Perspective
Here We Go Again — Another Failure of Postmarketing Device Surveillance
N Engl J Med 2012; 366:873-875March 8, 2012
Comments
open through March 14, 2012
- Article
The goal of postmarketing surveillance of medical devices is to enhance public health by gathering information about the incidence of adverse experiences with devices. However, patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration (FDA), despite multiple recalls and some tragic adverse events. The most recent example is the class I recall (a designation indicating a risk of serious injury or death) of the Riata and Riata ST implantable cardioverter–defibrillator (ICD) leads (St. Jude Medical), which are implanted in approximately 79,000 patients in the United States alone.1
According to the manufacturer, these lifesaving devices are subject to a unique failure mechanism whereby the conductor cables wear through the silicone insulation from inside out and end up outside the body of the lead (“externalized conductors”; see Panels A and B of the figure
Riata ICD Leads with Externalized Conductors.). Since the conductors are coated with ethylene tetrafluoroethylene (ETFE), a Teflon-like insulator, the lead may remain electrically intact and function normally. Thus, the externalized conductors may not be detected until they are seen on radiography or fluoroscopy or until the patient has an adverse event. St. Jude Medical recommends that physicians continue to monitor these leads every 3 to 6 months, rather than replace them prophylactically. This recommendation is based on no meaningful data, because in a system notorious for underreporting, no such data exist. Meanwhile, physicians and their patients are in a quandary: Will the lead work when lifesaving therapy is needed?So here we go again. After the debacle involving the Medtronic Sprint Fidelis lead for ICDs,2 involving 268,000 patients who received leads that had the potential to fracture, we are confronted once more with a critical clinical situation in which we have no scientifically valid information to guide us. Moreover, St. Jude Medical is marketing the Durata ICD lead, which has an outer sleeve made of silicone and polyurethane but is otherwise similar in design to the Riata ST leads. Should we continue to implant Durata leads? Thus far, the 85,000-plus Durata leads implanted in patients in the United States appear to be performing well, but we do not have a surveillance system in place that can detect low-frequency failures or adverse clinical events involving Durata leads or any other marketed medical device. So your guess is as good as mine.
Why are we guessing? Why are we placing patients at risk when the tools and technology are available to monitor vital medical devices such as ICDs, heart valves, and coronary stents? The problem is that our current passive postmarketing surveillance system fails to detect significant device defects before large patient populations have been exposed. Consequently, we repeatedly find ourselves reacting ineffectively, even dangerously, to big problems with devices by subjecting patients to care strategies that are not supported by solid clinical evidence.
The Riata and Riata ST recall occurred 1 year to the day after St. Jude Medical announced that it was phasing out these leads. In a letter to physicians dated December 15, 2010, the manufacturer described the insulation defect that causes the conductors to be displaced outside the lead, citing case reports and studies that were first published in 2008.3 But during the past year, neither St. Jude Medical nor the FDA has instituted the clinical studies that would be required to answer critical questions: Should the lead be replaced if the conductors are exposed but electrically intact? Is the ETFE coating on the externalized conductors sufficiently robust to perform reliably — that is, to deliver an effective high-energy shock when needed? Is monitoring with or without routine fluoroscopy a safe alternative to prophylactic replacement? What electrical parameters are important to adhere to?
The answers to these questions are needed today, but only now has the manufacturer acknowledged that “the clinical implications of leads with electrically intact externalized conductors are not fully known at this time. Consequently, more data are required in order to assess if specific patient subgroups with electrically intact externalized conductors are at greater risk or should be managed differently.”1
Where will these data come from, and how will they be analyzed? The existence of clinical registries and remote monitoring databases has created paths for improving the surveillance of medical devices. Opportunities have emerged for automated tools to prospectively monitor multicenter device databases for early, low-frequency adverse events and to compare suspect devices with established products that have been shown to be reliable.4 The goal is a postmarketing surveillance system that not only detects device problems early but also accumulates the data needed to guide patient care. Until such a system exists, St. Jude Medical should initiate a study with these attributes for recalled Riata and Riata ST leads and for the currently marketed Durata leads. Indeed, all manufacturers should conduct postmarketing studies of this type for marketed class III devices that sustain or support life.
