When you go to the hospital or doctor’s office, you expect and want to believe you are in good hands and that you will receive the best care possible. If you are sick or injured, the only thing on your mind is healing, and you believe the hospital is the safest place to be. You believe the equipment, medical supplies, and technology is safe, working properly, and up-to-date. Sadly, in a tightened economy full of budget cuts, this is not always the case, and people are often left with catastrophic injuries and death due to defective or malfunctioning medical equipment and devices. Each medical device you encounter, from the IV, to the blood pressure machines and heart monitors could pose a potential risk to your health if they are not properly maintained, or if they were manufactured or designed defectively. An improperly serviced or defective defibrillator, or one that is lacking batteries, for example, can mean the difference between life and death. Thousands of people suffer from chronic pain, failing organs, and debilitating diseases that require extensive medical care. New and exciting technology has led to state-of-the-art medical treatments like replacement knees and hips, stents and balloons to repair arteries around you heart, artificial heart valves, pacemakers to keep your heart beating correctly, and catheters that can automatically distribute medication to parts of your body. Medical devices can allow people to live longer, healthier, happier lives. Sometimes, however, these medical devices can become their worst nightmare. Every year medical equipment and devices are recalled for manufacturing defects, flawed design, and contamination, usually after an innocent victim has already suffered or death. The news has been flooded with stories about defective hip and knee implants that fail to work properly, or end up releasing toxic metal and contaminants into someone’s bloodstream. Metal on metal hip implants pose more of a significant risk of injury than other replacement hip implants. The metal ball and socket have been found to rub together during movement or exercise, causing metal pieces to break off the device, entering the individual’s bloodstream, leading to damage to bone and tissue, toxicity, and excruciating pain. Certain surgical and lifesaving equipment like tracheostomy tubes, catheters, and surgical mesh are reported as having caused catastrophic injury and death due to a defective part or flawed design, rendering them potentially lethal. Recently, synthetic bone grafting material has elicited reports of abnormal bone growth, swelling in the neck and throat, and causing sterility, along with reports of doctors hiding these adverse side effects from the public. Boston Scientific issued a recall of over 100,000 heart catheters after discovering that a brittle material used in the catheters could cause the tip to break off inside a patient, causing serious tissue damage, blood vessel injury, or death, and require emergency corrective surgery. Defective IV systems and pumps can administer too little or too much medication to a patient, broken monitors can fail to keep track of a patient’s blood pressure or oxygen levels, and diagnostic equipment can fail to diagnose someone of a potentially life-threatening condition. The Food & Drug Administration is charged with assessing, regulating, and recalling potentially dangerous medical devices, but a recent Senate report has called for enhanced assessment of recalls of medical devices, arguing that there are inadequate procedures in place to determine if recalled products have been repaired, or if the FDA needs to recall medical devices if the manufacturer will not voluntarily issue recalls. Defective medical devices and failing medical equipment can cause catastrophic injuries, permanent side effects, and death. Unfortunately, the defects in medical equipment are often caused by manufacturing errors, flawed design, and human error, like failing to maintain and repair equipment, and failure to recognize when medical products are not working properly. Negligence in the maintenance of medical devices can lead to very painful and life-altering consequences for patients, like you, your spouse, your children, or parents.
Device Recalls on the RiseIt is a scary statistic that medical devices have been increasingly recalled. The Federal Drug Administration conducted a review and systematic assessment of medical device recall information between the years of 2003 and 2012. According to their report there was an increase of 97 percent for annual medical device recalls. A recall is as defined at Title 21, Code of Federal Regulations (CFR), 7.3(g), “Recall means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.” A Class I recall is a situation in which there is a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Also, a Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. The most frequent device I recalls according to the FDA were:
- Pump, Infusion
- Accelerator, Linear, Medical
- System, Image Processing, Radiological
- X-Ray, Tomography, Computed
- Automated External Defibrillators
- Electrosurgical, Cutting, and Coagulation And accessories
- Prothesis, Knee, Patellofemorotibal, Semi-Constrained
Medical Device Products LiabilityWhen a medical devices or piece of equipment causes injury this is different form medical negligence, because medical negligence centers on the actions or inactions of the medical professional themselves. The law looks at medical negligence and determines whether or not a doctor was negligent measured against the appropriate medical standard of care. Liability based on a defective medical device or piece of equipment however, centers on whether or not the product was reasonably safe or not. There are generally three types of products liability as it pertains to medical devices and equipment. A medical device or piece of equipment can have a design defect, a manufacturing defect, or a marketing defect.
- A design defect is when a medical device or product is dangerous and defective simply because of its design.
- A manufacturing defect is when the defect in the product or device occurred during the manufacturing process.
- A marketing defect for a medical device usually refers to a situation where the products instructions or advertising present a problem or do not adequately warn of the dangers the product might pose.