Consumer Reports Investigates Safety of Implanted Medical Devices

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Is your implanted medical device safe?

Mar 28, 2012 6:05 AM

You might assume so, but many implanted devices, including artificial joints and surgical mesh, were never clinically tested on humans before being put on the market, according to a new Consumer Reports investigation. Worse still, if anything goes wrong, you might not hear about it—and may even have a hard time finding out what device you got.

Case in point: the DePuy ASR XL metal-on-metal hip replacement, which was implanted in 93,000 people worldwide before it was finally taken off the market in 2010 because it was failing at an unacceptably high rate.

One recipient of the DePuy hip, Susy Mansfield, 61, of Peterborough, N.H., who shared her story with our Safe Patient Project, said didn't know anything about the recall until she read a news item in the Boston Globe some five months later. The only evidence that she had a DePuy hip was a small card she was given to to help her through airport security that had that brand name on it.

But she told us that repeated calls to her surgeon's office to find out what exact device she had received met with resistance and no information, until she finally threatened to send a lawyer to get it. She recently had surgery to replace the hip with a safer model. You can hear and read more about her experience on National Public Radio's Shots blog.

"I would be happy to a sign a statement allowing my name and contact information to be given to the manufacturer so they could contact me in the event of a recall or product problem," Mansfield says.

We agree. Consumer Reports' advocacy arm, Consumers Union, is fighting to make the device industry safer for patients . One of our recommendations is that every implanted device should have a "unique identifier," similar to a serial number, to enable patients to hear quickly about recalls or other safety issues.

For details, read our report on Dangerous Medical Devices.

—Nancy Metcalf, Senior Program Editor

Wall Street Journal: Faulty Devices

LINK

(Fida blog bold/underline added.)

FDA Plans ID-Tag System to Detect Faulty Devices

By THOMAS M. BUR T  ON    Wall Street Journal 4/26/12

The Food and Drug Administration is devising a new system for detecting malfunctions in medical devices that will tap medical and billing records from hospitals and insurance companies.

The system is designed to catch malfunctioning devices like the St. Jude Medical Inc. STJ +0.82% heart defibrillator wires recently linked to at least 20 deaths. The agency wants to assign a new bar-code-like identification number to medical devices.

Some Recent Recalls, Complaints

Medical-device flaws that led to the FDA's new surveillance system

            Medtronic defibrillator wires: Sprint Fidelis heart wires fractured in rare cases; patients died from inappropriate shocks and failure to shock. Recalled in 2007.

            Surgical vaginal mesh: Used for urinary incontinence, mesh led to serious complications, including scarring, infection and pain. More than 1,000 complaints by 2008.

            Metal hips: Tiny metal particles wore off, damaging bone and tissue, causing pain and sometimes requiring revision surgery. Two brands recalled in 2008 and 2010.

            St. Jude defibrillator wires: March 2012 study linked the Riata wire to 20 deaths, after product was recalled in December 2011.

Source: WSJ reports; FDA

It would use that number to search large databases of records that could include veterans' and other hospitals, as well as large insurance companies. That could potentially allow the agency to know more precisely the rate at which a device is failing, and which patients have devices prone to malfunctions. The FDA plans to provide further details of its system as early as Thursday.

"The unique identifier is the real game changer," said William H. Maisel, deputy director for science of the FDA's medical device center. "With that number and a medical database, you could see, for example, if the reoperation rate for a certain defibrillator has become statistically a high outlier."

The agency's idea for the identification number—called a "UDI," for unique device identifier—has been awaiting action for about 10 months by the White House Office of Management and Budget. A bipartisan group of senators wrote to OMB recently complaining that the FDA's proposed new rules on the provision weren't yet public. OMB said it doesn't comment on such matters.

The Premier Hospital Alliance, a 2,500-hospital chain, said it is eager to allow the FDA to use its medical database for device- and drug-safety purposes. "We will definitely cooperate and do whatever we can with the FDA once the UDI goes into effect," said Blair G. Childs, Premier senior vice president. The Department of Veterans Affairs didn't immediately comment.

The FDA and St. Jude have struggled in recent weeks to understand the scope of defects in the company's Riata defibrillator wire, called a "lead." The lead connects the life-saving defibrillator to the heart of a patient. The Riata lead has been known to malfunction and has been linked to 20 deaths in reports to the FDA. St. Jude officials maintain the Riata has no more malfunctions than other defibrillator leads created around the same time.