It has been 3 years since the FDA launched the Sentinel Initiative, as Congress, in 2007, directed it to do.5 The intent of this new system is to supplement the current passive adverse-event reporting with an active, real-time network capable of identifying any safety or efficacy issues soon after a new drug or device is marketed and then communicating the information in a timely manner to health care providers and the public. Creating such a system is an ambitious undertaking, and the initiative aims to gather electronic health data from 100 million people by the end of 2012. Formidable challenges lie ahead, such as setting priorities, developing analytic tools, and deciding when and how to alert the public if a safety signal is detected. Thus, we are years away from a fully operational Sentinel Network.
Meanwhile, more than 150,000 patients in the United States alone rely on lifesaving medical devices. Professional societies, the medical device industry, and the FDA should mobilize available resources now to improve postmarketing surveillance for these patients. Otherwise, we will no doubt be back here again.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1114695) was published on February 14, 2012, at NEJM.org.
Source Information
From the Minneapolis Heart Institute Foundation, Minneapolis.
- References
References
1
FDA classifies voluntary physician advisory letter on Riata and Riata ST silicone defibrillation leads as Class I recall (URGENT MEDICAL DEVICE ADVISORY). St. Paul, MN: St. Jude Medical, December 15, 2011 (http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1640339).
2
Maisel WH . Semper fidelis -- consumer protection for patients with implanted medical devices. N Engl J Med 2008;358:985-987
Full Text | Web of Science | Medline3
Chester KM. Important information about Riata and Riata ST silicone endocardial leads. St. Paul, MN: St Jude Medical, December 15, 2010 (http://www.sjmprofessional.com/Resources/communications/important-information-about-riata-and-riata-st-silicone-endocardial-leads.aspx).
4
Resnic FS ,Gross TP ,Marinac-Dabic D , et al. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA 2010;304:2019-2027
CrossRef | Web of Science | Medline5
Platt R ,Wilson M ,Chan KA ,Benner JS ,Marchibroda J ,McClellan M . The new Sentinel Network -- improving the evidence of medical-product safety. N Engl J Med 2009;361:645-647
Full Text | Web of Science | Medline
- Citing Articles (4)
Citing Articles
1
Robert F. Padera. (2012) Pathologic Evaluation of Cardiovascular Medical Devices. Surgical Pathology Clinics 5:2, 497-521
CrossRef2
A. J. M. Boulton, S. Prato. (2012) Regulation of medical devices used in diabetology in Europe: Time for reform?. Diabetologia
CrossRef3
Jeffrey Liu, Genevieve Brumberg, Rohit Rattan, Sandeep Jain, Samir Saba. (2012) Class I recall of defibrillator leads: A comparison of the Sprint Fidelis and Riata families. Heart Rhythm
CrossRef4
Carlson, Mark D., . (2012) ICD Leads and Postmarketing Surveillance. New England Journal of Medicine 366:10, 967-967
Full Text
- Comments (6)
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6 Reader's Comments
LARS AANNING, MD | Physician | Disclosure: NoneYANKTON SDFebruary 17, 2012Flawed instructions-for-use also affect product reliability
In 2007 we published unequivocal data demonstrating that square knots are unreliable when used to anchor running sutures. However, every package insert by the major suture manufacturers still cautions that only square knots should be used in securing sutures. They obviously have never done the appropriate testing to determine the reliability of anchoring suture closures with square knots - quite different from just tying two suture ends together and testing the resulting loop. But I'm certain the real reason these suture manufacturers are not responding to our data (almost five years ago!) is that they would then be liable for most running suture failures where breakage occurs at the squared knots - with potential life-threatening complications and even death. Patient plaintiffs virtually always lose these cases because the manufacturers can easily demonstrate the flawless integrity of the suture lot and they then lay the blame on the surgeon for not tying square knots correctly or the tech for mishandling the suture! The problem is not the suture but the "junk science" in the potentially fatal manufacturers’ instructions. What world do these corporations live in?
