Regulatory Reform Options for Implantable Devices

Regulatory Reform Options for Implantable Devices



In 2011, some widely used implantable heart defibrillators, designed to correct potentially fatal irregular heart rhythms, developed cracked insulation on their high-voltage electrical wires. The result was that in some cases they caused severe shocks, and even deaths.

Consumers with the defective implants had to decide whether to undergo dangerous surgery to replace the device or simply monitor it. Until the defective device is replaced, consumers run the risk that it will deliver an unnecessary high-voltage jolt of electricity—described as a feeling similar to being hit across the chest with a baseball bat—or simply fail, which could lead to cardiac arrest and death.

As the population has aged and technology has advanced, the range and number of implantable devices, like cardiac pacemakers and artificial hip replacements, have become ubiquitous. Experts estimate that 7.2 million Americans are living with joint implants alone. These devices can significantly improve the quality of life and, in some cases, save lives. However, while implantable devices can provide benefits, they also carry substantial risks to patients, including serious injury and even death if they fail. A number of serious implantable device failures have caught the public’s attention and raised questions about the need to improve the safety and effectiveness of implantable devices. The 2011 example above illustrates the issue.

A recently published AARP Public Policy Institute Insight on the Issues  explores areas of public concern surrounding these devices. The report, “Implantable Devices: Regulatory Framework and Reform Options,” discusses the FDA’s process for approval and oversight of these devices. The paper suggests policy options that could both strengthen and streamline the process to better protect public health and safety while also encouraging the development and marketing of devices that will benefit patients. Some of the options discussed in the publication include:

  • Strengthening and streamlining the pre-market approval and clearance processes for implantable devices.
  • Strengthening post-market oversight and reporting for implantable devices through the use of more post-market surveillance studies, innovative monitoring techniques, and additional funding for these activities.
  • Making better use of patient registries to track device performance and patient outcomes.
  • Expanding use of unique device identifiers so devices can be tracked and identified.
  • Improving communication with stakeholders.
  • Strengthening quality controls by giving the FDA authority to conduct pre-market inspection of all facilities that make implantable devices.
  • Strengthening FDA enforcement activities through more effective recalls and other actions.

 

Open dialogue on these issues and options can help inform needed policy action. In another blog post, I discuss a second Insight on the Issues that deals with the lack of price transparency and need for greater competition in the implantable device marketplace.

 

 

Keith Lind is a Senior Strategic Policy Adviser for the AARP Public Policy Institute, where he covers issues related to Medicare and medical devices. 

 

 

 

 



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Utilizing Technology To Enhance Life

Utilizing Technology To Enhance Life


Have you ever asked yourself these questions, “What’s the best mobile app to use or the best device to purchase for achieving your everyday goals?” “How can I use technology to stay connected to family and friends, search for jobs,manage my homes, care for loved ones and learn a new skill?” Most of us have.  To help with answers, AARP is hosting a free Online Technology Fair, Thursday, June 8 from 1PM to 6PM EST.  You can register now to learn about the latest technologies for your daily life without feeling overwhelmed.

The fair will focus on utilizing technology to prioritize and simplify your life, finding work and connecting caregivers to loved ones, fellow caregivers and find local resources. You will find interactive videos and games, plus live webinars and video chats featuring industry experts.  You can get your questions answered by representatives from about two dozen non-profit organizations and government agencies that include American Institute for Cancer Research, Consumer Technology Association, Federal Emergency Management Agency (FEMA), the Federal Trade Commission (FTC), Volunteer Match and Next Avenue, to name a few.

By now, we probably all use technology to achieve and engage in most of our life activities. Through the use of our smart phones, computers, and now smart cars and smart homes, there is always something new being created to make our lives simpler.  To hear more about this and others, representatives from AARP Driver Safety will discuss the latest in smart vehicle technologies, and AARP Fraud Watch Network will discuss how to stay safe online. In addition, Dean Reistad of HelloTech will talk about how to simplify your life by using smart home automation, and author Jason Rich will discuss how companion robots, technology-controlled pill boxes, and other gadgets can enhance your life.

Using technology to find a job is now common practice. If you are job hunting you are probably using one or more online job boards. For this event, AARP work & jobs expert Kerry Hannon, Tom Ogletree of  General Assembly, and other knowledgeable staff will talk about how to better use technology to boost your skills, stand out in your field or transition into a new career. You will also learn about how the AARP Job Board and the AARP’s Employer Pledge Program can help you find relevant jobs for your skills and experiences. They will share information about AARP’s job seeking resources that range from how to prepare your resume to preparing for the interview.  You’ll even learn more about teleworking – from how to find a job that allows you to work from home, to how you can stay connected as you work from home.

Now that caregiving has now stepped into the world of technology, apps and gadgets can help you stay connected to your loved one as well as a network of other caregivers. We know caregiving takes a village to provide relief, moral support and help with identifying needed resources. Attend to hear about AARP’s Caregiving Resource Center and Caregivers in the Community (CINC) app that will help you prepare to care and connect to local resources and fellow caregivers.

Register now for the AARP’s free Online Technology Fair and participate from the comfort of your home or office. Take advantage of the myriad of tools and resources offered and discover surprising tricks and shortcuts that can help you from dawn to dusk.  Can’t make the live event? Register and you can view the event on demand.

 AARP helps people turn their goals and dreams into real possibilities, strengthens communities and fights for and equips Americans 50 and older to live their best lives. Discover all the ways AARP can help you, your family and your community at AARP.

Photo: AARP

Also of Interest

9 Ways to Use Technology to Save on Technology

Do You Know Tech Talk?

New Tech Tools For Working Smarter

 

 

 

 



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