The International Consortium of Investigative Journalists (ICIJ) has been busy lately following the launch of their “Implant Files” campaign that purports to investigate medical device safety, but is really no more than a misguided effort to stoke fear and doubt over the safety of life saving medical devices that so many Americans rely on.
The unfortunate part about the ICIJ’s coverage is they recognize that the data they use to support their campaign “is inconsistent and incomplete.” The report uses cherry-picked and often-outdated examples of adverse outcomes that simply are not reflective of the medical device industry – which has improved and saved the lives of tens of millions of Americans and patients across the globe.
Here are just 8 of the ICIJ’s greatest myths:
Myth #1: Medical devices aren’t adequately tested and patients are suffering as a result.
Virtually every single person in the United States has benefited from the advancement of medical technologies which aid in the prevention, diagnosis and treatment of various conditions to enhance quality of life. Tens of millions of Americans benefit daily from the more than 193,000 different medical devices available and in use in the country.
From the ICIJ’s own report, “pacemakers and implantable cardioverter defibrillators (ICDs) have revitalized and saved millions of lives. Hip and knee replacements have kept tens of millions of people mobile and out of wheelchairs. Intraocular lenses have restored and improved the sight of millions more.”
Before any medical device can go to market, it must first complete the rigorous clearance/approval process of the FDA, whose oversight is considered the gold standard for regulation worldwide. Low-to moderate-risk device types that have a well-established safety profile are cleared through the premarket notification or 510(k) process. Higher-risk technologies that often involve novel or first-of-a-kind innovations follow the premarket approval (PMA) application process, the agency’s most stringent review pathway. Regardless of the pathway, FDA determines the evidence necessary before any new device or diagnostic can be deemed safe and effective, and the data that companies need to provide is comprehensive and thorough.
Myth #2: The U.S. medical device industry is in need of drastic regulatory change.
The FDA has a 40+ year track record of protecting the public health while making safe and effective products available without unnecessary delays through its clearance and approval processes. Multiple studies have shown that less than 0.5% of 510(k)-cleared devices are subject to a serious recall and a recent study demonstrated that 98.4 percent of all 510(k) and PMA devices cleared/approved by the FDA between 2003 and 2009 have never had a Class I recall. Two studies presented before the Institute of Medicine found that in 99.6% of all medical device submissions, no safety issues at all were present.
The ICIJ went as so far to recognize the U.S. where “rigorous tests are also required for very innovative new devices.” Not surprising when you consider the agency’s process for clearing/approving devices before they can go to market. Regardless of the pathway, FDA determines the evidence necessary before any new device or diagnostic can be deemed safe and effective, and the data that companies need to provide is comprehensive and thorough, including hundreds or thousands of pages of documentation based on bench testing; animal studies (if deemed necessary by FDA); batteries of non-clinical tests (biocompatibility, shelf-life, shock and vibration, temperature cycling, etc.); tests demonstrating conformance with national and international standards; and any additional requirements specified by the FDA.
Myth #3: The FDA’s 510(k) pathway provides a “substantial equivalence fast lane” for new versions of high-risk devices.
Low-to moderate-risk device types that have a well-established safety profile are cleared through the FDA’s premarket notification or 510(k) process, which itself is rigorous. Higher-risk technologies are by definition Class III devices, the vast majority of which go through the Premarket Approval (PMA) pathway. This is the FDA’s most stringent review pathway for medical devices and includes the submission of robust clinical data to support claims made for the device. FDA’s review of a PMA will often include review by an advisory committee comprised of independent experts that will provide a recommendation to FDA regarding product approval.
Over the past several years, the agency’s Center for Device and Radiological Health (CDRH) has worked actively to eliminate the use of 510(k)-cleared predicates when the devices raised safety concerns that warranted treating them as high-risk technologies. To date, the agency has made the use of 1,758 devices ineligible as predicates in the 510(k) process through a process known as “up-classifying”, including previously cleared 510(k)s for vaginal mesh for the treatment of pelvic organ prolapse, automated external defibrillators, and metal-on-metal hip implants.
Further, the FDA states it did not clear any high-risk devices at all through the 510(k) pathway in 2017.
MDMA strongly supports the current regulatory scheme – including the 510(k) pathway – as a bedrock of the development of the world’s most innovative medical devices and a critical protector of patient health and safety.
Myth #4: Medical devices are held to lower testing standards than drugs, resulting in recalls, disasters and scandals once common in the drug industry that continue to plague devices to this day.
The ICIJ claim that “governments have allowed products on the market with little or no human testing that went on to cause great harm” is patently false.
