Posts Tagged ‘hospital liability’

Week in Review (April 23 – 29, 2011): The Eye Opener Health and Law Blog

Saturday, April 30th, 2011

From the Editor:

Last week was a busy but productive week for our firm’s blawgers – 6 posts – and we actually practiced law a lot! My personal thanks to our writers for taking the time to post some important pieces on health, safety, medicine and law. To our readers, my continued and sincere thanks as well. While it’s great to pull-out our soapbox and write about stuff we do and are passionate about, it’s incredibly rewarding to have you, our readers, take the time to read what we write. To those who left comments, a special thanks. We really enjoy interacting with you!

Now on to the business at hand. What did we write about that you may find interesting? Here you go.

My Pet Peeves About the New Age Mediation Process

Having been inspired by a fellow blawger from New York, Scott Greenfield, who chided legal bloggers (thus the name “blawgers”) for simply rehashing news and not taking a stand on issues, I wrote a piece called Mediation of Lawsuits: The 5 Top Things that Tick Me Off!

Having recently been through a number of mediations that were enough to pull your hair out because of the silliness that people engage in when they claim they are mediating to get cases resolved, I decided that it was time to take a stand and post a personal rant. While perhaps best understood by lawyers, claims adjusters and mediators, this blawg was not intended just for them. I’ve seen what impact foolish approaches and conduct by the participants to mediation can have on my clients, the injured parties. It was time to sound-off; so that’s what I did. I once again invite anyone who has been a party to a lawsuit mediation to do your own personal sound-off and tell us what it was like for you. It’s your turn to tell us just how much you enjoyed the process and what can be done to make it better. Read the horror story told in our Comments section by one of our Canada readers when she went through a domestic mediation process. Share your thoughts and stories as well.

Health Care: Who’s “Voiceless” When It Comes to Being Heard on Capitol Hill

Guess I had too much time on my hands at the beginning of this week (not really!). I couldn’t help but be inspired by a piece Jason Penn had done last week about how families were so adversely affected by the budget cuts that were made when the government shutdown was looming a few weeks ago. As I was going through my Google Reader early this past week, I came across an Op Ed by a doctor, who was complaining or at least suggesting that the president and congress need to hear more what doctors had to say about health care reform. Having read that, Jason’s piece jumped into my mind and the result was my blawg entitled Health Reform: What voice does the patient have in the debate.

The post brings to light the amount of money being spent by the healthcare industry in its lobbying efforts on health care reform. ObamaCare‘s raison d’etre is explored as well since it is ironic, if not sad, how the story behind all this money, lobbying and legislation seems to have been lost in the rhetoric. More affordable, better and available health care for our citizens? Then why were the most needy among us the victims of back room wheeling and dealing when the time came for budget cuts to save the federal government from closing its doors? I ask the question – who’s voice is being heard – but more important – who’s is not?

FDA approves use of “meningitis drug,” Menactra, for younger children

Hopefully you’ll never need to use this information, but if you do, Jason Penn reported on a condition – meningitis – that can affect not only adults and older children, but infants and toddlers as well. Meningitis is generally defined as an inflammation of the protective membranes covering the brain and spinal cord. Prior to a recent change in position by the FDA, there wasn’t a vaccine available for children under the age of 2. Now, with the FDA’s recent approval, Menactra can be used to vaccinate children from the age of 9 months to age 2.

In addition to this news release, Jason tells parents about the signs and symptoms they should be aware of to spot this condition.

The classic symptoms of meningitis are a high fever, headache and stiff neck. Detection of these symptoms, particularly headache and stiff neck are certainly difficult to detect in infants and toddlers. According to the Centers for Disease Control and Prevention, infants with meningitis may appear slow or inactive, have vomiting, be irritable, or be feeding poorly. Seizures are also a possibility.

To learn more about this important topic, read his piece Meningitis & Your Baby: Three Things to Think About.

Why are children still dying because of venetian blinds?

Sarah Keogh wrote what I believe is a very important piece for parents, grandparents or anyone who has a baby in the house. Years ago we all heard about the horror of parents finding their babies dead from strangulation when their necks became entangled in venetian blinds. Years have passed since those stories made the front page. Well, an update on just how well manufacturers and parents have been doing to avoid such tragedies was recently posted in The New York Times.

In her blawg entitled Window Blinds: Why are Children Still Dying, Sarah tells us the sad truth that these deaths and injuries still continue in our country. Find out what you as a caregiver of a young child need to realize about this product. Maybe you’ve put the cords up high and out-of-reach for your baby. Maybe you’ve taken other steps to avoid such a nightmarish event ever happening in your home and in your life. Unfortunately, many who have done so have still suffered this tragedy. Why? What is being done by manufacturers and the government to prevent these injuries and deaths ? Read Sarah’s piece for the answers and some practical advice you can take to make your home safer for your child.

Hospitals Reporting Methods for “Adverse Events”

We all know by now that if you want to look good to the public, all you have to do is “play with the numbers.” Well, it seems like hospitals have a penchant for doing just that. One of the key “numbers” that advocates of patient health and safety look at is how many “adverse events” take place in any given hospital. An “adverse event,” as you may already know, is – simply put – any harm to a patient as a result of medical care.

In his post this past week, Jason Penn compares some interesting adverse event bookkeeping by hospitals throughout our country. His blawg, The New Enron? Are Hospitals Cooking the Books?, brings to light serious flaws in the way that our medical institutions “count” the number of so-called adverse events taking place within their walls. His research for this piece reveals…

[M]edical errors occur 10 times more than previously thought.Maybe that wasn’t hard hitting enough. Let me try again. How about this: mistakes occur in one out of every three hospital admissions!

Frankly, that strikes me as an astounding and very concerning number. Are the numbers being reported reflecting this? The simple answer is no. Why not? Read Jason’s post and see what reporting systems are in place – or not in place as the case may be. We all remember Enron. Is this the medical version of “making the numbers look good” when they simply are not!

Surgeons and Booze – an Obvious Bad Combination – Who’s Protecting Us?

It doesn’t take a genius to realize that surgeons should not be under the influence when we as patients are “under the knife” What’s not so obvious is just how prevalent this may be in the operating rooms of our country (and throughout the world).

Wondering what the studies have been done by the medical profession to examine this problem? Have any idea what regulations are in place by hospitals to guard against the problem of “hungover surgeons”?

Wonder no more. Jon Stefanuca’s blog this past week, Hungover Surgeons: Watch Out! There’s Nothing Between You and Their Scalpel!,will tell you all you need to know. Jon queries: “Should hospitals regulate for patient safety?” What do you think? Share your comments.

A “Sneak Peak” of the week ahead

Some more good advice is on the way for parents of special needs children. We all know about what a wonderful aide dogs are for the blind. Mike Sanders will share what he’s learned how these canine wonders are being used for kids in need. Suffering from asthma or know someone who is? Jon Stefanuca will be sharing with  you some valuable information on this topic next week. A number of our clients or their now-deceased family members have suffered from this condition. Jon will share a story or two (without revealing protected confidential information) to bring to light just how this medical condition needs to be better recognized and treated by our health care providers before its too late. We all know what a difficult job nursing can be. That being said, Sarah Keogh will be telling us about some very concerning “trends” that are coming to light in this wonderful profession. Stay tuned for this important piece.

We’ll start next week off with a new blawg by our in-house medical specialist, Theresa Neumann. Her post on how important it can be to get a second opinion before you sign-up for a surgery, procedure or test is sitting in the queue just waiting to hit the pages of The Eye Opener – Views and Opinions from the Nash Community.

One Final Note: I wrote in last weekend’s Week In Review that we intended to post a new White Paper by Marian Hogan on a very important topic relating to Patient Controlled Analgesia (PCA). It didn’t happen – because of “my Bad.” I fouled-up and sent the wrong draft of Marian’ s piece to our graphic designer. He did a wonderful job – as usual – of getting it ready – it just wasn’t the right version. The problem is fixed, but my mistake will delay the posting of this important White Paper for another week. Public apology: Sorry, Marian! We’ll make it right soon.


Week in Review (April 18 – 22, 2011) The Eye Opener Health and Law Blog

Saturday, April 23rd, 2011

From the Editor:

This past week, our blawgers (guess I’ll use this term now since we are legal bloggers) were busy on their keyboards once again. They covered a number of topics relating to law, medicine, health and patient safety. This week we posted a primer on aortic aneurysms and how they can present as back pain, a blog about “robot” anesthesiology, a disturbing post about how the recent threat of a federal government shutdown was averted but at a cost to those who are in dire need of healthcare, an interesting piece about laughing gas making its way back into the American medical scene for labor and delivery and finally, and a highly read piece on a not-to-often discussed topic but one of potential grave concern – shift switching by nurses and how this might impact patient safety.

