Archive for the ‘Medical Devices’ Category

Donald
McLearn

Facing Recalls: Rules of the Road for Effective Communication

Monday, February 13th, 2012

Last Friday we looked at some of the circumstances that have led to the recent influx in FDA recalls. But what this conversation really begs is some examination of how we can approach the situation as communicators.

After years of working with manufacturers as they deal with recalls, I thought I would share the top five tips you may find helpful.

  1. Do not assume that quality or compliance issues will never reach the recall stage. Once a device is on the FDA’s radar, it is not likely to fade away. In this day and age, it is more appropriate – and helps companies to be ever ready – to assume that a recall is imminent.
  1. Be patient. These situations are more akin to marathons than sprints. They will not necessarily be resolved in a matter of days or weeks, but more likely months or even years. Settle in for a long haul.
  1. Be as open, transparent and responsive in all communications with the agency as possible.
  1. Communicate frequently with customers and other stakeholders. Keep them informed as to how you are assessing any problems. Reach out to them proactively and respond to their inquiries quickly and efficiently.
  1. Ensure that your employees, at all levels, are informed as well. In particular, keep your sales force and those working on the “front lines” with customers up to speed on the situation and have the tools and resources they need to communicate.

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Posted in FDA, Health Care Industry, Medical Devices
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Donald
McLearn

Why Have FDA Recalls Sky-Rocketed Lately?

Friday, February 10th, 2012

According to trade press and the Food and Drug Administration (FDA), the number of high-risk Class 1 medical device recalls skyrocketed to the highest point ever in 2010, nearly doubling from 23 in 2009 to 51 in 2010, a 122 percent increase.

Class 1 is FDA’s most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death. Years ago, when I was in FDA’s Public Affairs Office, there were only a handful of Class 1 recalls for the entire agency in a year. In contrast, in 2010, Bectin Dickinson and Cardiac Science tied for having the most Class 1 recalls with three each.

Back in the day, the Class 1 recalls that did arise were usually tied to fatalities. Take for instance, the Bjork–Shiley heart valve which became the subject of a famous lawsuit and recall after it was shown to malfunction with dire results. Today, there are many different scenarios in which a Class 1 recall may occur.

What could have caused this astronomical growth in Class 1 recalls? There are differing viewpoints. Having spent more than 17 years at the FDA, and many years since consulting with manufacturers on their interactions with the agency, I see several factors coming into play here.

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Posted in FDA, Medical Devices, Public Affairs, Public Health
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Luke Dickinson
Luke
Dickinson

Medical Device Recall and Crisis Response

Tuesday, October 25th, 2011

There have been countless recalls of faulty drugs and medical devices in the pharmaceutical and device industry. Some have been the result of malicious actions by external parties, while others can be attributed to production faults or other random incidents. No matter what the cause, the manufacturer is always placed directly in the spotlight and how they respond can have lasting effects on their reputation.

The most recent to capture the media’s attention – as they inevitably always do – is a voluntary recall of around 600,000 contact lenses made by New York-based CooperVision, Inc. Federal health officials claim that an “undefined residue” on the lenses has caused a range of eye problems, from blurred vision to painful corneal tears.

CooperVision has come under heavy criticism for their slow response to the recall. This delay has resulted in threats by the FDA to issue a public health warning and sweeping negative media coverage for CooperVision. As a voluntary recall, the Food and Drug Administration, which regulates contact lenses as a class III medical device, has only limited authority to force CooperVision into action, with much of the onus for notification and action placed on the individual retailers.

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Posted in Biotechnology, Community Involvement, Crisis Management, FDA, Health Care Industry, Medical Devices, Pharma
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Jaime
Wright

High Blood Pressure at My “Old” Age

Wednesday, July 6th, 2011

Throughout college, as a student-athlete, I used to get a slight feeling of tightness on the right side of my chest. Minutes later, that feeling would be gone and I would continue to run without pain. Then, 24 hours later, the tightness returned and I became concerned. I checked with an RN at my university’s health center the next day, and it was determined the tightness in my chest was likely caused by my high blood pressure. Wait a minute! Me, a healthy young person with high blood pressure?

Courtesy of CBS News; Credit: iStock photo)

Well, it turns out that I’m not alone.

In fact, according to recent findings in the National Longitudinal Study of Adolescent Health, one in five young adults has high blood pressure, or hypertension. Hypertension involves an extra high level of force pushing against the walls of the arteries as the heart pumps blood. If your blood pressure rises and stays high over time, it can damage the body, potentially causing kidney failure, heart failure or stroke. Individuals can help to control their blood pressure through exercise, diet and possibly drug therapy. So if high blood pressure is so common among young adults, why is there still so little education about it and how to control it?

