Posts Tagged ‘Product Safety’

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?

Medical Technology and Patient Safety: EMR’s, COW’s, iPads, etc. – are they really doing the job? Blog Series – Part I

Monday, March 28th, 2011

Medical Technology - source: Siemens.com

This is the first installment of a series of posts on issues relating to new advances in medical technology and how they may affect patient health and safety – not always for the good. Unless you live in a cave or just don’t care, you must have noticed news reports about how the medical industry is awash in the creation and implementation of new technologies. Presumably these new medical tech toys and gadgets are intended to advance the timely, enhanced, cost-effective delivery of healthcare with the end point being improved patient care and patient safety. The question is – do they always do that or can they, in fact, be tools the lead to patient injuries and – at times -even death?

I recently came across a posting by Dr. William L. Roper, MPH, CEO of the University of North Carolina Health Care System, which was in essence a transcript of a speech he gave at the Agency for Healthcare Research and Quality (AHRQ) in Washington, D.C. on March 23, 2011. Among his other vast accomplishments, in the spring of 1986, he was nominated by President Reagan and confirmed by the Senate for the position of administrator of the federal Health Care Financing Administration, with responsibility for the Medicare and Medicaid programs nationally. For the previous three years, he served on the White House domestic policy staff.

I bring Dr. Roper’s recent remarks to your attention since they are the inspiration for this series of blogs. While Dr. Roper’s address did not specifically address topics such as EMR’s, COW’s (still wondering how a cow fits into this topic? Stay tuned!), and the like, the following selected excerpts are the seeds of thought for the present series:

I have the job of leading an academic medical enterprise, and am challenged by the task of putting lofty ideas into practice at the local level. I remain very committed to the effort, but we are daily challenged to put the best ideas into practice.

The Institute of Medicine, under Sam Their’s and then Ken Shine’s leadership, played a very important role across the decade of the 1990s, defining “quality” in health care, and pointing to problems in quality and patient safety. Bill Richardson led a multi-year IOM initiative that included the groundbreaking report, To Err is Human in 2000, and then Crossing the Quality Chasm in 2001.

These reports were a clarion call for action – especially making the point that a systems approach was required to deal effectively with these issues.

While Dr. Roper’s speech was, in large part, an historical analysis of progress in the Medicare healthcare delivery system, it is also a well-versed commentary on the so-called advances in medicine for patient care and safety. Why else have so many toiled for so long in trying to find system-failures and methodologies for eradicating those failures and thereby improving the delivery of safe, efficient and effective healthcare?

Dr. Roper and so many other dedicated healthcare professionals are faced daily with the same issue – “…challenged by the task of putting lofty ideas into practice at the local level . . . [W]e are daily challenged to put the best ideas into practice.” Put another way – at least for me – taking public healthcare policy and practices and making a better widget.

As these lofty concepts were debated, published and analyzed, technology streaked along with its new bells and whistles at what some might call an amazing – almost mystifying – pace. Did you really envision yourself 25 years ago sitting with your iPhone or iPad and scouring the world’s news, chatting with your friends and followers on the other side of the planet, watching the latest streaming video of March Madness or sharing every random thought you have on Twitter or Facebook?

What has technology done to improve healthcare?

The answer, in short, is – some amazing things and some not so amazing things have taken place in terms of technological advances in healthcare. Unfortunately, as we will explore in this series, some of these technological advances have led to some catastrophic results for patients. One need look no further than how the medical institutions rushed to implement the newest, shiniest and “best” radiology machines and through their haste left in their wake scores of maimed and dead patients. We reported on this investigation by NY Times reporter, Walt Bogdanich  in Eye Opener, over a year ago.

Just over the course of the last year or so, our firm has been involved in case after case in which this issue of medical technology and patient care/safety keeps rearing its ugly and devastating head. We will share with you (leaving identifying information obscured as we are required to do) tales of just how medical technology can impact – positively and (unfortunately) negatively patient health and safety. We’ll analyze and discuss our views on just how well medical technology and its implementation (more the latter) have, in our view, negatively impacted – all too often – patient health and safety. We invite you to follow along as we consider the good, the bad and the ugly of medical technology such as EMR’s, COW’s, iPads and the like. Please join us and share your comments along the way.

