The Food and Drug Administration (FDA) has asked manufacturers of reusable duodenoscopes to provide more information on disinfection of those instruments. Scopes are used in about 500,000 procedures annually, particularly in procedures involving the bile ducts or pancreas. Although the FDA has regulated the use of scopes in the past, it is now asking for manufacturers for more information on the devices.
The FDA’s requests were prompted by the recent outbreak of a “superbug” at various hospitals. The outbreak is resistant to antibiotics and has proved deadly in some cases. Thus, the FDA plans to seek expert testimony on the subject and some congressmen have called for hearings on the issue.
The FDA hopes that its investigation will lead to information on better cleaning procedures for the device and possibly a new design that can be more effectively disinfected. Nevertheless, improvements and further investigation can take time. Interim safeguards, which may be costly, are sporadically implemented.
If you or a loved one was infected with a “superbug,” or suffers some other type of harm from a scope that was not properly disinfected, you can gain compensation for your injuries. Call Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC at 973-274-5200 today for help with your case.