Posts Tagged ‘product recall’

UPDATE: Window Blinds: Why are children still dying?

Wednesday, April 27th, 2011

UPDATE – October 20, 2011:

A few months ago, this blog highlighted the issue of dangerous window treatments. In the original article, I discussed how difficult it was for parents to know whether the window treatments in their home were safe and the relatively small cost it would take for manufacturers to make kids safer. So the unfortunate reality is that despite the ongoing safety concerns and injuries and even deaths due to window blind cords, manufacturers persist in making and selling dangerous blinds and shades that have cords that are accessible to children. This week, the Consumer Product Safety Commission has announced another recall of so-called Roman shades and roll-up blinds. These products have cords that allow a child to become strangled if they get their neck caught between the cord and the fabric or if the child accidentally wraps the cord around their neck. While the recall says that injuries have not yet been reported based on this product, these products are of the same type as many where injuries and deaths have been previously reported. It leaves me to wonder at what point the government or some external force will provide enough pressure on the manufacturers to stop creating and marketing dangerous blinds to the public? As my original post explained the cost savings in manufacturing blinds this way is not extreme, but the costs are huge to families when children are hurt. Furthermore, these products are being sold, at least in this case, at discount stores to families who are likely buying what blinds they can afford without any knowledge of the potential danger.

 

Photo: www.flickr.com/photos/stvcr/

For several years, there have been periodic news reports about major recalls involving window blinds. Window blind manufacturers have also provided a number of different types of safety elements on their blinds. These have included breakaway plastic pieces on the bottoms of the cords and other sorts of “safer” ways to deal with the cords involved in the use of the blinds. How many of you believed that these recalls and changes meant that new blinds or blinds that had not been subject to any recalls were safe?

As a parent, I thought that I was fairly up-to-date about this issue.  I had replaced all of the Roman style blinds in one room in my home with cordless blinds before my daughter was born. I had purchased another type of cordless blind system for the playroom. In the one remaining area with older style blinds, I had carefully checked to make sure that the cords were not tied into a loop and that they were cleated-up high so that no additional cord was accessible at child-height. Then, I basically went on living my life without thinking too much more about it.

Well, a recent New York Times article changed that for me. The article details the injuries and deaths of several children. These children were all severely injured or killed by window blind cords. The disturbing part to me, however, was that many of the parents had taken what I would have considered to be major precautions. They had baby-proofed their homes. They had tied-up the extra cords. Yet still, the boys and girls mentioned were hurt or killed by either the interior cords of the blinds and/or by climbing up and getting tangled in the supposedly secured/safe blind cords.

What a disturbing wake-up call. I certainly walked around my house last night with a different idea of child safety. But, as I mentioned, I know that a cordless type of blind exists.  So, why is this not the safety standard?

The New York Times article explains:

Now, prodded by a Missouri mother whose daughter was strangled in a window blind, the Consumer Product Safety Commission has asked manufacturers to devise a way to eliminate the risks from window cords or perhaps face mandatory regulations. Critics of the industry complain that manufacturers have dragged their feet on addressing safety hazards for decades, making minor tweaks or putting the onus on parents to shorten cords or buy tie-down devices. Until recently, regulators have done little to crack down, they say.

In response to the commission’s latest push, the industry, working with a task force of regulators and consumer advocates, says it will come up with a fix by the fall.

But the negotiations have gotten off to a rocky start. Like some other regulatory battles that involve consumer safety, this one comes down to a sobering question: how much should manufacturers, and ultimately consumers, be required to pay to prevent the maiming or death of a child?

When I read this, I imagined that it came down to this question because the cost of making all window blinds cordless was prohibitive.  The article even states that “… cordless blinds are more difficult to manufacture than corded blinds and can cost considerably more in stores, by some estimates, twice as much.” However, when you examine further, it seems that the cost of cordless blinds might not really be much more and certainly not prohibitively expensive.

The article goes on to say that James G. Onder, a St. Louis lawyer who represents parents whose children have been injured or killed by blinds, “…said manufacturers have repeatedly testified in depositions that the additional cost of making a cordless blind is $1 to $2.” If this is accurate and cordless blinds can be made for $1-2 more per blind, then why are children dying?

The Consumer Product Safety Commission (CPSC) issued a press release in March 2011 that said that:

About half of the deaths of children who strangle in window cords have not been reported, according to an article in this week’s Journal of the American Medical Association and co-authored by a staff member of the U.S. Consumer Product Safety Commission (CPSC).

The study found that 49 percent of the total number of window cord strangulations in the United States were not being reported to the CPSC. The study estimates that total number from 1981 to 1995 was 359. These figures mean that nearly one child is strangling in window cords every two weeks. Almost all of these deaths (93 percent) are children three years old and under.

What does it say if window blind manufacturers are selling cordless blinds for twice as much in stores, when they only cost an additional $1 or $2 additional dollars to make? What does that say about the cost of safety? What message does that send to the parents of the child who dies approximately every 2 weeks from window cord strangulation?

If the window blind manufacturers are not going to make safer blinds of their own, should they be regulated? What about the continued marketing of a product that proclaims to have safety features but is not as safe as it can be for children? Is it worth the risk?

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!