FDA Bans Powdered Surgical Gloves
The U.S. Food and Drug Administration (FDA) found powdered surgeon gloves create an unreasonable and substantial risk of illness or injury to patients and providers. Due to this issue and the fact that it cannot be prevented by altering the gloves’ label or warnings, the FDA has banned these medical devices. A ban like this is incredibly rare, demonstrating the seriousness of the risk to patients. The FDA has only banned one other medical device in 1983. The powdered glove ban went into effect Jan. 18, 2017.
Specifics of the Ban
The FDA has prohibited the sale, distribution, and manufacturing of all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder used to lubricate the gloves. This ban does not cover powdered radiographic protection gloves or the powder used during the manufacturing process of non-powdered gloves.
All hospitals, physicians, dentists, and veterinary providers will need to throw away remaining supplies of powdered gloves and purchase appropriate non-powdered gloves. Non-powdered gloves must include no more than two milligrams of residual powder or debris from the manufacturing process.
Why Powdered Gloves Are Dangerous
Powdered surgical gloves or powder used to lubricate physician’s gloves have been banned after being linked to allergic reactions including asthma, post-surgical adhesions, wound inflammation, granulomas, lung inflammation and damage, and infections. Some of these issues can lead to long-term consequences like bowel obstruction, infertility, and death. Even if the powder does not cause a significant injury, it can delay a person’s healing. These issues are caused when the powder is inhaled or gets into a patient’s wound. It can then cause a secondary injury or a new, unique injury to the patient.
When Powdered Gloves Cause an Injury
If an individual is hurt because of powdered gloves used during treatment after the ban went into effect, then that individual may have a right to file a lawsuit to recover compensation for his or her injuries. The FDA has determined that these gloves create an unreasonable risk of injury to patients. Physicians now have a duty to protect their patients by only using safe and permissible non-powdered gloves. Using powdered gloves following the ban is either a negligent or intentionally wrongful act that results in a valid medical malpractice claim.
Texas Statute of Limitations of Medical Malpractice
Under Section 74.251, individuals have two years to file lawsuits based on health care liability claims. This statute of limitations begins on the date the legal cause of action arises. This is often the date the person was injured or it is the date the person became aware that they were injured due to a negligent, reckless, or intentionally wrongful act.
Contact a Texas Lawyer for Help
If you were injured because of a physician’s carelessness, contact an experienced medical malpractice lawyer as soon as possible. The passionate New Braunfels defective product attorneys of the Bettersworth Law Firm are ready to analyze your situation and explain your legal rights.