Biomedical Consulting | Medical Device and Equipment Failures

Rimkus' biomedical engineers assist our clients, as well as juries, to understand the root causes and effects of failures of medical equipment in hospitals, medical offices or homes; and of medical devices such as replacement joints, fracture fixation devices, braces and pacemakers. Our biomedical engineers also evaluate medical equipment damaged in catastrophic events such as hurricanes, floods and power surges to determine the extent of damage and repair or replacement needs.

Medical Devices

When an implanted medical device fails, the solution often involves another painful and expensive surgical procedure. Rimkus experts help determine the root causes of such failures, whether they are due to design or manufacturing defects, installation defects or misuse. Other non-implanted medical devices, such as back and knee braces or artificial limbs, can also fail, resulting in further injury. Rimkus experts have the training and experience to review such failures, assess the root causes and evaluate the reported injuries from both a biomedical and biomechanical perspective.

Medical Equipment

Medical equipment failures can result in catastrophic injuries or death. When life-support devices such as ventilators, defibrillators or intravenous pumps fail, many different factors can contribute to the cause of the failure. Rimkus experts can determine whether medical equipment failure was caused by poor design, manufacturing defect, misuse or poor maintenance. They also evaluate whether the regulatory process used to approve the equipment was appropriate for the use of the product and if the product was applied in the manner intended.

Rimkus assesses failures of, and damage to, hospital equipment ranging from operating room tables and lights to MRI and CT scan machines, and whether they were caused by misuse, storms or other catastrophic events. We also evaluate therapy and exercise equipment that is damaged or that has failed and resulted in injuries.

Clinical Engineering

A wide-angle perspective on clinical operations often uncovers problems associated with facilities, equipment, operations, training, safety and other aspects of medical operations. Our engineers review facilities’ standard operating procedures to determine:

  • Whether those procedures are being followed
  • Whether training of personnel in the use of medical equipment and devices is adequate and obtained by all who need it
  • If the facility design, including all aspects of the mechanical, HVAC, plumbing and electrical infrastructure are adequate
  • Whether medical devices designed to be used in combination are in fact compatible and can be operated safely in tandem
  • If the building envelope and all internal structures provide the clean, sterile environment required for operating rooms, clean rooms and other areas of the facility

Medical Technology and Intellectual Property

Medical technology development is fast-paced, with new products entering the market almost daily. Disagreements arise as to ownership of that new technology, and litigation commonly ensues. Rimkus' experts assist in intellectual property disputes when two different entities lay claim to the same technology by evaluating patents in light of the technologies and their use.

 

To better serve our clients and provide rapid response to assignments, Rimkus maintains offices in the following locations: