Archive for the ‘Product Recalls’ Category

AED (Automated External Defibrillators): A Reader’s Comment Raises More Concerns About The Recent Recall

Monday, August 9th, 2010

At the end of last week, one of the firm’s medical specialists, Sharon Stabile, wrote a piece on a large recall of AED’s – automated external defibrillators. As I was editing and finalizing the piece for publication on the firm’s blog, I couldn’t help but wonder just how many people are aware of exactly what these ubiquitous devices do and how to use them should the need ever arise.

Every day I enter our office, I see an AED hanging from the wall in the common area of our building. I admit that until about a year or so ago when I began investigating the death of a young boy at one of our area school’s (an AED was used to no avail in an attempt to save his life), I personally didn’t know what this was or how to use one if I ever had to do so.

After Sharon’s blog was posted, which had dozens of readers as soon as it was posted, one of the readers, Denise Maier, posted a thought-provoking comment. It turns out the Ms. Maier has a website, www.defibillator.net, which is a retail site for certain brands of defibrillators. Having elected to review all comments before they are approved (mainly to avoid spammers – of which there are many), I initially wondered if this was just another piece of spam by someone trying to promote their product or website. After getting over my initial reaction and investigating her site more closely,  I realized that Ms. Maier’s site had a lot more to offer than just a product. I navigated on the home page to tabs entitled Articles and Blog and started to pay attention to the content of these postings. I was more than pleasantly surprised to find that this site offers some very valuable information regarding AED’s, policies, procedures, recommendations and news releases concerning matters such as the recall about which Sharon Stabile had written.

In her comment on our blog, Ms. Maier wrote in pertinent part:

I am an American Heart Instructor. I have been posting updates on the website http://www.defibrillator.net concerning the mandatory field updates released by Cardiac Science. One more problem that must be addressed regarding the update. If the AED’s battery does not have sufficient energy to complete the field upgrade, the unit may fail and the AED user must order a new battery. There is no test to determine whether the battery installed will perform through the upgrade. At the very least Cardiac Science should be supplying free batteries to AED owners to complete their upgrade. But the fact remains that only those end users specified as more likely to use their AED will be sent a new unit. There is a school district that has 22 units in our area. All units need the upgrade. None of their units are being replaced by the recall. What type of training will be provided by Cardiac Science in the event one of their AEDs fail? Recent reports indicate that schools are considered among the best places to have a Sudden Cardiac Arrest in the country since most have AEDs with trained responders. Cardiac Science distributed thousands of AEDs throughout the Ohio Schools subsequent to being awarded the AED Grant a few years ago. Without a replacement on those AEDs, how safe are the Ohio Schools?

These observations and commentary by Ms. Maier are exactly the reason I found Sharon’s blog posting important to publish. I truly didn’t know the depth of the problem with these devices or the recall and its limitations, but I certainly was aware of my own misgivings about the devices and the risks associated with their use by someone such as myself.

While I don’t usually post blogs about comments, I feel that Ms. Maier’s was precisely the kind of first-hand information from which our readers could benefit. How many schools, restaurants, office buildings, malls and the like which have AED’s available to the public for use are even aware of the recall? How many of these public locations have a policy of training responders to use these devices, or other complimentary policies in effect (e.g. periodic maintenance)?

In one of the site’s postings entitled Every School Needs AED Program Management, the author (I don’t know if it’s Ms. Maier or not) makes the following observations:

A panel of medical experts gathered by the National Athletic Trainer Association recommended the school guidelines below for anyplace where emergency medical services treatment isn’t assured within five minutes.

  • Establish an emergency communication system so help can be summoned quickly.
  • Coordinate their plans with local emergency medical services.
  • Ensure that an AED is handy and they establish a short response time – 3 to 5 minutes from anywhere at the site.
  • Train staff and students to respond, perform CPR and use the AED.
  • Practice their response to a cardiac arrest at least once a year.
  • Assume immediately that if an athlete collapses, it’s cardiac arrest.

The article concludes with the following recommendations that should not be overlooked in this whole discussion.

[S]chools should have comprehensive policies that authorize use by any willing rescuer, procedures to check the AED frequently, and signs along with accessibility.

