Revisiting the Issue of Reprocessing

In the June 2003 issue of EP Lab Digest, we presented an article entitled "New Provisions for Reprocessed, Single-Use Devices: An Interview with John R. Manthei." In this special feature, the provisions of The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 were discussed. As stated, Title III of this law was especially important, as Congress established stronger regulations for the reprocessing industry. Congress recognized that while reprocessing single-use devices (SUDs) may be beneficial, some risks still exist, and existing regulations were not fully protecting patients. These new requirements for reprocessed SUDs will ensure safety and effectiveness. It is important that all healthcare professionals, especially those in the EP lab, understand the new MDUFMA provisions. Below we have listed a series of questions on reprocessing. We want to hear how your EP lab handles reuse. Please complete the following form and fax your answers back to: (610) 560-0501. In a future issue of EP Lab Digest, we will share our results with readers.