Some related posts to get you started:

The Radiation Boom – Radiation Offers New Cures and Ways to Do Harm

FDA Unveils Initiative To Reduce Unnecessary Radiation Exposure from Medical Imaging

At Hearing on Radiation, Calls for Better Oversight

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

The Story of How a New York Times Reporter – Walt Bogdanich – Has Made a Real Difference in Medical Device Radiation Safety

Bone-Strengthening Drugs and Esophageal Cancer – Potential Link Should Not Be Ignored

Monday, September 6th, 2010

In the last year, there has been considerable debate about the link between bone-strengthening drugs, also known as bisphosphonates, and esophageal cancer. It started last year when the FDA released information regarding nearly two dozen cases of esophageal cancer in patients that have been taking oral bisphosphonates such as Fosamax. According to Diane Wysowski, PhD, the FDA official who first claimed that there may be a link between bisphosphonates and esophageal cancer, the FDA has continued to receive reports of esophageal cancer in patients on bisphosphonates since 2009.

The FDA’s announcement was followed by the release of a research study of more than 80,000 people, which focused on the link between bisphosphonates and esophageal cancer. The study, which was recently published in the Journal of the American Medical Association, claims that the link between bisphosphonates and an increased risk for developing esophageal cancer is insignificant.

“[Researchers] compared the rates of esophageal and stomach cancer in 83,652 people, half of whom had received at least one prescription for oral bisphosphonates in the previous decade. Just over 80% of the participants were women, and the average age was 70. … Eighty-nine and 92 cases of esophageal cancer were reported in the bisphosphonate and control groups, respectively, as were 49 and 57 cases of stomach cancer—a negligible difference.”

The authors conceded, however, that the study was not perfect.  For example, the study lasted for only 4.5 years, an insufficient period of time to measure the risk of esophageal cancer among patients on bisphosphonates.  Researchers were also not able to insure that all of the study participants actually took bisphosphonates as prescribed. Additionally, they did not account for other comorbidities and risk factors that might increase the risk for esophageal cancer.

According to Chris Cardwell, PhD, the study’s lead author: “Our study is the largest to date, but on the basis of our results we cannot rule out small increases in esophageal cancer risk in individuals taking bisphosphonates.”

A more recent study on the same subject was published last week in the British Journal of Medicine.  This study concluded that that there is an increase in the incidence of esophageal cancer among patients who have been taking oral bisphosphonates for several years (ten or more prescriptions or prescriptions over the course of five years).

“Researchers tracked almost 3,000 people with cancer of the esophagus or throat for eight years and compared them with a group of 15,000 people who did not have the disease. All were over age 40. The scientists found that 90 of the cancer patients had been prescribed the bone-building drugs, while 345 people in the larger group were taking the medication.”

According to this latest research study, the normal incidence of esophageal cancer among patients 60-79 who are not on oral bisphosphonates is about one per 1000. In the same age group, researchers found that the incidence of esophageal cancer doubled among those patients that have been on oral bisphosphonates for several years. It is suspected that bisphosphonates cause inflammation of the esophagus that may predisposes the patient to esophageal cancer.

Both of these studies seem to indicate a positive correlation between oral bisphosphonates and esophageal cancer.  Whether or not the correlation is significant is a determination the patient should be making with his or her physician.  The risk for developing esophageal cancer should not be ignored considering the number of people who take oral bisphosphonates on a regular basis. It is estimated that about 10 million women are diagnosed with osteoporosis in the U.S.  In this population, about 4.7 million take oral bisphosphonates on a regular basis.

If you have been taking oral bisphosphonates for five years or longer, discuss the risk of developing esophageal cancer with your physician and explore available alternatives if you are at risk. More important perhaps, be on the lookout for signs and symptoms consistent with esophageal cancer. They include throat, chest and digestive discomfort as well as difficulty swallowing.  If you have these symptoms, consult a physician immediately.

Contributing author: Jon Stefanuca

Medical Tubing Errors: deaths and catastrophic injuries continue while the health industry refuses to implement a simple solution.

Monday, August 30th, 2010

I was greatly dismayed reading last week’s health headlines.  A young 24 year old mother in her 35th week of pregnancy was admitted to a hospital for nausea and vomiting. She was receiving liquid food through a tube placed down her nose and into her stomach.  In addition, she was receiving intravenous fluid into her veins to prevent dehydration. The nurse mistakenly placed the tube containing the liquid food into her vein. Both the young woman and her unborn baby died. The New York Times reported their deaths and other serious injuries were among hundreds  related to similiar tubing mistakes.  The same articles cited little precise data is available on exactly how many are occurring because there are no requirements to report these mistakes.

As a young nurse working in a Neonatal Intensive Care Unit 32 years ago, I learned a busy nursing co-worker mistakenly placed a premature infant’s formula tube feeding into the infant’s vein. The infant suffered severe complications and serious permanent injury. Unbelievably, the same mistake is still occurring 32 years later. Reading the various articles surrounding the young mother’s death,  a simple solution – creating connections that can not fit into each other - which occurred when unleaded gasoline for cars was introduced – has met obstacle after obstacle. Various groups have been advocating for this change since 1996.  In fact, California passed legislation in 2008 mandating this tubing design change, but the bill was pushed back until 2013-14. The FDA has yet to declare interchangeable tubes unsafe.

