ACCE Educational Webinar - October 11, 2018Time to register for ACCE October 11th Webinar: The FDA Update: Service Regulation
Date: Thursday, October 11, 2018
Time: 12:00PM-1:00PM (EST)
Location: Online
Speaker: Katelyn R. Bittleman, Ph.D.; Center for Devices & Radiological Health, U.S. Food and Drug Administration
Synopsis:
In
May 2018, FDA published a report on the quality, safety, and effectiveness of
servicing of medical devices in accordance with section 710 of the FDA
Reauthorization Act of 2017 (FDARA). The report summarized FDA’s existing rules
and regulations, the responses to FDA’s public outreach, the available evidence
pertaining to the quality, safety, and effectiveness of medical device
servicing, key issues, and on-going activities. Stakeholders have differing
views about the quality, safety, and effectiveness of servicing performed by
original equipment manufacturers (OEMs) and third party entities, and the need
for imposing additional regulation. Based on our review of information, we
believe the currently available objective evidence is not sufficient to conclude
whether or not there is a widespread public health concern related to servicing
of medical devices, including by third party servicers, that would justify
imposing additional/different burdensome regulatory requirements at this time.
Athough we do not believe that additional, formal regulatory action is warranted, based on the available information and findings, we intend to pursue the following actions:
1.Promote
the Adoption of Quality Management Principles;
2.Clarify
the Difference Between Servicing and Remanufacturing;
3.Strengthen
Cybersecurity Practices Associated with Servicing of Medical Devices; and
4.Foster
Evidence Development to Assess the Quality, Safety and Effectiveness of Medical
Device Servicing
To register, click here
Celebrate the 4th Global Clinical Engineering Day with ACCEOn October 21, we will be celebrating the 4th Global Clinical Engineering Day!
Join ACCE to celebrate your Day. Send us your CE Success story describing significant contribution towards improving patient outcomes because of CE intervention. Or post it at ACCE Blog.
Tuned in to ACCE channel for the 2018 session (coming soon).
To tune in to other channels around the globe and for complete schedule of the 4th Global CE Day, click here
AIMBE Opportunities for Students and TraineesAs Student/Candidates members of ACCE, you are entitled to the following benefits.
First, make sure you are registered to attend
AIMBE’s Public Policy
Institute for Rising Leaders on October 29-30, 2018
in Washington, DC. This forum—offering travel awards to underrepresented
minority students with a September 14 applications deadline—allows trainees to
understand the public policy landscape shaping medicine and engineering.
Keynote speaker Dr. Keith Yamamoto, UCSF’s first Chancellor for Science Policy,
will kick-off the two-day event in Washington, DC. Click here for program
and travel award details.
The AIMBE FDA Scholars
Program is seeking distinguished post docs to participate in a 1-year
appointment at the FDA. AIMBE has a wonderful partnership with academia,
industry, and the Centers for Devices and Radiological Health at FDA. I’ll be
looking for your recommendations for your trainees to participate in this
highly competitive program.
Applications are due by December
5, 2018 for the 2019-2020 program year. (Only U.S. citizens are eligible
at this time.) Click
here for more information. ACCE Educational Webinar - November 8, 2018Time to register for ACCE November 8th Webinar: Implementing Program to Share User Experience Data for Medical Devices.
Date: Thursday, November 8, 2018
Time: 12:00PM-1:00PM (EST)
Location: Online
Speaker: Jonathan Gaev, MSE, CCE, PMP; Engineering Manager, 
Synopsis: ECRI User Experience Survey Program-How to conduct surveys and successfully communicate the results. Since 2016, ECRI Institute has surveyed clinical users and HTM department staff regarding their experience with medical devices. In addition to the opinions of clinical users, ECRI collects maintenance and repair data for 15 device categories each year. We will describe the survey process, show our unique graphical method to present survey results and will share unexpected results related to specific medical technologies.
To register, click here 2018-19 ACCE Educational Webinar Series Brought to you by the ACCE Education Committee. 10 monthly webinars starting September 13, 2018.
09/13/18:Security Patching for Medical DevicesSession Description:With a growing number of clinical systems and
corresponding threats to security, management of clinical systems is more
crucial than ever. Learn how to manage the exception list for Windows patches
and how you can best handle disaster recovery efforts. This management has
become more complicated as previously small groups of dedicated engineers have
been consolidated into larger enterprise management groups that thrive on
efficiency and standardization. Integrating clinical systems into the workflow
of a large enterprise server management group is a challenge but worth the
reward if implemented successfully.
Registration Form (Countries in Column#1)
Registration Form (Countries in Columns 2, 3, 4)
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Welcome to the American College of Clinical Engineering (ACCE). Founded in 1990, ACCE is committed to enhancing the profession of clinical engineering worldwide. |
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Institutional and Corporate
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What's New ACCE Board weighs in: The MITA narrative on third-party equipment service lacks merit Click here to read the article in dotmed ACCE's Support to keeping Medical Devices in states' "Right-to-Repair" legislation. Click here to read letter stating ACCE's position in support of New Hampshire's HB.1733 right-to-repair legislation and the inclusion of medical devices in that legislation (similar letters are being send to other states in support of their respective right-to-repair bills. |
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ACCE NewsletterACCE News July/August 2018Volume 28, Issue 4- President's Message
- Congratulations to the 2018 Class of CCEs
- 2018 Officer and Board Elections
- Updates from ACCE Committees: Education, International, Membership...
- Updates from AAMI, ECRI, HTF, and more
- Members updates, Penalty Box, and more...
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