care quality organization is being paid hundreds of thousands of dollars by two large medical companies that have a stake in the group’s work.
The payments to Dr. Christine Cassel raise new conflict-of-interest concerns at the National Quality Forum, which endorses benchmarks that Medicare uses to compensate hospitals based on performance.
As ProPublica recently reported, the Quality Forum is reviewing its conflict-of-interest policies after being stung by allegations that the former co-chair of one of its endorsement committees had accepted kickbacks to help a drugmaker win favorable treatment.
Cassel received about $235,000 in compensation and stock last year as a board member for Premier Inc., a North Carolina company that says it provides group purchasing and performance improvement consulting for an alliance of 2,900 hospitals and thousands of nursing facilities and other providers.
Cassel also was paid $189,000 as a board member for the Kaiser Foundation Health Plans and Hospitals in 2012, Quality Forum officials confirmed to ProPublica. Kaiser’s tax forms are not available for 2013, but they show that in 2010 and 2011 Cassel received a total of $357,125.
Cassel, who declined to be interviewed, took over as chief executive officer last summer after a decade as president and CEO of the American Board of Internal Medicine. She also sits on the President’s Council of Advisors on Science and Technology and has been active with the Institute of Medicine.
Quality Forum officials would not say how much Cassel receives to run the Quality Forum, but her predecessor was paid about $525,000 in salary and other compensation in 2011, tax documents show.
The group's chairwoman, Helen Darling, said in an email that the board was “fully aware” of Cassel’s outside compensation when she was hired in December 2012. Darling, president of the National Business Group on Health, initially agreed to an interview but did not respond to follow-up contacts.
Spokeswoman Ann Greiner said the board got a legal opinion and discussed it in depth before agreeing that Cassel could recuse herself “where her outside board service would be construed as an actual or perceived conflict of interest.” So far that hasn’t happened, Greiner said.
Two ethics experts interviewed by ProPublica said Cassel’s relationships with Kaiser and Premier present obvious conflicts given the Quality Forum’s broad involvement in health care.
The Quality Forum maintains a clearinghouse of more than 700 quality measures — covering everything from tracking hospital readmissions to setting information technology standards — that are established by expert committees and widely adopted by U.S. hospitals and other providers.
The ethics experts said they were uncertain how Cassel could recuse herself to anything related to Kaiser and Premier and still do her job.
“Would that mean every time somebody said the word ‘hospital’ she would have to say, ‘I can’t be in this conversation?’” said Eric Campbell, a Harvard School of Medicine professor who has published extensively on conflicts of interest.
“Conflict of interest is as much an appearance as it is an effect,” added Sheldon Krimsky, a medical ethics expert at Tufts University. He called Cassel’s conflicts “absolutely egregious.”
Campbell and Krimsky said the cleanest way to eliminate potential conflicts would be for Cassel to resign from the outside boards. Campbell also said Cassel could continue serve but without pay, which would at least remove possible concerns about the influence of money.
No one has suggested that Cassel has used her post to benefit Kaiser or Premier. But the disclosure of her outside compensation comes as quality is increasingly becoming a bottom-line issue for the industry.
Not so long ago, hospitals and other medical providers were paid the same fees by Medicare and other payers based on services they provided, regardless of whether outcomes were good or bad for patients. But as medical errors continued to cause harm and drive up costs, the federal government and others began experimenting with ways to link payments to performance.
That’s where the Quality Forum’s endorsements come in.
Established in 1999, the Washington, D.C., nonprofit invites hundreds of participants from across the health care spectrum — insurers, practitioners, researchers, health care systems and consumer groups — to become members and help pick the best quality benchmarks for endorsement by consensus.
Kaiser and Premier are among the group’s 375 dues-paying member organizations.
In 2009, Medicare awarded a $40 million contract to the Quality Forum to recommend measures it could adopt. President Obama’s health care reform law accelerated the move to pay-for-performance. Medicare already has begun penalizing and rewarding hospitals based on readmission rates, mortality and patient satisfaction measures. By 2017, it’s expected that 9 percent of Medicare payments will be based on performance.
Much of the Quality Forum’s work has been behind the scenes. But that changed last month when allegations arose that questioned the group’s vulnerability to commercial influence.
In settling federal whistleblower lawsuit, the Justice Department accused a well-known patient safety leader, Dr. Chuck Denham, of accepting $11.6 million in kickbacks from a drug company while he co-chaired a Quality Forum committee to endorse patient safety measures.
