The FDA informed health care professionals of instances in which pieces of tissue have remained within arthroscopic shavers, devices used in orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer's instructions.
Since retained tissue in these devices can compromise the entire sterilization process, the FDA is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact, the agency says.
The FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures and has provided recommendations for minimizing the potential risk to patients, the agency notes.
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The FDA asks that surgical facilities that discover retained tissue in arthroscopic shavers after following the manufacturer-recommended cleaning procedures file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program online. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA communication about the ongoing safety review, at: