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Laws That Kill Innovation Will Ultimately Kill People

March 27, 2015 2:02 pm | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Blogs | Comments

February 2014 can be defined by updated DFA proposals supporting updated standards specific to blood glucose monitor accuracy standards for devices used in both home consumer and healthcare facilities. Twelve months later, February 2015 is...

Maker of Tainted Medical Scopes Issues New Cleaning Guide

March 27, 2015 1:40 pm | by The Associated Press | News | Comments

The maker of medical scopes that have been linked to two recent "superbug" outbreaks at California hospitals has issued new cleaning instructions for the devices amid scrutiny from regulators, lawmakers and medical professionals. Olympus...

6 Mantras for Medical Device Manufacturers

March 27, 2015 11:32 am | by Bart Reitter, Director, QAD Life Sciences | Articles | Comments

If the physician’s maxim is Primum non nocere – first, do no harm – then a similar phrase can be applied to medical device manufacturers: produce safe, high-quality products with a reasonable return on investment. Lengthier and less succinct...

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Lawmaker Questions Maker of Scopes Tied to 'Superbug' Issues

March 26, 2015 1:45 pm | by Matthew Perrone, AP Health Writer | News | Comments

A federal lawmaker is seeking details from the manufacturer of medical scopes that have been linked to several "superbug" bacteria outbreaks at U.S. hospitals, increasing pressure on the company. U.S. Rep. Ted Lieu, D-Calif., wants to know...

Don't Forget About Patient Isolation to Ensure Safety

March 26, 2015 8:30 am | by Daniel Ruth, Medical Team Leader, TUV Rheinland | Blogs | Comments

The IEC 60601-1 standard for basic safety and essential performance of medical devices deals with many functional issues. They are typically addressed by manufacturers in their risk management files to ensure the device does not harm the...

The Challenge of ‘Big Data’ in Healthcare

March 25, 2015 10:01 am | by AAMI | News | Comments

Aviation and other sectors have been harnessing the power of big data for years. As a result, these industries have witnessed improved safety, finding a way to turn such data into valuable knowledge that can guide decisions and strategies...

Understanding Differences in 'Reprocessing Guidance for Industry and FDA Staff'

March 24, 2015 11:26 am | by Emily Mitzel, B.S. M.S. RM (NRCM), Healthcare Reprocessing Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Blogs | Comments

The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance. Based on the content and addition of Appendix E, this...

7 Criteria to Improve Reprocessed Medical Device Instructions

March 23, 2015 10:59 am | by Emily Mitzel, Consulting Manager; Alpa Patel, Senior Scientist; and Nick Workman, Study Director; Nelson Laboratories | Nelson Laboratories, Inc. | Articles | Comments

When it comes to the reprocessing of medical devices in the healthcare facility, simple is better. For decades, reusable medical devices have been used to enhance the health and well-being of patients undergoing medical procedures. Reprocessed...

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6 Considerations When Implementing Agile in Medical Device Development

March 23, 2015 10:18 am | by Heidi Giesbrecht, MEng, Project Manager, StarFish Medical | Blogs | Comments

The benefits of Agile include improved quality, more opportunities for midcourse corrections, improved customer or business satisfaction, better alignment between business and IT and improved time to market,” according to a Forrester Research...

Medical Device Tax Repeal Included in Senate Republican Budget

March 23, 2015 9:42 am | by The United States Senate Committee on Finance | News | Comments

Finance Committee Chairman Orrin Hatch (R-Utah) and U.S. Senator Pat Toomey, (R-Pa.), a member of the Committee, praised the inclusion of the medical device tax repeal in the Senate Republican budget. Under Patient Protection and Affordable...

FDA Approves MRI-Safe Pacemaker

March 23, 2015 9:37 am | by The Associated Press | News | Comments

BIOTRONIK, a manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved its ProMRI Eluna pacemaker system. BIOTRONIK ProMRI technology allows patients to undergo full-body magnetic...

FDA Hosting Public Workshop On Device Risk in Postmarket Setting

March 23, 2015 8:38 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) is hosting a public workshop next month on the clinical considerations of risk with a medical device that is already on the market and in use. The agency says it wants to hear from all stakeholders...