Here’s our usual “quick summaries” for you to peruse, click on, read and comment:

Aneurysms – a deadly condition you need to know about!

Our in-house medical specialist, Theresa Neumann, wrote another highly educational and need-to-know piece about a condition that can present as back pain but which has deadly consequences for those who have this condition.

As Theresa’s research made us aware – “1 in every 50 males over the age of 55 have an abdominal aneurysm, this is a more common pathologic diagnosis than some others.  Men also corner the market at an 8-to-1 ratio as compared to women with abdominal aneurysms.”

As is the case with all of Theresa’s writings, we offer through her valuable information from someone who’s “been there” and “done that” in the clinical setting. Don’t miss her post entitled Aneurysms: A Potential Deadly Condition That May Present as Back Pain.

Who’s using remote control and a joy stick to put a breathing tube down your throat?

Mike Sanders brought to our attention a new practice of anesthesiologists – in Canada – that may soon be part of anesthesia management in the United States as well – using robotics to intubate patients. While you can certainly learn about the concept of intubation by reading Mike’s blog, basically, this is placing a small tube down a patient’s airway so that the anesthesiologist can control the airway and provide ventilation to a patient undergoing surgery.

Here’s an except -

Medical News Today is reporting that Dr. Thomas Hemmerling of McGill University and his team have developed a robotic system for intubation that can be operated via remote control.

For more on this fascinating new project by Dr. Hammerling and his team, read Mike’s post entitled Robot Anesthesiologists?

Government Shutdown Avoided – but who will pay the price for the “deals” that were cut?

The newest member of our blogging team, Jason Penn (fast approaching veteran blawger status) did a fascinating piece of the story-behind-the-story of the recent crisis our country faced when the federal government was on the verge of a shutdown. We all know about deals being cut in the back rooms of congress. We all know that the government avoided a shutdown this time around when the senate and house worked out a compromise that resulted in millions of dollars being earmarked for cuts in the budget.

Jason tells us what programs relating to healthcare will suffer as a result of these negotiated cuts. As some wise person once said, “why is it always those who are least represented who bear the burden of budget cuts?” Maybe it’s because they can’t afford lobbyists to protect them like those who need protection the least can.

Read Jason’s eye opening and no-punches-pulled report on just who will be the victims of the deals in his post of this past week Budget Crisis Avoided, But What About the Babies? Can They Live With $504 Million Less in Funding?

Will moms-to-be now be “laughing” their way through labor and delivery?

One of our seasoned blawgers, who every now and then is driven to report on the off-beat issues of law, medicine and healthcare, Jon Stefanuca, stepped up to the plate once again and took a swing at the return of an old-timer to the arsenal of pain relief for mothers-to-be undergoing labor and delivery – laughing gas!

As Jon’s piece in Eye Opener this past week tells us -

It appears that a number of hospitals are now considering making laughing gas available as a pain relief measure for women in labor. A hospital in San Francisco and another in Seattle have been using laughing gas in their labor and delivery units for a while. Hospitals like Dartmouth-Hitchcock Medical Center plan to offer laughing gas to laboring mothers in the immediate future.

For more about this return of laughing gas to our obstetrical units, read Jon’s piece Laughing Gas Making Its Way Back Into the Labor and Delivery Department.

Nursing and Sleep Deprivation: Is it a risk factor for patient safety?

I suspect somewhere along the line you have done “an all-nighter” – whether it was getting ready for a big test, a social event, or for some other reason. Remember how you felt as you made it through that night or the next day? Have you ever done it several nights in the same week? How about doing it a few times one week and then do the same thing the next week and the next…. Well you no doubt get the idea. You’ve been exhausted, right? Well what about nurses, who have to do this for a living?

Nurses have lives too. They have children, home responsibilities and obligations, and some form of social life. What happens when they swap shifts or are asked to do “a double”?

Sarah Keogh was back blogging this past week and wrote a fascinating (and concerning) post entitled Nurses Switching Shifts: Does a Lack of Sleep Put Patients at Risk? We invite you to read Sarah’s piece and share your comments. Are you a nurse who lives this lifestyle? What are your thoughts about nurses being allowed to work multiple shifts or back-to-back shifts in terms of patient safety? Should there be restrictions on nurses’ shifts just as there (finally) are work restrictions on doctors-in-training?