The device has since been recalled, but an estimated 79,000 Americans still have the Riata and Riata ST recalled leads implanted in their chests.

FDA officials say an individual doctor played a crucial role in alerting them to the problems with the Riata lead. The doctor, whom the agency didn't name, had a 23-year-old patient who died July 16, 2010. The young man had a defibrillator implanted, along with a Riata lead.

Defibrillators are designed to dispatch a powerful shock to the heart when the heartbeat goes lethally haywire. If the lead gets damaged, it can start dispatching powerful shocks when they're not needed.

That's what happened to this young patient, whose Riata lead became damaged and began shocking him, according to the doctor's report to the FDA. Doctors then put in a new Riata-class lead and a new defibrillator. But according to reports to the FDA from the doctor and St. Jude, the new lead became damaged and didn't work properly either. This time, when his heartbeat went awry, the needed shock was "truncated" and failed to revive the patient, the doctor and the company told the FDA.

FDA analysts grew intrigued. They asked St. Jude for more detail beginning that September. By later in the fall, agency officials said, they had become convinced that the failure of the Riata-class leads could represent a possible broader serious defect. In December 2010, St. Jude pulled the Riata and Riata ST silicone-coated leads off the market.

St. Jude said that only the first lead that was put in the patient was among those pulled from the market. They said the second lead put in the patient was not, and that its failure may have been caused by scraping against the other lead that was left inside the patient. Doctors sometimes leave leads inside patients since their removal can trigger complications.

FDA officials credit the young man's doctor for an especially detailed and vivid report that enabled the agency to focus on the Riata lead. His information presented to the FDA "shows the difference between a great report and a mandated report," said the FDA's Dr. Maisel.

"I suspect that the lead design cannot withstand the vigor of cardiac contraction of a young adult and should not be recommended for active persons," the doctor wrote to the FDA. "This lead design needs to be re-evaluated." St. Jude said it stopped selling that lead model in December 2010 and that "our current-generation leads have a different design and a newer, more abrasion-resistant insulation material."

Write to Thomas M. Burton at tom.burton@wsj.com

A version of this article appeared April 26, 2012, on page B3 in some U.S. editions of The Wall Street Journal, with the headline: FDA Plans ID-Tag System To Detect Faulty Devices.

Implanted Device Risk: Congress Favors Industry Lobby or Patient Safety

http://bit.ly/JDd5Zk

FDA rips Europe's system for medical device reviews         Article by: JIM SPENCER and JAMES WALSH , Star Tribune Updated: April 22, 2012 - 9:33 AM

Agency disagrees with device makers who see Europe as a model for product approvals.

WASHINGTON - CorCap was a mesh bag that fit over the bottom of the human heart to treat congestive heart failure. Nobody questioned whether surgeons could safely install it. It sold in Europe for years.

But CorCap never got on the U.S. market for one reason: Its maker, Acorn Cardiovascular of New Brighton, could not convince the U.S. Food and Drug Administration (FDA) that CorCap worked better than drug therapy.

Today, Acorn Cardiovascular is out of business, despite $100 million in development capital. CorCap is no more.

In a new internal report obtained by the Star Tribune, the FDA claims the device's demise as a victory for American patients and an affirmation of the U.S. medical device approval process.

The strongly worded document details what the FDA says are 12 classes of malfunctioning or needlessly invasive high-risk medical devices approved for sale in Europe but not the United States. It represents an FDA defense of its practices while industry groups, patient advocates and some in Congress propose changes in the way the agency does business.

"If a device gets on the market somewhere else first [and] it's a good device, good for them; if it's a bad device, bad for them," said Dr. Willam Maisel, FDA's deputy director for science. "The only way to know that is to look at some of the devices and see how they played out."

The report, "Unsafe and ineffective devices approved in the E.U. that were not approved in the U.S.," indicts a European system that American medical device makers, including hundreds of Minnesota companies, have held up as a model for getting lifesaving devices to market faster. It comes as Congress debates reauthorization of the Medical Device User Fee Act, the law under which devices are reviewed.

"We were anticipating questions about the type of data we ask for," Maisel said in explaining why the agency gathered the information. "This is the evidence."

Device recall expert Diana Zuckerman of the National Research Center for Women & Families said the report looks like FDA pushback against industry lobbying. "One of the big issues for lobbying is the device industry telling Congress that the system in Europe is so much better than the system in the U.S.," Zuckerman said.

