The Case for Quality, a collaborative effort between the FDA and the medical device industry, released its 1st report today, focused on the safety and efficacy of knee implants and cardioverter defibrillators.
The Case for Quality looks to assess the feasibility and effectiveness of using standardized medical device performance data and analytics in an effort to help hospitals compare and evaluate product quality, the group said.
The collaboration is being coordinated by the Medical Device Innovation Consortium, which the group said is the 1st public-private partnership between the FDA and the industry, with goals of advancing medical device regulatory science.
“The goal is to help hospitals make better purchase decisions and potentially improve patient outcomes. This is the first step toward applying a standardized model of data and techniques to device performance. More work remains ahead to mitigate data bias, ensure accurate interpretation and use of the data and independent management of it. We look forward to undertaking this work, which may lead to better tools for monitoring device performance—and, ultimately, better patient outcomes,” Case for Quality member & Boston Scientific global quality & regulatory senior veep Joanna Engelke said in prepared remarks.
The Case for Quality is a multi-year FDA-launched initiative which looks to develop best practices, standards, tools and metrics for both the agency and industry to use to improve product quality, according to a press release.
The report included data from 7 hospitals on knee implants and implantable cardioverter defibrillators, with data collected focusing on safety, effectiveness, reliability, usability, compatibility, patient experience and availability.
Data collected was “analyzed to calculate key performance indicators, which was presented to VACs via four quality dashboards that contained an overview and rankings by data source, manufacturer and product,” according to the report.
“Case for Quality is setting a cultural shift in motion to focus the medical device ecosystem on sustained product quality that enhances patient safety and outcomes. We’re making great progress and we expect even greater participation from the medtech ecosystem in 2017,” MDIC prez & CEO Bill Murray said in a press release.
The group said its next public forum is scheduled for Oct. 26 in Washington D.C.
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