AAMI/IEC 80001-1 – Successfully Launching an 80001-1-Based Program
ANSI/AAMI/IEC 80001-1:2010 introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers. The standard stresses the need for cooperation internally as well as between hospitals, medical device manufacturers and IT systems and service vendors.
Every network deployment is unique — from the physical connectivity technologies used to attach devices and systems to the functions supported and intended uses — even though they are crafted with mostly standardized components. 80001-1 provides the basis for care providers to establish their own risk management policies and processes, and then apply it to their own unique circumstances and needs.
To avoid gaps, 80001-1 recognizes that care providers can manage the risks from these networks as part of a team. Therefore, it sets expectations of medical device manufacturers and other IT component suppliers to provide information to the care provider and to assist in the identification and management of hazards that can negatively impact the key properties.
The program covers:
- Identifying the problem – background and intent of 80001-1
- When 80001-1 applies and who is involved
- 80001-1 basics
- Fitting 80001-1 into your organization
- Starting a project
- Managing network risk
- Monitoring the network
- Problem and event reporting
- Change permits
- When changes require a new project
- What’s next
SPEAKERS
Todd Cooper
- Co-convener of the joint IEC and ISO working group that developed IEC 80001-1
- 20+ years experience in medical device software architecture and informatics
- Convener, ISO TC215 WG7 Health Informatics - Devices
- Co-chair, HL7 Health Care Devices and IEEE 11073 WGs
- Board, Integrating the Healthcare Enterprise (IHE) International
Yadin David
- Directed biomedical engineering department and implemented medical technology assessment and risk mitigation programs at the largest medical center in the country
- Editor/author of several books and chapters on clinical engineering and technology management
- Asst. Professor, University of Texas School of Public Health
- Member of the AAMI/EM Electromagnetic Compatibility Committee
- Member AAMI/ES Electrical Safety Committee
- Member AAMI/IT Committee
- Chairman IFMBE/Clinical Engineering Division (CED)
Sherman Eagles
- Co-convener of the joint IEC and ISO working group that developed IEC 80001-1
- 40+ years software experience including 20 years in medical device software safety and reliability
- Convener of the joint IEC and ISO working group that developed ANSI/AAMI/IEC 62304, Medical Device Software Life Cycle Processes and ANSI/AAMI/IEC TIR 80002-1, Medical Device Software Guidance on the Application of ISO 14971 to Medical Device Software
- Member of GHTF software ad hoc committee
- Co-chair of the AAMI Software Committee and member of AAMI IT Committee
TARGET AUDIENCE
The webinar is designed for clinical technology managers, clinical and biomedical engineers, hospital IT staff, device risk managers, field support personnel, telecommunications implementers and system integrators.
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD.
- $150 for webinar registrants
- $250 for non-registrants
- Please note: domestic and international shipping rates apply
THREE WAYS TO PURCHASE
- Phone - 1-800-373-3174 to order with a credit card
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
AAMI - Webinar CD - Launching 80001
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For
questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.