Winchester Engineering Analytical Center (WEAC)
WEAC is accredited for ISO/IEC 17025:2005 and serves as the lead laboratory for medical device and radioanalytical testing; it is the only FDA facility that performs analyses of the Medical Device Program areas including device sterility and device safety. Products tested range in complexity and include: medical gloves, surgical instruments, transdermal patches, infusion pumps, tampons, sunlamps, defibrillators, and diagnostic X-ray systems. WEAC engineers and scientists perform foreign inspections for a variety of consumer electronic products including lasers, microwave ovens and sun tanning devices. They also provide analytical support to criminal investigations such as those conducted by ORA’s Office of Criminal Investigations (OCI). WEAC collaborates with CDRH to disseminate equipment and training courses at recently redesigned and equipped WEAC X-ray labs. WEAC tests procedures and concomitant hardware and software to allow state, local, and tribal partners to conduct tests on X-ray systems and determine compliance in a timely manner.
WEAC has specialized capabilities to conduct radionuclide chemical and microbiological analyses for the Food Program area and enables the FDA to protect the public from radioactive contamination, especially in imported foods. WEAC has developed methods for testing the liquid barrier performance of medical gowns, for determining the proper function and critical parameters of Automated External Defibrillators.
WEAC’s analysis capabilities include performing specialized sterility testing of medical devices and surgical products. In addition, novel methods have included: 1) Development of novel antimicrobial-free biofilm-eliminating strategies to treat and prevent medical device-associated biofilm infections. This research is aimed at addressing recent outbreaks of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiothoracic surgery. 2) Evaluation of Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) for the rapid identification of fungal pathogens isolated from medical products. 3) Validation of a new commercially available technology platform that detects Listeria in 6-hours.
At the direction of and in concert with the Center for Tobacco Products (CTP), WEAC is designing parameter testing for the electronic components of e-Cigarettes, batteries, and test methods for the following: Coil resistance, Battery current operating range, Battery voltage operating range, Power delivery unit current operating range, Power delivery unit voltage operating range, and Temperature control deviation (if adjustable). WEAC develops field exams for use by ORA consumer safety officer’s and investigators to efficiently screen imported devices. Laser Comparison Kits are deployed in the field to compare samples to controls, whereby substandard screened samples are then forwarded to WEAC. Projects include plans and prototypes for the Impact resistance of lenses, gown exams and blood pressure cuff exams; concurrently, field tools are currently in development.