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Posted in Chronic Disease, Disease Awareness, Medical Devices
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Imagine That – Smart Phone Diagnosis

Friday, April 29th, 2011

Here’s a cool idea – a team of University of Central Florida students is working on a smart phone application that will help healthcare workers in remote locations diagnose malaria quickly and easily. Using a smart-phone equipped with Windows 7 and a microscopic camera lens, the app will take pictures of a blood sample, identify and point out malaria parasites, and tell the user how much malaria is in the blood. Because it doesn’t use the internet, the application could be especially useful for a healthcare worker in a remote location without Internet access, such as an African village. The data can be uploaded later, however, to help identify disease trends.

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Posted in Awards, Disease Awareness, Health 2.0, Immunization, Infectious Disease, Medical Devices
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Leticia Diaz
Leticia
Diaz

Text Alert: You’re having a heart attack

Wednesday, October 13th, 2010

imecIt wasn’t long ago that LifeCall, often remembered for the notorious, “I’ve fallen and I can’t get up” advertisements, was breaking into the market place with a medical alert device that, when activated, allowed individuals to call out to a device and connect to a live operator for assistance. At its core, the device provided an additional level of safety or security at home for patients and caregivers alike.

Fast forward 20 years and today’s medical alert device market is on the rise providing individuals with the ability to capture a multitude of health behavior on their mobile phones including calorie counts, physical activity and heart rate monitoring. Armed with this data from their mobile phone, patients are using the information to more closely monitor their own day-to-day health and report back to their doctor to make adjustments to diet, activity level or medication as needed. But, what if a new medical alert device sent out status updates to your physician on your body’s health in real time via your mobile phone?

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Posted in Biotechnology, Medical Devices, mobile
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Anthony LaFauce
Anthony
LaFauce

mHealth is the Future

Monday, August 16th, 2010

welldocWellDoc, a company focused on developing next generation medical tools, announced that the FDA has approved its DiabetesManager System. I can hear you now, “what’s the big deal? There are plenty of those on the market already.” The key to this new system is that it delivers real-time monitoring results to a person’s mobile phone.

Again, is it really that great of a tool? The DiabetesManager System also links directly to the patient’s caregiver via the patient’s phone and can provide automated health updates. HIPA you say? Well the company’s press release says nothing about privacy issues, but because this is an ‘opt in’ program that communicates directly with a patient’s caregiver, the information passed is no different than a patient calling his or her caregiver.

After a quick read-through of the WellDoc’s site, I was able to read that the information captured is held in a highly secure database that only allows for approved member access. I understand the need for HIPA, but on the other hand I understand the need to provide healthcare information on the go. (more…)

Posted in E-Patient, Health Care Industry, Health Care Reform, Medical Devices, mobile, Technology
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Innovation

Technology Tuesday: How Changes to the 510(k) Process Impact Us All

Tuesday, March 23rd, 2010

If you work in health care or as a communications partner to a medical device manufacturer, chances are very high that you are familiar with the 510(k) process. Yet, the average patient who benefits from the medical technology approved through this process each year may know very little about it.    

All medical devices must go through the Food and Drug Administration (FDA) for approval. The Medical Device Amendments Act of 1976 established a regulatory framework that would classify all devices based on their complexity and the degree of risk to the public. This legislation made it easier for manufacturers to bring simpler products to market like tongue depressors, elastic bandages and gauzes. Other devices like medical imaging equipment, endoscopes and dialysis catheters, for example, are subject to the FDA’s 510(k) or premarket clearance of devices that examines whether a device is “substantially equivalent” to a predicate or existing device.  The FDA also determines whether additional clinical testing is needed before the device can be sold in the U.S. While originally designed as the exception to the approval rule, the 510(k) process has now become the norm. In fact, approximately 90 percent of medical devices in the U.S. have been evaluated by the FDA through this process.

Today with the majority of devices going through this process, the 510(k) is facing scrutiny from within the FDA itself, advocate groups and lawmakers on Capitol Hill who are questioning whether this process, as it currently stands, still provides safe and effective devices to consumers. (more…)

Posted in Innovation, Medical Devices, Technology
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Shellie Byrum

Device Companies Slow to Join Digital Revolution

Monday, February 1st, 2010

Medical device companies may be their own worst enemy when it comes to social media.

Since I started working in this field, I’ve noticed that device companies in general are behind in joining the digital revolution, especially when compared to other FDA-regulated companies in the pharmaceutical and biotechnology fields. In fact, a survey released in December showed that only 16 percent of FDA-regulated device companies reported using social media to connect with customers or prospects. (more…)

Posted in Biotechnology, Health 2.0, Health Care Industry, Medical Devices, Social Media
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