Tag Archives: Root Cause Analysis

Root Cause

13-Inch Surgical Tool Left In Patient for Months

By Kim Smiley

For about two months after surgery to remove a large malignant tumor Donald Church complained of severe pain.  Initially, he was told that it was normal pain associated with recovery from a major surgery, but an x-ray was ordered after his physician felt a lump in his abdomen.  The x-ray revealed that a malleable retractor similar in size to a ruler had been left inside his body after surgery.  A second surgery was done to remove the tool.  Mr. Church is not expected to suffer long-term health consequences and received a $97,000 settlement.

A Cause Map, a visual format for performing a root cause analysis, can be built to help understand how this issue happened.  Once all the causes that contributed to an issue are found, potential solutions can be found and the most promising can be implemented to help reduce the risk of a similar issue reccurring.

So how did this happen?  How does a large surgical tool get left inside a patient?  This occurred because the patient needed surgery to remove a tumor, the malleable retractor was used during the surgery and the surgeons were unaware that the tool remained inside the patient. (These causes are vertical on the Cause Map with “and” between them because all 3 were necessary for the issue to happen.)  A malleable retractor was used while the wound was being closed to help protect the organs under the wound from possible puncture from the suturing needle.

The surgeon was unaware that the tool was inside the patient because he couldn’t see it and there wasn’t an adequate system in place to manage surgical tools.  Malleable retractors are normally held partly out of the wound, but it had slipped entirely inside the wound during the surgery.  Once the tool was out of sight, it was forgotten.  While many hospitals have requirements to formally count surgical tools as they enter and leave the operating room to ensure that all are accounted for, there wasn’t a policy in place in the facility that performed the surgery at the time.  With no formal system to track tools, there weren’t any easy indications to the operating team that there was a problem.

While this is a particularly egregious example, there are an estimated 4,000 cases of retained surgical items each year in the United States. Better solutions need to be found to reduce the risk of this preventable and potentially deadly problem from happening.  A simple solution to reduce the risk for retained surgical items is to institute a formal procedure for counting surgical supplies and tools before and after surgery.  Simple manual counts are a first step, but errors still occur, especially in the often hectic and stressful environment in an operating room.  Some hospitals use a visual inventory system where tools are brought in a special storage bag with an individual compartment for each item.  As items are done being used they are put back into their specific spot.  If all compartments are full, everything is accounted for so it’s easy to tell if something is missing.

Another solution that is gaining in popularity is use of an electronic tracking system.  The most common use of electronic systems is to track sponges, which are by far the most common object left inside patients.  Each sponge has an electronic tag and the patient is scanned after surgery to verify that none were left behind.  Sponge tracking systems add about $8 to $12 to the cost of each surgery and have dramatically reduced the number of retained sponges when used.

To view a high level Cause Map, click on “Download PDF” above.

Root Cause

New Study Finds that Dirty Stethoscopes May Spread Germs

By Kim Smiley

It’s been well documented that washing hands can prevent infections and in the same vein some researchers are now asking questions about potential contamination risks posed by stethoscopes and other small medical equipment used to examine multiple patients. In a recent study, stethoscopes were tested after they were used to examine patients and most were found to have bacteria on them.  Unlike the guidance provided for hand washing, there are currently no guidelines that require physicians to disinfect their stethoscopes between patients.

This issue can be analyzed by building a Cause Map, a visual format for performing a root cause analysis.  In a Cause Map, the causes that contribute to an issue are laid out to show the cause-and-effect relationships to aid in understanding the role the causes played.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information for a problem such as the location and time it occurred.  Additionally, how the issue impacted the organizational goals is documented on the Outline.  The possibility of patient exposure to bacteria is an impact to the safety goal in this example.  Once the impact to the organizational goals is defined, the Cause Map is built by asking “why” questions.

Why is there a risk of patient exposure to bacteria?  This is happening because a contaminated stethoscope may be placed on a patient’s skin.  Stethoscopes are commonly used to listen to a patient’s heart and lungs and they work best when placed directly onto the skin.  Stethoscopes may get contaminated from being used on a person with bacteria on their skin and stethoscopes are not necessarily cleaned between uses.  Stethoscopes aren’t always cleaned between uses because there are currently no guidelines requiring it.  There aren’t any guidelines because it hasn’t been clear if they are needed.  There has been limited research done to understand the issue and determine how much of a risk of illness a contaminated stethoscope may pose, especially if used on healthy skin.

