The Food and Drug Administration is conducting an investigation of arthroscopic shavers after receiving reports from several manufacturers of the shavers that human tissue remained in some of these medical devices after surgery, despite doctors following the manufacturer’s instructions for cleaning.
The FDA is not yet ordering public health professionals to discontinue use of arthroscopic shavers because the tissue is not visible to the naked eye. Moreover, the FDA stated: “the nature, magnitude and possible health impact of the situation is not yet clear”. They also cite that they are working with manufacturers of the devices to gather more information about the severity of the situation and its potential health and safety implications for patients that have had arthroscopic surgery. However, the tissue that remains in the shavers compromises the sterilization process.
The FDA is urging facilities that use the devices to thoroughly evaluate their cleaning procedures and to also adhere to the following steps to minimize potential health risks from contamination:
· Ensure that medical staff know and comply with manufacturer-recommended cleaning procedures
· Inspect the inside of the shaver after cleaning with a 3mm video scope to ensure that the channels of the shaver hand piece are free of tissues.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.