Although it is thought that an untrained person can use an AED within about 90 seconds, training increases the comfort level with using the device and thus increases the likelihood that someone will do so when needed. The chief of the Division of Pediatric Cardiology at The Children’s Hospital of Philadelphia states “Schools have to have plans. Unless people are trained and go over it and over it, you are not ready to act.”

While these observations and recommendations are made in the context of schools, are they not equally valid and significant for all businesses and locations that have these devices accessible for use? It’s one thing to have a device available, it’s a totally different matter to have devices that are functional, non-defective and usable by those who may find themselves called upon to save the life of someone who has suffered a potentially fatal arrhythmia.

The recall, though highly questionable in terms of its scope, is only of value if those who have such devices are (1) aware of the recall and (2) check their devices to see if they are subject to the recall and take corrective action.

If any of you have other information to share about these devices, the recall, policies and procedures at your institutions or enterprises, it would be a great public service to share your information and thoughts with others. These devices are intended to save lives. If the word doesn’t get out about their limitations, defects and proper use, they may just serve to cause someone’s death. Help get the word out. If you have something important to share, we will certainly publish it and make sure the word gets out.

Would you use an AED if called upon to do so? Would you have a clue how to use it? Is the one you pull down for use really working right? How does training in the use of the device get done? Does your school, gym or office have trained responders? Do you even know if they do? Lot’s of questions, let’s start getting some answers.

Product Safety: 24,000 Defective external defibrillators (AED) recalled – 4 products by Cardiac Science involved

Thursday, August 5th, 2010

How often have you passed a device hanging on a wall in an office building, a mall or an airport, that has a sign such as the one pictured here or a similar signage telling you that this device is available to use so you might save someone’s life if their heart goes into an abnormal rhythm?

If you are still wondering what an AED is, our friends at Wikipedia provide this information:

An automated external defibrillator or AED is a portable electronic device that automatically diagnoses the potentially life threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient, and is able to treat them through defibrillation, the application of electrical therapy which stops the arrhythmia, allowing the heart to reestablish an effective rhythm.

AEDs are designed to be simple to use for the layman, and the use of AEDs is taught in many first aidfirst responder and basic life support (BLS) level CPR classes.

Well – that’s what they are supposed to do! Turns out, there are a whole lot of these devices out there that are simply defective.

On July 19, 2010,  Cardiac Science Corporation, considered a global leader in automated external defibrillator (AED devices), announced their plan to replace 24,000 defective AED devices in the United States.  This comes after significant FDA pressure that began in November 2009.

The FDA first published a MedWatch Safety Alert  following multiple complaints of devices failing to deliver electric shocks in emergency situations, and also failing to internally detect a device failure/problem during routine safety checks.  The FDA then followed in March 2010 by issuing a formal Class I recall followed by an expanded scope in April 2010.  A Class I recall is the most serious public notice and applies to devices that have a reasonable probability of malfunctioning and causing serious adverse health consequences.

The product models involved include Cardiac Science Powerheart, CardioVive, Nihon Kohden, and the GE Responder External Defibrillator manufactured between August 2003 and August 2009.  The FDA has listed the specific models involved on their website.

At present time, 24,000 AED devices in the US will likely not work if needed in an emergency situation as defined by a Class I recall. The FDA reported the devices may fail to deliver shocks; fail to identify life threatening ECG rhythms needing shock delivery; fail to identify lead placement problems; fail to filter background noise that may interfere with ECG analysis and delivery of a shock.

Four months after the FDA Class I recall notice, on July 19, Cardiac Science Corporation detailed their plan to replace the 24,000 devices.  While no specific time frame was detailed in the public statement, a priority based plan to repair or replace the defective devices was presented. Devices issued to police, fire, and ambulance services will be addressed first.  Once this is accomplished, hospitals, medical clinics, dialysis centers, and assisted living facilities will be addressed next.  According to the FDA, Cardiac Science will be responsible for contacting all users and setting a replacement schedule.  However, there is no plan to replace devices that were issued into the general public domain. Instead, public purchasers of any listed defective products need to contact the company or go online (www.cardiacscience.com/aed175) or call (877-941-0844, reference ID4331134) to receive an updated software component.  Cardiac Science urges the public to replace the software as soon as possible.