The new study is a good early step in understanding the issue, but it was a relatively small study and a larger scale study may be needed in the future.  The study “Contamination of Stethoscopes and Physicians’ Hands after a Physical Examination” looked at the stethoscopes used by three physicians as they examined a total of 83 patients in a Swiss hospital.  The researchers found bacteria on the stethoscope after 71 of the patient examinations.  It’s also difficult to determine whether bacteria on stethoscopes is responsible for spreading bacteria and whether it has actually caused illness.

The final step in the Cause Mapping process is to come up with solutions that can reduce the risk of the problem recurring in the future.  One good thing about this particular issue is that the solutions are relatively easy and cheap.  Physicians who are concerned about the cleanliness of their stethoscopes can either give them a give clean with disinfectant between patients or use disposable covers that are already commercially available.  Guidelines about cleaning stethoscopes are likely years in the future, but you can always ask your physician about the issue or to clean the stethoscope if you are concerned.

Root Cause

Failure to Read Back Physician Order Causes Patient Death

By ThinkReliability Staff

A patient suffering from pneumonia required a bedside bronchoscopy in a California hospital.  In order to provide sedation for the procedure, the physician performing the procedure requested a dose of Versed.  Although the actual dosage requested was not recorded, the nurse gave the patient 2 milligrams via IV and, a minute later, another 2 milligrams.  The maximum published dose for Versed is 1.5 milligrams over no less than 2 minutes.

Because of the bedside scenario and the verbal order for medication, the nurse was required by hospital policy to repeat back the order.  He did not, so there was no opportunity for the physician to realize the error.  Within a few minutes, the patient stopped breathing and was administered CPR.  However, the patient never regained consciousness and died nine days later.

We can look at this issue within a Cause Map, a visual root cause analysis that addresses all the cause-and-effect relationships that resulted in the issue being investigated.  The analysis begins with the impacted goals.  In this case, the patient safety goal is impacted due to the patient death.  The failure to follow hospital policy regarding repeat back of verbal orders is an impact to the compliance goal.  The patient services goal is impacted by the overdose that was administered.  The overdose resulted in extra care required for the patient, an impact to the labor goal.  As a result of the issue, the hospital was fined $50,000 by the California Department of Public Health.  (Click here to read the report, which was used to create this blog.)

Beginning with an impacted goal and asking “Why” questions adds more detail to the analysis.  In this case, the overdose occurred due to the need for Versed and the larger than ordered dose.  The larger than ordered dose resulted from a miscommunication between the physician, who ordered the Versed, and the nurse, who administered it.  The nurse did not repeat back the order as required, and the physician did not request a repeat back.  Although the requirement was apparently for the person receiving the order to repeat back, patient safety is everyone’s responsibility.  Pausing the procedure to ask for a repeat back would have likely saved the life of this patient.

Not mentioned in the analysis was the conditions under which the order and procedure were performed.  Clearly ability to hear was a concern.  A study published in May of 2013 determined that background noise in the operating room can result in difficulty in communication between team members, not only by affecting team members’ ability to hear each other, but could also impair an individual’s ability to process auditory information.  Other studies have found that other environmental factors can impact medical errors.  Specifically, one study found that most medication errors were more likely to occur when the previous 30 minutes were hectic and involved staff member distraction.  It is unclear how much of a role the environment played in this case.

The hospital involved in the issue focused efforts on ensuring hospital policies were re-emphasized.  While this is a typical response in this type of situation, the training efforts must ensure that the importance of the policies is emphasized, possibly by using lessons learned from actual cases to demonstrate the risk of these policies not being followed.  Additionally, all staff must take responsibility for patient safety.  Even though the policy required repeat back by the nurse, other staff members involved with the procedure should have played a role in ensuring that the communication between members was adequate to ensure patient protection.

Want to learn more? See our webpage about medication errors in medical facilities or watch the video.

 

Root Cause

Norovirus Outbreak on Cruise Ship Sickens Over 600

By Kim Smiley 

A cruise ship has once again made national headlines for a negative reason.  A norovirus outbreak on Royal Caribbean’s Explorer of the Seas sickened nearly 700 hundred people during a cruise that ended on January 29, 2014.  Noroviruses are extremely unpleasant and cause extreme stomach cramps, vomiting and diarrhea, not exactly the stuff fantastic vacation memories are made of.  According to the Centers for Disease Control and Prevention (CDC) there have been 56 gastrointestinal outbreaks on cruise ships in the past five years, but this outbreak is notable because it was one of the largest in 20 years.

This incident can be analyzed by building a Cause Map, a visual format for performing a root cause analysis that intuitively shows the cause-and-effect relationships between the causes that contribute to an issue.  A Cause Map is built by asking “why” questions and documenting the answers. ( To view a high level Cause Map of this example, click on “Download PDF”.)

In this example, the initial source of the norovirus is not known and may not be able to be determined, but a Cause Map can still be helpful in understanding how the outbreak spread and how the outbreak impacts the goals of the company.  The CDC did investigate the outbreak, but it can be difficult to determine how the norovirus was brought onboard.   Noroviruses are common, especially during the January through April peak season for norovirus infections, and cruise ships need to have a plan to deal with sick passengers because simply preventing a norovirus from coming onboard isn’t realistic.

Once a person infected with a norovirus is onboard a cruise ship, the illness can spread quickly because is highly contagious.  Noroviruses can be transmitted by contact with an infected person, consuming contaminated food and even touching contaminated surfaces such as stair handrails.  Cruise ships, along with other confined spaces such as nursing homes, are particularly susceptible to fast spreading outbreaks of norovirus because there is a large number of people in a small space and it can be a challenge to isolate sick people.  Many cruise ships also serve meals buffet style which can pass the virus quickly to a large number of people.

The cruise ship did have a plan in place to help mitigate any outbreaks and the number of ill passengers was decreasing by the time the ship returned to port.  Sick passengers were isolated to their cabins and crew increased cleaning and sanitation of the ship during the cruise.  The ship was also given an especially thorough cleaning and extra sanitizing prior to departure of the next cruise.  In order to track and help cruise ships prevent outbreaks the CDC also runs a Vessel Sanitation Program, which monitors illness at sea and provides information about disease prevention.  If plan to take a cruise, the best way you can protect yourself is by frequently and thoroughly washing your hands with soap and water.

Visit our previous blogs if you are interested in learning more about other cruise ship examples:

Engine Room Fire Results in Cruise Ship Nightmare

Cruise Ship Loses Power

The Salvage Process of Costa Concordia

Root Cause

Man Found Dead After Waiting 8 Hours for Emergency Treatment

By ThinkReliability Staff

A man seeking treatment for a rash at a Bronx hospital emergency room (ER) was found dead eight hours later, still in the waiting room, of as-yet unknown cause.  The incident is currently under investigation by the New York State Department of Health and the cause of death will be determined by a medical examiner.

When performing an investigation of a case like this one, it’s important to focus on the goals that were impacted by the incident and determine all the causes that resulted in the goals being impacted, not just finding one “root” cause.  In this case, the impact to the patient safety goal has clearly been impacted because of the death of a patient within the hospital itself waiting to be seen.  The patient service goal was clearly impacted because the patient did not see a doctor in the six hours – or more – between arrival and his death.  The schedule goal is impacted by the significantly higher-than-average wait at this particular ER.  Lastly, the labor goal appears to be impacted by insufficient staffing levels.

According to the hospital, the cause of the patient’s death is simple.  Per the Hospital spokesperson: “His name was called several times on several occasions, and he did not respond… People have personal responsibility when your name is called, you have to get up and see the doctor.”  The hospital says that all guidelines were met and, even goes so far to add that “probably this scenario in this shape and form has happened in any big hospital in New York City.”

Many don’t find that answer acceptable. Although hospital guidelines may have been followed, there’s no discussion of whether the guidelines were adequate.  It is apparent that the hospital guidelines do not include any sort of care or supervisor for patients prior to being called in to the waiting room.  However, there’s no discussion of whether that meets the standard of care expected of these hospitals.  As this lack of oversight resulted in the death of a patient going unnoticed – potentially for hours – in a hospital waiting room.

