Bacterial Contamination of Tampons

By ThinkReliability Staff

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.

The specific source of the contaminant has not been identified.  Investigations of previous instances of contamination with the Enterobacter sakazakii have had difficulty determining an exact source, as this bacteria is found within human  and animal guts.  However, even with limited information, we can begin a Cause Map, or visual root cause analysis, which allows us to view the areas where more data collection is needed in order to gather evidence to complete the analysis.

We begin by capturing the basic information about the incident as well as the impacts to the goals.  The safety goal is impacted due to the risk of infection from the contamination tampons.  The environmental and customer service goals are impacted because a product was bacterially contaminated.  Additionally, the product recall impacts the production, property and labor goals.  We begin our Cause Map with the impacts to the goals.

Both the risk for infection and the product recall were caused by the bacterial contamination of a product.  The product was contaminated because contaminated raw material was used for its manufacture.  This occurred both because the raw material was contaminated and because the quality control or testing process for the raw material was insufficient.  Whether there was no testing process for the given bacteria or whether the process did not recognize the bacteria and stop the use of the contaminated raw material is unclear.

At this point, because the source of the raw material contamination is unknown, an open question which requires evidence-gathering is “how did the raw material get contaminated”? This will require cooperation from the raw material manufacturer.   The other necessary information is to do a detailed review of the quality control and/or testing that is used on raw materials prior to manufacturing and determine how the contaminated material was able to be used to make a final product.  Once this process is looked at in detail, specific solutions that would prevent a recurrence of this type of contamination can be implemented.

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

America’s Food Deserts

By Kim Smiley

A food desert is a community that lacks adequate access to healthy, nutritious food because they don’t have sufficient stores that sell these items at an affordable price, such as a supermarket. Both isolated rural areas and low income urban neighborhoods are typical locations where a food desert might exist in the United States.  In these locations, residents typically must rely on the food that is available nearby, usually small convenience stores and fast food restaurants.  Smaller convenience type stores generally don’t offer a variety of fresh food and vegetables and the prices are typically higher.  Many times the result is a less healthy diet and the potential health problems that go along with it.

A significant percentage of the US population lives without relatively easy access to a supermarket.  In a report to Congress, the USDA stated that 2.2 percent of the US population lives more than a mile from a supermarket and does not have access to a vehicle.  That’s 2.3 million people who constantly struggle with the logistics of buying groceries, even before the rising cost of food is considered.

How did food deserts come to exist?  In a country as wealthy and as industrialized as the United States, how is it that so many people don’t have access to a grocery store?

Food deserts came to exist because companies followed demand and built grocery stores where they would be most profitable, which is not typically low income urban locations or very rural areas.  Low income families typically have less money to send on groceries so more supermarkets were built in the more profitable, affluent neighborhoods than in poorer communities.  Some low income urban areas are also associated with higher crime rates so companies were hesitant to build in those areas.  People with lower incomes are also less likely to have access to a vehicle so the problem of buying food is compounded when the supermarkets are farther away from the low income communities.  Supermarkets are also less likely to be built in low population density rural areas because there are fewer potential customers and the stores aren’t as profitable.

While it’s relatively easy to identify why food deserts came to be, it’s still a tricky problem to solve.  Some groups have suggested that the government should provide subsidies to companies that build stores in food deserts.  Others are working to bring in foods to the people living in food deserts.

If you’re curious about where food deserts exist in the US, click here to view a map of the locations.  Click here to read a previous blog that discussed how food deserts are a cause of childhood obesity.

Young Boy Killed by Projectile During MRI

By Kim Smiley

It has been over ten years since six year old Michael Colombini died as a result of injuries that occurred during a routine MRI.  He was undergoing a post-surgery MRI after removal of a benign brain tumor when he was hit by a magnetic oxygen tank that was pulled toward the MRI machine at high speed.  His skull was fractured and he died two days later.

How did this horrible accident happen?

A Cause Map, or visual root cause analysis, can be built to help explain the causes that contributed to this death.  In this example, the patient needed an MRI because he had a brain tumor removed and he was hit by a magnetized oxygen tank while in the MRI machine.  This occurred because the oxygen tank was attracted by the huge magnet in the MRI and flew towards the machine at high speed.

MRI magnets will always attract magnetic things, even when the machine is off.  Bringing a magnetic oxygen tank into a MRI examination room is a dangerous situation.  In this example, there are several reasons why the tank was brought into the MRI area.  The tank was bought into the room by a well-meaning nurse who heard the anesthesiologist calling for oxygen.

The nurse had returned to the MRI area in order to retrieve something she had left there earlier in the day when she had accompanied a patient to the space.  She heard the anesthesiologist calling for oxygen and saw the tanks nearby so she handed one to the doctor.  Contributing to this accident is the fact that the oxygen tanks were stored near the door to the MRI exam room.

The anesthesiologist was calling for oxygen because the patient had low oxygen saturation levels and needed additional oxygen.  The patient was a six year old boy so he had been sedated for the MRI procedure.  A piped in system normally supplied oxygen for use during MRIs, but the system had malfunctioned.  Both MRI techs on duty had gone to investigate the piped in oxygen system failure so nobody trained on MRI safety was around when the nurse bought in the oxygen tank.

Some simple solutions that might have helped prevent this accident, even with the oxygen system failure include storing oxygen tanks far away from the MRI exam room and not allowing unescorted non-MRI staff into the space.  It’s also always a good idea to have an acceptable back up for important systems planned in advance.  If a second safe oxygen supply was already provided, this accident could have been prevented.

The magnets in MRI machines are 200 times stronger than a refrigerator magnet and, as this example illustrates, the potential for injuries from projectiles is very real. Like most accidents, this death was caused by a number of failures that occurred at the same time.  All of the staff involved was trying to do the right thing, but the end result was the unnecessary death of a young boy.