Non-USA purchased devices for first responders, hospitals, clinics, dialysis centers, assisted living facilities, and general customers will also only receive the software replacement. The company boasts distribution of products in over 100 countries.

The FDA recommends that all users not listed in the priority replacement plan including home users, public access defibrillation programs, and facilities with only one AED device do the following:

  • Obtain and install the software components as soon as possible.  The FDA cautions, the software upgrades may not detect some failures.  However, still try to use the device as the unit may likely be able to deliver the necessary therapy.
  • If the device indicates service is needed, then contact the company to repair or replace the device.  Use an alternative AED device in the meantime.

In the 4th paragraph of their public statement, Cardiac Science listed the impact on earnings.  The company estimates spending $28.5 to $33.5 million dollars over the next 12 months.  They have extended the company line of credit to fund the recall, so the public and investors can be reassured of the company’s ability to manage the recall.

The FDA urges all who experience any problems with AED devices to report the problems promptly through their online MedWatch, Safety Information and Adverse Reporting program. Be sure to include the make, model, and serial number of the device; the initial and final condition of the patient; and a description of the device problem. Healthcare providers should follow their institutional policy/procedure for FDA reporting.

The public should have major concerns about shopping malls, airports, planes, and trains, etc.  that rely on these devices.  Persons in these settings usually are less trained and less experienced in using such devices.  In all likelihood, they would be less likely then first responders to know what to do in an emergency situation with a defective malfunctioning device.  Based on the press release, the company has not issued new training guidelines.  This recall has also not been picked-up by the national/international media, so how will global general users know a major recall is in process? Spread the word. Ask your building manager if they are aware of the recall and  have them check their AED and confirm whether or not it is on the recall list of these devices.

It is simply mind-boggling how it has taken so long for this information to get out and how long it took for the recall to be made. Whatever the price, these devices need to be corrected or removed without any further delay!

Do you have “Recall Fatigue”?

Saturday, July 3rd, 2010

Early in my foray into blogging, I thought tracking and reporting on recalls would be a worthwhile project. I did the usual setting-up of RSS feeds, email notification of updates and the like. As time passed and my inbox filled with new recall after new recall, I began to wonder – is this really worth it? Is anyone really paying attention to these seemingly endless postings about a defective this and a life-altering that? After a few months, I decided that maybe we should only be reporting on the important recalls. Well, what’s important? Is it the crib that severs limbs or kills babies? Is it the food product that poisons a host of people? Perhaps it’s that nice pull-over for toddlers that can choke them. Of course, that piece of clothing that can burst into flames has to make the list.  Week in, week out – they came rolling in and out on the blogosphere some went. I started identifying less and less of these recalls as newsworthy, but I’m not sure why I did that. One reason was clear – no one seemed to be reading what we posted on the recalls – well maybe a hit here or a hit there.

Then on Friday I came across an article in the Washington Post that brought a good deal of clarity to the apparent disinterest of the public and our readers to product recalls – “recall fatigue.”

Lyndsey Layton, a staff reporter for the Post, must have wondered about the same issues bothering me – thus her article entitled “Officials Worry About Consumers Lost Among the Recalls.” I commend it to your reading. Putting the recall overload into perspective, she writes:

McDonald’s asked customers to return 12 million glasses emblazoned with the character Shrek. Kellogg’s warned consumers to stop eating 28 million boxes of Froot Loops and other cereals. Campbell Soup asked the public to return 15 million pounds of SpaghettiOs, and seven companies recalled 2 million cribs.

Then comes the most telling line – “And that was just a fraction of the products recalled in the United States last month alone.”

Ms. Layton reports that “one recent study found that 12 percent of Americans who knew they had recalled food at home ate it anyway. After Hasbro recalled the iconic Easy Bake Oven in 2007 because about two dozen children had gotten fingers stuck in the door, the toymaker received 249 more reports of injuries over the following six months. One 5-year-old girl was so seriously burned that doctors had to partially amputate a finger.”

