FDA Ruling Questions Safety and Effectiveness of Antibacterial Soaps

By Kim Smiley

The Federal Drug Agency (FDA) has formally questioned the safety and effectiveness of antibacterial soaps with a ruling on December 16, 2013.   Manufacturers of antibacterial soaps have one year to provide data that proves that anti-bacterial soaps are both safe and more effective than regular soap and water. Any antibacterial products that have not provided sufficient data to satisfy regulators by late 2016 would have to be reformulated, relabeled or removed from the market.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map visually lays out the many causes that contribute to an incident to intuitively show the cause-and-effect relationships.  When starting the Cause Mapping process, the first step is to fill in an Outline. The Outline documents the basic background information as well as lists how the issue impacts the goals.

In this example, there are a number of impacts to the goals worth considering.  The potential financial impacts are certainly significant.   It is estimated that it will cost companies between $112 million and $368 million to comply with the new regulations.  The safety goal is also a key component of this issue since safety concerns are one of the driving factors for the new push for additional data.

The FDA is concerned about the safety of antibacterial soaps because many contain triclosan and other similar chemicals.  Studies using lab animals have found that triclosan can disrupt hormones, such as sex hormones and thyroid hormones.  Interference with the body’s natural hormone levels can have a huge impact on how the body functions, especially in children who are still growing.  Use of antibacterial agents has also been associated with an increase in allergies, although more data would be needed before a definitive link could be established.  Use of antibacterial products may also lead to increased resistance to antibiotics which is an issue generating increasing concern.

In addition to questions about safety, there are also questions about the effectiveness of the products.  Microbiologists at the FDA have stated that there is currently no evidence that use of over-the-counter antibacterial soap is any more effective at illness prevention than simply washing with soap and water.  Consumers buying the products assume that they are getting some sort of additional protection against illness, but that doesn’t appear to be the case.  It is also worth noting that viruses are the most common cause of infection in the United States and antibacterial products are powerless against them.

The bottom line appears to be that antibacterial soaps are more expensive, have potential risks associated with them and aren’t better at preventing illness.   Manufacturers will have the opportunities to present data about their products to the FDA, but I expect that there will be some significant changes to antibacterial products in the future.

The current ruling does not apply to hand sanitizers which are typically alcohol based so don’t be afraid of using sanitizer if hand washing is unavailable.  Also, studies have proven triclosan is effective at fighting gingivitis in toothpaste.  This current ruling only applies to personal hygiene products (like hand soap), but I suspect this is just the first of many hard questions for the billion dollar anti-bacterial product industry.

To view the Outline and Cause Map, please click “Download PDF” above.

Patient Gets MRI (and a Diagnosis) Only After 24 Visits to 13 Doctors

By ThinkReliability Staff

In a tragic case of incorrect diagnosis, a 16-year-old patient died January 24, 2013, eleven months after being diagnosed with “migraines”.  In fact, the patient had a rare brain tumor (known as a disseminated oligodendroglioma-like leptomeningeal tumor).  She died eight days after receiving an MRI that finally properly diagnosed the causes of her headaches, numbness, nausea and eyesight problems.

It’s unclear if earlier diagnosis would have saved the life of the patient.  Though the prognosis is poor for a leptomeningeal tumor, a oligodendroglioma that is treated before it is disseminated gives a long-term survival chance to 80-100%.  The tumor had disseminated once it was found on the MRI, eleven months after the patient was diagnosed with migraines.  However, even if her prognosis was poor, the patient could have spent the last eleven months of her short life enjoying time with her family and friends, instead of making 24 trips to 13 different doctors and, in one particularly devastating appointment, being accused of “putting the symptoms on”.

Although the coroner at the inquest said there was no need to make a formal recommendation for changes at the hospital that failed to diagnose the patient, a spokesperson for that hospital said “In the next few weeks, many of the clinicians who looked after Natasha will be meeting to discuss this sad case and ensure that any opportunities for learning are not missed.”

It is hoped that these opportunities for learning can reduce the possibility of another patient suffering as this patient did, due to a misdiagnosis.  Misdiagnosis is a common source of medical error.  According to an article by Michael Astion, MD, PhD, “Available data suggests that misdiagnoses occur in 15% or more of clinical cases, but overall there is very limited data on the frequency of misdiagnosis in medicine.”  Especially in rare clinical cases such as this one, sharing details of the disease and diagnosis may help other clinicians in the same position.

In order to effectively determine lessons learned and improvements that can be made, the details of a case need to be presented clearly and concisely.  I’ve put together the details of the case in a Cause Map, which uses cause-and-effect to demonstrate the linkage of the issues that led to the tragedy discussed here.

In a blog discussing the cases and possible responses, Suzanne Leigh suggests that if an MRI was denied, other cheaper alternatives, such as a CT scan, be considered.  She also suggests a much more thorough review to “ensure that in the future, scans are  not withheld from patients with potentially life-threatening conditions”  and that the hospital involved should “study the flaws in the system and human errors that led to the failure of 13 doctors to order a diagnostic MRI that would have resulted in emergency treatment earlier in the disease’s progression”.  Given the tragedy of this case, the suggestions seem far more appropriate than the treatment of the patient over the last year of her life.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Baby Suffers Brain Damage After Delay in Newborn Testing Results

By ThinkReliability Staff

A recent watchdog report by the Milwaukee Journal Sentinel found that 3.9% of screenings from a particular hospital took 5 days or longer to reach the lab, though the state guidelines are 24 hours.  (Statewide, 2.9% of samples take five days or more.)   This typically occurs because of a practice called “batching”, where multiple samples are saved to send in as a group.  Although the practice of batching is not recommended, and the state guidelines warn “DO NOT BATCH SPECIMENS”, there are no laws requiring hospitals to send in samples within the 24 hours, nor are there are penalties for not doing so.  According to the state’s newborn screening advising committee, some hospitals continue to batch samples, even though it is the state – not the individual hospitals – that pay to have the blood samples sent to the lab.

A case turned tragic illustrates the problem with waiting to send these blood samples.  We can capture the cause-and-effect relationships that led to a baby suffering brain damage within a Cause Map, or visual root cause analysis, which allows a detailed examination of the issues that led to the nearly fatal outcome.

On October 2, 2012, a baby was born at a Wisconsin hospital.  Per guidelines, a blood sample was taken for newborn screening when the baby was 32 hours old.  However, that blood sample (likely due to batching, though the hospital has not officially confirmed this), was not sent to the state lab until October 8.  The state lab tested the sample October 9 and determined that the baby had Argininosuccinic aciduria, which occurs in only 1 of 70,000 babies in the US. Though it can be fatal, if it’s caught early, the treatment involves some extra care with feeding and an extra day or two in the hospital.

In this case, because the sample was delayed, a diagnosis wasn’t made before the baby had lapsed into a coma.  He was transferred first to a larger hospital, then to one of two hospitals in the state that can perform newborn dialysis – necessary due to his off-the-charts ammonia levels.  A quick-thinking doctor utilized a novel technique of cooling that baby, which saved his life.  The cost of all this treatment was nearly $500,000 and the baby has suffered brain damage, though the extent is not known.

The Journal Sentinel has published data showing how long samples took at Wisconsin hospitals in an attempt to raise public consciousness of this issue.  The state, as well as other experts, continues to advise hospitals of the importance of sending blood samples to the lab for screening within the recommended 24 hours.  It could save a life.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.