Tag Archives: improvement

Root Cause

“Artificial Pancreas” May Dramatically Improve Management of Type 1 Diabetes

By Kim Smiley

As many as 3 million Americans have type 1 diabetes and for many managing the autoimmune disease requires constant vigilance.  Patients have to carefully monitor what they eat and their blood sugar levels, often pricking their fingers and injecting insulin multiple times a day.  The number of people diagnosed with type 1 diabetes has been increasing, but there is some good news.  There is no cure for type 1 diabetes, but a new device, an artificial pancreas, may make managing the disease significantly simpler.

Type 1 diabetes is caused when the immune systems attacks insulin-producing cells in the pancreas so the body can no longer produce adequate insulin.  Insulin is needed because it works to allow sugar to enter cells where it is used for energy, reducing the levels of sugar in the blood stream.  Sugar builds up in the blood when food is consumed and from natural processes in the body.  Without enough insulin, blood sugar levels will continue to increase.  High blood sugar can damage major organs and can have significant impacts on long-term health.  Low blood sugar is also dangerous and can quickly become a life-threatening emergency so patients with type 1 diabetes are constantly working to keep blood sugar within acceptable levels.

The artificial pancreas works by monitoring blood sugar levels every 5 minutes and using two pumps to deliver two different hormones (insulin to lower blood sugar levels and glucagon to raise blood sugar) as needed with minimum intervention required by the user.  The current version of the artificial pancreas consists of three parts (two small pumps and iPhone contacted to a continuous glucose monitor) but there are plans to simplify the device in the future.  The components connect to three small needles that are inserted in the patient to allow blood sugar levels to be monitored.  Insulin pumps currently used by many type 1 diabetics can only inject insulin and require more input from the user, so the artificial pancreas is a significant improvement over currently available technology.

The artificial pancreas is still in the development stage and needs additional testing and modification prior to becoming widely available for patient use.  The first test was done using about 50 patients (20 adults and 32 teenagers) who wore the new device for 5 days.  The results were very promising, but more testing will need to be done. During the 5-day test, the patients had lower blood sugar levels overall and the device simplified management of the disease.  Researchers reported that the patients didn’t want to return the devices because they worked so well. The next step is to have patients use the device for a longer time period.  It’s essential to ensure that the device is very robust, because the consequences can be dire if it fails.  Once the design is finalized, the hope is to seek FDA approval and have the artificial pancreas available in about 3 years.

To view a Cause Map of this issue, click on “Download PDF” above.

Root Cause Analysis

Technique Increases Availability of Donor Kidneys

By ThinkReliability Staff

Transplanted donor kidneys save lives, but availability does not meet demand.  Contributing to the problem is that some people who are willing to be donors have organs that are considered unsuitable for transplant.  A new procedure has been successful in making some of these previously rejected kidneys usable again.

The procedure involves flushing donated kidneys, which would previously have been rejected as unsuitable for transplant, with oxygenated blood (normothermic perfusion).  This can allow use of some damaged kidneys, such as those from the elderly or those with high blood pressure or diabetes.  It decreases the risk of a marginal organ being rejected.  It is believed that this could increase the availability of organs by about 500 a year in the United Kingdom, reducing the number of people on transplant waiting lists by about 10%.   (There are more than 6,400 kidney patients waiting for a transplant in the UK.)

So far, 17 organs that have been through the procedure have been successfully transplanted, between November 2010 and November 2011.  They are all functioning well.  The success of this procedure can be examined in a Cause Map, or visual root cause analysis.   Positive impacts to the goals can be examined in the same way that negative impacts are – by identifying the impacts and asking “why” questions to identify the causes.  Due to this procedure, the patient safety goal has been impacted by reducing the risk of rejected transplanted organs.  The patient services and material goal has been impacted by increasing the availability of donor kidneys.  And, the “labor” goal has been impacted by reducing the amount of time people wait for donor kidneys.

Beginning with these impacts and asking “why” questions, we can identify that the procedure is allowing the use of previously marginal organs by allowing treatment outside the recipient body and  reducing the risk of rejection.  This increases the number of organs that can be used, and since there are still more organs needed than available, this reduces the amount of time on the waiting list.

Although this procedure should increase the number of organs available and reduce time on the waiting list, it still will not provide enough organs for everyone who needs one.  Donor outreach to increase donors and family understanding of the life-saving organ donation process is still needed.

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