Denham said he had legitimate contracts with the drug company, but the payments were not disclosed to the Quality Forum. ProPublica found that the group’s final 2010 Safe Practices report endorsed the company’s surgical antiseptic, a decision that other committee members said was unintended.
In response to the Denham case, the Quality Forum launched a review of the committee’s work and the organization’s conflict-of-interest policies. The review is expected to be complete by Feb. 25.
The Quality Forum’s policy for committee members defines a “conflict of interest” as any financial or other interest that could actually, or be perceived to, impede a person’s objectivity or “create an unfair competitive advantage for you or an organization associated with you.”
Cassel’s outside board positions create conflicts, according to ethics experts, because Kaiser and Premier could be affected by Quality Forum endorsements.
Kaiser, an integrated system that’s been touted as modeling the future of health care, had hospital revenue of $18 billion and health insurance plan revenue of $37 billion in 2011. The organization operates in eight states and the District of Columbia at 37 hospitals and hundreds of medical buildings.
Kaiser spent $1.6 million lobbying Congress, the Department of Health & Human Services and other agencies last year, according to the website OpenSecrets.org. A Kaiser executive, Jack Cochran, sits on the Quality Forum’s board.
In an email, Kaiser spokesman John Nelson said the health system was “incredibly fortunate” to have Cassel on its board for the past decade and that “any organization smart enough to engage with her will receive wise counsel and honorable service."
Premier reported revenues of $869 million in the fiscal year ending last June. It spent more than $1 million on lobbying in 2013, according to OpenSecrets.org. In August and November, the company urged members of Congress to instruct Medicare to run any quality measures through the Quality Forum.
Premier featured Cassel’s status as a board member and future top executive of the Quality Forum in documents last May describing its initial public stock offering. In September Cassel acquired 3,704 shares of Premier stock that were then worth about $100,000.
The company’s business involves group purchasing and a consulting arm that uses data analysis to help providers perform better on various quality metrics. In October, a measure sponsored by Premier to track hospital care by the average length of stay was up for renewal by the Quality Forum.
Blair Childs, Premier’s spokesman, said the company is still evaluating the average length of stay metric and that it could be submitted for consideration as a Medicare pay-for-performance measure.
Childs said Cassel’s role on the Premier board doesn’t pose any conflict of interest, and that her relationship with Premier was vetted carefully by the Quality Forum’s board. Cassel was a good addition to the Premier board because of her commitment to improved care and lower costs, he said.
Defining the Strike Zone
Harvard’s Campbell said Cassel’s dual roles aren’t necessarily a problem if disclosed and carefully managed. But he offered a baseball analogy to show why they present a risk for the Quality Forum.
Imagine, Campbell said, training umpires to call balls and strikes — except the person doing the training is also being paid by the New York Yankees, and the strike zone favors the swing of Derek Jeter.
Campbell said he wasn’t being judgmental about Cassel’s conflicts of interest. But the Quality Forum is paid taxpayer dollars by Medicare to perform a public service in a quasi-regulatory role, he said. When the Quality Forum’s leader is paid hundreds of thousands of dollars by hospital companies, Campbell said, it creates a potential incentive to shape the rules in their favor.
Krimsky, the Tufts ethics expert, was more critical of the arrangement. He said it’s not enough for Cassel to recuse herself from decisions or discussions related directly to Kaiser and Premier. She still could be involved in choosing who sits at the table to have discussions or make decisions, he said.
“When there’s a conflict of interest in the management group, that’s a serious problem,” Krimsky said.
Dr. Peter Pronovost, a well-known patient safety leader from Johns Hopkins Medicine, said he did not see how Cassel’s outside board roles would present a direct advantage for Kaiser and Premier. But he said conflicts of interest in the world of quality improvement are often indirect, and the industry hasn’t clearly defined how to navigate them.
“That doesn’t mean (the conflicts) are not real,” Pronovost said. “But they’re less risky. The field does need to articulate the boundaries for these indirect conflicts.”
Although Cassel’s relationships were known to the board, it does not appear that they were widely shared with the Quality Forum’s membership. Cassel’s biography on the Quality Forum website mentions about a dozen other affiliations but not Kaiser and Premier.
Some who are active on Quality Forum committees also said they were unaware.
