FDA approvals and manufacturing processes allow medical devices to be carefully crafted to solve specific solutions in the medical field. There are many resources such as instructions to use, video demonstrations, and purchasing specific products in order to prevent off label use. However, this is still a worry in the medical world today.
The ECRI Institute discusses how off-label use can be proven to be safe and efficient through peer reviewed medical literature. They go on to explain that although this is true, off-label use can cause harm without FDA approval. This is due to the fact that the degree of risk has not been predicted.1
With off label use, the degree of risk varies. Using products in a way they were never intended or have the FDA approval for, can cause various side effects, interactions and complications.
Sidman, Margulis, and Fairman LLP explain how physicians believe by using medical devices off-label, they may be benefiting the patient. However, the physician takes up many liabilities and risks, possibly causing the patient to suffer a lifetime of complications.2 They go on to explain an instance where a stent was used on a young patient in order to fix a leak in the child’s esophagus. Through this off-label use, the child’s artery was punctured and is now in need of lifetime care.
The physicians in this instance believed that by using the stent for an off-label use, they would benefit the patient. This was not true and by taking the risk, they took on more liabilities and caused long term damage to the patient. This further resulted in a $30 million lawsuit against the hospital.
Medical device companies are constantly advocating for medical products to be used for their intended purpose.
Starboard Medical cares about the risk and liabilities of off label use. This is why we designed our products to help reduce the risk of off label use. One example is our skin temperature sensor. When designing this product, we found that oftentimes other manufacturers’ skin probes are dismantled and used off label to measure temperature in the nasal cavity. There have been reports of nasal bleeding associated with this off label use. We added extra security in our design by placing the sensor in between 2 foam layers. This makes it difficult to dismantle and dissuades using the product for a use it is not indicated for. We believe medical devices should be used as instructed for the safety and care of our patients.