The United States generally requires proof that high-risk medical devices benefit patients in "clinically significant" ways, while the European Union generally does not. The difference can mean years of expensive clinical trials.

The device industry contends that the FDA's slower approval of high-risk devices drives U.S. businesses overseas, costing high-paying jobs and keeping U.S. patients from badly needed relief.

"Nobody knows how to define clinically significant," said Acorn Cardiovascular founder Steve Anderson, whose company spent six years trying to prove CorCap's effectiveness. "We were burning more than $1 million a month just for personnel running the [clinical] trial."

Shay Mandle, vice president for government relations at industry group LifeScience Alley, said there are no data to suggest that people in the E.U. are getting more bad devices than in the United States.

"The E.U. system is working better today than the U.S.," said Mandle, whose group represents more than 600 medical technology businesses employing 250,000 people in Minnesota. "The rationale for most companies going to the E.U. is that it's more predictable."

University of Minnesota law professor Ralph Hall, who consults for medical device companies and studies the device industry, branded the unpublished FDA report "political." It is intended to deflect criticism from the FDA's performance and to neutralize legislation the FDA doesn't want, Hall said.

He called the report one-sided, looking only at E.U. failures. In some cases, the FDA went back more than 15 years to make its point, Hall said.

FDA critics in the House and Senate hope to add language to new-device legislation that, among other things, expands humanitarian exemptions for high-risk devices that require no effectiveness testing. Industry-driven measures also aim to change the FDA's mission statement to include job creation.

The report makes clear that the FDA does not want to move toward a more European approval model.

"Lowering standards of approval for devices in order to speed access can jeopardize patient health and impose high but often hidden costs," the FDA warns.

In the report, the FDA included a chart that compared approval standards. The agency says that the E.U. demands less evidence and allows private, for-profit companies to approve products for sale throughout the E.U.'s 27 member countries. Approvals and the evidence on which they are based are not disclosed publicly, the FDA said. Neither are side effects or recalls, the FDA says.

Others have questioned the European system. A February article in the New England Journal of Medicine reported that "a recent recall of a popular breast implant that was approved only in the European Union has reinforced European concerns about the clinical evaluation of high-risk devices."

Linda Alexander, who leads Alquest, a Minneapolis firm that helps device makers navigate the FDA, believes that the FDA prepared its report to boost staff morale.

Alexander said effectiveness testing is not as black-and-white as the FDA tries to make it. Annual recalls of risky medical devices are the same in the United States and the E.U., said Alexander, who worked 10 years for Minnesota device maker Medtronic.

"Companies are going to Europe in order to stay in business," she said. Selling devices in Europe often provides money manufacturers need to pay for clinical testing here.

Congressional efforts

Sen. Amy Klobuchar, D-Minn., and Rep. Erik Paulsen, R-Minn., have been especially vocal supporters of industry efforts to get medical devices to market faster.

Paulsen said in an interview that he favors effectiveness tests before allowing devices on the market.

"You should absolutely test for efficacy and safety, and I've never suggested otherwise," Paulsen said. "I've held up the European system as a model, not because it has a different standard, but because it is consistent, it's transparent, it's efficient and it's predictable. The U.S. system has become less so."

Klobuchar issued a statement: "I believe we can still make the approval process more efficient while increasing predictability, transparency and safety."

At least one Minnesota-made device awaiting FDA approval falls into a group that comes under severe FDA criticism in the report.

The agency blasted patent foramen ovale (PFO) occluders -- surgically implanted devices that close a congenital heart defect in stroke patients -- as no better than aspirin in preventing future strokes.

St. Paul-based St. Jude Medical Inc. sells its Amplatzer PFO occluder in Europe and other major world markets and hopes to sell it in the United States. The company just completed a major clinical trial but has not shared results with the FDA, said spokeswoman Amy Jo Meyer.

But a March 15 article and editorial in the New England Journal of Medicine reported results of a clinical trial involving another PFO occluder, the NMT StarFlex. It proved no more effective than aspirin in preventing a recurrence of strokes, researchers found. Worse, it caused a greater incidence of potentially harmful irregular heartbeats.

"During the nine years it took for the results of this trial to be reported," Dr. Claiborne Johnston of the University of California San Francisco Medical Center wrote in an editorial, "... $400 million was spent [around the world] on a procedure that had no apparent benefit, to say nothing of the clinical risks involved."

