Nearly one in four patients admitted to U.S. hospitals will experience harm, according to a study published earlier this year in the New England Journal of Medicine. And medical error is the nation’s leading cause of accidental death, with conservative estimates of more than 250,000 patients dying annually from preventable medical harm.
Every time I walk into a hospital, I’m haunted by comments hospital executives have made to me outlining the challenges of addressing harm to human life due to medical errors. First, a chief financial officer at a prominent hospital told me, “We generally don’t collect data on things that are going to cost us money to fix.” The second came from the chief medical officer of a large hospital network: “Our business model is to provide the least amount of healthcare for the most amount of money.” While shocking, these sentiments represent the struggle between the drive for patient safety and the business models of our healthcare system.
In an effort to combat this issue, U.S. Representative Nanette Diaz Barragán introduced H.R.9377 – the National Patient Safety Board Act – late last year. The National Patient Safety Board (NPSB) would model the efforts of the National Transportation Safety Board (NTSB) and Commercial Aviation Safety Team (CAST), and would exist as a new independent federal agency dedicated to improving and promoting public health and welfare by monitoring and anticipating adverse events and creating recommendations and solutions to prevent medical error.
One of the foremost issues of safety facing patients in the U.S. healthcare system is IV safety as over 80% of admitted patients will receive an IV. These errors can result in dire outcomes for patients, including drug dosing errors and scarring, as well as very serious conditions like skin necrosis and even amputation in severe instances.
The administration of radiopharmaceuticals via IV placement provides an illustrative example of why the oversight of reporting by a National Patient Safety Board is so desperately needed. Radiopharmaceuticals are drugs containing radioactive isotopes which are delivered via bone scans, heart scans, and cancer treatments. While they are regulated by the Nuclear Regulatory Commission (NRC), that body has failed to make the infiltration and extravasation (i.e. accidental delivery of this type of drug outside the vein) of radiopharmaceuticals a required reportable medical event.
To demonstrate how woefully behind much of the medical industry is when it comes to IV patient safety, the NRC says it is “working with stakeholders” to determine how to address this issue. That solution? Leaving it up to patients themselves to report their own extravasation events as well as any of the ensuing issues they may experience as a result. Do we require passengers in a plane crash to report this themselves? Of course, we don’t, and yet this is what has been passing for IV safety regulation in this country.
IV infiltration and extravasation problems are not limited to nuclear medicine. What happens when someone experiencing a stroke needs clot-busting drugs but the drug isn’t delivered because of an IV misplacement? They die. And, it’s never reported.
And then there are the most vulnerable of patients: neonates. No matter the patient population, IV injury presents a considerable danger, but when this happens within a NICU environment, you are dealing with a very specific series of risk factors. For instance, premature babies have very thin and brittle blood vessels inherently, which increases the risk of IV injury.
But also consider the fact that these infants cannot communicate their pain as adults can, which is something we heard directly from one of the nurses involved in a study that was conducted at Wilhelmina Children’s Hospital in Utrecht, Jozua van Duuren: “A man or a full-term baby would scream in pain. But these young babies are not sufficiently developed yet, so they silently endure the pain.”
Reporting on this everyday problem is minimal at best. Clearly, if a hospital was required to report these types of rates publicly, it would create a sea of red flags.
Patients are making their injuries public – just search the term “extravasation” and click on the “images” tab for proof – and they need an advocate. If just one plane crashes, the NTSB acts, but in the medical arena, we hear things like, “It’s just a small percentage, so it’s fine.” But it’s not fine, and that is why we need a National Patient Safety Board.
Gary P. Warren
Gary P. Warren is the president and CEO of Virginia-based ivWatch, which develops and markets biomedical sensor technology focused on safe and effective infusion therapy and vascular access.