In addition, the incident has brought up questions about the impact of the long wait time.  The wait at the emergency room for this hospital is an average of 306 minutes – more than 5 hours.  The national average is 137 minutes and the average in the state of New York is 155 minutes.  When the patient was called, starting at 2 and a half hours after entry, he may have well been asleep, given that the next interaction he had was with a security guard who woke everyone in the waiting room at 2 a.m.  This periodic waking of people in the waiting room – meant to ensure that nobody was using the waiting room as a shelter – next happened at 6:40 AM, and is when the patient was found dead.  Unofficial reports suggest the patient may have been dead for hours.  The patient was last seen moving at 3:45 AM on security cameras.

These questions demonstrate the fallacy of the one “root” cause approach.  The hospital’s assessment begins – and ends – with placing blame on the patient for not responding to a call in the ER.  But this expectation may not be appropriate in all cases.  Although a shorter ER wait time may or may not have saved the life of the patient in this case, it would certainly ease the strain of an ER visit for most patients and potentially save a life.  There have been several publicized cases of deaths or significant disabilities resulting from waiting too long in the ER.  Certainly an incident like this occurring at a hospital merits a review of policies that allowed a man to die unnoticed by staff.

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

Root Cause

Inappropriate Antibiotic Risk Not Decreasing for Adults

by ThinkReliability Staff

Infections caused by bacteria (such as sinusitis and tonsillitis) respond to antibiotics; those caused by viruses (such as bronchitis and influenza) do not.  Prescribing antibiotics for viral infections will not treat the infection and contributes to the rise of antibiotic-resistant bacteria. This is known as inappropriate antibiotic use.   A recent study showed that efforts to reduce inappropriate antibiotic use have been effective in pediatric, but not adult, patients with acute respiratory tract infections.

To thoroughly understand the issue, we consider both the effects and causes of inappropriate antibiotic use.  A cause-and-effect diagram, or Cause Map, visually lays out these cause-and-effect relationships.

The effects of the issue are captured in a problem outline.  Effects are captured with respect to an organization’s goals.  In this case, the impacted goals are wide-ranging, so we look at them from a general health industry perspective.  Unnecessary antibiotic use can impact the person to whom they are prescribed, which impacts the patient safety goal. Unnecessary antibiotic use also increases antibiotic resistance, a growing public health problem with no easy answers.  This can be considered an impact to the public safety goal.  (For more information, please see our previous blog about antibiotic resistant bacteria and fungus.)

Besides patient and public health safety concerns, unnecessary use of antibiotics can result in unnecessary cost.  A program at a University of Maryland hospital that monitored antibiotic use resulted in $3 million in annual savings with no impact to care quality.  However, when the program ended, so did the savings.

In addition to capturing the impact to the goals in the problem outline, we can capture general information about the issue being analyzed, including important differences.  These differences can provide valuable information about potential causes to be evaluated.  An interesting difference noted in the study is that efforts to reduce unnecessary antibiotic use were effective for pediatric patients but not adults.  So far, the reason for the difference in pediatric and adult use has not been determined, but a decrease in inappropriate antibiotic use for children is a positive step forward.  (And not just because of antibiotic resistance.  A 2012 study found that antibiotic use in infants can lead to obesity.  Click here to learn more.)

After the effects of an issue are determined, cause-and-effect relationships that will lead to the causes of an issue can be developed by asking “why” questions.  In this case, several possible causes for inappropriate antibiotic use have been suggested.  Identifying causes allows more opportunities for solutions to address these causes.

Perceived pressure from patients to receive an antibiotic when presenting to the emergency room for an acute respiratory infection and difficulty making a definitive diagnosis to determine whether the infection is viral or bacterial are two of the reasons given for the continued inappropriate use of antibiotics.  Patient education can help.  A review of 89 studies in 19 countries found that prescriber access to education and advice or restrictions on prescribing antibiotics have been effective in reducing inappropriate antibiotic use.

A surprising increase in the use of antibiotics appears to be due to a reduced out-of-pocket cost borne by patients.  After Medicare Part D went into effect, reducing drug costs for some patients, a study found increases in antibiotic use for acute respiratory infections.  The study suggested that changes in patient cost-sharing may be effective in reducing unnecessary antibiotic use.

