I was greatly dismayed reading last week’s health headlines. A young 24 year old mother in her 35th week of pregnancy was admitted to a hospital for nausea and vomiting. She was receiving liquid food through a tube placed down her nose and into her stomach. In addition, she was receiving intravenous fluid into her veins to prevent dehydration. The nurse mistakenly placed the tube containing the liquid food into her vein. Both the young woman and her unborn baby died. The New York Times reported their deaths and other serious injuries were among hundreds related to similiar tubing mistakes. The same articles cited little precise data is available on exactly how many are occurring because there are no requirements to report these mistakes.
As a young nurse working in a Neonatal Intensive Care Unit 32 years ago, I learned a busy nursing co-worker mistakenly placed a premature infant’s formula tube feeding into the infant’s vein. The infant suffered severe complications and serious permanent injury. Unbelievably, the same mistake is still occurring 32 years later. Reading the various articles surrounding the young mother’s death, a simple solution – creating connections that can not fit into each other - which occurred when unleaded gasoline for cars was introduced – has met obstacle after obstacle. Various groups have been advocating for this change since 1996. In fact, California passed legislation in 2008 mandating this tubing design change, but the bill was pushed back until 2013-14. The FDA has yet to declare interchangeable tubes unsafe.
Deborah Campbell, RN. pediatric ICU manager at Kosair’s Children’s Hospital in Louisville, Kentucky and Charlene Roberts, RN. director of system accreditation for Children’s HealthCare Atlanta, participate on the Women and Children’s Safety Committee. The committee advises the Premier Safety Institute, a division of Premier Inc. Premier Inc. is owned by 200 hospitals and healthcare systems. The company’s mission is to collect, analyze and report clinical and financial data in efforts to promote quality, safety, and cost effective US healthcare initiatives. Premier also reported the tubing problem has been identified in published studies for about 12 years.
Premier Inc. shared 3 widely known injuries:
- 1994: Premature infant given formula via a feeding tube into a vein over 3 hours. Permanent brain damage, blindness, and hearing loss.
- 1998: 4 month old child given formula via a feeding tube into a vein over 9 hours. Seizures and sepsis.
- 2002: 6 month old infant given pureed carrots into a vein. Death.
Reports cite other tubing related injuries:
- 2006: Mistakenly placed spinal anesthesia solution meant for the spinal canal was run into a vein. Killed a 16 year old mother giving birth.
- Blood pressure cuffs have been mistakenly connected to intravenous lines. Inflation led to fatal air embolisms.
- Intravenous lines have been connected to lines delivering oxygen leading to suffocation deaths.
Most tubing in hospitals is interchangeable and looks exactly alike. A multitude of hospital clinical staff change and manage tubing lines each day. A Peggi Guenter, Director of Clinical Practice for the American Society of Parenteral and Enteral Nutrition revealed in a recent article, ” There are 6 systems that should be kept separate: feeding, respiratory gases, urinary, neuroaxial, blood pressure cuffs, and intravenous tubing.” Hospitals have varying procedures to ensure clinical staff properly identify any tubing before using it. However clinical settings are very complex, stressful, and unpredictable. Chaos can occur at any moment. Staff are subject to long working hours with little sleep at times. As a result, these deadly and costly human factor mistakes continue to happen.
Why has such a simple design concept as non-interchangeable tubing met with national and international obstacles for decades? An international standards group studying various solutions for years has yet to offer recommendations. Another international task force that includes manufacturers, clinicians and the FDA report nearing completion of a design. Once introduced and approved, manufacturers will get another 3 years to transition into the new design. AAMI, the Association for the Advancement of Medical Instrumentation, a US organization created by manufacturers has already offered a specific design standard for adult tube feeding sets. The new sets will be incompatible with intravenous female adaptors. However, most manufacturers will not unite behind the recommendation. Again, why not?
Let’s take the redesign of premature infant feeding tubes as an example of the obstacles to safety in US healthcare. The Premier Safety Institute for Women and Children Committee met with manufacturers in 2003. Manufacturers were asked to design a complete safe premature infant enteral feeding system. Only one company responded. Premature infant feeding systems are a small market niche. Only 30% of NICU babies require tube feedings out of 333,000 premature infants born each year. Presumably as a result of the small market niche, the product has yet to be introduced and is still in testing. There is no US competition to date. Therefore, the new safe enteral feeding system will reportedly cost 50% more then the $9 to $10 current unprotected enteral feeding system.
A French competitor has sold a new safe premature infant enteral feeding system in France for over 2 years and introduced it into Britain. They have just begun to apply for US approval and do not know how long it will take. Materials Management Magazine reports European manufacturers are required to redesign unsafe products based on stiff human factor (HF) engineering requirements effecting all manufacturers. Design experts say healthcare is 30 years behind other industries (auto and airline) in HF design requirements.
Another problem Premier Inc. found was in manufacturer polling results. Both the American and French companies polled American NICU nurses. Nursing managers reported few errors involved feeding and intravenous mix ups. To this group, the higher price for the safer systems was not cost effective based on the low error rate. These polls are driving manfacturers decisions. Critics and those who have studied hospital error reporting have repeatedly shown over many years there is wide-spread under-reporting of mistakes. Basing safe product research and development on unreliable incident data has stalled US efforts by these 2 companies. Without some force driving product development as well as competition, it is unknown as to when (if ever) US patients will have safe tubing systems.
I can only ask the question any mother who has lost an infant, a daughter in labor , or anyone who haswatched a loved one suffer one of these horrible mistakes, ”How many more?” For me personally, will it take another 32 years? As a nurse, I have witnessed the complete devastation of a clinical practitioner who made this mistake and severely injured her patient. Shame on the FDA and American Hospital Association for failing to place the highest priority on resolving this decades old patient safety problem.