In an interview, Johnston said "the pendulum has swung too far" toward time-consuming FDA approvals, but that does not eliminate the need to measure product benefits.

"Society," he said, should not be "reimbursing for worthless devices."

Jim Spencer • 202-408-2752 jim.spencer@startribune.com James Walsh • 612-673-7428 • jwalsh@startribune.com

http://bit.ly/JDd5Zk

The U.S. joint replacement registry 4 years later: none!!!

(link) August 2008 AAOS Journal endorsed a national registry      (FiDA Blog bold/underline added.)
AAOS-American Association of Orthopedic Surgeons

Value of total joint registries: The jury is in

By Norman A. Johanson, MD

Current evidence makes a compelling case for a national registry

Registries for hip and knee replacement procedures are a world-wide reality with growing importance. Many of the preeminent registries—such as those in Sweden, Finland, Norway, Australia, Denmark, and New Zealand—have more than 10 years of experience and are currently collecting data on more than 90 percent of procedures nationally.

Registries are also growing in the complexity of data collected. The minimum recommended data set (http://www.ear.efort.org/E/03/01-03.asp) includes patient, surgeon, and hospital identifiers; core surgical data, date of surgery, diagnostic and treatment codes, laterality, and implant information. This may be augmented to include comorbidity and patient-administered questionnaires. Registries also address important issues such as prophylactic antibiotic and anticoagulant administration by measuring their impact on the incidence of infection and thromboembolic events. Published evidence from registries can now potentially guide important clinical decision-making.

A snapshot of clinical practices A distinguishing feature of registries is that, with several thousand consecutive patients entered, they have no exclusions—a characteristic of methodologically sophisticated clinical trials. What is sacrificed in terms of potential bias inherent in inappropriate group comparisons, however, is offset by the breadth of applicability of the findings.

Most significantly, registries provide a snapshot of the realities of current clinical practices and real-time assessment of the associated outcomes. The timely feedback of these observations to surgeons may result in significant behavioral change, particularly if a practice pattern can be clearly associated with a desirable or adverse outcome.

National registries, by virtue of their inclusiveness, can detect significant risks to patient health associated with a particular procedure. For example, registry data show that pulmonary embolism (PE) following total hip or knee replacement is rare. In total hip arthroplasty (THA), the 90-day rate of nonfatal PE has been reported to be 0.93 percent in 58,521 Medicare patients who underwent primary THA with or without prophylaxis during 1995 and 1996. Death following PE in THA is very rare, with a 90-day death rate of just 0.22 percent, according to an analysis of 44,785 patients in the Scottish Morbidity Record from 1992 to 2001.

Nonfatal and fatal PE following total knee arthroplasty (TKA) are even less common. A survey of a California discharge database (222,684 patients who had undergone TKA from 1991 to 2001) found a 90-day nonfatal PE rate of 0.41 percent. The rate of fatal PE in 27,000 TKA patients in the Scottish Morbidity Record was 0.15 percent.

Most importantly, registries show that, despite significant changes in venous thromboembolism prophylaxis and surgical techniques over the past 10 to 15 years, the rates of PE and PE-related mortality are remarkably stable. Based on these findings, one might question both the current stereotype of all orthopaedic patients being at high risk for serious thromboembolic complications and the real value of using the newer and more expensive pharmacologic agents for routine thromboprophylaxis in all THA and TKA patients.

Is a U.S. registry needed?
In March 2008, the AAOS presented a symposium on the value of national registries, inviting representatives of several registries to discuss the real and potential benefit of total hip and knee registries. In his introductory comments, William J. Maloney, MD, underscored the following threefold value of registries:

•                They provide an early warning system for early implant failure.

•                They provide evidence that, if delivered to physicians in a timely and understandable fashion, will positively influence physician behavior to the benefit of patients and society.

•                They have the power to ultimately decrease the burden of disease and cost associated with surgical morbidity and mortality, and reduce the volume of premature revision procedures.

The remainder of the symposium contained ample evidence to support these claims, lending weight to arguments for the absolute necessity of developing the American Joint Replacement Registry.

Registries as early warning systems
 Early implant failure has not been adequately addressed through the traditional follow-up and publication strategy. Registries have proven more effective in identifying problems with particular implants or new surgical procedures used for implantation.