It’s likely that a combination of causes will be needed in order to reduce the prescribing of unnecessary antibiotics to a minimal level that can aid in the fight against antibiotic resistance.  Ideally, further studies will be able to develop lessons learned from the successful pediatric programs that have reduced inappropriate antibiotic use so they can be implemented for adult patients as well.

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

Root Cause

The Willie King Case: Wrong Foot Amputated

By Kim Smiley

In one of the most notorious medical error examples in US history, the wrong foot was amputated on a patient named Willie King on February 20, 1995.  Both the hospital and surgeon involved paid hefty fines and the media had a feeding frenzy covering the dramatic and alarming mistake.

So how did a doctor remove the wrong foot?  Such a mistake seems difficult to comprehend, but was it really as mind boggling as it looks at first glance?

The bottom line is that the doctor honestly believed he was removing the correct foot when he began the surgery. The blackboard in the operating room and the operating room schedule all listed the wrong foot because the scheduler had accidentally listed the wrong foot.  After reading the incorrect paperwork, the nurse prepped the wrong foot.  When the doctor entered the operating room, the wrong foot was prepped and the most obvious documentation listed the wrong foot.  Basically, the stage was set for a medical error to occur.

The foot itself also looked the part.  The patient was suffering from complications of diabetes and both of his feet were in bad shape.  The “good” foot that was incorrectly removed looked like a candidate for amputation so there were no obvious visual clues it wasn’t the intended surgery site. Other doctors had testified in defense of the doctor saying the majority of other surgeons would have made the same mistake given the same set of circumstances.

There was some paperwork that listed the correct foot to be amputated, such as patient’s consent form and medical history.  This paperwork was available in the operating room, but no procedures in place at the time required the doctor to check these forms and these forms were far less visual than the documents where the incorrect information was listed.  Additionally, the doctor never spoke directly with the patient prior to the surgery which was another missed opportunity for the mistake to be caught.

Clearly the procedures needed to be changed to prevent future wrong site surgeries from occurring and a number of changes have been incorporated in the time since this case occurred to help reduce the risk of this type of medical error.  Surgeons in Florida are now required to take a timeout prior to beginning a surgery.  During the time out they are required to confirm that they have the right patient, right procedure and right surgical site.  This rule has been in place since 2004.

Mistakes will always happen, such as numbers being transposed or misheard words over the phone, but small mistakes need to be caught before they become big problems. Procedures like a timeout can significantly reduce the likelihood of an error going uncorrected.  In an ideal world, the simple mistake by the scheduler would have been caught long before it culminated in a surgery on the wrong body part.

A visual root cause analysis, called a Cause Map, can be built to illustrate the facts of this case.  A Cause Map intuitively lays out the cause-and-effect relationships including all the causes that contributed to an issue.  To view a Cause Map of this example, click on “Download PDF” above.

Root Cause

Patient Dumping Has Dangerous Results

By ThinkReliability Staff

“Patient dumping”, when hospital patients are improperly discharged, sometimes to dangerous areas, or even out of state, and sometimes without proper instructions for care, is a serious risk to patient safety and health and can result in serious costs for the hospitals and people involved.  In a recent case, a California hospital made a settlement for $250,000 in civil penalties and legal fees for leaving a patient at skid row without making any arrangements for her.

This case – and others like it – lead to obvious concerns for the health and safety of these patients.  That’s led city attorneys and homeless advocates to crack down.  Operators of homeless shelters and rescue missions in the area have installed “dump cams”, which allow them to identify cases where patients are being “dumped”.  In Los Angeles, the police department has stated they will arrest anyone who leaves patients outside a shelter.  And Mike Feuer, a city attorney, says, “Patient dumping is intolerable to me. I do have it in my mind to send a message to other hospitals that this won’t be tolerated.”

Although patient dumping appears to have lessened in recent years, it’s still a real problem.  In other newsworthy cases, another Los Angeles hospital settled a group of charges in 2011 when it discharged a disoriented patient – still in her hospital gown – by taxi and she was left in the street.  Yet another area hospital was sued for negligence in 2012 when it left a patient being treated for schizophrenia outside a rehabilitation center without notifying the patient’s family.  In 2013, the city of San Francisco filed suit against the state of Nevada, saying that a psychiatric hospital had issued bus tickets to California cities for mentally ill patients without making arrangements for them.