A “Sneak Peak” of the week ahead

As part of our continuing effort to “get the word out there” on issues relating to health, medicine, patient safety and the law, we post from time to time more extensive research pieces called White Papers. Well, the time has arrived for another White Paper to be posted on our website. Marian Hogan has completed her piece on a very important topic – Patient Controlled Analgesia in today’s hospital environment. She examines how some hospitals are now heavily marketing a spa-like environment so you choose them over the competition. Yet lurking in the shadows of these facilities which promote flat screen TV’s, valet parking, in-room safes and the like is a very dangerous practice: placing patients on patient-controlled-analgesia (for pain relief) without vital monitoring devices and patient safety practices. It’s at the “printer” now; we hope to have it online this week.

From our blawgers you can expect reports on a disturbing fight between manufacturers and child safety experts over – blinds! After decades of controversy, you’ll find out where the battle lines are now drawn, who’s winning and who the real losers are in this war. Wonder how healthcare safety is doing since the report To Err is Human was published by the Institute of Medicine over a decade ago? Jason Penn will be providing an updated report card, which you should not miss. Alcohol and surgery – not a good combination! Jon Stefanuca plans on posting a piece that looks deeper in the obvious problems with this potentially deadly combination.

This is just a taste of what’s to come. I better wrap-up now. I’m working on finishing the third installment on Medical Technology and Patient Safety. Oh yeah, if time permits, I might even get to post a piece I’ve been working on this past week – a lawyer’s rant about our modern day love affair with mediation practices and trends.

As always, don’t forget - subscribe to the Eye Opener and tell your friends about us too! …and… don’t forget to join our social networking communities on Facebook and Twitter.

Hope you have a great weekend!

Report Card on Failing Hospitals: Prince George’s Hospital Center Tops ‘Complications’ List

Tuesday, April 12th, 2011

From the Editor (Brian Nash):

The following is the first of many blogs-to-come by our new associate lawyer, Jason Penn. Read about Jason’s background and enjoy reading his first venture into the blogosphere of medicine-law-healthcare.

By: Jason Penn

Prince George’s Hospital Center finds itself at the top of yet another dubious list.  With 4 out of every 1,000 patients experiencing a complication, Prince George’s Hospital has failed to meet a target for the prevention of complications set by the Maryland Health Services Cost Review Commission.

The penalty for Prince George’s Hospital?  The hospital’s ‘rate increase’– or how much the hospital can charge for services rendered — will be lowered by $890,000 for next year.  The State uses a payment-related methodology to reduce the frequency of hospital-based complications.  The State of Maryland has the authority to establish hospital payment levels applicable to both private insurance companies and public insurers such as Medicare and Medicaid.  The methodology links payments to hospital performance on a list of 52 acquired conditions.  These conditions are complications that are unlikely to be a consequence of the natural progression of an underlying disease.  The program seeks to eliminate some of the most serious and injurious patient complications in Maryland’s 47 acute care hospitals:  bed sores, infections, accidental punctures or cuts during medical procedures, strokes, falls, delivery with placental complications, obstetrical hemorrhage without transfusion, septicemia, collapsed lungs and kidney failure.

The Maryland Hospital Acquired Conditions Initiative, begun in 2009, is an effort to tie financial incentives and penalties to how well hospitals perform in reducing life threatening, dangerous and preventable complications.  Maryland’s motivation in starting the initiative is not pure; rather, as the Commission’s name suggests, it is a cost savings measure.  Patient safety taking an apparent backseat, the Commission recognized that many of the complications that occur in the hospital setting are costly, to the tune of $521 million in 2010.

Prince George’s Hospital Center is not alone, however.  Eight other Maryland and Washington D.C. area hospitals will face penalties for complications.  Doctors Community, Washington Adventist, Montgomery General, Shady Grove Adventist, University of Maryland Medical Center, St. Joseph Medical Center, and Civista Medical Center of Cumberland, Maryland have been penalized due to their failure to meet targets for the prevention of complications.  Those hospitals will lose a combined $2.1 million in the amount they can charge patients, according to a story first reported by Kaiser Health News.

The Commission’s Executive Director Robert Murray noted in a news release that in fiscal year 2008, the Commission estimated preventable, hospital-based complications were seen in “55,000 of the State’s total 800,000 inpatient cases,” representing $522 million in hospital payments that could have potentially been avoided.  The number of complications is staggering:  The University of Maryland Medical System had an observed number of complications of 1223 cases; Prince Georges Hospital had 553; while Montgomery General Hospital had 304 listed.  All three hospitals were worse than the state average.

