For the last year or more, there has been unprecedented global scrutiny around the regulation of medical devices. While pre-market regulation is more stringent for pharmaceutical products, many medical devices are approved for use with relative ease through pathways such as the US Food and Drug Administration’s (FDA) 510(k) clearance. If new medical devices are deemed substantially equivalent to existing – or predicate – devices, they can be approved on an accelerated timescale.
Given the looser pre-market regulation of medical devices, especially those considered low and medium-risk (defined as Class I and II by the FDA), there is an even greater emphasis on the importance of post-market surveillance and failure reporting to protect patients. Real-world data generated by devices as they are used is the best source that regulators – not to mention clinicians, patients and device manufacturers themselves – have to assess their developing risk and efficacy profiles.
“Access to robust and timely data, including more extensive and informative post-market data and real-world evidence, is central to empowering the FDA to identify, communicate and act on new or increased medical device safety concerns,” said recently-departed FDA commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) director Jeff Shuren in a November statement.
Cracks in the device failure reporting system
Despite the clear importance of post-market vigilance to medical device safety, evidence abounds that reporting systems around the world may not be adequately protecting patients. Much of this evidence has come from strong journalism over the past year, which in itself could suggest that device failure reporting mechanisms aren’t doing the job they’re built to do.
The ‘Implant Files’, a series of investigative reports by newspapers around the world and co-ordinated by the International Consortium of Investigative Journalists (ICIJ), were a revelation to those with little knowledge of medical device regulation, and a cause for concern for many in the industry.
The reports, using information gleaned from hundreds of Freedom of Information requests, exposed the ongoing safety issues with commonly-used implants and devices, many of which have been on the market for years, from toxic hip replacements to defective implantable defibrillators.
The global investigation also shone a light on the pain, injury and misery often caused by vaginal mesh implanted to treat pelvic organ prolapse. Despite opposition from the industry, the investigation prompted the FDA to block the sale of this type of mesh in April, after its sale had already been suspended or banned in countries such as Australia, Ireland and the UK.
After 100,000 lawsuits worldwide related to mesh implants and extensive reporting in the media, an obvious question arises with regards to vaginal mesh and other devices: why has the world’s foremost medical regulatory body been playing catch-up?
The FDA’s hidden safety database
An important element of the ICIJ investigation’s reporting was the existence of non-public device failure reporting systems that operate separately from the FDA’s public database of device malfunctions and adverse events, which is called the Manufacturer and End User Facility Device Experience (MAUDE) database.
While MAUDE is publicly accessible and acts as an important tool for clinicians and surgeons to make decisions on medical device safety, until very recently it was complemented by another, more secretive database – one which was reportedly unknown even to former FDA commissioner Dr Robert Califf, who held the position between 2016 and 2017.
The FDA’s so-called ‘alternative summary reporting’ database was launched in 2000, allowing the manufacturers of certain devices with well-known risk profiles to receive exemptions (other than in cases of patient death) from publicly reporting malfunctions and adverse event through MAUDE, instead sending regular spreadsheets directly to the regulator, each of which might contain hundreds or thousands of individual incidents.
The ICIJ investigation showed that the FDA provided such exemptions to breast implant manufacturers, with the result that tens of thousands of reports have been submitted privately, and are not reflected in MAUDE. ICIJ alleges that the 350,000 reports related to breast implants received by the FDA since 2009 represent more than 20 times the number that are publicly available through MAUDE.
Another excellent investigation by Kaiser Health Network, published in March 2019, further explored the alternative summary reporting system, noting its obfuscating effect on the safety statistics of surgical staplers. The report found an astonishing discrepancy between public and private reporting of surgical staplers dangerously misfiring or having other malfunctions.
It cites FDA data showing that in 2016, only 84 stapler-related malfunctions and injuries were reported publicly, while nearly 10,000 incidents were hidden from public view. Overall, Kaiser Health Network concluded that 1.1 million device failure reports have been filed in secret using alternative summary reporting since 2016, with 480,000 in 2017 alone.
At the beginning of May, the FDA announced its plan to shut down the alternative summary reporting scheme, with records set to be opened to public scrutiny in the following weeks.
Pushing for transparency in device failure reporting
Alternative summary reporting was always intended as a more efficient way of reviewing large volumes of medical device safety data, and reflects the capacity issues that many national regulators experience when relying on small teams to review huge reams of device failure data.
There are other issues that make gathering post-market safety data incredibly complex, whether due to patient reticence to report incidents through the proper channels, the difficulty of tying any given adverse event to a device specifically, and, of course, the inherent conflict of interest for device manufacturers, which directly benefit from keeping products on the market regardless of safety concerns.
One thing that is not in dispute is the value of transparency, and opening a previously inaccessible database to the public is a positive step for the FDA. In any case, the original rationale for the alternative reporting mechanism was flawed from the start, as long-term post-market data can reveal new or more serious risks even in ‘well-known’ devices, as demonstrated by the hundreds of devices that the FDA has ‘upclassified’ to a higher-risk device class after they are launched on the market, including vaginal mesh, metal-on-metal hip implants and automated external defibrillators.
Opening the post-market medical device safety review process to public safety not only makes such processes more effective, but also protects regulators from understandable accusations that they have become more concerned with device makers’ convenience and profits than with patient safety.
“Transparency is necessary to ensure that patients are receiving appropriate care and the benefits and risks have been properly researched,” said Transparency International Health Initiative director Rachel Cooper in November. The public must be able to trust that the medical products they rely on are going to improve their health rather than undermine it.”
A global challenge
While the FDA has provided a useful case study here, it’s important to note that this problem isn’t confined to the US; virtually all regulators in developed markets have similar flaws in their systems, and many developing countries are only beginning to establish reporting procedures, let alone refine them.
Nevertheless, the FDA aims to be second-to-none in global medical regulation, and has set itself the goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices”. To achieve this in the age of big data, it is working to transition from a passive to an active post-market surveillance system, setting up the National Evaluation System for health Technology (NEST), which aims to make better use of real-world evidence (RWE) to “continuously generate, access and evaluate large data sets on device performance and clinical outcomes associated with device use in routine clinical practice”.
“Based on our early activities, we have evidence that NEST will help improve the breadth and quality of RWE we can access and analyse,” said Gottlieb and Shuren in November.
Regulatory bodies must continue to improve the intuitiveness, scope and public accountability of medical device failure reporting. Secrecy in this area benefits no one but device makers themselves, and leave patients vulnerable to flawed advice on the potentially life-threatening risks of implants and other devices.
To avoid the necessity of bolstering the pre-market approvals process with stricter requirements for clinical studies, post-market surveillance systems must prove that they can improve patient safety over time and apply the proper scrutiny to approved devices, something they have failed to do thus far. The myriad stories of repeated failures of supposedly safe medical devices, and the trauma these failures cause, prove that there is very little room for error when patients’ lives are on the line.