Biomed News – April 2015

April 01, 2015

The Food and Drug Administration (FDA) announced it will host a public workshop entitled “Clinical Considerations of Risk in the Postmarket Environment,” on April 21 at the FDA’s White Oak Campus in Silver Spring, Md., and will also be made available via webcast. Registration for the one-day event closes on April 13, 2015.

Focus points for the workshop will revolve around the assessment and management of risk in the use of medical devices. The agency will be discussing a draft list of risk principles and factors to consider in analyzing postmarket risk, which was created during their meeting with the Association for the Advancement of Medical Instrumentation (AAMI) in 2014.

Additionally, the FDA will be discussing the following general questions:

  1. What factors are important to take into account when conducting risk assessments of safety and quality issues that occur with marketed medical devices?
  2. What principles best guide the risk assessment process to assure timely, consistent, and optimal results?
  3. Are there improvements that FDA and stakeholders could make to enhance risk assessments in recall and shortage situations with medical devices?
  4. Are there specific activities or issues related to postmarket quality, safety, or compliance activities where approaches used by FDA and industry currently differ enough to create confusion or delay or limit appropriate public health actions?
  5. In which activities and areas of postmarket quality, compliance, and safety would more detailed policies or guidance be most useful?

The public workshop will allow participants to engage in open dialogue to talk about the responses to issues raised by the presenters and the questions raised by the FDA. Through the event, the FDA aims to gain input on dealing with medical device hazards that were not identified during approval or clearance.

Constant dialogue between agencies, manufacturers, and the different stakeholders in the medical community is important to ensure patient safety. AIV is dedicated to providing support for various biomedical associations in the United States and around the world. To learn more about the various biomedical and healthcare technology management associations that AIV supports, visit http://aiv-inc.com/biomed-associations.html.

UPCOMING EVENTS:

AAMI to Hold 3rd Quality System Requirements and Industry Practice Course

The Association for the Advancement of Medical Instrumentation (AAMI) will be holding its second intensive 4-day program on quality system requirements and industry practice from April 13-16, 2015 at Novotel Sydney Central in Sydney, Australia. Interested participants will have the option to take an online exam following the class.

For more information, visit http://www.aami.org/meetings/courses/qs.html

ASHE to Host 2015 Region 6 Conference

The American Society for Healthcare Engineering (ASHE) will be hosting its 14th ASHE Region 6 Annual Conference from April 16 to 17, 2015 at the Kahler Grand Hotel in Rochester, Minnesota. The event is an educational and networking event open to all health care facility managers. A new addition to this year’s event is the Barrier Management Symposium, which will be held prior to the conference, from April 14 to April 15, 2015.

To learn more about the symposium and conference, visit https://www.regonline.com/builder/site/default.aspx?EventID=1640875

AAMI to Hold Process Validation Requirements and Industry Practice Course

AAMI will be holding a two and a half day course discussing the practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized Process Validation Guidance from Global Harmonization Task Force. The event will be held at the Lorien Hotel in Virginia from April 15-17, 2015.

For more details on the course, visit http://www.aami.org/meetings/courses/pv.html

BMES to Hold Regional Biomedical Engineering Conference

The Biomedical Engineering Society (BMES) will be hosting the 2015 BMES Northeast Regional Conference on April 17, 2015 at the Rensselaer Polytechnic Institute. The event is open to biomedical engineering students and working professionals.

To learn more about the conference, visit: http://bmes.org/

AAMI to Host Sterilization Standards Week

AAMI will be hosting an event entitled Sterilization Standards Week from April 27 to 30, 2015 at the Historic Inns of Annapolis in Annapolis, Maryland. This week-long event will feature a series of meetings that will give participants a chance to better understand the AAMI standards program. The organization also hopes to facilitate standards development by garnering ideas from participants.

To learn more about the event, visit http://www.aami.org/events/Content.aspx?ItemNumber=1740

AAMI to Conduct Advanced Human Factors Course

AAMI, in collaboration with the Human Factors and Ergonomics Society (HFES), will hold a one and a half day course following the HFES Symposium. The course will be held on the afternoon of April 29 until April 30. Topics to be discussed will include contextual inquiry, concept evaluation tools, task analysis and more.

To learn more about the course details, visit http://www.aami.org/meetings/courses/humanfactors_advanced.html

ASHE to Hold CHC Exam Review

The American Society for Healthcare Engineering (ASHE) will be conducting a review course for the Certified Health Care Constructor (CHC) exam on April 30, 2015 at the Holiday Inn Mart Plaza, Chicago, Illinois. The program will provide participants with test taking tips, key topics, and sample questions identified in the CHC content outline.

To learn more about the review program, visit http://www.ashe.org/learn/seminars_and_workshops/CHC/index.html#.VSc9yvmUdUV

PAST EVENTS:

AAMI Hosts S3 Challenge 2015

The Association for the Advancement of Medical Instrumentation (AAMI), in collaboration with the Food and Drug Administration (FDA), hosted the S3 Challenge 2015 from April 1-2, 2015 at Herndon, Virginia. Attendees of the event participated in rigorous discussions, analyzed problems, and formulated solutions for safer and better performing medical devices while reducing time to market.

To learn more about the event, visit http://www.aami.org/s3/

AAMI Conducts Integrating Risk Management into the Quality System Course

AAMI’s Integrating Risk Management into the Quality System educational course was conducted from March 23 to 25, 2015 at Double Tree in Bethesda, Maryland. The course was designed with medical device manufacturers in mind. The program covered topics on risk management concepts used throughout the quality system and the product lifecycle.

To learn more, visit http://www.aami.org/meetings/courses/risk.html

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

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