Deborah Campbell, RN. pediatric ICU manager at Kosair’s Children’s Hospital in Louisville, Kentucky and Charlene Roberts, RN. director of system accreditation for Children’s HealthCare Atlanta, participate on the Women and Children’s Safety Committee. The committee advises the Premier Safety Institute, a division of Premier Inc. Premier Inc. is owned by 200 hospitals and healthcare systems. The company’s mission is to collect, analyze and report clinical and financial data in efforts to promote quality, safety, and cost effective US healthcare initiatives. Premier also reported the tubing problem has been identified in published studies for about 12 years.

Premier Inc. shared 3 widely known injuries:

  • 1994: Premature infant given formula via a feeding tube into a vein over 3 hours. Permanent brain damage, blindness, and hearing loss.
  • 1998: 4 month old child given formula via a feeding tube into a vein over 9 hours.  Seizures and sepsis.
  • 2002: 6 month old infant given pureed carrots into a vein.  Death.

Reports cite other tubing related injuries:

  • 2006: Mistakenly placed spinal anesthesia solution meant for the spinal canal was run into a vein. Killed a 16 year old mother giving birth.
  • Blood pressure cuffs have been mistakenly connected to intravenous lines. Inflation led to fatal air embolisms.
  • Intravenous lines have been connected to lines delivering oxygen leading to suffocation deaths.

Most tubing in hospitals is interchangeable and looks exactly alike.  A multitude of hospital clinical staff change and manage tubing lines each day. A Peggi Guenter, Director of Clinical Practice for the American Society of Parenteral and Enteral Nutrition revealed in a recent article, ” There are 6 systems that should be kept separate:  feeding, respiratory gases, urinary, neuroaxial, blood pressure cuffs, and intravenous tubing.” Hospitals have varying procedures to ensure clinical staff properly identify any tubing before using it. However clinical settings are very complex, stressful, and unpredictable. Chaos can occur at any moment. Staff are subject to long working hours with little sleep at times.  As a result, these deadly and costly human factor mistakes continue to happen.

Why has such a simple design concept as non-interchangeable tubing met with national and international obstacles for decades? An international standards group studying various solutions for years has yet to offer recommendations.  Another international task force that includes manufacturers, clinicians and the FDA report nearing completion of a design.  Once introduced and approved, manufacturers will get another 3 years to transition into the new design. AAMI, the Association for the Advancement of Medical Instrumentation, a US organization created by manufacturers has already offered a specific design standard for adult tube feeding sets. The new sets will be incompatible with intravenous female adaptors.  However, most manufacturers will not unite behind the recommendation. Again, why not?

Let’s take the redesign of premature infant feeding tubes as an example of the obstacles to safety in US healthcare. The Premier Safety Institute for Women and Children Committee met with manufacturers in 2003. Manufacturers were asked to design a complete safe premature infant enteral feeding system. Only one company responded. Premature infant feeding systems are a small market niche. Only 30% of NICU babies require tube feedings out of 333,000 premature infants born each year.  Presumably as a result of the small market niche, the product has yet to be introduced and is still in testing. There is no US competition to date. Therefore, the new safe enteral feeding system will reportedly cost 50% more then the $9 to $10 current unprotected enteral feeding system.

A French competitor has sold a new safe premature infant enteral feeding system in France for over 2 years and introduced it into Britain. They have just begun to apply for US approval and do not know how long it will take. Materials Management Magazine reports European manufacturers are required to redesign unsafe products based on stiff human factor (HF)  engineering requirements effecting all manufacturers. Design experts say healthcare is 30 years behind other industries (auto and airline) in HF design requirements.

Another problem Premier Inc. found was  in manufacturer polling results. Both the American and French companies polled American NICU nurses. Nursing managers reported few errors involved feeding and intravenous mix ups. To this group, the higher price for the safer systems was not cost effective based on the low error rate. These polls are driving manfacturers decisions. Critics and those who have studied hospital error reporting have repeatedly shown over many years there is wide-spread under-reporting of mistakes. Basing safe product research and development on unreliable incident data has stalled US efforts by these 2 companies. Without some force driving product development as well as competition, it is unknown as to when (if ever) US patients will have safe tubing systems.

