Archive for August, 2010

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.

Drug information found lacking

Thursday, August 19th, 2010

Millions of people take daily or weekly medications for a variety of health concerns.  As we all know, each prescription we get comes with a leaflet or other print-out from the pharmacy that explains what the drug is, how it is to be taken, what the side effects are, etc.  The National Institute of Health and Reuters Health are reporting a new study that raises serious questions as to how useful and effective these leaflets actually are.

Dr. Carole Kimberlin and her colleagues at the University of Florida, Gainesville, studied product leaflets on two common medications:  lisinopril (a blood-pressure medication sold as Prinivil and Zestril) and metformin (a diabetes drug sold as Glucophage and Fortamet).  The study found a “great deal of variance” among the various leaflets, including substantial differences in word count, content, and readability.  The reason for these variances?  Unlike prescription labels, which are subject to strict FDA regulation, the leaflets provided by pharmacies are not.  The FDA only provides recommendations for leaflets.  Private publishing companies actually provide the content for leaflets and the pharmacy then decides what information to put on its leaflet, as well as the format of the leaflet.

The differences found by Dr. Kimberlin were striking.  Word counts on leaflets for the same medication ranged from 30 words to 2,500, with a corresponding difference in the amount of drug content contained on each leaflet.  Only three percent of leaflets for the drug lisinopril met at least 80% of the FDA’s recommendations of usefulness criteria.  Only one leaflet for metformin met this same criteria.  The study also found lacking the amount of information related to drug interactions, i.e., how the medication may react to other drugs the patient is taking.

While the differences in content were significant, the study found that even greater differences existed in readability.  It is up to each pharmacy to format its leaflets so there can be large differences in the size of type, the spacing of the text, and general visual clutter – including store ads or coupons.  All of this can make deciphering these leaflets even more difficult.

In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets’ readability. On average, leaflets from all pharmacies met less than half of the criteria for “comprehensibility/legibility.”  For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.

The bottom line – carefully read the product leaflet that comes with your prescription.  And if you have any concern about the drug’s usage, side-effects, drug interactions, etc., be sure to talk to your pharmacist or doctor directly.  You may not be able to rely on the information contained in the product leaflet.


Laughter rings out as a child dies.

Saturday, August 14th, 2010

This past week I interviewed the parents and maternal grandparents of a young child who died in a well known hospital in our area. While our investigation of a potential medical malpractice action against this institution and some of its staff is just beginning, one part of the story being told by this family drove me to post this article.

As resuscitation attempts were underway following the cardiac arrest of this 3 year old boy, the mother, holding her child’s hand during this unspeakable tragedy, heard laughter coming from two uninvolved members of the cardiac resuscitation team. Having interviewed thousands of clients and witnesses for over 35 years in practice, I believe I have a fairly good sense of who is telling a story the ‘way it was’ and those who embellish. I have absolutely no doubt that what I was hearing from this mother was nothing but the raw, unvarnished disgusting truth.

Can you imagine being in her position? Your child has undergone a medical procedure several weeks before. You are with your child 24/7, sleeping in a chair and watching for every small sign of improvement, distress, or turn for the worse. You are assured that he is doing well and that you can leave his room for a break while the staff is attending to some routine follow-up care. You come back to the room periodically just to make sure all is going well and are assured everything is just fine. Suddenly, as you are out of the room, you are found by a staff member and told that you should return to your child’s room immediately. You rush back, enter the room and see your little boy surrounded by medical personnel and your baby lying there in a fight for his life. You are allowed to come near (since apparently the resuscitation efforts are now reaching the stage of futile), you grasp his hand and try to offer whatever love and support you can possibly muster in your state of utter shock and disbelief. As you are grappling with this nightmarish situation, you hear some members of the team engaged in some apparently humorous, laugh-provoking conversation. Talk about surreal. Talk about utter stupidity and insensitivity. Not able to process all that is going on around you, you are then told that it’s time to let him go – “We’ve lost him.”

I am recounting this story since I think it bears telling. As I was listening to this tragic and at the same time repulsive story, I couldn’t help but think about all the years I have seen shows and heard stories of how a few healthcare providers (or police, or paramedics, or firemen – or other people who have to deal with tragedy and death on almost a daily basis) can at times become so jaded to death that they lose all sense of propriety and basic decency when in these situations.

How many times have you viewed a scene on TV or in a movie where the humor is so black that it makes you cringe? This real life story didn’t just make me cringe, it has made me resolute – but more on that in a bit.

Psychologists talk about the use of humor as a means of “coping with the fear of death.” Others have observed: “Humor can be an effective way to ease tensions, reduce stress, and open lines of communication among family members when they are faced with death and abjection.” I suspect you have seen black humor which is the hallmark of TV medical shows such as Scrubs, Grey’s Anatomy and Nurse Jackie. Obviously, we as human beings must find that humorous handing of real life situations such as illness, injury and even death have an important function in our lives. Why else would these shows have any popularity.

