Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 19 February 2015 | By Alexander Gaffney, RAC,
US regulators have issued a warning to healthcare providers about design flaws inherent in a type of endoscope which could increase the spread of harmful infections in surgery patients.
The device, known as an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, is a flexible, lighted tube commonly used in surgical procedures to inject contrast dye or to obtain tissue samples.
"Unlike most other endoscopes, duodenoscopes also have a movable 'elevator' mechanism at the tip," FDA explained in a notice posted on its website. "The elevator mechanism changes the angle of the accessory exiting the accessory channel," which allows the device to be much more nimble and useful.
As a recent USA Today investigation found, while the innovative design of the device makes it more effective, it also makes it considerably more difficult to clean. The device has been associated with the transmission of carbapenem-resistant enterobacteriaceae (CRE), a hardy and potentially deadly bacterium.
"Some parts of the scopes may be extremely difficult to access and clean thoroughly," FDA told the newspaper. USA Today's investigation faulted the products' manufacturers and FDA for failing to "publicize" or offer guidance regarding the scope of the problem and how to avoid it.
Now, less than a month after USA Today published its investigation, FDA is announcing new precautions meant to help assure the devices' safe use.
In a warning issued on 19 February 2015, FDA said it wanted to "raise awareness among healthcare professionals … that the complex design of ERCP endoscopes may impede effective reprocessing."
FDA's notice explains that "microscopic crevices" within the devices' elevator mechanism can trap "residual body fluids and organic debris," which can in turn transmit microbial contamination to subsequent patients.
The agency continues to monitor the association between the devices and "the transmission of infectious agents," it said. To date, the agency says it knows of at least 135 patients in the US affected by microbial contamination potentially transmitted by the devices. "It is possible that not all cases have been reported to the FDA," it added.
FDA's warning advises device reprocessing facilities to "meticulously clean the elevator mechanism" of the device, and to implement a "comprehensive quality control program for reprocessing duodenoscopes."
No new regulatory requirements have yet been announced at this time.
FDA Warning
USA Today Investigation
Tags: Warning, endoscopic retrograde cholangiopancreatography duodenoscope, ERCP, CRE, Contamination, Reprocessing
Regulatory Focus newsletters
All the biggest regulatory news and happenings.