Tungsten Particles Remain in Patient’s Bodies After Clinical Trial

By ThinkReliability Staff

Thirty women who participated in a research clinical trial that hoped to revolutionize the treatment of breast cancer are now facing the possibility of long-term effects from tungsten particles left in their body or disfiguring surgery.  The trial involved radiation treatment that could be performed in one short session instead of over many weeks, offering obvious benefits to the patients.  However during follow-up checks after the trial, many women found particles of tungsten, a heavy metal, in their breasts and chest muscles.

Some physicians have recommended removal of the affected areas.  The choice between that, or living with the risk of tungsten particles, whose long-term effect has not been thoroughly studied, is an impact to the patient safety goal.  In addition the particles will look like calcium deposits, which can be an indication of cancer, in future mammograms, resulting in an impact to the patient services goal.  The device has since been recalled, which is an impact to the property goal, and at least one suit has been filed against the manufacturer of the device and the hospital performing the trial.  It is believed that 30 women are affected.

The health issue of leaving the tungsten within the patient’s body is caused by a particle of unknown long-term safety being deposited in the body.  The tungsten appears to have been shed by a device used during radiation treatment to prevent radiation from reaching other parts of the body.  It’s still unknown how a device that would shed particles into a patient’s body made it into a human clinical trial.  What is known is that the device went through the accelerated FDA approval process known as 510(k) for devices that are similar to devices that have already been approved.  It’s unclear which device was considered similar enough to allow for the approval of this one, but there have been many concerns that the FDA’s approval process is insufficient.

An in-depth look at the approval process of the FDA is currently underway to determine where changes in the process may result in a more thorough review and , most importantly, prevent an issue like this one from reoccurring.

Aging Surgeons

By ThinkReliability Staff

Over 20% of today’s physicians are over the age of 65.  Should this be cause for concern?  After all, we rely on our doctors to take care of us when we are often at our most vulnerable.  While increased age means increased experience, there are also down sides.  Age can bring with it a decrease in physical and mental capabilities, as well as a reluctance to adopt newer technologies.  At least this is what multiple studies have hinted at over the past few years.

The problem is that such a “decrease in capabilities” is highly subjective and difficult to measure.  Surgeons rely on a variety of cognitive and tactile skills in their craft – steady hands, learning new techniques, composure under stress, communication skills, and so on.  As highly trained professionals, it is sometimes difficult to decide when it is time to call it quits.

Furthermore, in the United States, age-based discrimination is outlawed in most industries except where regulated.  For instance, airline pilots and air traffic controllers are both subject to earlier-than-average retirements due to public safety concerns.  Many federal and state public workers, such as corrections officers and firefighters, are similarly limited. It’s difficult to argue that some physicians don’t make similar split-second, life-and-death decisions – especially surgeons.

The associated Cause Map visually lays out the dilemma.  Surgeons who aren’t performing adequately do so for two reasons.  First, they have a medical condition precluding them from performing to standards.  (Note that to keep this Cause Map simple, other issues such as mental health problems, addiction, and failure to maintain their continuing education were not examined.)  Second, they are allowed to continue practicing.

Such physicians continue after their abilities are impacted for a number of reasons.  Some might be unaware of their condition or unwilling to accept it, both stemming from a belief that they are still competent to practice.  Additionally, current processes at most hospital are slow to identify such physicians.  Most hospitals rely on co-workers to identify such doctors, clearly a highly subjective and ethically complex system.  Age-based screening is not common at many hospitals, partly because of resistance from hospital staff.  In fact, only 5-10% of hospitals have directly addressed this issue.  Labeling doctors as “unfit to practice” isn’t necessarily a bad thing.  If such doctors are identified early, patient safety is enhanced.  Additionally, early identification can sometimes allow those doctors to continue practicing in a controlled and safe environment.

Now that the problem has been laid out, the next step is to look for possible solutions.  It’s clear that little can be done about age-related deterioration.  So the focus moves to the other branch of the Cause Map.  Here there are a number of possibilities.  While age-based screening is certainly an option, it’s not the only one.  For instance, including hospital staff in making decisions might also help decrease resistance to identifying deficient physicians.  Additional training on the impacts of age might make co-workers more willing to discuss their concerns.  Or doctors might be more willing to adapt to their limitations if regular screening can identify possible health problems.

While more research is needed to determine how extensive this issue is, it is clear that at most hospitals current procedures to identify deficient physicians are lacking.

Why Potassium Iodide?

By Kim Smiley

In addition to evacuating the people near the nuclear plants in crisis, the Japanese government has distributed potassium iodide.  There has also been a run on potassium iodide on the West Coast of the United States.


