By: Andrés J. Calderón, Ph.D.
According to a global investigation by the International Consortium of Investigative Journalists, in the past decade nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices. Many of these devices were approved with little to no clinical testing. Medical errors also cause a significant number of Americans to be harmed. Two studies evaluated a large sampling of hospital admissions, one in New York using 1984 data and another in Colorado and Utah using 1992 data, found that the proportion of hospital admissions experiencing an adverse event, which was defined as injuries caused by medical management, were 2.9 and 3.7 percent, respectively. The proportion of adverse events attributable to errors (i.e., preventable adverse events) was 58 percent in New York, and 53 percent in Colorado and Utah. Out of these events a significant number was a result of medical device malfunction or mismanagement. A Biomedical Engineer is an important asset and can assist in this type of medical malpractice case.
As a forensic expert, the Biomedical Engineer provides a knowledge of engineering principles relating to the design, invention, and creation of medical or scientific equipment, devices, computer systems, and software that are an aid to medical professionals. These devices include vascular and orthopedic implants, machines to diagnose medical problems, dental chairs and surgical instruments, as well as many other devices. Biomedical Engineers provide safety efficacy for equipment or instruments, and as such are experts in understanding how these machines work and operate. Biomedical Engineers provide a diverse area of expertise in understanding medical products and devices, in particular when the engineer’s undergraduate studies were in mechanical and electrical engineering. For example, Biomedical Engineers can analyze and design software to run medical equipment, as well as design rehabilitation exercise equipment. Biomedical Engineers also have the knowledge to make sure devices are safe for their intended use and for the patient those devices serve.
There are varying classifications for medical devices, which are regulated by the FDA. Biomedical Engineers design devices with specific safety parameters and should be familiar with the FDA Medical Device Regulations. Medical devices can range from tongue depressors to MRI machines, orthopedic and vascular implants, to infusion pumps, etc. Biomedical Engineers understand the Premarket approval (PMA) of the FDA, which is the scientific and regulatory review process the FDA uses to evaluate the safety and effectiveness of Class III devices. Class III devices are those that support or sustain human life. There are other devices that may not require PMAs, a Premarket Notification called 510(k). Biomedical engineers can assist you in understanding whether a specific medical device should be under the scrutiny of a PMA or 510(K), and the different safety standards that each medical device should have. Navigating the review of patents and determining the category of an approval process for a specific device by the FDA is also an investigation where a Biomedical Engineer can assist.
We have provided biomedical engineering forensic assistance on matters including pharmacology mixing devices, joint implants, transport chairs, dental equipment, and other medical devices. At Consulting Engineers & Scientists, we can provide assistance in litigation cases where medical devices were used or were the cause of an injury. This includes infusion pumps, cardiovascular implants, orthopedic implants, medical equipment, transport chairs, safety software implementations, among others. We have a vast knowledge in engineering ranging from Metallurgy and Mechanical Engineering to Electrical Engineering that are coordinated with Biomedical Engineering to be able to aid you in the majority of medical device cases. Please do not hesitate to contact us with any questions regarding medical devices or medical products.