Safe Power for Medical Devices Used at Home

March 20, 2015 11:25 am | by Diane Cupples, Vice President of Marketing, Schurter Inc. | Schurter, Inc. | Articles | Comments

An aging population and the rising cost of healthcare around the world are a matter of concern to the general public these days. This is especially true in the U.S.A., where keeping costs under control becomes more and more challenging. In order...

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FDA Focuses on Reprocessing Instructions in New Guidance

March 20, 2015 9:00 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) has finalized guidance that includes recommendations for writing clear reprocessing instructions for reusable medical devices. The document comes at a time of heightened interest in the sterility of...

No One Risk Applies to All Devices

March 20, 2015 8:46 am | by Steven W. Badelt, Ph.D., Director of Outreach, Healthcare Working Group, INCOSE | Blogs | Comments

Medical device companies sometimes fail to follow a robust risk identification process. That process can neglect the risks that emerge when a device is integrated into the larger healthcare system. There is no one risk that applies to all...

Lack of Interoperability Contributes to Medical Errors

March 19, 2015 10:04 am | by AAMI | News | Comments

For years, healthcare technology professionals and patient safety organizations have decried the lack of medical device interoperability in hospitals. Now, another voice, nursing, is echoing the call for better interoperability, saying a lack...

Consider the Patient to Ensure Safety in Device Development

March 19, 2015 8:30 am | by Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Blogs | Comments

It will be no surprise that the most critical consideration to ensuring patient safety when developing a medical device is to consider the patient: who are they, who will be using the device, how will they interact with the device, and what’s...

Focus On 'Why?' Instead of Just 'How' for Device Design

March 19, 2015 8:30 am | by Ed Trevis, President and CEO, Corvalent | Blogs | Comments

Every facet of the process – from circuit board design and assembly to on-site implementation of fully developed medical equipment – can affect the patient experience. Because of this, design strategies that consider long lifecycle and consistent...

FDA Advances Medical Product Innovation

March 18, 2015 9:03 am | by Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration | Blogs | Comments

On March 10, I had the pleasure of appearing with my colleague Dr. Francis Collins before the Senate Committee on Health, Education, Labor and Pensions to testify at a hearing on the subject of “Continuing America’s Leadership in Medical...

How Long Does Clearance on a 510(k) Submission Take?

March 17, 2015 5:13 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Blogs | Comments

Debate rages on over the FDA — Has it become less efficient? More efficient? Is it a barrier to innovation? Is it doing exactly what it needs to do? While these questions are not likely to be definitively answered anytime soon, one query that many do have regarding the FDA could be resolved...

FDA Approves Left Atrial Appendage Closure Device

March 17, 2015 9:04 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN Left Atrial Appendage Closure Device. The WATCHMAN Device offers a new stroke risk reduction option for high-risk patients with...

Devices Safeguard Patient Safety Only When They Work

March 16, 2015 10:57 am | by Ellen Turner, Market Development Manager, Specialty Plastics, Medical Devices, Eastman Chemical Company | Eastman Chemical Company | Blogs | Comments

Medical devices are under a lot of pressure — doing more for caregivers and patients with each innovation, all while having to withstand the wear and tear that comes with constant use. A heightened focus on patient safety, resulting from evolving...

Patient Safety Takes Center Stage at AAMI

March 16, 2015 9:55 am | by AAMI | News | Comments

The goal of using healthcare technology to deliver safe and effective patient care is front and center this week at AAMI with the kick-off of the National Coalition for Infusion Therapy Safety and a separate meeting for experts who are committed...

FDA Wants More Info on Scopes Linked to "Superbug" Outbreaks

March 16, 2015 9:34 am | by Matthew Perrone, AP Health Writer | News | Comments

Federal health officials are stepping up their oversight of medical scopes linked to potentially fatal "superbug" outbreaks. The Food and Drug Administration released stricter guidelines for manufacturers of reusable medical instruments, including...

FDA Approves CPR Devices that May Increase Chance of Surviving Cardiac Arrest

March 14, 2015 8:30 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may...

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