Why would pills protect against radiation?  The first part of the answer lies in the thyroid gland.  The thyroid contains some of the only cells in the body that can absorb iodine.  The thyroid needs iodine in order to produce thyroid hormones which are used by nearly every cell in the body and help regulate important functions such as metabolism.  The second part of the answer is that iodine-131 is a common isotope produced by the fission of uranium atoms during the operation of nuclear reactors.  When fission products are released into the environment and consumed by humans, the thyroid can absorb radioactive iodine, just like it absorbs stable iodine.  Exposure from radioactive iodine can lead to thyroid cancer.

When exposure to radiation is possible, potassium iodide is used because the thyroid has a limit to how much iodine it needs.  If the thyroid has been flooded by stable iodine, it decreases the chance that radioactive iodine will be absorbed.  Any unneeded iodine should be passed through the body relatively quickly, limiting the amount of exposure to the radiation emitted by the iodine-131.

History has shown us that the threat of thyroid cancer is very real following a nuclear reactor accident.  There has been an epidemic of thyroid cancer in the area affected by the Chernobyl accident in 1986.  Experts believe that distribution of iodide potassium could have largely prevented this long term health consequence.  Additionally, the majority of iodine exposure came from drinking milk produced by cows living in the area contaminated by the accident.  If people had avoided drinking contaminated milk in the months following the accident, the effects of radioactive iodine would have greatly been diminished.  Another possible solution that could be applied to help prevent thyroid cancer following a reactor accident would be to test all food and drink for contamination.

There are a few other important facts to consider about potassium iodide.  It is not recommend for low levels of radiation.  The U.S. Nuclear Regulatory Committee has stated that very low levels of radiation may reach the United Stations, but that the amount is well below any harmful limit.  Officials have repeatedly stated that there while use of the potassium iodide is an appropriate precaution for individuals near the accident site in Japan, there is no need for people within the US to take potassium iodide to protect against the effects of radiation.  There are also a number of unpleasant side effects associated with potassium iodide and it is recommended that you speak to your doctor before taking the supplement.

Click on the “Download PDF” button above to view a Process Map of how the body absorbs iodine and a high level Cause Map of the thyroid epidemic following Chernobyl.

Toddler Dies From Contaminated Wipes

By Kim Smiley

A 2 year old boy died December 1, 2010 following a routine surgery to remove a benign cyst from near his spinal cord and brain.  He appeared to be recovering well when he contracted bacterial meningitis and quickly succumbed to the infection.  Tests revealed the bacteria were a rare strain, Bacillus cerus, which is typically associated with food poisoning and not hospital infections.  How the patient was exposed to the bacteria was initially unknown, but now a potential source has been identified.

On January 5, 2011, The Triad Group, one of the nation’s largest medical product suppliers, announced a massive recall of alcohol wipes, swabs and pads because of contamination from the same rare bacteria, Bacillus cerus.  Products by this manufacturer were used to care for the boy during his hospital stay.  Although, a definitive link between the death of the boy and the recalled pads has yet to be established, there is a lawsuit pending.

Since the time of the recall, other people have come forward with possible cases of infection from Bacillus cerus from using the recalled products.  The FDA has launched an investigation.

Even through the investigation is not completed, this example can be built into a Cause Map based on the information that is available.  A Cause Map is an intuitive, visual method of performing a Root Cause Analysis. Any additional information can be added to the Cause Map as it becomes available and any necessary changes made.

When beginning a Cause Map, the first step is to determine the impact to the organizational goals and document them in an Outline.  In this case, the Safety Goal was impacted because a boy died and there is potential that more people were infected by the same harmful bacteria.  Once the impact to the goals is completed, Causes are added to the map by asking “why” questions. In this case, the boy died from bacterial meningitis because he was exposed to Bacillus cerus.  Next, we would ask “why” he was exposed to the bacteria.

Because the link between the recalled wipes and the death of the patient has not been officially determined, a question mark is included with that information when it’s added.  It’s important that all evidence or lack of evidence is documented on the Cause Map so that it is clear which Causes are agreed upon, known facts and which still need to be proven. Click on the “Download PDF” button above to see a high level Cause Map of this example.

The recall is a short term solution to this problem, but at least all products known to be contaminated should be removed from shelves and hospital storerooms.  It isn’t clear yet what steps are needed at the manufacturer to ensure safety of consumers, but the affected products will not be sold again until they are tested and deemed safe.

Kidney Transplant Mix-up

By ThinkReliability Staff

On January 29, 2011, a kidney was transplanted into the wrong patient.  No one was injured, but this was known as a “near miss” – had things gone slightly differently, it could have resulted in severe consequences.  Namely, the patient who received the incorrect kidney could have been killed or seriously injured, had the kidney not happened to be compatible with that patient also.  (The kidney donor had Type O blood, known as the universal donor, which aided in the compatibility.)  The patient who was supposed to receive the kidney could have had a long wait back  on the transplant list.  Luckily, a new donor was found for the second kidney and a new kidney was found for the second donor fairly quickly.  Although there were no injuries, the high potential for injury results in an impact to the patient safety goal.

To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center.

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here).

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.