All posts by Kim Smiley

Mechanical engineer, consultant and blogger for ThinkReliability, obsessive reader and big believer in lifelong learning

New Studies Shed Light on Statin Side Effect Concerns

By Kim Smiley

Usage surveys have found that the majority of people prescribed statins in the United States discontinue using them within a year. The number one reason stated by patients for stopping statin use is concern with side effects.

This issue can be analyzed by building a Cause Map, a visual method for performing a root cause analysis.  The first step in the Cause Mapping process is to define the problem by filling an Outline with the basic background information (who, what, when, where, etc.).  Additionally, the Outline is used to capture how the problem impacts the goals so that the magnitude of the problem is well understood.   Once the Outline is complete, the analysis is done by building a Cause Map by asking “why” questions to find the causes that contribute to an issue.

For this example, the fact that patients aren’t taking prescribed statins is an impact to the patient goal.  This occurs because patients were prescribed statins and they are not using them.  Looking at each cause individually, let’s first ask why patients were prescribed statins.  A physician wrote a prescription for statins because the patient was considered at risk for heart disease and statins can reduce the risk of heart disease.  Statins have been shown to reduce cholesterol levels in the blood and high cholesterol can lead to blocked arties that can contribute to heart disease.  Cholesterol is reduced because statins inhibit an enzyme in the liver that controls cholesterol production in the body and the majority of cholesterol is produced by the liver.

So the question that still needs to be answered is why aren’t patients taking their statins if they can reduce their risk of heart disease?  The most significant reason that patients are discontinuing statin use is because they are concerned about side effects and the concerns haven’t been adequately addressed. Patients are concerned about side effects because they believe they have experienced side effects or they are generally worried about potential side effects.

Like most other medications, statins can have serious side effects, such as liver injury, cognitive impairment and potential for muscle damage (especially when combined with certain other medications.  According to the U.S. Food and Drug Administration, the value of statins in preventing heart disease has clearly been established and the benefits outweigh the risks, but one of the reasons that patients are concerned about side effects is that there are very outspoken critics of statins that do not agree with this assessment.  For the purpose of this example, we will assume that the FDA is correct that patients would benefit from taking statins if they are prescribed and that it is in fact a problem if patients discontinue using stating when their physicians have recommended them.

The final step in the Cause Mapping process is to come up with solutions that can be implemented to help reduce the risk of a problem occurring in the future. So how can the risk that patients will discontinue statins be reduced?  One possible solution would be to give patients reliable information that shows that statins are relatively safe and are effective at reducing the risk heart disease.  If patients believe that the benefits of statins outweigh the risks, they will be significantly more likely to take them.  More information is becoming available as researchers continue to study the benefits of statins and the frequency and severity of side effects.  For example, a recent study that used 83,000 patients and randomized statin therapy and a placebo found that “only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo”.  With more data about the effectiveness of statins and the accurate information the risks associated with them patients can make decisions based on real data and better determine if they should keep taking the statins.

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

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.

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.

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

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.

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.

FDA Proposes Restrictions that Would Essentially Ban the Use of Trans Fats

By Kim Smiley

On November 7, 2013, the US Food and Drug Administration (FDA) proposed reclassifying trans fats so that they would no longer be “generally recognized as safe.”  This move would essentially eliminate the use of trans fats because companies would need to prove that they are harmless before adding any to food products.  This hurdle would likely be impossible to jump since current research shows that trans fats are the least healthy fat and contribute significantly to heart disease in the US.  In fact, it’s estimated that the increased restrictions on trans fat proposed by the FDA would prevent 20,000 heart attacks and 7,000 deaths from heart disease each year.

Trans fats are an especially dangerous form of fat because they raise the levels of “bad” cholesterol, while also lowering the “good” cholesterol.  This double whammy significantly increases the likelihood of heart disease. One of the interesting twists in the history of trans fat is that its rise to popularity was partly fueled by a belief that it was a healthy alternative because it was manufactured from plants, unlike traditional saturated animal fat like butter or lard.    Trans fats were also cheaper, increased product shelf life and were kosher.   From the 1950s until recently, trans fats were widely used in a variety of processed foods.

