The FDA collaborated with the medical device industry, healthcare providers and quality experts on "The Case for Quality" which released its first report on the feasibility and effectiveness of standardized medical devices at hospitals.
"The goal is to help make better purchase decisions and potentially improve patient outcomes," said Joanna Engelke, senior vice president, global quality and regulatory, Boston Scientific. She is also a member of the Case for Quality Product Quality Outcomes Analytics Working Group.
The Case for Quality Product Quality Analytics Working Group conducted a pilot study standardizing knee implants and implantable cardiovascular defibrillators. They collected data publicly available, including in the MAUDE database and from manufacturers themselves. The survey developed standard definitions for safety, efficacy, reliability, patient experience, usability, availability and compatibility.
There were 59 percent that thought the seven domains defined medical device quality very well; another 25 percent felt the domains described medical quality pretty well but would add more domains.
The facilities that established a quality culture were able to accelerate device design, innovation and market introduction.
"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," said Bill Murray, president and CEO, MDIC.