The Kaiser-Permanente Total Joint Registry, along with several national registries around the world, demonstrates the proficiency of this function by providing data on unicondylar knee replacement, an increasingly popular procedure. Data from multiple registries, however, demonstrate that the aseptic loosening rates of unicondylar knees is significantly higher than those of total knee replacements. At Kaiser, reporting this finding to its physicians led to a decrease in the rate of unicondylar replacements.

After the higher rates of loosening were found to be concentrated among surgeons who performed a lower volume of unicondylar replacements, a subsequent redistribution of the procedures toward higher volume surgeons was noted. The procedure itself was not discredited, but the need to refine the procedure’s indications and surgeon’s qualifications was underscored.

Impact on physicians
 During the past several years, minimal incision surgery (MIS) for THA has been aggressively promoted as leading to more rapid recovery times and better short-term outcomes when compared to conventional THA. Much of this promotional information passed from the implant manufacturers directly to the public.

The Kaiser Registry was used to track the increase in volume and the outcomes of this new procedure. Within a few years of its inception in 2001, the registry detected a higher complication rate and compromise in early clinical outcomes associated with two-incision MIS THA. In addition, MIS TKA was found to produce increased pain and a decrease in patient satisfaction during the early postoperative period. When surgeons were informed of these observations, the number of these procedures performed dropped dramatically.

Registries in patient selection
 The Australian National Joint Replacement Registry was used to study the impact of the rapid rise in resurfacing hip replacement during the past decade. An analysis of 5-year cumulative data found a significantly higher revision rate for resurfaced hips compared to total hip replacement. Women were found to have more than twice the risk for revision than men.

On further analysis, a femoral head size of less than 50 mm was found to be the primary risk factor. This finding has helped to clarify the population that may be most suitable for undergoing hip resurfacing: Men younger than 65 years old, with osteoarthritis, who require a femoral head size of 50 mm or more.

Reducing the burden of disease
 In calling attention to the compelling case for a national total joint registry, David G. Lewallen, MD, chairman of the AAOS American Joint Replacement Registry Project Oversight Board, made the following observations:

During the life of the Swedish Hip and Knee Registries, the revision burden has been reduced from 17 percent to 7 percent.

In 1 year, the Australian National Joint Replacement Registry reported a 0.6 percent decrease in revision knee surgery at a savings value of $8.7 million. Using the volume of revision hip and knee replacements performed in the United States during 2003, a mere 1 percent reduction in the revision rate would have resulted in a 1-year savings of $30 million.

The evidence presented at the AAOS Symposium documented the value of national registries and made an excellent case for moving ahead in cooperation with the international orthopaedic community in developing a national total joint replacement registry in the US. The ability of registries to realize value has been amply demonstrated. A rapidly growing, evidence-based argument favors action now to avoid unnecessary injury to our patients, to promote improved clarity and rationale in developing clinical practice guidelines, and to facilitate the most cost-effective use of our progressively limited healthcare resources.

Norman A. Johanson, MD, is a member of the Evidence-Based Practice Committee. His disclosure information is available at www.aaos.org/disclosure

More information about the Evidence-Based Practice Committee and evidence-based medicine can be found at www.aaos.org/Research/Committee/Evidence/ebpc.asp

Read more...Joshua J. Jacobs, MD, leads a roundtable discussion on "Building a national joint replacement registry"

References

1.             Katz JN, Losina E, Barrett J, et al: Association between hospital and surgeon procedure volume and outcomes of total hip replacement in the United States Medicare population. J Bone Joint Surg Am 2001;83(A):1622-1629.

2.             Howie C, Hughes H, Watts AC: Venous thromboembolism associated with hip and knee replacement over a ten-year period: A population-based study. J Bone Joint Surg Br 2005;87:1675-1680.

3.             SooHoo NF, Lieberman JR, Ko CY, Zingmond DS: Factors predicting complication rates following total knee replacement. J Bone Joint Surg Am 2006;88:480-485.

4.             Lie SA, Engesaeter LB, Havelin LI, Furnes O, Vollset SE. Early postoperative mortality after 67,548 total hip replacements: Causes of death and thromboprophylaxis in 68 hospitals in Norway from 1987 to 1999. Acta Orthop Scand 2002;73:392-399.

5.             American Academy of Orthopaedic Surgeons clinical guideline on prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. Rosemont, IL: American Academy of Orthopaedic Surgeons (AAOS); 2007.