Things began to change in 2003 as more and more research showed that trans fats were less healthy than initially thought and the FDA added a requirement that artificial trans fats be listed separately on food labels.  Manufacturers begin to shift away from the use of trans fats after their visibility was increased and the public became more aware of the dangers of trans fat.  The shift away from the use of Trans fats has already dramatically impacted the American diet.  In 2006, Americans consumed an average of 4.6 grams of trans fats daily which decreased to about 1 gram in 2012.  Food manufacturers are not predicted to fight the new FDA proposal too aggressively since so many have already voluntarily reduced the use of trans fats.  Additionally, no company wants to be associated with the negative publicity surrounding trans fats.

The impacts of trans fats can be analyzed by building a Cause Map, a visual root cause analysis, which intuitively lays out causes that contribute to an issue to visually show the cause-and-effect relationships.  A Cause Map is built by determining how the overall goals are impacted by issues and then asking “why” questions to determine all the causes that contributed to the problem.  Click on “Download PDF” above to view a high level Cause Map of this issue and view a completed Outline.

United Nations Sued for Role In Haitian Cholera Epidemic

By Kim Smiley

A class action law suit has been filed against the United Nations (U.N.) on behalf of Haitian families afflicted by the cholera epidemic that has been raging since 2010.  Many believe that cholera was inadvertently brought to Haiti by U.N. peacekeeping forces.

Some of the basic facts are still debated, but one that is known is that Haiti is experiencing the worst cholera epidemic in modern history with thousands of new cases each month. Nearly 7 percent of the Haitian population has had cholera since 2010.  It’s estimated that around 8,400 people have died of cholera and more than 685,000 have been sickened by the disease.

So why is the U.N. being blamed for this epidemic? A Cause Map, or visual root cause analysis, can be used to explain what many believe occurred.  All causes that contributed to an issue are captured on the Cause Map, which illustrates the cause-and-effect relationships between them.  In this case, people became infected with cholera after drinking contaminated river water.  Many believe that the river was contaminated when sewage leaked from a U.N. camp near the river with inadequate sanitation facilities.  U.N. peacekeepers from Nepal were stationed at the camp and cholera, specifically a nearly identical strain of cholera, was present in Nepal at the time.  It’s assumed that at least one person in the camp had cholera and dangerous wastes managed to contaminate the river. The cholera epidemic seems to be a deadly case of unintended consequences that occurred when the U.N. attempted to aid Haiti following a devastating earthquake.

Once cholera got a foothold in Haiti, the epidemic exploded.  The population had little immunity to the disease because a case hadn’t been seen in Haiti in over a century prior to 2010.  Haiti lacked the sanitation and medical facilities to quickly contain a cholera epidemic.  People continued to drink water from the river because there weren’t many other options. The country had also suffered major damage from the 7.0 magnitude earthquake that hit on January 12, 2010.  Medical facilities, transport facilities, communication systems and all the things a country needs to battle an epidemic had been significantly impacted by the earthquake.  Basically, it was a perfect recipe for a disaster.   A sick U.N. soldier may have brought cholera to Haiti, but the conditions in the country amplified the situation.

The world is still struggling to understand the cholera epidemic and determine what lessons learned should be applied going forward.  Clearly there is something to learn about the need for sufficient sanitation so that illness doesn’t spread unnecessarily.  The U.N. may potentially want to screen troops more closely before stationing them on foreign soil or implement other changes to help prevent anything like this from occurring in the future.  It’s also a powerful reminder to be aware and on the lookout for unintended consequences whenever a solution is implemented.  For example, the U.N has always had legal immunity, but some believe that may change as a result of the cholera lawsuit.   It’s impossible to predict if a verdict against the U.N. would impact future U.N. aid efforts, but it’s easy to imagine that it could have damping effect on their efforts, causing a whole other wave of unintended consequences to occur.

To view a high level Cause Map of the cholera epidemic in Haiti, click on “Download PDF” above.

New Prostate Cancer Tests Look Promising

By Kim Smiley

One in six American men will be affected by prostate cancer during their life making prostate cancer the most common non-skin cancer.  Despite the number of people impacted by this disease, screening and treating prostate cancer remains problematic and even controversial at times.

