Arthroscopic Shavers May Retain Tissue After Cleaning: FDA
The FDA warns that some arthroscopic shavers, used during orthopedic procedures to cut and abrade tissue and bone, may still have small pieces of flesh and bone in them from prior patients, even after medical facilities clean the devices. This could expose patients to a risk of infections and blood borne diseases.
According to a statement released Monday, the FDA is conducting a safety review of cleaning problems with arthroscopic shavers after it became aware of instances where pieces of tissue remained in shavers even after medical professionals indicated they cleaned the devices according to manufacturer recommendations. The pieces of tissue are often minute and could be missed by the human eye.
Arthroscopic shavers use powered blades to scrape away tissue and for the debridement and cleaning of bone in a variety of procedures. They are used for fine, delicate work, often inside and around bone and joints.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
The manufacturers of several different arthroscopic shavers recently sent a warning letter to healthcare providers stressing the importance of following their recommended cleaning procedures. However, the FDA indicates that they remain concerned because retained tissue can compromise the entire sterilization process.
The FDA review will include working with the manufacturers to determine what the health impact and specific risks associated with improperly cleaned arthroscopic shavers could be.
In the interim, the FDA advices that medical staff charged with cleaning the shavers pay very close attention to manufacturer-recommended cleaning procedures. But even after those procedures are followed, the FDA recommends that the insides of all arthroscopic shavers be closely inspected for remaining tissue. The agency notes that one facility used a 3mm video scope to inspect the channels of the shaver’s hand piece.
The FDA did not identify any specific brands of devices that may be prone to the cleaning problems. In addition, the agency has not recommended doctors stop using the instruments.
Further recommendations and possible regulatory actions are being reserved until the FDA has better assessed the situation.
"*" indicates required fields
More Top Stories
Bard claims two cases selected for the third and fourth bellwether trials are no longer representative of the litigation due to the plaintiffs' worsening injuries and need for additional surgeries due to their failed hernia mesh products.
More than 775 Exactech lawsuits have been filed in federal and state courts as parties work toward a plan for bellwether early test trials.
A federal judge has announced he will soon begin remanding 3M earplug lawsuits back to their originating districts for trials over claims of veteran hearing loss.