6.             Proceedings of the 75th Annual Meeting of the AAOS, San Francisco, March 5-9, 2008, pp 190-205.

AAOS Now
August 2008 Issue
http://www.aaos.org/news/aaosnow/aug08/research1.asp

Congress Not Protecting Patients: Consumers Union News Release

LINK to CU   (FiDA Blog underline added.)

CONSUMERS UNION NEWS RELEASE

Thursday, April 19, 2012

Medical Device Bills Missing Critical Patient Safety Protections 

Medical Device User Fee Bills Face Key Votes in Congress Next Week

WASHINGTON, D.C. – Key House and Senate Committees will vote next week on legislation to reauthorize the statute governing medical devices at a time when the law has come under increasing criticism for failing to ensure devices are safe and effective.  While the Senate legislation is stronger than the House version, neither bill includes critical reforms needed to protect patients from dangerous or defective devices, according to Consumers Union, the policy and advocacy arm of Consumer Reports.  

 “Our system for overseeing medical implants and other high risk devices is clearly broken and allows too many dangerous devices on the market,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.  “Tens of thousands of patients have been injured or died in recent years because current law fails to ensure medical devices are safe.  Unfortunately, these bills don’t fix the most serious flaws in our current system and leave patients at risk.”

 The Senate Health, Education, Labor and Pensions Committee will hold a mark-up of its bill to reauthorize the Medical Device User Fee Act on Wednesday, April 25.  The House Energy and Commerce Committee’s Health Subcommittee will mark up its bill on Thursday, April 26.  

 Despite the fact that 78 percent of high-risk medical devices are reviewed through the FDA’s fast track 510(k) process, industry lobbyists have urged Congress to ease federal oversight in order to promote innovation and speed up new device approvals.  But according to a March 2012 Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

“We all want patients to get timely access to effective new medical technologies,” said Lisa Swirsky, senior policy analyst for Consumers Union.  “But Congress needs to make sure that patient safety isn’t sacrificed in the drive to speed up medical device approvals.”

The House bill is particularly weak, according to Consumers Union.  Among other things, it diverts the FDA’s mission of protecting public health to include job creation and innovation and  constrains the FDA’s ability to get needed clinical data from manufacturers.  The Senate bill includes some important reforms, including streamlining the process for “up-classifying” devices so they can be subject to more rigorous review.  But a number of critical protections are missing from both the House and Senate bills, including: 

 Prohibition on clearing new devices based on recalled devices:  The FDA clears more than 90 percent of all medical devices without requiring any clinical testing.  These devices are cleared based on whether they are “substantially equivalent” to existing devices already on the market.  Under the 510(k) process, the FDA has to approve a new device if the manufacturer proves it is similar to a previously cleared one, even when the existing device has been recalled because of safety problems.  

 The Senate and House bills do not include a provision preventing medical devices with known safety problems from being used as the basis for clearing new devices.  Currently, the FDA does not even have the authority to require manufacturers seeking clearance for new devices to demonstrate that they have addressed the flaws of the recalled device. 

Consumers Union has urged Congress to prohibit recalled devices from being used as predicates for new devices.  The Consumer Reports poll found that 71 percent of Americans believe that a new medical device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

A system to monitor devices after they are cleared for sale:  The FDA does not have the tools and resources to adequately track and evaluate how patients with implants and other high-risk devices are faring.  The Senate bill provides some improvement in this area while the House bill does not.  Five years ago, Congress required the FDA to create a Unique Device Identifier (UDI) system to monitor what happens to implants once they are on the market, but it is still not in place. UDIs are essential for including devices in the Sentinel Initiative, a surveillance system currently being implemented that monitors how prescription drugs perform once on the market.  The Senate bill officially includes medical devices in the Sentinel Initiative and reaffirms the importance of implementing the existing UDI requirement by establishing a December 31, 2012 deadline for promulgating the UDI regulations. 

UDIs coupled with a national registry of patients with devices would help the FDA more quickly identify problem devices and notify patients when their device has safety problems or has been recalled.  The Senate and House bills do not address the need for a national registry.  The Consumer Reports poll found that 95 percent of Americans believe that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. 