Here’s the truth: the FDA requires different tests for drugs than for devices because the two products are entirely different. When testing drugs, there is a biologic reaction in the body whereas when testing devices, the reactions are typically mechanical. Given this, bench testing – which allows manufacturers to test the safety and durability of devices in the human body using wear-and-tear simulation technology, without actually implanting the device in a human – is extremely valuable. Clinical trials are done where appropriate and needed, but bench testing allows companies to replicate the human body while minimizing patient risk. Further, the FDA can – and does – often require additional robust clinical data.
While we all can recognize the desire to bring new, potentially life-saving devices and therapies to patients as soon as possible, patient safety and quality of care are paramount to the medical device industry. With that in mind, companies employ scientists, physicians, engineers, quality experts and other professionals to research and examine every aspect of a medical device to ensure that it performs as intended and it has been confirmed to be safe and effective in treating the medical condition at issue. This process includes extensive testing and evaluation, including meeting stringent pre- and post-market requirements set by the FDA, whose oversight is considered the gold standard for regulation worldwide.
Multiple studies have shown that less than 0.5% of 510(k)-cleared devices are subject to a serious recall and a recent study demonstrated that 98.4 percent of all 510(k) and PMA devices cleared/approved by the FDA between 2003 and 2009 have never had a Class I recall. Two studies presented before the Institute of Medicine found that in 99.6% of all medical device submissions, no safety issues at all were present.
Myth #5: Manufacturers are in charge of testing their own products after faults have developed – and can shop around for approval to market their products.
This statement is incredibly misleading. In the pre-market stage, manufacturers of medical devices have extensive scientific, clinical, and engineering expertise that best position them to spearhead the development of testing new products. In the U.S., the FDA strictly regulates the conduct of any clinical trials to ensure the integrity of clinical trial data and to guard against potential conflicts of interest. The agency also scrutinizes trial data in its evaluation of applications for approval of new products. No device will go to market unless and until it has been found to operate safely and effectively as intended. Of course, manufacturers are able to market their products in other countries, in which case products are subject to applicable regulations.
The burden is not lifted once a product has gone to market. Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. User facilities are also required to submit an annual summary of death and serious injury reports to the FDA, as part of the post-market regulatory process.
Myth #6: The FDA is now exploring further loosening its rules in order to get some new devices onto the market with substantially less testing than before to compete with countries like Europe that have less stringent regulations.
This is false. The FDA recently announced changes to modernize its 510(k) clearance pathway (first adopted in 1976), which accounts for the majority of the devices that the FDA reviews. The agency states it is pursuing these changes, “to help keep pace with the increasing complexity of rapidly evolving technology.” The proposed changes are intended to reflect advances in technology, safety, and the capabilities of a new generation of medical devices, and MDMA will work with the FDA and all stakeholders to ensure that the United States remains the global leader in medical technology innovation.
Myth #7: When device manufacturers and regulators do learn of problems, this fact often doesn’t reach doctors, let alone patients.
Device manufacturers are subject to any post-market guidelines set by the FDA or other regulatory bodies. Additionally, the industry regularly collects data from post-market clinical studies, review studies conducted by independent researchers, analyzes scientific literature involving product performance, and proactively seeks out information and feedback from physicians using devices, in an effort to continue monitoring and improving the performance and efficacy of devices.
Adverse event reports for medical devices are publicly available on the FDA’s Medical Device and User Facility Device Experience (MAUDE) database. The FDA posts information about any correction or removal of a device on the market and may also post company press releases or other public notices about recalls, market withdrawals, and safety alerts that may potentially present risks for consumers or users. This database is a valuable tool for device manufacturers and regulators as well as for physicians and patients.
In extreme cases, when medical device recalls are needed, they are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. In either case, a public warning is required.
Myth #8: The FDA is unable to protect the American public from unsafe or ineffective devices.
This is fear mongering, and the ICIJ should be ashamed. The FDA has a 40+ year track successful record of protecting the public health while making safe and effective products available without unnecessary delays through its clearance and approval processes. Multiple studies have shown that less than 0.5% of 510(k)-cleared devices are subject to a serious recall and a recent study demonstrated that 98.4 percent of all 510(k) and PMA devices cleared/approved by the FDA between 2003 and 2009 have never had a Class I recall. Two studies presented before the Institute of Medicine found that in 99.6% of all medical device submissions, no safety issues at all were present. The agency is currently taking steps to modernize the approach first adopted in 1976 in order to reflect advances in technology, safety, and the capabilities of a new generation of medical devices. This is an important step and we’re confident the agency will do this keeping patient safety in focus.