On October 31, 2011, FDA issued a report titled “Understanding Barriers to Medical Device Quality.” The report results from an initiative launched by the Center for Devices and Radiological Health (“CDRH”) “to assess and understand gaps in medical device quality.” The focus of this assessment was on marketed device quality assurance, not pre-market activities, and consisted of information gathered from interviews with internal and external quality experts, a set of blinded industry interviews, a scan of databases, including the Manufacturer and User Facility Device Experience (“MAUDE”) database and the recall database, relevant articles, and conferences, and an outside press search.
The report states that its assessment “uncovered several key facts about marketed medical devices, as well as potential catalysts for quality improvement.” In short, the “key facts” discovered by FDA about marketed devices appear to be: (1) the medical device industry has enjoyed “tremendous growth in both revenues and the technical complexity of the products that it produces over the past 10-20 years”; (2) “serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001”; and (3) quality risk is not evenly distributed, with cardiovascular, IVD, and general hospital/surgical devices accounting for approximately 60% of adverse event reports. The report states that recalls have also increased, but not as quickly as adverse events.
From the outset, FDA acknowledges some of the limitations in its analysis of MAUDE and recall reports. Perhaps most importantly, FDA notes that some of the growth in adverse event reporting may be “due to growth in the number of medical devices in use.” The report later states that FDA “should consider adjusting absolute numbers of adverse events and recalls for ‘device usage,’ or the number of devices on the market.” Adjusting for the number of devices on the market seems to be an obvious first step in assessing whether there are real safety concerns associated with medical device use. That the volume of adverse events will increase with the number of medical devices in use makes perfect sense; the question is whether the number of adverse events as a percentage of total device usage has increased. FDA does not answer that question in its report.
FDA also notes other factors that could contribute to the growth in volume of adverse event reports, including “greater outreach by FDA emphasizing reporting requirements, along with greater manufacturer sensitivity to reporting requirements following notable recalls.” Regarding the increase in recall reports, FDA states that the increase in recalls could be due to greater FDA “emphasis” on FDA recall reporting requirements. Although not stated by FDA, this “emphasis” is often in the form of Warning Letters or other enforcement actions, which almost certainly has led to manufacturers erring on the side of reporting MDRs and recalls, even if they don’t believe the event in question meets the regulatory reporting requirements.
All of these factors certainly must be considered when reviewing the MAUDE and recall data, and must be accounted for before drawing any conclusions about the connection between these data and device quality. Although FDA notes these considerations, it nevertheless implies that the increase in volume of both adverse event and recall reports can mean only one thing—it is reasonable to question the quality of currently marketed medical devices.
Just as reporting the volume of adverse events and recalls without considering total devices on the market will lead to incorrect conclusions, FDA’s statement that cardiovascular, IVD, and general hospital/surgical devices make up the majority of adverse event reports does not account for the unique circumstances particular to those device types. For instance, general hospital/surgical devices make up a significant percentage of medical devices on the market, and it therefore stands to reason that the number of adverse events will be higher in that group.
FDA also states that cardiovascular devices “have increased as a share of total serious adverse event reports even faster than for adverse events overall.” FDA fails to account for (or even mention) the most obvious aspect of cardiovascular devices that may contribute to this finding: the health condition(s) of patients likely to be using the devices. Cardiovascular patients are likely to be older and in a more fragile state of health than the general population, and therefore more likely to experience an adverse event—whether or not related to the device itself. FDA’s findings in this report are based on information obtained from MAUDE, and reports must be submitted to MAUDE if the device “may have caused or contributed” to the death or serious injury—there need not be a definitive determination that the device actually did so. Given the likelihood that patients using cardiovascular devices may already be unhealthy, it is difficult to state with particularity that the adverse events suffered are reflective of poor quality of the medical devices in question.
In light of its apparent conclusion that the quality of medical devices is sub-par, FDA suggests “opportunities to improve quality assurance and reduce risk across the medical device industry,” including product/process design, supplier management, manufacturing, and post-production activities. FDA also states that three themes emerged from its interviews with industry: (1) without greater transparency around competitive quality performance, the market rewards rapid product innovation and low cost but not better quality; (2) products and the environments in which they are used are becoming increasingly complex; and (3) there is a misalignment between quality outcomes and pure regulatory compliance.
The interviewees informed FDA that companies are often forced to prioritize compliance over quality, because any failure in compliance is more likely to result in issuance of a Form 483 at an inspection, receipt of a Warning Letter, or other enforcement action. Industry representatives also told FDA that there is an inconsistent application and interpretation of compliance requirements across investigators and district offices, and “inadequate transparency into how investigators arrived at specific decisions and dealt with specific cases.”
Not only does industry feel there is inconsistency in application of the regulations, but it believes there is in fact a disincentive for making safety-related quality improvements since FDA often requires an update to, or recall of, the existing device in light of the safety improvement. This observation has particular relevance in light of FDA’s recent release of its draft guidance describing when changes to a device may necessitate a new 510(k) notification. The draft guidance, discussed in our previous blog post, specifically stated that a modification to a device to respond to a known risk or failure mode will likely require a new 510(k) notification, and may require a recall. Industry has now clearly made FDA aware that companies may elect not to make a safety modification to a device for fear FDA will require a recall of the marketed device. How FDA chooses to respond to this knowledge remains to be seen.
FDA concludes the report on device quality by describing certain steps FDA may take to engage with industry, with a focus on increasing enforcement transparency and clarity. Two areas of focus include “predictable and reliable benchmarks of quality system compliance and (particularly for smaller companies) guidance on how to reach them” and “updates to the company involved on the status of enforcement cases in process.” These seem to be reasonable goals. We can only hope that FDA will work to achieve them.