I can only ask the question any mother who has lost an infant, a daughter in labor , or anyone who haswatched a loved one suffer one of these horrible mistakes, ”How many more?” For me personally, will it take another 32 years? As a nurse, I have witnessed the complete devastation of a clinical practitioner who made this mistake and severely injured her patient. Shame on the FDA and American Hospital Association for failing to place the highest priority on resolving this decades old patient safety problem.

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 It Best Recalls Bicycle Bells Due to Violation of Lead Paint Standard

Sunday, March 21st, 2010

Approximately 1,000 bicycle bells were placed under a recall this past week by the Consumer Product Safety Commission (CPSC)  The following are some of the relevant details, and the full recall information can be located at the following link: recall notice.

Name of Product: Bicycle Bells                        

Units: About 1,000

Distributor: Do It Best Corp., of Fort Wayne, Ind.

Manufacturer: Botou Baite Bike Bell Co. Ltd., of Botou City, China

Hazard: The red paint on the bicycle bells contains excessive lead levels, violating the federal lead paint standard.

Description: This recall involves children’s bicycle bells. The bells are red, black and white and has “I ♥ My Bike” printed on the top. The green and white packaging reads “bike bell” and “$1.”

If you or your child has a bicycle bell, please make sure it is not one of the recalled bells.  Thankfully, as of today’s date, there have not been any reported injuries to the CPSC.








Infant Deaths Prompt CPSC Warning About Sling Carriers for Babies

Wednesday, March 17th, 2010

The Consumer Product Safety Commision (CPSC) has posted a warning about infant sling carriers, due to at least 14 deaths associated with the product.  The warning, posted in a release by the CPSC on March 12th, contains illustrations of the different positions, many of which are dangerous, of how babies are known to be carried in sling carriers.  The release also which infants are most at risk, as well as how to protect a child should the caregiver choose to use a sling carrier:

Many of the babies who died in slings were either a low birth weight twin, were born prematurely, or had breathing issues such as a cold. Therefore, CPSC urges parents of preemies, twins, babies in fragile health and those with low weight to use extra care and consult their pediatricians about using slings.

CPSC recommends that parents and caregivers make sure the infant’s face is not covered and is visible at all times to the sling’s wearer. If nursing the baby in a sling, change the baby’s position after feeding so the baby’s head is facing up and is clear of the sling and the mother’s body. Parents and caregivers should be vigilant about frequently checking their baby in a sling.

The CPSC has now added slings to products that require a mandatory standard.  Because time is of the essence, the CPSC is working with ASTM International to attempt to put voluntary standards in place for infant sling carriers, as soon as possible.  The release also has a link for reporting infant sling carrier problems: www.cpsc.gov/cgibin/incident.aspx.

Product Recalls: Granola bars – Trader Joe's Chocolate Chip Chewy Granola Bars

Monday, February 22nd, 2010

I suspect that many of you love to grab that ‘healthy’ and ‘quick fix’ granola bar.  Well before you do, you may want to   check which one it is you are getting ready to bite into.  This notification just in from the FDA of a voluntary recall by Trader Joe’s on it’s product - Chocolate Chip Chewy Coated Granola Bars -Product Recalls: Granola bars.

[I]t has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The FDA’s press release advises that there have been “no illnesses . . . reported to date in connection with this product.” Forewarned is a good policy – so be  forewarned!

For details on contact information on the product’s recall, see the FDA announcement.

Consumer Product Safety Commission vows to crack down on defective cribs – washingtonpost.com

Monday, February 22nd, 2010

An announcement last week by the Consumer Product Safety Commission (CPSC) will hopefully prevent future catastrophic injuries and deaths of infants from crib defects, through tougher federal legislation regarding cribs.  The chairman of the organization, Inez Tenenbaum, made a powerful statement in a recent Washington Post Article in this regard:

While we are on the subject of cribs, I have a message for manufacturers, a message that actually applies to makers of any consumer product,” Tenenbaum said. “I say no more to the tired tactic of blaming parents in the press when CPSC announces a recall that involves a death. Take responsibility and show respect to the grieving family, yes, even if they are pursuing litigation. Those who tread into this arena when CPSC has found your product to be defective will be called out.

The article also details the number and type of crib recalls to date by the CPSC:  

The CPSC has recalled more than 6 million cribs since September 2007, many due to failures related to drop sides, hardware and wooden slats. Consumer advocates and health professionals have long complained that federal safety requirements governing cribs do not address the durability of drop-sides on cribs and related hardware, as well as wood strength and quality and other issues.

Let’s hope that these actions send a powerful message to crib manufacturers and retailers alike, to put safety first, especially when it comes to our little ones.  What could be more important?  We will monitor developments within this and other related recalls.

Contributor: Rodd Santomauro