This issue can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information.  How the issue impacts the overall goals is also documented in the Outline.  In this example, there are several significant impacts that need to be considered.  The first is that it’s estimated that about 30,000 men will die from prostate cancer in the US in 2013.  The second major issue is that many men are treated unnecessarily for prostate cancer.  Unnecessary treatments are a waste of resources and the side effects cause significant suffering.  The next step of the Cause Mapping process is to build the actual Cause Map by asking “why” questions and laying out the causes visually to show the cause-and-effect relationships.  (To see a high level Cause Map for this issue, click on “Download PDF” above.)

One of the factors that leads to so many deaths from prostate cancer is that it is generally found at later stages.  Most patients have few symptoms with early stage prostate cancer and current screening methods for prostate cancer are far from perfect.  Conditions other than prostate cancer, such as enlarged prostates, can result in positives during blood tests for prostate cancer.   The positive indications of cancer then trigger needle biopsies in areas of the body no one wants biopsied.  Less than half of these follow up biopsies find cancer cells. Physical exams for prostate cancer are uncomfortable and usually only find larger cancers.  Additionally, many prostate cancers grow so slowly that they will not impact a patient’s life span and do not require treatment, but there is currently no test that can accurately determine whether a prostate cancer is dangerous.

This inability to distinguish between types of prostate cancer is what leads to so many being treated unnecessarily for prostate cancer.  Many patients opt for treatment once prostate cancer is found because they have no way of really knowing whether it’s safe to leave the cancer untreated.   But treatment is not without significant costs, both financially and in suffering.  Many of the prostate cancer treatments, such as radiation or surgery, can cause major side effects such as  incontinence or sexual dysfunction.  Most patients will willingly undergo treatment for life threatening cancers, but it’s terrible that some patients endure cancer treatments without need.

The final step in the Cause Mapping process is to find solutions.  In this example, the good news is that many researchers are working to develop better prostate cancer tests, which would rapidly lead to better patient care.   Better tests could save lives by finding prostate cancers earlier and could help reduce unnecessary treatment by identifying the more dangerous cancers.  A urine test for prostate cancer is now available that has been found to be more accurate than current screening methods.  Other research groups are working to develop other urine prostate tests with a focus on developing accurate, low cost tests that can be performed at home.  None of these tests are perfect yet, but they are a significant step in the right direction.

 

New Limits Proposed for Arsenic in Apple Juice

By Kim Smiley

The FDA recently proposed a new limit for the amount of arsenic allowed in apple juice.  The proposed limit would match what has already been established for bottled water.  This marks the first time that the FDA has established an arsenic limit for food or drinks other than water.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map lays out the causes that contribute to an issue in an intuitive, visual format so that the cause-and-effect relationships are obvious.  The first step of the process is to fill in an Outline with the basic background information for an issue.  The Outline also documents the impacts that the issue is having on the organizational goals so that the full effect of the issue can be clearly understood.  In this example, the concern that consumers may be exposed to arsenic, a known carcinogen, is an impact to the safety goal.  The media hype surrounding this issue is also important to consider because consumer concern could impact sales.

After the Outline is complete, the next step is to ask “why” questions and use the answers to build the Cause Map.  So why is there arsenic in apple juice?  Arsenic is a naturally occurring substance that is found in the environment.  There are also places that have been contaminated by arsenic, primarily the result of arsenic-based pesticides.  Use of arsenic-based pesticides in the US ended by 1970, but parts of the world still use them.

To understand this issue, it’s also important to understand the public relationships portion of  the puzzle. The concern over arsenic in apple juice exploded after the issue was featured on the “The Dr. Oz Show” in 2011.  Outcry after the segment was well covered by major media outlets and the issue has repeatedly made headlines over the past two years. Consumer Reports has also issued a report about samples of apple juice that test above the limit for drinking water.  None of this can possibly be good for the apple juice business.

The final step of the Cause Mapping process is to use the Cause Map to develop solutions.  A limit for arsenic in apple juice should go a long way to easing concerns if it is established.  The proposal is to set the limit for arsenic in apple juice to match that for drinking water, which should be conservative since consistent consumption of more apple juice than water seems unlikely.   Producers of apple juice that is found to contain arsenic above the limit could face legal action and the juice could be removed from the market.  How much the new limit will actually impact the products on the shelf is unclear because different sources have reported widely different sample results, but at least action could be taken if any juice is found to have arsenic levels above the limit.