ATLANTA — Jonesboro resident Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life.
In 2013 she was implanted with a defibrillator to help with her congestive heart failure. She went to the doctor for checkups every six months. Robinson thought her device would keep her healthy for years. But last month the hospital called to tell her that device’s battery was failing. Robinson rushed to the emergency room.
“I was scared they wasn’t going to get to me in time,” Geraldine said.
The next day doctors replaced her device. The reason for the surgery noted on her patient information card was, recall.
Channel 2's Nicole Carr searched the FDA recall database and found Robinson's device had been recalled two years earlier. The manufacturer's suggested course of action was to monitor the device.
[Do you have an implanted medical device? Find out the approval process for your device here]
While Robinson said she had no idea her device was recalled, her hospital said she was mailed a letter to notify her. Robinson said she never got that letter.
Diana Zuckerman, president of The National Center for Health Research, said she wasn’t surprised that Robinson’s recalled device remained implanted for years.
“This is the doctor having to say to the patient, ‘This implant in your body has been recalled but we don’t think you should have it removed unless you’re having obvious problems with it,” Zuckerman said.
Zuckerman was also said Robinson is most likely not alone in her confusion, and often patients don’t learn their device is recalled.
“Perhaps the patient has moved and the doctor or even the hospital doesn't know where that patient is anymore,” Zuckerman said.
Linda Radach, an implant recipient herself, said she believes the recall process needs an overhaul.
“The FDA is very, very slow to use their authority to issue a recall instead requiring warning letters and requiring post market surveillance studies. Most of which are never completed,” Radach said.
According the FDA website they hardly every issue a recall, instead trusting manufacturers to self-report. An FDA spokeswoman said recalls are not the only way they get dangerous products off the market.
There are several patient resources available for medical device recipients, including questions to ask your doctor about the approval process.
Radach said a 2006 metal on metal hip replacement failed leaving dangerous cobalt chromium debris in her system.
“I’ve now had six total hip replacements,” Radach said. She said her issues were never reported to the FDA by her doctors and her device was never recalled. She did her own research and found her device had been approved for market three years after it was put in her body. “That alarmed me enough to realize this was much, much bigger than just me.”
Radach told Channel 2 Action News many of the parts that made up her implant were cleared through the 510k process which rarely requires clinical trials on human patients. The process has been in place since 1976.
Zuckerman said the 501K process it's not enough.
“All those companies have to do is prove that their new device is substantially equivalent to a device that’s already on the market,” Zuckerman said.
In 2011 Zuckerman co-authored a report that found from 2005 until 2009, 113 recalls were class one. Only 21 of those recalls went through clinical trials. She said things haven't improved.
“Instead of saying ‘let’s be more stringent and require clinical trials for more implants,’ they’re doing exactly the opposite,” Zuckerman said.
The FDA sent Channel 2 Action News this statement on the modernization and regulation of the 510K device approval process:
We believe firmly in the merits of the 510(k) process. Thousands of devices are cleared through this process each year and countless thousands more patients benefit from these technologies. But, the FDA is committed to ensuring that the 510(k) program is keeping pace with the important innovations we’re seeing in device development. We’re doing this through several efforts, including issuing new guidances and soliciting public feedback on ideas. For example, we recently issued draft guidance on the Safety and Performance Based Pathway, which we hope will modernize our approach to moderate risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices.
We’re also considering whether the FDA should post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. Doing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements.
The FDA’s device program is risk-based, which means devices that pose the highest risks to patients have the most rigorous requirements before they can be marketed. This system was set up by Congress to ensure patients are as best protected as possible from risks, while also enabling timely access to safe and effective medical devices, consistent with the FDA’s mission to both protect and promote public health.
Generally, new technology is subject to a pre-market approval application (PMA) when it is high risk and subject to the De Novo pathway when it is lower risk. The 510(k) pathway is typically available for lower risk devices for which one or more similar technologies are already on the market.
The FDA may require extensive testing for devices subject to a 510(k), generally requiring more evidence for more complex technologies. Because most devices, unlike drugs, are hardware and have localized effects on the body, robust non-clinical testing can demonstrate that a device performs similarly to comparable devices already on the market and that its benefits outweigh its risks. And we can often get this information without subjecting patients to clinical trials. For example, for some devices, such as syringes and infusion sets, bench testing—for biocompatibility, and mechanical and physical performance tests—can provide the information the FDA needs to determine that these devices are safe and effective for patients. For others, such as some bone void fillers or substitutes, animal studies provide information in cases where histology and destructive testing cannot be done on humans. And, when appropriate, we do require clinical studies for certain devices subject to a 510(k).
PMA is the most rigorous type of device marketing application required by the FDA, and is appropriate for higher risk devices where general and special controls are not sufficient to provide reasonable assurance of safety and effectiveness of the device. However, the PMA pathway is not appropriate for all medical devices. Requiring a PMA for lower risk devices that are similar to other devices already on the market—those eligible for a 510(k)—would not necessarily provide better patient safeguards, but would result in unnecessary costs and delays while diverting FDA staff resources away from studying and evaluating higher-risk and novel devices.
In a recent 2018 report, we discuss in detail efforts we've taken to strengthen the 510(k) program, including eliminating the use of 1,758 devices as predicates, how 30% of 510(k) submissions are not accepted for initial review, a 150% increase in the number of pages for each 510(k) since 2009, that FDA's staff spend more time reviewing each 510(k) submission than ever before yet continue to meet required performance timelines, and the publishing of more than 50 final and cross-cutting guidances and device-specific guidance documents to help improve predictability, consistency, and transparency of submission content while clarifying expectations, policies, and procedures surrounding review of 510(k) submissions.
Adverse Event Reporting and Postmarket Surveillance
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
“When a device raises safety concerns, we will take steps to have those concerns satisfactorily addressed or have the device removed from the market. Voluntary recalls are used in the vast majority of these cases and almost always result in a faster action to remove or correct devices than the mandatory recall process. The FDA’s experience is overwhelmingly that companies will voluntarily correct the problems—either on their own or at the FDA’s request—to ensure that their proposed device can be placed on the market or their predicate device can remain on the market.
A 2018 FDA report on our enforcement activities outlines some highlights of recalls and other enforcement efforts including, a 50% increase in the annual number of voluntary recalls reported since 2009. The infusion pump case study in that report is a good example of how the FDAs enforcement activity led to an initial 3-fold increase in voluntary recalls from affected firms, a 56% reduction in annual recalls related to these devices since 2014, and an 82% reduction in annual medical device reports since 2015.
"MDRs submitted to the FDA are only one source we use to monitor marketed medical devices. These reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence. Additionally, we may receive multiple reports related to the same event making it difficult to determine actual numbers of events.
When appropriate, the FDA employs a targeted, risk-based approach to address specific device areas of concern. The FDA monitors medical device malfunctions, industry compliance trends, and public health concerns. When the FDA identifies device quality or manufacturer compliance concerns, we inspect firms, take enforcement actions as needed, collaborate with stakeholders to address contributing scientific and policy challenges, and publicly communicate to ensure transparency and reduce the chance of similar, recurrent issues.
FDA suggested useful links:
- Medical Device Safety Action Plan and Commissioner's statement about the plan
- REPORT: FDA Has Taken Steps to Strengthen the 510(k) Program - November 26, 2018
- REPORT: CDRH Medical Device Enforcement and Quality Report - November 21, 2018
- Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
- November 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA's 510(k) program to advance the review of the safety and effectiveness of medical devices
- November 27, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
- December 18, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety
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