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Medical Devices › Safety Precautions

Patrick Malone & Associates P.C. | DC Injury...

FDA warns surgeons against experimental robot-aided cancer operations

Patrick Malone & Associates P.C. | DC Injury... on

The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and...more

Shook, Hardy & Bacon L.L.P.

Can Robot-Assisted Surgery Be a Pain?

Shook, Hardy & Bacon L.L.P. on

Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed. Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or...more

Knobbe Martens

Cook Medical Issues Voluntary Global Recall of Beacon Tip

Knobbe Martens on

FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. ...more

Knobbe Martens

FDA Medical Device Safety Tracking System Reform

Knobbe Martens on

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more

Snell & Wilmer

Adopting a Safety Policy and Assembling a Safety Team

Snell & Wilmer on

Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more

Bergeson & Campbell, P.C.

EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of...

Bergeson & Campbell, P.C. on

The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential...more

Faegre Drinker Biddle & Reath LLP

What's Safety and Effectiveness Got to Do with Substantial Equivalence? FDA Clears it Up.

Faegre Drinker Biddle & Reath LLP on

On July 15, 2014, FDA issued draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. We think of it as a...more

King & Spalding

U.S. Customs And Border Protection Announces Three New Members Of Commercial Targeting And Analysis Center

King & Spalding on

Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more

Snell & Wilmer

Malware in the Machines: Cybersecurity for Medical Devices and Hospital Networks

Snell & Wilmer on

Within the last week the Food and Drug Administration (FDA) issued a pair of Safety Communications directed towards the medical device and healthcare industries regarding cybersecurity. Computer virus and other malware...more

BakerHostetler

Alarm Fatigue: Joint Commission Considering National Patient Safety Guideline for Alarm-Equipped Medical Devices

BakerHostetler on

The Joint Commission (TJC) recently published a Sentinel Event Alert (Alert) regarding “alarm fatigue,” which occurs when physicians are so overwhelmed by the constant barrage of medical device alarms, most of which do not...more

King & Spalding

FDA Issues Draft Guidance on Medical Device Recalls - How to Distinguish Recalls from Product Enhancements

King & Spalding on

On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more

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