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Posted 20 June 2012 | By Alexander Gaffney, RAC
A new report put out by the US Food and Drug Administration's Office of Science and Engineering Laboratories (OSEL), part of the Center for Devices and Radiological Health (CDRH), provides an overview of the Office's activities during 2011 and insight into what it considers to be its priorities.
OSEL is primarily engaged in two core activities, the report explains. First, the office manages research activities with the aim of "providing a scientifically sound basis for responding to current needs and anticipating future regulatory challenges." Second, OSEL provides other CDRH offices with technical consultations to support the evaluation and postmarketing surveillance of medical device products.
The two activities are apparently keeping the office busy. In 2011, OSEL provided CDRH with 1,780 premarket device consultations and 142 postmarketing consultations. These scientific consultations were used in a wide range of activities, including evaluations, compliance actions, scientific collaborations, responding to inquiries and guidance document feedback.
Not content to let the numbers tell the story, the OSEL report provides a huge range of highlighted vignettes of staff accomplishments. Among the office's scientific accomplishments include the development of an implantable brain computer interface platform, a nanoparticle-based test method to ensure the accuracy of optical coherence tomography data, and the launch of a joint program with the Department of Homeland Security (DHS) to assess the risks of patients to electromagnetic interference on airplanes.
Another interesting observation from OSEL involves the postmarketing failure of medical devices. "As many as one-third of medical device failures causing patient harm reported to the FDA appear to be failures of medical device use rather than failure of the device itself," the office observed. To assist with the development of device safety, OSEL formed the Functional Performance and Device Use Laboratory within its Division of Physics, which serves to test the usability and use of medical devices.
Still another oft-encountered problem deals with the increasing use of unvalidated computational safety and efficacy models to support premarket applications. OSEL said its Division of Physics has teamed up with the Institute of Electrical and Electronics Engineers and the International Electrotechnical Committee to standardize validation procedures for computational codes using specific methods.
OSEL 2011 Activities Report
Tags: OSEL, Report, Latest News, medical device