Barrage of Adverse Event Coverage Hits Device Industry

The International Consortium of Investigative Journalists has taken aim at the medical device industry with a series of articles on device recalls and adverse events, a series that has not gone unnoticed among device makers. The initial question for device makers is whether these reports will affect how regulatory authorities review devices, but it appears that at least one regulatory entity has acted on the report with a call for tighter premarket scrutiny.

The ICIJ, a 200-plus member watchdog group founded in 1997 by the Center for Public Integrity, has previously published on tax havens in the 2015 report titled the Panama Papers. The latest set of reports, the Implant Files, focuses principally on medium- and high-risk implanted medical devices, taking on subjects such as breast implants and transcatheter aortic valves, but the organization also picked out Dublin-based Medtronic for a report on alleged abuses.

Yet another report takes on the device regulatory picture in the European Union, which is still implementing the Medical Device Regulations that will not be fully in force for another two years for non-diagnostic medical devices. One of the difficulties of the data unearthed by the ICIJ is that there is no denominator for the increase in the total number of medical devices in use over the past few years, but the reports also suffer from the long-standing problem of the absence of information that clarifies whether the adverse event was principally or entirely the fault of a malfunctioning device.

Health Canada Among the First to React

Despite the concerns regarding the difficulty of interpreting raw adverse event data, the reaction among regulators has been fairly swift. Health Canada posted a Nov. 29 statement from Ginette Petitpas Taylor, Canada’s Minister of Health, who said she was “deeply concerned” by the Implant Files coverage, although she said that Canada “has one of the best regulatory systems in the world for medical devices.”

Nonetheless, Taylor said she had directed Health Canada to draft a plan that would, among other things, amend the premarket review process to require more clinical data for medical devices. Health Canada will also increase its capacity for medical device inspections and bolster its postmarket surveillance capacity, while greater transparency for medium-high and high-risk devices is also on the agenda. Taylor said the agency will publish its response “in the coming weeks.”

The reaction in Western Europe has come from a number of sources and includes a claim on the ICIJ website that the health ministers for Denmark and Italy have vowed to take action despite that the MDR overhaul is still in the works. Stakeholders in several nations have reacted to the news with calls for tighter government scrutiny, including the U.K. Royal College of Surgeons, which urged the Medicines and Health Care Products Regulatory Agency to implement an exhaustive registry for all implanted devices. MHRA has not declared how it will deal with regulations after the Brexit, which itself is not scheduled to go into force until early 2019.

For its part, the FDA has responded to media inquiries by stating that it is limited in its ability to rapidly access data for adverse events, a predicament that the National Evaluation System for health Technology (NEST) is designed to resolve. However, the FDA also announced several moves in conjunction with its medical device safety initiative earlier this year.

In its latest announcement, the agency said it is considering a ban on the use of predicates older than 10 years in 510(k) filings, along with measures that would more or less put an end to the use of the substantial equivalence paradigm. All this is drawing fire from the regulatory bar, some members of which have voiced the view that these proposals might require more than mere consultation with Congress. The agency is not stating whether these latest proposals were prompted by the ICIJ report, but the timing is difficult to ignore, particularly given the seeming improbability that it will be able to implement some of the more far-reaching of those proposals.