Even though the risks to patients are apparent (and financial costs to hospitals are possible), these problems continue to occur.  In cases where organizations don’t seem successful at ensuring the safety of its patients (or employees), the government will step in.  In this case, Los Angeles in particular has implemented a “patient safety zone” which encompasses most of the city’s downtown, where it is illegal to leave patients unless they are in the care of a family member.  Additionally, hospitals must obtain written consent from patients to take them to a place other than their home.

This of course can be tricky when dealing with homeless, mentally ill, or patients without relatives living nearby.  Although patient resources when dealing with these cases are limited – making proper discharge difficult in some cases – leaving a patient alone in an unfamiliar, dangerous area is never the right answer.

The impacted goals resulting from patient dumping, some potential causes, and the solutions that have been implemented by the city of Los Angeles are shown in a Cause Map, or visual root cause analysis.  To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause

27 Patients to be Tested After Ultrasound Probe Sterilization Error

By ThinkReliability Staff

On December 21, 2013, 27 men were notified that, due to improper sterilization of equipment used for their prostate procedures, they should be tested for HIV and hepatitis B and C.   Both the medical center and patients involved are understandably concerned about how they got to this point.

In order to better understand the issues involved, we can put together an investigation file using Cause Mapping, a visual form of root cause analysis.  First, we capture the basic information about the issue.

The procedures were performed from September 19 to December 10 of this year at a Seattle medical center and involved ultrasound probes used for prostate procedures.  Because more than one date is involved, we can use a timeline to add more detail to the investigation.  In this case, patients were found to have been affected beginning September 19 and ending December 10, though it’s not clear if the incorrect sterilization began on that date, or if that was the first date that a probe was used on a patient with a communicable disease.  The improper sterilization was reported to hospital officials December 17 and affected patients were notified beginning December 21st.  As a result of information released by the medical center, we know that one step in the sterilization process for the probes was not completed.  We capture this as an important “difference” that may aid in the analysis.

Next, we determine the goals that were impacted as a result of the issue.

The patient safety and patient services goals were impacted due to the risk of disease transmission for the 27 patients (the probability of which is estimated to be very low).  The compliance goal is impacted because of equipment that was not sterilized as required.  The labor goal is impacted because the medical center is paying for two rounds of HIV and hepatitis testing for the affected patients.  If it is determined over the course of the investigation that other goals were impacted as well, these can be captured in the Problem Outline as well.

Once we have determined the impacted goals, we use these goals as the first “effect” to determine the cause-and-effect relationships that resulted in the issue.  In this case, the patient safety and services goals were impacted due to the risk of disease.  The disease risk resulted from the reuse of prostate probes that had the possibility to spread disease.  The disease risk occurred because the probes may have been used on a patient that had a communicable disease and the probes were not properly sterilized before their reuse.

We can show the steps that should have occurred in the sterilization process of these probes, as well as where the specific issue in the process occurred, in a Process Map.  This map shows the steps involved in a procedure, in this case the ultrasound probe sterilization procedure.  After a probe is used, it goes through a three-step process, involving cleaning, disinfecting or decontaminating with a disinfectant spray, then sterilization by being doused with sterilization fluid.  Then the sterilized equipment is placed in a protective sheath before re-use.  (Because of the use of this protective sheath, the probe, when properly used, does not contact the patient, decreasing the risk of disease transmission.)  In this case, the sterilization step was not performed.

We include the fact that the procedure was not performed properly in the Cause Map.  The Chief Medical Officer reports that their investigation found that the cause was “human error” and no more information has been released.

In order to determine effective solutions to prevent the issue from recurring, more detail needs to be obtained about the expectations for the process being performed, as well as the verification (if any) that took place to ensure that the procedure was being performed correctly.  Once it’s possible to determine what allowed the process to break down, safeguards that will reduce the risk of it happening again can be implemented.

To view the initial investigation file, including the Outline, Cause Map, Timeline and Process Map, please click “Download PDF” above.

Root Cause

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.