Stronger authority for the FDA to require post market studies:  The FDA currently does not have the authority to require post market studies of new devices as a condition for clearing them through the 510(k) process.  Further, if the agency issues an order for a “522 study,” which can now be required when safety concerns arise after a device is cleared for the market, it doesn’t have the authority to rescind the clearance of the device if the device maker fails to comply with the order or if the study shows that the device is unsafe or ineffective. Neither the House nor the Senate bill provides the FDA with these needed powers.     

The Senate bill improves current law by establishing a timeline for 522 studies. However, the bill allows manufacturers to delay beginning these studies for fifteen months after the FDA orders them.  While these studies are being conducted, doctors can still implant these questionable devices in patients.  

Retaining Existing Conflict of Interest Standards:  Both the House and Senate bills weaken current standards that aim to prevent conflicts of interest on FDA panels that review medical devices and prescription drugs.  The bills eliminate existing limits on the number of waivers the FDA may grant to experts with financial ties to the medical device industry.  These limits were championed by consumer advocates and adopted by Congress just five years ago.  The House bill also eliminates certain disclosure requirements for FDA advisory panelists.  The FDA has provided no substantial evidence to demonstrate a problem with finding experts without conflicts.  The Consumer Reports poll found that 66 percent of Americans had a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers. 

Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell)

Daniela Nuñez

Grassroots Organizer

www.SafePatientProject.org

Twitter: @CUSafePatient

512.477.4431 x.117

Submit your story: TED talk 4/28/12

On Saturday 4/28 Dave DeBronkhart (a.k.a. ePatient Dave) from the Society for Participatory Medicine is giving another TEDx talk.  It won't be like the Maastricht one ‘Let Patients Help’ link to "TED talk" - this time 
he will present an overwhelming array of e-patient stories, including non-U.S. ones.  
These talks are short so each one will be short - 15-30 seconds. 

He’s a last-minute guy :) so he has to collect a lot of stories in a little time. So the awesome Bogdan Rau created a simple online form for this:

https://docs.google.com/a/epatientdave.com/spreadsheet/viewform?formkey=dElCanFqVjNCcF9DaHlfSkFXTjVNSWc6MQ#gid=0

It's simple - 

Give us your story/example of how your efforts (as a patient or friend or relative of a patient) improved the outcome or added value to your case. *

Have you used Google, the internet or peer groups to get information about your case? Have you engaged with other patients on or offline? Have you used SPM or other communities as a resource? Tell us how being an engaged patient altered the course of your medical history.

If you have such a story, or you know of one, please fill it out and he'll be in touch.

Patient Harm: A Political Game for Senator Franken?

Steven Baker is holding a component of the Tornier elbow replacement that the Mayo surgeon/designer removed in a 'revision' surgery just 4 months after implanting the elbow.  Tornier claims to be a global company-from Amsterdam, from France or from Edina, MN.   No matter, regulation of the medical device industry does not include pre-market clinical trial, there is no FDA Advisory Panel of stakeholders that votes, no post-market registry and no accountability for patient harm.
Senator Franken is aware of this, yet he introjects himself as the "friend" of industry rather than representing his harmed constituents.  The medical device industry can only be sustained by addressing the "bad players" it is harboring and provide care to those who have been (and will be harmed) if this practice continues.
My 4 year mission as an uncompensated patient advocate to change federal public policy prompted me to compile a timeline of articles (FiDA blog) that would guide other harmed patients to understand the causes of the broken system and hopefully prevent others from entering this "perfect storm" of entitlements to the medical device industry, lack of regulation and suppression of patient protections.  

Senator Al Franken's staff were called 4/13, 4/16 and 4/17/12 to arrange for a meeting to discuss the Star Tribune article announcing his partnership with industry and the lack of accountability of Tornier.  No call has been returned to this harmed patient.  ( FiDA Blog)  04/19/12 update:  Franken's MN staff are all "incredibly busy" and will meet with Steven Baker on first opportunity:  April 26.

Tornier consolidates to MN (LINK)

04/17/2012

Tornier Restructuring to Save Up to $2.8M, Add MN Jobs

By consolidating some of its European offices and relocating its Texas distribution operations to the Twin Cities, the company expects to reduce annual operating expenses by up to $2.8 million beginning in 2013.

Tornier, Inc., on Friday announced plans to relocate its distribution operations from Texas to Minnesota—a move that will involve adding 50 to 60 jobs in the Twin Cities.

Tornier is an Amsterdam-based medical device company that has its U.S. headquarters in Edina. The company went public last year, raising $166 million through an initial public offering. It manufactures joint replacement, trauma, sports medicine, and other products for the medical industry.