In the original Kaiser Health article, Mr. John O’Brien, president of Prince George’s Hospital noted that “the problem mainly lies in how the hospital tracks, codes and reports data, not in patient care.”

One thing seems certain – Prince George’s Hospital is failing.  The numbers certainly suggest that it is failing in its patient care responsibilities yet Mr. O’Brien reports that it is merely a “failure of its tracking system.”  If, theoretically, it is as Mr. O’Brien says – that the tracking system is faulty, how does he conclude that the system is creating false positives and is not underreporting the errors?  The common thread is clear.  Prince George’s and other local hospitals are failing, either at tracking untoward events or at patient care and likely injuring their patients in the process.

The truly frightening aspect is that there are an untold number of patients that were irreparably harmed by these complications.  At first blush, the State’s attempt is laudable, clearly designed to hit the hospitals in their wallets for its misgivings.  The penalties notwithstanding, the State’s initiative offers no mechanism to compensate the victims of these hospital complications.  Every indication is that the injured patients and their advocates are left to pursue alternative avenues to obtain compensation for these so-called “complications.”

 

Why do so many patients die when their in-hospital alarms go unheard or unheeded?

Thursday, February 17th, 2011

ICU alarm monitor

Sunday’s edition (February 13, 2011) of the the Boston Globe online (boston.com) tells a chilling story of how many times the alarms used to monitor patients go unheard and unheeded by medical staff leading to death or catastrophic injuries for patients throughout this country. The story, which was a two part series (for the second installment, see For nurses, it’s a constant dash to respond to alarms) by Globe reporter Liz Kowalczyk, narrates numerous incidents in which alarms simply went unnoticed, ignored or unmonitored. Numerous other issues such as lack of education of hospital staff as to how to properly connect the devices, failures to realize the batteries had gone dead, turning the alarms so low in volume they could not be heard, taping over amplification systems to avoid the “annoyance” of the alarms and the like are also chronicled in this series. While it is documented by an analysis of the FDA’s database of adverse events involving medical devices that 216 patients died nationwide between 2005 and mid-2010, it is also certain that this number of alarm-related deaths is probably much higher. The ECRI Institute, which was hired by the Globe to analyze the FDA database, believes that the health care industry under-reports these cases to the FDA.

Some examples of alarm-related deaths

Since links to the Globe’s original articles are provided above, I will not go into the level of detail that is otherwise available through reading the original reports. Here is a sampling of the types of “alarm failures” leading to patient deaths:

  • staff misprogrammed complicated monitors
  • staff had forgotten to turn the monitors on
  • batteries had gone dead leading and failed to function (one instance where a man had a “flat line” for more than two hours that went undetected)
  • defective wires or connections on the monitors
  • malfunction or design flaws in the monitoring devices
  • staff ignored the device warnings because of “alarm fatigure

Alarm Fatigue

According to one computation at Johns Hopkins Hospital in one 15 bed unit as to how often alarms go off during the course of day, it was documented that there were 942 alarms per day – “about 1 critical alarm every 90 seconds.” There is no doubt that the number of alarms and the clinical settings in which they are used have increased over the years. As Ms. Kowalczyk noted, “[W]ith the use of monitors rising, their beeps can become so relentless, and false alarms so numerous, that nurses can become desensitized – sometimes leaving patients to die without anyone rushing to their bedside.”

In some cases, busy nurses have not heard or ignored alarms warning of failing batteries or other problems not considered life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, can go unheeded. At one undisclosed US hospital last year, manufacturer Philips Healthcare, based in Andover, found that one of its cardiac monitors blared at least 19 dangerous-arrhythmia alarms over nearly two hours but that staff, for unexplained reasons, temporarily silenced them at the central nursing station without “providing therapy warranted for this patient.’’ The patient died, according to Philips’s report to federal officials.

Keep in mind that many of these alarms are not only audible in the patient rooms; they also sound at the central nurse’s station. In some instances, hospitals have put up hallway speakers for nurses to hear the alarms more readily. In other facilities, in addition to audible alarms, various pieces of critical data information (e.g. heart rhythm, heart rate) are visible on displays at nurses stations and in some places, it is reported, “on brightly colored scrolling signs in corridors.”

The article quotes one nurse at Boston Medical Center, who addresses some of the issues at the heart of this “alarm fatigue” phenomenon.

