FDA announces "key" plans to improve safety action plan

The Food and Drug Administration (FDA) has announced “several key actions” to update its Medical Device Safety Action Plan with the aim of creating a more robust medical device safety net through better data.

The regulator has outlined new steps to improve data available when it comes to devices for women’s healthcare, including on breast implants, “vaginal rejuvenation” devices and gynaecologic surgical mesh.

It says it is investing in new tools, policies and resources to enhance post-market safety, and trying to move to an active surveillance system that “relies on real-world evidence and timely receipt of robust safety information.”

The Administration added it is putting more resources into the new national system for gathering real world evidence through the National Evaluation System for health Technology (NEST), saying that the FDA has evidence that NEST will “help improve the breadth and quality of real world evidence (RWE)” they can access and analyse.

In September, an extra $3 million in agency funding was allocated to the project to support demonstration projects and building out active surveillance capabilities. Eight test case projects using real world data began this month undertaking work such as: testing the feasibility of using patient registries and claims data to evaluate the safety and effectiveness of total joint and knee replacement surgeries, comparing safety and effectiveness of different tissue closure techniques, and to evaluate the safety of intervertebral body fusion devices used to treat spinal conditions.

Part of that $3 million funding is being used to focus on addressing clinical questions on device therapies unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilisation and long-acting reversible contraception.

The organisation has heard from patients who are concerned their breast implants may be linked to other conditions, with the aim of a partnership with the National Breast Implant Registry (NBIR) may help to identify risk factors for complications.

On “vaginal rejuvenation” devices, the statement read: “This past summer, we warned women and health care providers about a growing number of manufacturers marketing “vaginal rejuvenation” devices to treat conditions and symptoms related to menopause, urinary incontinence or sexual function – even though the FDA has not received evidence that these devices are safe or effective to use for these indications.

"We’re announcing that after reaching out to the seven manufacturers marketing their devices for unapproved or uncleared uses, all of them have made significant changes to their websites to remove claims associated with vaginal rejuvenation and other unapproved treatments. Our efforts to address these safety concerns is part of our broader work to improve our analysis of data and generation of RWE concerning the safety and effectiveness of health technologies in clinical areas that are unique to women.”

The FDA also said the advisory committee will seek “expert opinion” regarding the available evidence of the benefits and risks of mesh and transvaginal pelvic organ prolapse (POP) repair – as well as providing an opportunity to hear from the public, including patients, about their experiences.

The Advanced Medical Technology Association (AdvaMed) appeared to welcome some of the content of the statement.

An AdvaMed statement read: “Patient safety is the number one priority of the medical technology industry, and we are always willing to look at new ways of ensuring patient safety -- whether on the regulatory end with FDA, or on the manufacturing and distribution side with new tools for monitoring and preventing adverse events.

“This is a collective effort, and one we can continually improve when we work together. FDA’s latest updates to its Medical Device Safety Action Plan are another positive step in this collective effort, and we’re ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices.

“While we’re still reviewing the details of FDA’s updated Safety Plan, industry has long supported many of the programs highlighted, including development of the National Evaluation System for health Technology (NEST) to more efficiently generate better evidence on device performance and deployment of a unique device identification (UDI) system to ensure companies can effectively identify their products through their distribution and use while ensuring patient access to the most innovative, life-saving technologies.”

The FDA will announce further aimed at modernising the process for medical device review next week.