The company said Friday that it will relocate its distribution operations from Stafford, Texas to the Twin Cities, bringing together its U.S.-based marketing, training, regulatory, clinical, supply chain, and corporate functions at a single site. Chief Financial Officer (CFO) Carmen Diersen said in a Monday e-mail to Twin Cities Business that the relocation will be completed this year, although the company hasn’t yet determined where the operations will be located. The company currently employs 55 workers in Edina, who represent its entire Minnesota work force.

As part of its restructuring plan, Tornier will also consolidate some of its offices in St. Ismier, France and Dunmanway, Ireland with other nearby Tornier facilities.

Tornier expects to incur restructuring charges of between $6 million and $7 million, most of which the company will record this year. But it estimates that the restructuring will reduce annual operating expenses by $2.3 million to $2.8 million beginning in 2013.

“Our strategy of innovation has resulted in a rapid pace of new product releases,” President and CEO Douglas Kohrs said in a statement. “The facility consolidations will bring key components of our product delivery chain together, facilitating communications and enabling greater productivity as anticipated by our current operational plans.”

Diersen declined to comment on how the restructuring plans will affect its overall employee headcount, but the company said it will disclose additional details about its consolidation plans during a May 8 conference call.

—Jake Anderson
(janderson@tcbmag.com)

Posted at 12:49 PM in Human Capital, Manufacturing, News | Permalink

Franken "friends" MN medical device industry.

Franken says U.S. can improve medical device approval process while ensuring safety

Posted by: James Walsh Updated: April 12, 2012 - 1:53 PM

The United States does not have to choose between the vitality of its medical device industry or the health of its people, U.S. Sen. Al Franken said in an interview at the Design of Medical Devices Conference hosted by the University of Minnesota. It is possible to improve both.

By bringing regulators and manufacturers together to communicate and find common ground, he said, they can find a way to get life-saving devices to market faster while not compromising patient safety. “To some degree, there is a false choice there,” said Franken, who is a member of the Senate Health Committee.

While acknowledging that the range of issues involved are “pretty complex stuff,” Franken pointed to his efforts to bring Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, to Minnesota to meet with leaders of the medical device industry.

Those meetings subsequently led to an agreement between the FDA and the industry to develop a Regulatory Sciences Partnership that will be centered in Minnesota. The idea is to help two very different cultures – regulatory and manufacturing – find common ground to improve the system while enhancing safety.

“These people better start talking to each other,” Franken said of any hoped-for improvements in the American device-approval system. “I want to be a bridge there.”

Franken has introduced legislation, included in a larger medical device bill now being considered by the U.S. Senate, that has two provisions: the first would make it easier for the FDA to work with experts from around the country in the review of proposed medical devices, providing a deeper well of technical expertise. The second would remove the profit prohibition for medical devices that are developed to treat patients with rare diseases, essentially streamlining the development and approval of such devices.

“The longer things take to get to market, it makes the thing not cost-effective to do in the first place,” Franken said Thursday. “There are people who need these devices.”

mcgili

Apr 13, 12

7:22 pm

Medical devices could be safer with some common sense changes, such as ending the practice of approving new devices based on their similarity to devices that have been recalled for safety concerns. This has to be among the most absurd federal policies on the books, yet Sen. Franken has not publicly supported the elimination of this major safety loophole. This policy has put devices on the market that have harmed thousands of people, including transvaginal mesh implants and several cardiovascular catheters. Franken has a chance to vote to change this policy in the next few weeks when the committee he sits on starts writing legislation on medical device issues.

explanthis

Apr 16, 12

5:35 pm

Steven Baker (MedWatch Adverse Event #5009052) has met with the Senator and his staff since 2009 with patients with failed implanted medical devices. They are asking for Congress to update the charter of the FDA. When medical device rules were written in 1976 the explosion of devices was not anticipated. Poor regulation (confirmed 7/29/11 by the Institute of Medicine) combined with weak judicial protections for patients and entitlements for the industry has designed this "perfect storm" of harm. Senator Franken's efforts should not be on bridging the gap between just regulator and industry, but on convening public health leaders, aviation safety leaders, patients/advocates with regulators and the industry to prevent major global snafu's like surgical mesh and J&J ASR hips. Senator Franken and the MN device industry must aim higher and be more collaborative and responsive.