TODD JANUS, MD | Physician | Disclosure: NoneDES MOINES IAFebruary 17, 2012I agree
I agree with the commentary.
The only reasonable solution to protect patients is to pull all defibrillators and pacemakers off the market.
We need to have prolonged prospective clinical trials to evaluate the risk to patients of device or wire failure. Any failure should lead to discontinuation of the trial and redesign of the failed product. We can then introduce a new prolonged prospective clinical trial until we better understand the risk of failure of this new product to the patient. We can then either be assured that we are not subjecting patients to any risks or else evaluate the data, formulate evidence based solutions to the problem if and when it occurs (which should never happen).
Further we need to have an independent review board funded by the device company comprised of physicians to closely monitor each device and wire trial. These august physicians can then stop the trial immediately after any failure of product and suggest solutions to the company for correction of the defect. This will allow the company to return to the development stage and develop a product that we can safely and confidently offer to our patients.Ira Leviton, MD | Physician | Disclosure: NoneBRONX NYFebruary 16, 2012Otherwise?
I completely agree with this Perspective column, except for one word in the last sentence - otherwise. We WILL be back here again - there is no otherwise about it. There are all sorts of life-saving devices, including some that are left in our bodies, and others that are inserted and used in our bodies temporarily. There is no question that rare malfunctions, failures, and other bad outcomes will be discovered after a device is marketed, similar to the rare side effects of medications. Since that's inevitable, it is incumbent on device makers to develop the best surveillance systems possible, and for those who use and insert devices to utilize those systems.
Anything less will provide us with inadequate scientific information and result in unnecessary risk to both our current and future patients.WALT BEADLING | Other | Disclosure: NoneBELLE MEAD NJFebruary 15, 2012Yes, Medical Device Manufacturers should be required to pay . . .
. . . and subject to litigation for devices that fail due to poor design and/or manufacture. But it ain't gonna happen because FDA-approved devices are protected by federal pre-emption and the Supreme Court of the United States.
I'm a guy whose wife was almost killed when her ICD failed in 2008.
Current thinking in DC is that "more FDA oversight" will solve the problem. I say manufacturers should be liable for making dangerous products, and held accountable in courts of law. That will be far more effective - and less expensive - than all the taxpayer dollars and bureaucracy the federal government can throw at it.WILLIAM GETCHELL, MD | Physician | Disclosure: NoneKIRKLAND WAFebruary 15, 2012What about the financial impact on patients, providers and overall costs?
I am a practicing Interventional Cardiologist and the Medical Director for the Device Program at a midsized community hospital. We follow about 1500 device patients regularly, with about 100 Riata patients and slightly more Durata patients. We have struggled since the FDA announcement in December to develop policies and protocols with little valuable input from the manufacturer, and as described, minimal literature to guide us.
An additional major concern is the financial impact on patients, on clinics and on the entire health care system. Any options for increased surveillance escalate the burden on patients, providers and clinics, without any clear additional reimbursement. St Jude has a program for patients to apply for reimbursement for medical expenses that they incur, but the manufacturer has declined to offer any compensation for our clinic's additional costs- much of which is not reimburseable through standard mechanisms. The increased need for monitoring of the devices, fluoroscopic evaluation, potentially changing leads is likely to be borne by the providers or the insurers.
Shouldn't the manufacturer be required to pay the costs for the failure of their product? - Letters
Post marketing surveillance
While reading this article I could not help but notice a similarity in the lack of effective post marketing surveillance of these devices and the utter lack of post marketing surveillance of mandated vaccines. Noting that only a very small portion of adverse reactions are ever reported, with the vast amount of adverse events involving vaccination that have been reported, the system yet remains passive. As a former public health nurse, i am painfully aware how this practice is hurting the confidence in our vaccine program. I know this is in a sense off topic as I am not commenting on device monitoring but for the safety of my patients and confidence in our vaccine program, it is imperative that this passive reporting system be reengineered to ensure product safety.