Everyone who walks through the door gets a monitor. We have 17 [types of alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes...background

False Alarms - the cry wolf issue

It is well known that some alarms can go off when a patient sits up, coughs, turns or makes other normal movements. According to the Globe report, "'[s]ome studies have found that more than 85 percent of the alarms are false.” I have no idea how this statistic was compiled, but even if it is accurate (which is debatable), that still leaves dozens if not hundreds (if not thousands) of alarms going off daily in every hospital throughout this country that are an indication of a patient in need of rapid response life-saving care.

Another nurse is quoted by the Globe in expressing both the frustration and the need for attentiveness when the alarm goes off. “You have to respond to the alarm[, b]ut there are some days when you feel you’re just running from alarm to alarm. It can be exasperating.”

The Fix

The short answer appears to be: there is no easy, quick fix. Here are some of the measures institutions have taken to address this problem:

  • working with engineers at prestigious institutions (e.g. MIT’s work with Boston’s Children’s Hospital) to develop more sophisticated monitors to identify true crisis alarms.
  • hiring of dedicated monitor technicians and/or nurses, who man the central nurses’ station to triage alarms.
  • specialized education programs to avoid misprogramming or connection mistakes due to lack of knowledge by staff
  • establishing tighter standards of which patients should be connected to alarmed monitors – to cut down on the “background noise” of alarms.
  • replacement of old equipment for more advanced, accurate alarm/monitor systems
  • implementation of new programs in-hospital to require bioengineers to check the monitors daily to make sure they are working properly.
  • implementation of standardized settings on machines so that alarms are not turned so low they are non longer audible. (One case of a patient death was attributed to staff turning the the “vexatious” alarm down to a 40% of full volume – no one responded to an arrhythmia alarm for 40 minutes because no one heard the reduced volume alarm during that time.)
  • changing batteries every day in monitors to make sure they are, in fact, charged and working

The Blame Game

As you might suspect, the finger-pointing that takes place after a patient is found dead or severely injured is rampant. As the Globe reports, “Initially, hospitals almost always blame the monitor’s alarm for not sounding when it should have, according to reports. But the company investigations show the assertion is often false.”

In 40 of the cases reviewed by the Globe, the alarms did not sound, usually because the staff had not properly programmed or turned on the machines.; in only eight cases was there a malfunction or design flaw.

[I]n nearly 100 cases, manufacturers ere unable to determine exactly what went wrong, often because they didn’t have enough information, or they told federal regulators they still were reviewing the death.

Where to from here?

While I certainly don’t have to contend with the incessant noise of alarms going off all day long, nor am I required to jump away from what I’m doing to respond to a false alarm, I can’t help but think that in a health industry as advanced as ours allegedly is, there must be some steps that can readily be taken so that others don’t die because some nurse has “alarm fatigue,” or a battery died, or the volume was turned down too low to avoid the annoyance of the alarm or some other ill-conceived and unacceptable reason.

What suggestions do you have for the healthcare industry to deal with this problem? Have you ever worked in a setting where this is a problem? If so, how did you and/or your institution deal with this issue? There are a lot of smart people in bioengineering and in our health institutions; why is this still such a problem in a country that claims to be so advanced?

Image by ectopicinteractive.com

FDA warning to healthcare professionals: use sterile prep pads!

Tuesday, February 8th, 2011

Sterile Prep Pads

On February 1, 2011, the FDA issues a News Release about the use of non-sterile alcohol prep pads in certain clinical situations.

“Non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery.”

This reminder/warning was issued in the wake of a recall on January 5th of all lots of alcohol prep pads and swabs manufactured by The Triad Group of Hartland, Wisconsin citing concerns about the product’s potential contamination with Bacillus cereus, a bacterium that can be harmful to humans.

While I guess we all need reminders now and then, do healthcare professionals really use non-sterile pads for pre-procedure prep when sterile technique is called for? Isn’t this basic training?

We have heard over and over again about the problems with infection control in medical facilities. Isn’t this a basic way to improve infection control – using sterile prep pads when doing open or penetrating skin procedures? Oh my!

While we in law deal with the end-result of failures to use “sterile techniques” – including the basic concept of using sterile pads - is this really such a problem in the healthcare industry that the FDA needs to remind providers to use the right kind of pad?

A number of our readers are members of the healthcare profession. Tell us – please, is this really a problem in the industry? Are there not basic protocol, stock control, safety measures in place that deal with this apparent problem? The rest of our readers either have been a patient or have a family member who’s been a patient; have you ever encountered a problem with an infection because your provider used the wrong type of prep pad?

Image from dailymed.nlm.nih.gov

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.