FDA:New Instructions for design and cleaning of Reusable Surgical and Medical devices

Cleaning of reusable surgical and medical devices
Cleaning of reusable surgical and medical devices

The U.S Food and Drug Administration makes announcement that it will introduce the steps which will reduce the risk for spreading of disease through reusable surgical and medical devices. This risk becomes more exposed if these were not properly sterilized.

Non disposable Surgical and medical devices are made to use repeatedly after cleaning process. These devices are made with the marital which can sustain sterilization and disinfecting process to clean biological materials and debris that can infect next patient. It is found that nearly all devices can be successfully reprocessed, but still there are some which are objectionable.

As it was studied that not 100% reusable surgical and medical devices qualify for 100% sterilization and cleaned from biological materials and debris, FDA identified the guidelines for designs of these reusable surgical and medical devices that will reduce the possibility of retention of biological materials and debris on these devices. These guidelines are of smooth facing with long narrow interiors so that reprocessing fluid can easily move through the devises.

“Reprocessed devices play an integral role in health care. The FDA, industry, and health care facilities share the responsibility of making sure that reprocessing procedures work and are properly implemented,” said William Maisel, M.D., M.P.H., deputy director for science at the FDA’s Center for Devices and Radiological Health.

FDA will sponsor a workshop for public in June 2011 in collaboration with representatives from all stakeholders of health sector including manufacturers, healthcare professionals and all healthcare governmental agencies to discuss on future surgical and medical devices design and reprocessing. FDA found that the risk of infections from reprocessed devices are comparatively low than the importance of the surgical procedure which is to be done on patient, therefore it is not recommended that patient delay his/her surgical procedures.

FDA is looking for releasing a guideline for the manufacturer that will provide a clear scientifically validation of reprocessing instruction which will be the part of device labeling on manufacturing stage of there devices. FDA is also working for setting up standards like Association for the Advancement of Medical Instrumentation that will helps in development of standards for update processes, technical information reports, test methods, material, design and acceptance for cleaning reusable surgical and medical devices.