I also understand how some are fascinated and truly entertained by gallows humor. A classic example is attributed to Sir Thomas More, who, as he climbed a rickety scaffold where he would be executed, said to his executioner: “I pray you, Mr Lieutenant, see me safe up; and for my coming down, let me shift for myself.”

Did you know there is a series called Dead Baby Comedy? One so-called joke goes like this: “What’s funnier than a dead baby? A dead baby in a clown’s suit.” This pathetic excuse for entertainment is described in one online piece as follows: “Whether or not all the jokes are funny, they’re designed to be as potentially offensive as possible.” Well as far as I’m concerned, they succeeded – it’s about as offensive as it gets!

Speaking of being “as offensive as it gets,” I cannot begin to tell you the depth of my outrage while I sat listening to our new client’s story this past week. What is wrong with people? Can medical staff be so insensitive, callous, disrespectful and repugnant as to not understand how their pathetic jaded lives or poorly timed “coping mechanisms” can affect families in such a situation?

I can only hope that if this case is determined to have merit that I will have the opportunity to cross-examine the participants in this moment of humor. I want to see just how funny they find the experience of being deposed in a lawsuit to be. Hopefully I will give them more moments to treasure the next time they find themselves in such a clinical situation. Maybe, just maybe, they’ll be more sensitive to others.

Thank goodness people like these caregivers are in the minority. They should be drummed out of the medical profession. At the same time I wonder – did any other member of the resuscitation team report or discipline these fools?

What is wrong with people?!

New study links gene to ovarian cancer and may assist in early detection

Tuesday, August 10th, 2010

A new study by Yale University Cancer Center identifies new genetic markers that may be used to assess a woman’s risk for ovariancancer. Specifically, researchers concluded that women with variations or mutations of the KRAS gene were more likely to develop ovarian cancer. The KRAS gene is a stretch of DNA, which is specifically designed to code the KRAS protein. The KRAS protein serves an important function in tissue signaling. In many ways, the protein is a catalyst. When it is activated, it  promulgates various growth factors and stimulates a number of receptors. It has been known for some time that KRAS gene variations or mutations are linked to various types of cancer. This study suggests that the KRAS gene variation is specifically linked to ovarian cancer.

About a quarter of all patients with ovarian cancer were found to have a KRAS gene mutation. About 61% of the patients with ovarian cancer that also had a family history of ovarian or breast cancer were found the have the KRAS gene mutation as well.

To date, scientists have identified a number of genetic markers for ovarian cancer. Among the better known markers are the BRCA1 and the BRCA2 genes. The new KRAS marker appears to have a stronger correlation to ovarian cancer. While about 50% of women with ovarian cancer had the BRCA1 and BRCA2 genes, 60% of women in the same patient population had the KRAS gene mutation. It is also important to note that women with the BRCA genes were more likely to develop ovarian cancer at a younger age. In contrast, the incidence of ovarian cancer in the population of women with the KRAS mutation was more prevalent after menopause.

The Yale study appears to be great news for all women. Ovarian cancer is a particularly difficult and lethal cancer because of its apparently latent and suttle  development. The sings and symptoms are not easy to recognize, and for many women, it is often too late by the time the cancer is diagnosed. This study suggests that testing for KRAS gene mutations is a significant step forward to better screen and assess women for ovarian cancer. For more information on ovarian cancer, please read our prior posting entitled Ovarian Cancer – The Smear Test Won’t Tell You Much.

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.

FDA Proposal Would Increase Oversight of U.S. Medical Devices

Thursday, August 5th, 2010

The Baltimore Sun recently reported on an August 4th announcement made by the U.S. Food and Drug Administration (FDA) that may have a significant impact in the approval process for medical devices here in the United States:

Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.

The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government’s ability to revoke approval for products that prove unsafe or ineffective.

The article discusses the recommendations, which came after “two internal FDA panels that were tapped to draft changes in the wake of the outside criticism.” Of course, there are both critics and supporters of the recently published information.  The article provides a snapshot of each side of the issue:

“Taken together, these preliminary reports show a smarter FDA, an agency that recognizes both sides of our mission to protect and promote public health,” said FDA devices chief Dr. Jeffrey Shuren.

FDA’s critics said the recommendations are a positive first step, but that they hoped for bolder action from regulators.

“The good news is that I think the agency is admitting there are loopholes in the system that have allowed products to be sold that aren’t safe, the bad news is they haven’t yet figured out what to do about it,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families.

This being said, the FDA breaks down their assessment into three objectives, as listed in their announcement: the “three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.”  In addition, recommendations are stated within each of the three objectives.  These recommendations are also preliminary. The FDA announcement quotes a source, CDRH Director Jeffrey Shuren, M.D., as stating:

“Even with our significant outreach, it’s important to remember that these recommendations are preliminary,” said Shuren. “CDRH opened another public docket to receive additional comments on both reports. We will make a decision on which recommendations to adopt only after a thorough review of additional comments.”

It will be interesting to see what the comments are regarding these recommendations.  We will continue to monitor developments and report as they become available.

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!