Leah Binder, president and CEO of The Leapfrog Group, a coalition of employers that advocates for quality and transparency in health care, said she respects Cassel but would have liked to have known about her outside board roles.
“Maybe we need to understand from Chris how she recuses herself from any kind of decision making that might have an impact on those two organizations,” Binder said. “I think she would owe us an explanation of that.”
Lisa McGiffert, director of the Consumers Union Safe Patient Project, sits on a committee that’s recommending possible pay-for-performance metrics to Medicare. Recently a debate about a proposed hospital readmission measure pitted the consumer-minded members, who favored it, against the providers, who were against it. In the end, the consumer side didn’t get its way, she said.
“All of this is about relationships, and (Cassel) has a relationship with that hospital system,” she said. “That relationship means that Kaiser might weigh in with her on those hospital measures.”
McGiffert said all Quality Forum conflict-of-interest disclosure forms should be posted online so anyone can easily see various allegiances.
Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.
“The insiders don’t see it,” Gibson said. “It’s like a fish in water.”
ProPublica is investigating health care quality and welcomes your input. Medical providers – help us by completing a brief Provider Questionnaire. Patients can complete ProPublica’s Patient Harm Questionnaire.
Comment: Joleen Chambers
At the FDA, trained patient representatives are eliminated because OSHI (Office of Special Health Issues) must 'vet' the participants in medical device advisory panels. Harmed patients are often not selected because of their 'bias' (real-life experience!), but industry insider financial conflicts-of-interest are not an issue that interferes with their full participation. When the established standard is engaged patient advocates having access to define and populate panel discussions at FDA, NQF, IOM, TMIT, PCORI, (etc.) and have equal time at the microphone on webinars with all compensation (and non-compensation) listed in the program, the shame of the disparity will highlight the good medical leaders from the profiteers. For me, a bell weather will be seeing Regina Holliday properly compensated for her leadership and accomplishments! Google her.
Friday, February 14, 2014
Out of the Dark Ages! FDA requires medical device manufacturers to report adverse events on a computer!
Posted: February 13, 2014 - 3:30 pm ET
Hospitals, physicians and their patients soon may know if a medical device is faulty more quickly than in the past thanks to a Food and Drug Administration final rule issued Thursday. The rule requires manufacturers to submit reports of injuries or deaths associated with their products electronically to the FDA instead of via a paper report as is currently done.
Electronic submissions will make it easier for the FDA to review adverse events and rapidly communicate information about suspected problems to the medical-device industry, healthcare providers, consumers and other government agencies, it said in the rule.
For decades, the FDA has received these reports in a paper format through the mail. In 2009, the agency released a proposed rule that called for electronic reports on a voluntary basis. The final rule makes it mandatory to do so starting Aug. 14, 2015.
The FDA on average receives roughly 200,000 adverse events annually and can take anywhere from three days to six to properly analyze a report received by mail, according to the FDA. Others argue it could be even longer in some instances.
“It is no secret that, for years, paper medical-device reports were mostly warehoused,” said Jeffrey Shapiro, an attorney at Hyman, Phelps & McNamara.
The FDA estimates it oversees more than 20,000 device manufacturers and importers. The industry will face one-time costs of $40 million in training and IT changes to make the switch, the FDA estimated. However, device makers will save about $9.2 million annually because electronic submission should reduce the time needed to submit documents and reduce delivery costs.
A major change between the proposed and final rule: user facilities such as hospitals will not be required to comply with the e-filing requirement.
“This change from the proposed rule was obviously in response to comments concerning the increased costs for electronic submissions by entities that file a small number of reports each year,” said William Kitchens, a partner at the law firm Arnall Golden Gregory.
Small devicemakers are not exempt from the new requirement, however.
“There are many very small device manufacturers and I believe that this is going to be a burden for them,” said Wally Pellerite, an industry consultant and former FDA compliance official, adding that it makes the agency appear inconsistent to exempt hospitals but not small devicemakers. “Small device firms with few medical-device reports should be allowed to submit paper reports.”
Follow Virgil Dickson on Twitter: @MHvdickson
Thursday, February 13, 2014
Fri Feb 7, 2014 11:53am EST
(Reuters) - Merck & Co said on Friday it will pay $100 million to resolve all U.S. product liability lawsuits alleging it downplayed serious health risks involving its NuvaRing intrauterine contraceptive device.