Are Americans just bleary eyed, immune, overwhelmed in today’s endless stream of information? Do stories of recalls like the Toyota fiasco so dominate the news that we lose sight of the less publicized recall stories? What is it that would let a parent ignore the dangers to their child from a life-threatening or maiming recalled product? Do they just not know about it? That may be true for some, I would imagine, but how does that answer the mind-boggling statistic cited by Ms. Layton that 88% of Americans who knew they had recalled food products in their home – ate the food anyway?! What percentage of parents knew they had a dangerous crib and let their child sleep in it anyway? You know that the vast majority care deeply for their child’s safety. So how on earth could they simply ignore the danger warnings?

Ms. Layton suggests the problem is twofold: “Some people never learn that a product they own has been recalled, and others know they have a recalled product but don’t think anything bad will happen.”

Craig Wilson, assistant vice president for quality assurance and food safety at Costco says, “We call it the Chicken Little syndrome. If you keep shouting at the wind — ‘The sky is falling! The sky is falling!’ — people literally become immune to the message.” He believes the system in place simply doesn’t work.

The “system” – in case you were not aware – includes a government maintained website, http://www.recalls.gov, offering information about all kinds of recalls, and consumers can subscribe for e-mail alerts about specific products. That’s what we subscribed to and which we still track. Check it out for a week or two (hopefully longer if you can get over the ‘fatigue factor’). You’ll see what we are talking about – you’ll be amazed at the number of product recalls. Oh, just in case you don’t have time to boot-up your desktop or laptop, a new mobile version for your smartphone was just announced.

Whether it’s information overload, the ‘it won’t happen to me” syndrome, the “Chicken Little syndrome – people simply need to start paying more attention! Sure – you can say, what are the odds that this will happen to my family? Well – when it happens to YOU or YOUR FAMILY, the odds just became 100%.

What is the best – or at least a ‘better’ way to get people to pay attention and take heed of these warnings? Any psychologists or maybe people with just good common sense have any good ideas? Do you care about product recalls? Do you want to hear about them more often or less often? Since we are an internet and TV society – is this the way to go? Maybe flash warnings like we get for hurricanes, tornadoes, floods? Oops – the remote control’s fast forward might kill that approach.

So what is the answer? Is there an answer? Should we keep blogging on these recalls? I’m not sure anymore. Ms. Layton’s article makes me at least wonder – if one person gets the message and one life is saved or one person not maimed – maybe it is worth it. On the other hand, if we report on it, are we adding to “recall fatigue”?


Over Two Million Cribs Recalled…What About Yours?

Friday, June 25th, 2010

Earlier this week, the Consumer Product Safety Commission (CPSC) made a sweeping recall announcement regarding drop-side and other types of cribs:

The U.S. Consumer Product Safety Commission (CPSC), with the cooperation of seven firms, is announcing voluntary recalls of more than two million cribs to address drop-side hazards and other hazards that affect the safety of young children. The recalling firms are providing consumers with free repair kits to immobilize the drop sides or other remedies. Do not attempt to fix these cribs with homemade remedies.

We previously highlighted crib recalls in several blogs on our website. This recall also includes some fixed-side cribs.  There are authorized repair kits available from the manufacturers involved.  They include: Child Craft (this firm is out of business, according to the CPSC), Delta Enterprise Corp., Evenflo, Jardine Enterprises, LaJobi, Million Dollar Baby, Simmons Juvenile Products Inc. (SJP).  Consumers should contact these companies directly for more information.

The recall notice from the CPSC also discusses their efforts to make cribs safer overall:

“Cribs should be the safest place in the home for infants and toddlers,” said CPSC Chairman Inez Tenenbaum. “CPSC is committed to addressing the hazards with cribs and to restoring parents’ confidence that their child will have a safe sleep.”

CPSC continues to actively investigate various cribs for potential drop-side and other hazards as part of a larger effort by the agency to rid the marketplace and homes of unsafe cribs. CPSC staff is also working on a new mandatory standard to make cribs safer, which is targeted for completion in 2010.

