Tag Archives: cause mapping

Root Cause

The Race to Develop an Ebola Vaccine

By Kim Smiley

Traditional public health methods have not been able to stop the Ebola epidemic raging in West Africa and some experts are speculating that a vaccine may be necessary to quash the outbreak.  The only problem is an approved vaccine against Ebola doesn’t exist.

A Cause Map, a visual root cause analysis, can be built to analyze this issue by intuitively laying out the causes that contribute to the problem.  A Cause Map is built by asking “why” questions and documenting the answers on the Cause Map to show the cause-and-effect relationships.

So why isn’t there an approved Ebola vaccine?  There are several promising vaccines in development, but some of them are newer efforts that haven’t had time to go through the lengthy approval process.  A few potential vaccines have been around for years, but development stalled prior to the necessary human trials.  Prior to this year, there was limited potential revenue from an Ebola vaccine because of the limited demand so it has never been a high-priority product. Demand for, and interest in, producing an Ebola vaccine, has of course skyrocketed as a result of the ongoing epidemic in West Africa and Ebola cases popping up in other countries.

Now that companies are putting significant resources in the race to produce an Ebola vaccine there are still huge logistical obstacles that must be overcome.  At least two different vaccines should be ready for large-scale human trials early next year, but actually distributing the vaccine and tracking volunteers will require significant resources.  The vaccine must be kept at a constant temperature which can be difficult in regions of West Africa without reliability electricity.  Keeping track of thousands of volunteers is always a massive undertaking, but will be even more challenging in the middle of an epidemic in a region where the medical systems are overtaxed.  There is also a chance for significant political fallout if the vaccine created by Western countries and given to poor African nations turns out to have harmful side effects.

This topic raises some really difficult ethical issues.  How much do you fast-track a vaccine?  People are dying and an effective vaccine would save lives, but distributing a vaccine prior to the normally required testing could also result in significant human suffering if there is an unexpected side effect.  When has a vaccine been tested “enough” to justify giving it to people in a high-risk environment?  Even designing the human trials requires some hard decisions.  Do you conduct a blind study with a control group, knowing that some of that group is statistically likely to be infected with a deadly disease? There is a lot of gray area and it’s difficult to know what the right answer is.  Thousands of lives may hang in the balance and there isn’t a lot precedence in how best to respond to the challenge of this Ebola outbreak.

If you’d like to learn more about this epidemic, you can read our previous blogs:

Patient With Ebola Sent Home From ER

Ebola Outbreak Claiming Lives of Medical Staff

Hundreds Affected in ‘Unprecedented’ Ebola Outbreak

 

Root Cause

Humidity May Cause Loss of Hospital Accreditation

By ThinkReliability Staff

A hospital in California has received a preliminary denial of accreditation from The Joint Commission, which may lead to a loss of Medicare and Medicaid funding.  This move is rare – less than 1% of hospitals are denied accreditation.  The ruling was made during an onsite survey after reports that four patients had developed surgical-site infections after hip replacement surgery within a month.  (The patients all recovered after administration of antibiotics.)

Says the hospital’s Associate Director of Emergency Services, “Surgical infections are extremely rare. When we saw the cluster we stood up and took notice. We stabbed every corner and every crevice.”

However, that may not be entirely true.  First of all, surgical infections are probably not what’s considered “extremely rare”.  In a recent study, the Centers for Disease Control and Prevention (CDC) found that 1 in 25 patients acquires an infection while in the hospital  and infections are among the leading cause of death worldwide.  (See our previous blog for more details.)  Only slightly more than 20% of those infections were found to be surgical site infections from inpatient surgery, but that still results in about 157,500 surgical site infections a year.

There’s also a question about how quickly action was taken to address the issues identified by The Joint Commission, specifically high humidity.  After the four patients were infected with enterobacter (a bacteria that is harmless in the gut but can cause illness in a wound), the hospital cultured equipment and instruments and found no contamination.  However, three of the surgeries which resulted in the surgical site infections took place in an operating room that had been identified in February or March to have high humidity due to issues with the heating and ventilation system.  Although a new system would not be installed for several months, surgeries continued to take place in that operating room until The Joint Commission identified problems with heat and humidity.