The product, which contains the hormones estrogen and progestin commonly found in birth control bills, is associated with an increased risk of developing blood clots that can cause heart attacks, strokes or sudden deaths. Available to women in the United States since 2001, NuvaRing is one of several contraceptive products linked to this higher risk.
Merck, the second-biggest U.S. drugmaker, denied any fault under the agreement, which must be accepted by 95 percent of about 3,800 eligible patients involved in lawsuits pending in federal and state courts.
A lawyer for the plaintiffs, Roger Denton of Schlichter, Bogard and Denton, said the settlement, reached after nearly a year of negotiations, is "an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of Nuvaring."
Under the settlement, Merck would pay a fraction of what at least one company has paid in a similar settlement.
German drugmaker Bayer AG said last year it had paid nearly $1.6 billion to settle thousands of lawsuits involving accusations that its Yaz and Yazmin birth control pills caused blood clots that led to strokes and heart attacks.
Merck shares were up 1 percent at $54.32 on the New York Stock Exchange, in line with a 1.2-percent advance in the ARCA Pharmaceutical Index of large U.S. and European drugmakers.
(Reporting by Ransdell Pierson; Additional reporting by Jessica Dye; Editing by Jeffrey Benkoe and Bernadette Baum)
The article states “NuvaRing intrauterine contraceptive device”. NuvaRing is an intravaginal contraceptive device, not an intrauterine device.
Tuesday, February 11, 2014
The Women's Health Activist, National Women’s Health Network NWHN.org
By Kate Ryan, NWHN Senior Program Coordinator
When cars, baby cribs, or even microwaves are recalled because there’s a safety problem or the product doesn’t work, you can check the unique serial number on your car, crib, or microwave to immediately discover if the one you own has been recalled, or if there’s no need for you to worry. Having systems that facilitate the quick and accurate identification of unsafe and ineffective devices is just common sense — so most people would be surprised to learn that, until six months ago, the system for tracking problems with medical devices was so ineffective that many people never even found out about recalls of defective products — which has the potential to put their health at risk.1
If, like me, you watch cop shows such as CSI or Bones, you probably think that implanted medical devices can be traced back to the medical record of the person whose body they’re implanted in. Shows like that have plenty of episodes where the murder victim is speedily and accurately identified because she has a hip replacement or pacemaker that can be tracked by its unique identification number. Unfortunately, until now that’s been fiction! In reality, the lack of a basic, commonsense system that allows someone to find out if she has a recalled device has left U.S. women and health care providers struggling to get their questions about specific products answered -- even basic information like whether the product a woman is using has been recalled.
That’s the scary news. The good news is that health advocates have finally persuaded Congress and the Food and Drug Administration (FDA) to establish a unique device identification (UDI) system and the National Women’s Health Network (NWHN) is working with the FDA to develop that system.
This is an important advance for women. The NWHN has advocated for a medical device UDI system for many, many years. This system is key to the FDA’s ability to protect millions of people from the harm caused by flawed and dangerous products.
The new protections will begin this summer, starting with the highest-risk devices like certain pacemakers, heart valves and joint replacements. Over the next seven years, the FDA will roll out requirements for medical device manufacturers to include a unique number and bar-code on the label of certain medical devices so patients, consumers, health care providers, and hospitals can track and identify these devices.2 The new UDI system will provide women who use medical devices with better information and prevent the unnecessary harm that results when recalled devices remain inside the body. The system also has the potential to improve how device problems are reported to the government, so the FDA can more quickly identify dangerous devices and remove them from the market — which will help all of us.
How much do you know about your device?
Currently, women do not have enough information about the specific devices they use or have had implanted to be able to tell if they’re affected by a specific device recall. Many patients leave surgery without knowing what company made their new hip, let alone what brand of hip they have — and it can be very difficult to track down those details later. The general information you get from scary lawsuit ads that warn of safety problems with surgical mesh or from news reports about a recall of hip implants do not provide enough detailed information about the recall, or the specific hip or mesh, for anyone to be able to tell if the product they have is affected.
You could try going to the FDA’s website to get more information about the recall, but you will only find the brand name and description of the device being recalled….which still won’t tell you if you have the specific recalled hip. The most likely place to find the relevant information is from the health care provider who either provided or implanted your device. The best-case scenario is that your provider documented which manufacturer and what specific brand or model of device you received. Unfortunately, labels for implanted devices are usually on the packaging, which is often thrown away during surgery, and the information doesn’t always make it into a patient’s medical records. Even if your provider did keep good records, it can be next to impossible to find that information if your provider has retired, moved, or gotten rid of her old patient files. The lack of a system has — until now — created enormous barriers to patient’s access to vital information.
Women are safer with more information
Once the new UDI system is fully implemented, women will be able to ask for their device’s specific UDI number when they get the device. That way, a woman will have all of the information she needs when she hears about an FDA device recall, and that may minimize both unnecessary worry and unnecessary harm. If her device hasn’t been recalled, she can stop worrying about the potential harm immediately – no need to make an unnecessary trip to her provider because she kept a record of what device she has and hopefully so has her provider. If her device has been recalled, she can promptly schedule an appointment with her health care provider and talk about whether she needs to stop using the device — or, if it's an implanted device, if she should get it removed and replaced.
The new UDI system will also improve the device recall system and decrease the amount of harm caused by slow or incomplete device recalls. With UDIs, it will be easier for hospitals and providers to stay current on the latest safety information and list of recalled devices. They will have the information that will allow them to check medical records for affected UDI numbers so they can contact patients directly with the recalled device, rather than waiting for patients to learn about the recall and seek information themselves.
Making it easier to for hospitals to identify and track recalled devices will also prevent unsafe devices from being given to patients in the first place. Without UDIs, recalled devices are, unfortunately, likely to remain in use, and a patient could have surgery and receive a device that has already been identified as flawed and potentially dangerous. While we’d all like to believe this is extremely rare, right now there’s no way to know how often it occurs. Of the approximately 700 medical device recalls that happen each year, about half of the faulty devices (53 percent) stay on the market, because manufacturers currently have no way to track their devices electronically. The UDI system will allow hospitals and providers to scan the bar-codes of all the medical devices in their supplies and assess the safety of the devices they intend to use. When a hospital or other health care provider is notified of a recall, the new UDI system will allow them to quickly find and remove any recalled devices from their storerooms.
Tracking devices will improve public health
The UDI system will have broader benefits for everyone, including people who do not have a medical device. That’s because it will also increase the accuracy of the information about all of the devices on the market.
Currently, when someone experiences a problem with a medical device, she or he can report it to the FDA, which maintains lists of what are called “adverse events.” But, these reports often lack detail, and may only state that a patient had a problem related to surgical mesh, or a hip, in general. While reports from health care providers sometimes include more information about the problematic brand or manufacturer, it still isn’t usually enough information to help the FDA estimate the extent of the problem. Is there just one faulty device out there? Do the adverse event reports indicate there’s a problem with one batch of a device stemming from a manufacturing problem? Or, do the reports signal that there is a larger issue with the design for a particular device model?
Under the new system, patients and providers will be able to include a UDI number in their adverse event reports, and the FDA will gain access to better information to help answer those questions and more quickly flag bigger problems.
Making the UDI system work for you!
Once the UDI system is fully in place, when you hear about a device recall, you’ll be able to find out whether the recall affects your specific device by checking the UDI number on the label against the FDA recall alerts and safety notifications. To do this, you’ll need to keep the label of any device you purchase or are given at a health care facility (like an insulin pump) and/or have surgically implanted (like an artificial hip). If you have a medical device implanted through surgery, make sure that the UDI number is included in your medical record and ask for a copy of the number to keep on hand. That way you can check the FDA’s safety notifications and recall alerts to see if your UDI number is on the recall list.
At the NWHN, we will continue to watchdog the roll-out of the UDI system to ensure that it meets women’s needs. We will advocate for the FDA to raise awareness about the new UDI system and to clearly communicate to patients and other consumers any recalled UDI numbers. We will also continue to push for more devices to be directly marked with the UDI number so people won’t need the label to keep track of their UDI number.
We want to ensure that you have the information you need as quickly and easily as possible. Knowing your UDI number will empower you to take action to protect your health when you hear about a possible safety problem or recall.
▪ NWHN’s article about device regulations: http://nwhn.org/blog/medical-mishaps-what-you-need-know
▪ NWHN’s article about Metal-on-Metal (MoM) hip replacement devices: (http://nwhn.org/newsletter/node/1369).
1. The Food and Drug Administration’s definition of a “medical device” is available here: http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm
2. Read more about the new rules on the FDA’s website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevi...