The Truth About Medical Device “Never Events” In Ohio Healthcare
We want to believe that medical devices and products used extensively in hospitals and clinics to treat and care for patients will be safe, sterile, and effective. Considering that there are federal agencies overseeing the production and sale of medical devices and products, and that skilled medical professionals are using those products, there are certain medical device injury incidents that we hope would never happen in a healthcare setting.
But unfortunately, avoidable bad outcomes – known as “never events” because they really should never happen – occur on a regular basis. Careful medical professionals who are using well-made medical products should obviously not cause injuries or death in otherwise healthy patients. But it does happen.
Never events are defined as healthcare results that meet all three of the following criteria:
- They are clear and simple to identify as unambiguously bad results;
- They are severe events, leading to serious injury, disability, or death; and
- They are typically preventable, and they could be totally avoided with due care.
These events would never occur if all the people and products throughout the process did their jobs correctly. But all it takes is one negligent act, or one faulty medical device, to cause terrible harm that could have been avoided.
Products And Devices In Medical Care
Medical products and devices of all types are subject to rigorous safety and quality standards under the oversight of federal safety and health regulatory agencies. Those devices are then put into use by well-trained and qualified doctors, nurses, and healthcare professionals who are required and trained to understand the proper use of those devices, as well as the risks and dangers of misusing those products. Too often, however, a quality control oversight at the manufacturing plant causes a faulty device to be sold, or a nurse or doctor misuses a medical product, causing harm that could have been avoided.
Never Events In Medical Care Products Or Devices
Incidents classified under “never events” related to a medical product or device usually involve one of just a few potential situations. One type of situation involves contaminated devices, biological matter like blood transfusions, or drugs being used to accidentally harm the patient. In those cases, questions as to where and how the object became contaminated prior to its use in patient care have to be resolved. Another category involves cases where the product or device is used in a way other than how it is intended or directed to be used, causing serious injury or death to the patient. A well-made product that is used correctly will not cause any of these problems. Therefore, we know that human negligence was to blame somewhere along the line.
Who Is To Blame?
Legal liability is a complex issue in many cases, especially in medical product and device law. The number of parties involved in the creation, distribution, and deployment of the product at issue raises questions about how to assign responsibility for the ultimate failure of the product at the point of its use with the patient. The patient who is injured is not in a place to know where that product or device came from, what companies made or supplied it, and what hospital employees had access to it before it was used to treat the patient in a way that caused harm. Indeed, hospitals and insurance companies often do their best to obscure the path of potential blame, to avoid damage to reputations and to avoid paying fair compensation to injured patients.
Paying The Costs Of The Never Event
Following recent changes in federal law, the Center for Medicare and Medicaid Services (CMS) stopped authorizing federal payors to reimburse medical care and services used to treat certain complications resulting from medical error. CMS defines these complications as “reasonably preventable” outcomes in healthcare settings that have evidence-based care guidelines in place. Some media sources reported these changes in dramatic terms, associating the restricted repayment guidelines with the outcomes of “never events.” As written, the federal laws simply restrict payment for complications that are “reasonably preventable” if the professionals had followed proper health care principles and protocols.
What Happens After A Never Event Occurs?
It’s disappointing that many healthcare facilities, medical professionals, and care providers seem to do their best to avoid taking responsibility for serious errors that lead to avoidable death and injury. In most cases, those responsible spend much more time and devote much greater resources protecting their money during a lawsuit than they do protecting their patients in the first place.
The Eisen Law Firm – Medical Malpractice Lawyers
When never events happen as a result of improper use of medical devices and products, they can lead to catastrophic injuries. To learn more about these types of calamities, including who is to blame and what to do if you are injured, you should touch base with a medical malpractice attorney.
Critically, for you to obtain the justice and compensation you deserve, you will want to work with an experienced medical malpractice attorney. With more than 40 years of experience resolving malpractice cases, The Eisen Law Firm is skilled at exposing harmful mistakes by doctors and hospitals and holding them accountable to the victims who suffer the effects of those mistakes. Our skilled trial attorneys are ready to thoroughly analyze your situation, explain the legal options that are available to you, and work tirelessly to help get you the most compensation possible from the medical professionals who have caused you harm. Find out more about how The Eisen Law Firm can represent you by calling (216) 687-0900 or by contacting us online today.