The germs that caused these infections can also be introduced to a surgical site by medical staff – usually due to improper hand washing or surgical prep procedures.  It’s unclear if this may have been the case here – there has been no discussion of this possibility – but handwashing issues are a constant source of infections at healthcare facilities.  According to studies, more than 50% of infections are largely preventable with good hygiene and technique.

The hospital has 23 days from the October 8th preliminary denial of accreditation to meet federal standards.  The hospital is installing new heating and air conditioning equipment and is reviewing its procedures for “hospital documentation and staff communication”.   Hopefully other processes will be reviewed as well.  The hospital expects to reopen its operating rooms soon.

To view an overview of the investigation of this issue, please click “Download PDF” above. The downloadable PDF shows the goals impacted by this issue, a visual layout of the cause-and-effect relationships that led to the impacted goals, and the solutions being discussed by the hospital to improve patient safety regain their accreditation.

Root Cause

FDA To Device Maker: Complaints Not Properly Investigated

By ThinkReliability Staff

The Food and Drug Administration (FDA) issued a warning letter – a possible precursor to regulatory action – to a manufacturer of pulse oximeters challenging its response to violations identified during a facility inspection in 2013.  Specifically it found that:

1) Complaints of device failures were not adequately investigated,

2) Investigation records did not include required information,

3) Procedures did not identify all potentially affected product, and

4) Causes of failures were not investigated.

The company’s response to the initial violations found during the FDA inspection was found to be unacceptable.  Some of the comments to the FDA regarding the violations were: “The reported event poses no risk to user or patient safety, therefore, no Corrective and Preventive Action required”, “The cable and sensor that were returned with the instrument were also investigated and no problem was found”, “Through the investigation process, it was determined that Masimo’s product did not malfunction”. To each of the violations, the company claimed that either no problem was found, or that the problem did not involve any failures of the pulse oximeters identified in the complaints.

This doesn’t ring true to Diana Zuckerman, the president of the National Center for Health Research.  She says, “It may well be that it’s a user error. But you have to investigate that and show that it’s a user error and not a device error… When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible.  Especially when users made complaints that the company’s product put patients at risk.”

Included in the complaints are that the manufacturer’s pulse oximeters failed to alarm in a patient that died and that they resulted in burns on both an 11-month old and 33-year-old and a skin tear on another patient.  Complaints also indicated issues with consistency of readings and exposed wires at the connection points.  The failures are getting attention not only because FDA warning letters are fairly rare – this is the first such letter to the company in its 25-year history – but also because of the company head’s views on medical errors and funding of the nonprofit Patient Safety Movement Foundation.

Pulse oximeters are used to monitor a patient’s pulse and blood oxygen.  Abnormal readings can indicate a change in a patient’s condition which may require medical intervention.  If the device fails to function, it can lead to patient injury or even death.  Because the devices are intended for use in diagnosis, they are regulated by the FDA and have to conform with FDA practices.  If the violations identified by the FDA in the warning letter are not corrected, the company may face regulatory action.

For now, the company has not released its plans to ensure compliance with the FDA requirements.  The FDA is clearly looking at updates to the investigation process used to respond to customer complaints and ensuring that causes identified as part of those reviews result in changes to other processes, such as manufacturing and quality control.

To view an outline and analysis (in the form of a Cause Map, a visual form of root cause analysis) of the FDA’s findings, click on “Download PDF” above.

Root Cause

Patient With Ebola Sent Home From ER

By Kim Smiley

If you have been paying any attention to the news lately you have heard that a patient was diagnosed with Ebola in the United States for the first time.  The fact that the patient sought treatment at an emergency room (ER) and was sent home is particularly alarming and people are naturally very interested in how such a thing could happen.

The media has been flooded with breaking news about this case. In situations like this, keeping track of what information is current and reliable and what is already outdated or has been determined to be inaccurate can be a moving target.  A Cause Map, a visual format for performing a root cause analysis, can be useful in these situations as a way to document the available information.  A Cause Map visually lays out the causes that contributed to an issue in an intuitive format.  It is relatively easy to quickly expand a Cause Map as more information becomes available.

Generally, a Cause Map is built in an Excel workbook so old versions of the Cause Map can be easily saved as different tabs and that the evolution of the investigation isn’t lost.  Additionally, it’s easy to add evidence supporting each individual cause onto the Cause Map itself so that all relevant information is documented in one location and easily referenced.  There are often things that are being considered that may have played a role in a problem, but lack evidence to determine whether or not they are actually relevant to the investigation.  This situation can be documented on a Cause Map by listing the potential cause and adding a question mark to show that a cause is being considered, but that it needs more evidence.  If that cause is later determined to not have been a factor it can be crossed out to document that it has been considered so that no work is duplicated.

So what information is known at this point about the patient with Ebola who was sent home from the ER?  A man has been diagnosed with Ebola in Dallas, Texas.  Statements by friends and family indicate that he helped transport a sick woman prior to traveling to the US.  It’s not clear whether he knew that she had Ebola or not.  After being exposed to Ebola, he passed through the airport screening because he did not have a fever at that time and he did not indicate possible exposure on the required questionnaire.   He arrived in Dallas, Texas on September 20, 2014.

His family has stated that he started feeling ill on the 24th and he sought treatment at a hospital on September 26.  He was released with a prescription for antibiotics.  Ebola can be difficult to diagnose because the early symptoms, such as fever and muscle pains, are very nonspecific.  The only information the hospital would have had to indicate that patient might have Ebola is his travel history.  Statements by the hospital indicate that the patient told the nurse he had recently been in Liberia.  The travel history information doesn’t seem to have been known by physicians that treated the patient.  Initial statements by the hospital indicated that issues with electronic health records may have played a role in the confusion, but later released more information that modified their position.  Exactly how the risk of Ebola was missed isn’t clear and this portion of the Cause Map will need to be expanded as more information is available.

It is not shocking that an Ebola case would be diagnosed in the US with travelers still arriving from West Africa and the long incubation period.  As long as Ebola is still a problem in Africa, US hospitals could see more patients with Ebola and need to be prepared for the possibility.  But it is concerning that someone who had recently traveled from West Africa with a fever wouldn’t trigger any alarms at an ER.   Individuals with Ebola must be quickly identified and isolated In order to prevent the spread of the deadly disease and hospitals in the US need to ensure that no other potential Ebola patients fall through the cracks.

Click on “Download PDF” above to see an initial intermediate level Cause Map for this example.

Root Cause

Healthcare Worker with Active TB May Have Infected Infants

By ThinkReliability Staff

A healthcare worker may have exposed more than 751 infants and 55 coworkers to tuberculosis (TB), a potentially deadly disease, during the 11.5 months she worked with newborns in the nursery and post-partum unit.  The employee was found to have symptoms of active TB (the only kind that is contagious) in July 2014 and was tested on August 21, 2014.  Infants and coworkers who were in those units between September 1, 2013 and August 16, 2014 are potentially affected.

The impacts of the potential exposure are significant.  The goal of ensuring patient safety has been impacted because of the potential exposure of 751 infants (so far identified).  Additionally, the goal of ensuring employee safety has also been impacted as 55 coworkers are also potentially impacted (those already screened have not shown any signs of infectious tuberculosis).  Because of the close contact required to spread TB, the issue has not been identified as a public health threat.  Regulatory agencies are still interested – the hospital has been cited by the Department of State Health Services for issues relating at least in part to infection control that are “an immediate jeopardy to patient safety”.  (It wasn’t clear how or if these issues are directly related to the TB exposure but were found in an inspection that occurred as a result of it.) All the patients who have been exposed may potentially require a course of antibiotics, typically six to nine months.  Infants under six months are being given the course as a preventive measure.  This impacts the patient services goal.  All the screening and treatment is being provided by the hospital free of charge, which is an impact to the hospital’s labor and time goal.

Developing the cause-and-effect relationships that led to the goals that were impacted can provide clarity to the investigation and potential solutions.  Exposure to TB occurred when an employee with an active infection came to work and was potentially aided by the hospital’s infection control policies or procedures, which may not have been effective in preventing the spread of the disease.  It’s unclear how the employee contracted tuberculosis, but she was likely not vaccinated. Although a vaccine against tuberculosis exists, it’s rarely used in US.

A question raised by this issue is why the long period of time during which there was a potential exposure?  Tuberculosis can remain latent in the body for months or even years before turning into an active case.  (It is only contagious when active.)  The employee appears to have passed a routine annual health screening in July 2013 and started showing symptoms at or near her next annual health screening in July 2014.  However, she was not tested for the disease until August 21st and appears to have continued work until August 16th.  It’s unclear why the delay occurred, and the hospital will surely be looking to ways to minimize patient exposure to workers who may be sick.

The hospital is working with the Texas Department of State Health Services and the Centers for Disease Control and Prevention to screen and treat patients and other healthcare workers that came into contact with the infected worker based on employment and medical records in an extensive outreach campaign.  The employee has been placed on leave and is being treated.  The hospital is required to submit a corrective action plan to the Texas Department of State Health Services, which should identify corrective actions to issues raised as a result of the state’s inspection and by the Centers for Medicare & Medicaid Services.

To view the impacted goals, cause-and-effect relationships and potential solutions in a Cause Map, or visual root cause analysis, please click “Download PDF” above.  Or, click here to learn more.

Root Cause

Wrong Dye Injected into Spine During Surgery

By Kim Smiley

In the high stress, fast paced operating room environment, high consequence errors can and do happen, but the risk can be reduced by analyzing medical errors and improving standard work processes.  A recent case where a woman died unexpectedly after a routine procedure to insert a pump underneath her skin to administer medication offers many potentially useful lessons.  The wrong dye was injected into her spine during the surgery, which is the type of error that should be entirely preventable.

A Cause Map, or visual root cause analysis, can be used to analyze this issue.  To build a Cause Map, all causes that contribute to the issue are visually laid out to show the cause-and-effect relationships.  The general idea is to ask “why” questions to determine ALL the causes (plural) that contributed to the problem, and not focus the investigation on a single root cause because this allows a wider range of solutions to be considered.

So why did the wrong dye get injected into the patient?  The dye was injected because it was used during the surgery to verify the location of tubing that was threaded into the patient’s spine and the wrong dye was used.  The surgeon needed the dye to verify the location because the tubing was inserted during the surgery and it was difficult to see. The tubing was part of a pump that was being stitched under the patient’s skin to administer medication directly to the spine to treat symptoms from a back injury.  The patient had broken several vertebrae during a fall.

And now on to the meatier part of the discussion in regard to medical error prevention – why was the wrong dye used? The request for medication (dye) was given orally by the doctor to the nurse who passed it along to the pharmacy so it is possible that the pharmacist missed that the dye was intended for use in the spine.  The exact point where the work process breakdown occurred wasn’t clear in the media reports, but it is known that there were several checks in the process that failed for this type of error to occur.

Following this incident, the hospital did make changes in their work process to help reduce the likelihood of a similar error occurring.  The hospital now uses detailed written orders for medications except in emergencies when that isn’t possible.  The written order includes information about how the medication will be administered, which would have clarified that the dye was intended for use in the spine in this case.

Root Cause

Health Declines as Veterans Wait for VA Care

By ThinkReliability Staff

On September 5, 2014, a tragic story was released of a man who lost most of his nose due to spreading cancer.   When diagnosing cancer, it’s generally acknowledged that the earlier the cancer is caught, the less the risk of the cancer spreading.  In this case, the veteran waited over two years for a biopsy.  He is one of thousands of patients who have had to wait unreasonable amounts of time for care through the Veterans Administration (VA) system.

Although the issues with delay of veterans care appear to be nationwide, looking at one particular incident can help shed some light on not only what went wrong, but possibilities for reducing the risk of it happening in the future.  The Inspector General examined dozens of cases of patients who died while waiting for care at the Phoenix VA hospital in order to determine the impacts of the delayed care, the causes related to it, and recommendations for fixing the problem.  We can also examine the impact, causes and potential solutions for the care issue by performing a root cause analysis based on the story of this particular patient.  (His case was not covered in the IG report, which primarily examined deaths of veterans while waiting to be seen at VA facilities.)

We can capture the analysis in a Cause Map, which visually lays out the cause-and-effect relationships that resulted in an incident in order to provide the maximum opportunities for improvement.  After the what, when and where of the incident are captured, it’s important to determine the impacts to the goals resulting from a particular issue.  In this case, the patient’s safety was endangered because of the spread of cancer.  The patient services goal was impacted because the patient lost most of his nose as a result of inadequate treatment at the healthcare facility.  The schedule/operations goal is impacted due to the delay in treatment of the patient.  In order to better quantify the effects of an overarching issue such as this one, a frequency of events is essential.  In this case, the Inspector General found that delayed treatment was clinically significant for at least 28 other veterans at the same VA hospital.  (The Inspector General also found that 40 veterans died while waiting for appointments but was unable to determine if the deaths were due to the delays.)

Beginning with an impacted goal, asking “Why” questions adds detail to the Cause Map.  The spread of the patient’s cancer was caused by a delay of treatment.  Treatment was delayed due to the exceptionally long wait for a biopsy (two and a half years) as well as the wait between the diagnosis and treatment (surgical removal).  Insufficient capacity and large numbers of veterans seeking care at the VA hospital resulted in veterans waiting months or even years for care.  Because (as described by a whistleblower physician from the site) the site used “secret” waiting lists (where patients were effectively put on a non-official waiting list for the waiting list so that the reported wait was within an acceptable time frame), oversight of the facility was minimal.  As in this case, many veterans prefer to get care at a VA facility and/or don’t have another type of insurance that would cover the costs incurred for healthcare needs.

As expected, the results of these investigations have resulted in a number of personnel being removed from their positions in the VA.  The “secret” waiting lists were used to hide the fact that the VA hospitals don’t appear to have the capacity for the number of veterans that need treatment.  Significant additional funding is being directed towards the VA in order to build more hospitals and hire additional medical staff.   In the meantime (and possibly continuing into the future if capacity continues to be inadequate), arrangements for veterans to receive covered care at other facilities are being made.

In light of these highly publicized issues, hopefully the VA will receive the funding and oversight it needs so that the nation’s veterans can receive the care they deserve.

Root Cause

Toxic Algae Bloom Makes Toledo’s Water Unsafe

By Kim Smiley

On the evening of August 1, 2014, 400,000 people living in the Toledo, Ohio region were told not to use or consume tap water.  The water ban was imposed after higher levels of a toxin,  microcystin, than were deemed safe were detected in the water supply.   The water ban was lifted on the morning of August 4, but the issue may not be over since many of the factors that lead to the problem are still present.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map intuitively lays out the cause-and-effect relationships that contributed to an issue.   In order to build the Cause Map, “why” questions are asked and the answers are documented on the Cause Map.

So why were people told not to use their tap water?  Microcystin is a toxin that can cause vomiting, cramps, rashes and even significant liver damage, and it was detected in the water supply at levels officials deemed unsafe.  (No illnesses have been reported as a result of the toxin.)  The investigation is still ongoing, but many scientists believe the microcystin came from a recent algae bloom in Lake Erie, where the area draws their water.  Algae blooms in Lake Erie are relatively common, but recent weather patterns meant that this particular bloom occurred near  the water treatment plants’ inlets.

Algae are always present in Lake Erie; they can reproduce rapidly and may form a bloom when conditions are conducive to growth and there is high nutrient availability.  Scientists are still working to understand more about the algae blooms, but many believe that phosphorus in agricultural runoff is the main source feeding them.  Phosphorus is commonly used in fertilizer and rain washes it into the lake where it may be consumed by algae.  There are also other possible sources of phosphates such as cattle feedlots and leaky septic systems that need to be investigated.

While it’s tempting to over simplify this issue, it really is very complicated.  There is research showing that an invasive species, the zebra mussel, may be adding to the problem by selectively consuming the non-toxic algae so that any blooms that form are more likely to be toxic. There is still debate about what exactly is causing the algae blooms to form. There are limited federal regulations in place to limit or monitor agriculture runoff and there isn’t agreement on what, if anything, should be done.  There are not even federal limits on the allowable levels of microcystin in drinking water.  Toledo officials used the limits set by the World Health Organization because there isn’t a federal standard.

There are many open questions and not enough answers.  One of the things that we do know is that this particular algae bloom wasn’t particularly bigger or more intense than what has been normal in recent history.  Its main distinguishing characteristic was the location near the water plant inlets.  Scientists are predicting that blooms will peak in September this year so the impacts on the water supply may not be over for the year.

Root Cause

Ebola Outbreak Claiming Lives of Medical Staff

By ThinkReliability Staff

On July 29, 2014, the ongoing Ebola epidemic in west Africa was hit a hard blow when Dr. Sheik Humarr Khan, a leading doctor who treated Ebola patients and  national hero in Sierra Leone, died from the deadly virus.  The outbreak, which began this spring, has now infected thousands and killed nearly 900 people across Sierra Leone, Liberia, Guinea and Nigeria, including more than 90 healthcare workers who were treating victims.  It’s the most widespread and deadliest yet, due to the relative ease of travel and an apparently new strain of the disease.  (Read our previous blog about the outbreak.)

Because of the deadly and quick-spreading nature of the Ebola virus, many precautions are taken to protect healthcare workers from the disease.  Says Marie-Christine Ferir, the Emergency Coordinator of Médecins Sans Frontières/ Doctors Without Borders, “As well as the personal protective equipment that our staff wears, we have a series of strict procedures and protocols.  Our treatment centers are designed to ensure the safest possible working environment for our staff.”  Adds Dr. Tom Frieden, the Director of The Centers for Disease Control and Prevention (CDC), “We work actively to educate American health-care workers on how to isolate patients and how to protect themselves against infection.”

Yet workers are still getting sick – and dying.  In an interview with Armand Sprecher, the medical advisor to Doctors Without Borders, he noted that, though the suits worn by healthcare workers when dealing with infected patients are impervious to fluid, procedures and protocols still have to be followed.  For example, wearing or taking off the suit improperly can cause fluid transfer to the face, or hands, which then may touch the face.  An accidental needle stick can also result in a transfer of fluids that can lead to infection.

Now people in other countries are concerned Ebola may spread further.   In order to give stricken healthcare workers the best shot possible, they are generally returned to their home countries for treatment, raising concerns that their presence will allow the virus to take root there.  An American doctor and nurse were returned to the United States for treatment on August 2nd and August 4th, respectively.  Officials note that every precaution is being taken to isolate the patients and that Ebola can be spread only by bodily fluids, which requires very close contact.

Though there are no vaccines or currently approved treatment for Ebola, the infected American personnel received experimental treatment while still in Liberia. The treatment attempts to use antibodies produced by animals exposed to Ebola to help the immune system fight off the virus.  Dr. Brantly received a blood transfusion from a boy who survived Ebola under his care (surviving Ebola appears to provide immunity against re-infection).  Both vaccines and treatments are in development, but funding is difficult given the relative rarity of Ebola.

In the ongoing attempt to contain the spread of the virus, Sierra Leone has quarantined neighborhoods, cancelled public meetings and overseas trips, while Liberia has closed schools, most borders, and put state employees on leave.  The CDC has issued a Level 3 Travel Warning to Guinea, Liberia and Sierra Leone.  The World Health Organization has launched a $100 million campaign with the aim of bringing the epidemic under control, partially by providing new doctors.

To view the impacts this disease is having on the public as well as healthcare professionals, the causes of these impacts and what is being done to reduce the risk of these impacts, please click on “Download PDF” above.  Or read our previous blog to learn more about the outbreak.

 

Root Cause

Surgical Tool May Spread Cancer

By ThinkReliability Staff

Women who suffer from painful uterine fibroids may have their uterus removed for relief.  The most common hysterectomy procedure involves a 3-to-7-inch incision through which the entire uterus is removed intact.  Surgeries that can be performed laparoscopically through a smaller incision offer less scarring, fewer complications and shorter recovery time.  In order to remove the uterus through a smaller incision, it first has to be cut up into pieces.  This is performed using a laparoscopic power morcellator.  The device can also be used to remove fibroids only (called myomectomy) in a laparoscopic procedure.

On April 17, 2014, the Food and Drug Administration (FDA) issued a statement saying it “discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” An advisory panel then provided a variety of recommendations, some going so far as to recommend completely banning the use of the device.

The issues surrounding the use of the morcellator can be examined in a Cause Map.  The Cause Map allows a visual diagram of cause-and-effect relationships that include the impacts associated with a particular issue.  In this case, the use of the power morcellator is found to increase the risk of spreading cancer, a clear impact to the patient safety goal.  Concerns about the delay in determining the safety risk (morcellators have been used since the 1990s) can be considered an impact to the patient services goal.  Sales of morcellators have been stopped, and as discussed above, the use of morcellators is being questioned by the FDA.

Beginning with the impacted goals, we can ask “Why” questions to determine the cause-and-effect relationships.  The risk for spreading cancer results from undetected cancer in tissues that are then cut up inside the body.  Uterine cancer is difficult to detect with available testing and can be difficult to distinguish from fibroids.  Additionally, cases have been found where cancer was missed in testing prior to surgical treatment.  Recent studies have shown that women who seek such surgeries have a higher incidence rate of uterine cancer (1 in 368 post-hysterectomy patients were found to have uterine cancer versus 1 in 10,000 for the general population).

The morcellator cuts up tissue so it can be removed laparoscopically in a minimally invasive hysterectomy or myomectomy for fibroids.  Until recently, there was no data or warning indicating that morcellators weren’t safe to use.  The device did not provide clinical trial data, which is not required for new products considered “substantially similar” to existing products that are already marketed.  The FDA does not believe that the cancer risk would have been discovered even with a higher level of scrutiny.  The FDA depends on a database of medical-device problems reported by doctors.  However, doctors are not required to report issues.  In addition, it’s not clear that many made the link from the spread of cancer after the use of the morcellator.  Or, some healthcare professionals say they didn’t report it because they believed the undetected cancer – not the use of a device – was to blame.

The link over spreading cancer has now clearly been established.  (Data is still being examined to see if the device worsens cancer as well.)  The FDA is working to determine what – if any – restrictions will be placed on morcellator use.  It’s pretty clear to some, especially given that this treatment for fibroids is considered elective and there are alternatives, including a traditional hysterectomy.  Says Dr. Craig Shriver, surgical oncologist at Walter Reed National Military Medical Center, “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”

However, others think the tool still has a place for minimally invasive surgery and that patients should be able to determine for themselves if the risk is worth taking.  According to Dr. Jason D. Wright, the lead author of a study regarding morcellators published in the Journal of the American Medical Association study, “I don’t know that necessarily morcellation should be banned. But this data is important to allow people to make decisions.”

In the meantime, some facilities are attempting to enclose the uterus in a protective bag before morcellation to minimize the risk of tissue remaining in the body, but there is no evidence that this reduces the risk of cancer spread.  Until the FDA’s final decision, each patient and healthcare facility will have to do their own risk assessment to determine whether or not the tool should be used.