The CPSC goes on to state that “incorrect assembly or age-related wear and tear” may cause drop-side crib incidents.  In addition, the CPSC recommends that a crib more than 10 years old should not be used as “many older cribs do not meet current voluntary standards and can have numerous safety problems.”

If you have precious little ones at home, please check your cribs and follow the proper instructions from the CPSC and companies involved.

The ‘Motrin Retrieval’ – Was it a ‘phantom recall’?

Saturday, June 12th, 2010

Sometime around the middle of 2009, McNeil Consumer Healthcare discovered that certain of its over-the-counter pediatric Motrin products did not dissolve properly. What followed thereafter in the manufacturer’s efforts to get the product off consumer shelves has led to an ever-growing battle between Johnson & Johnson and Congressional investigators, which hit a new pitch on Friday when new company documents were revealed.

These documents indicate that McNeil Consumer Healthcare, a division of Johnson & Johnson, sought to remove the defective products from targeted retail locations by having companies it hired ‘purchase’ the products to get them out of the stream of commerce. What was not done, however, was the issuance of a formal recall in cooperation with the FDA.

The details of this activity and the feud it has led to were reported in yesterday’s New York Times in an article by Natasha Singer. According to the Times –

One document on McNeil letterhead instructs contractors involved in the Motrin buyback program not to alert stores about their activities.

“Do not communicate to store personnel any information about this product,” the document says. A separate McNeil instruction said, “Just purchase all available product.”

Representative Edolphus Towns, a New York Democrat who is the chairman of the committee conducting the investigation, believes these documents show that “McNeil had directed surreptitious activity by its contractors. He has repeatedly referred to this incident as a “phantom recall.”

As you might expect, McNeil, through its spokesperson, Bonnie Jacobs, has a different ‘take’ on the events surrounding the removal of the pediatric Motrin products.

“Given that there was no safety risk, the objective was to remove the affected product from a unique distribution channel, mainly convenience stores and gas stations, with as little disruption and consumer confusion as possible,” Ms. Jacobs said on Friday.

What somewhat belies this proclaimed innocence is another document recently provided to Congress that reveals to a large degree the purpose and motive behind the conduct of McNeil’s contractors.

“Simply ‘act’ like a regular customer while making these purchases. There must be no mention of this being a recall of the product!” — when buying back the Motrin for McNeil.

How does Ms. Jacobs reply to this? She claims Johnson & Johnson and its subdivision McNeil had nothing to do with this subcontractor’s written communication.

So where was the FDA in all of this? Were they advised of this plan to ‘buy-up’ the defective Motrin and not issue a formal recall?

On the issue of informing the F.D.A. about its activities, Ms. Jacobs said McNeil had contacted the agency after it discovered that two lots of Motrin did not dissolve properly. The company informed the agency that it planned to retrieve the products from stores and kept the agency apprised of its progress, she said.

And the FDA’s response to this claim?

“It seems that your company is doing a recall even though you are calling it a ‘retrieval,’ ” Neisa M. Alonso, an investigator and recall coordinator with the F.D.A. in San Juan, P.R., wrote in a message date July 16, 2009, to an executive at McNeil. “The agency’s position is that your company should do a voluntary recall of the product since it appears to be that you are already doing a recall of the product.”

McNeil’s formal voluntary recall of “6 million bottles from over 40 different types of medicines including brands such as Children’s Tylenol, Infants’ Tylenol, Children’s Motrin, and Children’s Benadryl”  (source: Committee on Oversight and Government Reform)  occurred on April 30, 2010 – almost a year after McNeil discovered that it’s products ‘may not meet standards. It is unclear when McNeil first had knowledge of this problem; hopefully the Congressional investigation will make this known. ‘ Here is the language contained in the recall notice issued this year:

[T]hese products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events.  However, as a precautionary measure, parents and caregivers should not administer these products to their children.

So what motivated this ‘re-purchase’ program of McNeil? They didn’t want to set-off a panic? I wonder if it had anything to do with making sure there wasn’t a dip in corporate profits if consumers learned that these products for children and infants on the retailers’ shelves and in their medicine cabinets “may not meet standards.”