Parker Waichman LLP

Medical Device Patients and Magnetic Resonance Imaging

FDA Issues Draft Guidance with Updated Labeling and Testing Advice for the Use of Medical Devices in the Magnetic Resonance (MR) Environment UNITED STATES – As reported in an online article published by www.raps.org, the FDA released a draft guidance with updated advice to evaluate the safety and compatibility of medical devices when used in […]

FDA Issues Draft Guidance with Updated Labeling and Testing Advice for the Use of Medical Devices in the Magnetic Resonance (MR) Environment

FDA Issues Draft Guidance on Medical Devices in the Magnetic Resonance (MR) Environment

Magnetic resonance imaging

UNITED STATES – As reported in an online article published by www.raps.org, the FDA released a draft guidance with updated advice to evaluate the safety and compatibility of medical devices when used in the magnetic resonance (MR) environment.

Magnetic resonance imaging (MRI) systems have been changing as technology advances.  A new draft guidance was issued by the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on the use of medical devices in the MR environment.  The draft guidance is intended to adapt to the changing MR environment and will replace a final guidance issued in 2014, addressing a broader range of medical devices.

The draft guidance provides specific instructions on what steps to take to mitigate safety hazards, as some medical devices may not be safe in the MR environment.  For example, some patients with implantable infusion pumps who were subjected to MRIs suffered injuries and death.  The FDA “raised concerns in 2017 with implantable infusion pumps in the MR environment after receiving serious adverse events reports of patient injury and death, recommending patients with such devices and their caregivers use an implant card.”

Risks to patients of having medical devices in the MR environment include, but may not be limited to, tissue damage and image corruption. Clearer labeling regarding the safety of medical devices in the MR environment, as explained in the draft guidance, is intended to help healthcare professionals know what medical devices may be unsafe in the MR environment.

A patient medical device card is one way to help ensure patients are not subject to harm in the MR environment.  Patient implant cards currently exist for some implantable medical devices, such as breast implants and hearing aids.  However, the introduction and requirement of patient medical device cards will reach a much broader range of medical devices and may include any device which is either implanted or in some way attached to or used by a patient.

[sc name=”post-footers”]
[contact_js_widget content=”Have you or a loved one been harmed or killed due to an MRI scan malpractice?” button=”Click To Get A Free Case Review” link=”/contact-new-york/”]

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness
Jessica Samantha
2 years ago
5 Star Reviews 150
Michele josama at parker waichman is a wonderful and extremely polite person she has made my experience an easy and best experience ever I thank her from the bottom of my heart for all she has done. And I would highly recommend her to everyone I know. Parker waichman are extremely lucky to have her.
Maxine Fuentes
4 years ago
5 Star Reviews 150
My Experience with the lawyer Jessie Salcedo has been excellent, she has helped me at all times and answered any questions I had at some point. Thank you! Jessie Salcedo Paralegal Parker Waichman LLP
Keisha Reyes
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038