Human Factors Guidance Listed in FDA 2016 Priorities
The FDA has released the CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance.
In it they included Applying Human Factors & Usability Engineering to Optimize Medical Device Design on their “A-list” (…a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published…).
It should be noted that the draft guidance was also on the A-list for FY 2015. I’ll be interested to see if the final guidance is published this year and whether it is substantially different or not from the draft guidance.
University of Washington Fostering Leadership Series
In the fall of 2010, the Michael G. Foster School of Business at the University of Washington collaborated with UWTV Channel 27 to present the eight part series Fostering Leadership.
Each episode was a half-hour and focused on exploring key questions pertaining to leadership. The series includes interviews with Bruce Avolio, Sally Jewell, Jim Sinegal, Howard Behar, John Yokayama, John J. Nance, Kathleen Bartholomew, and Brad Tilden, just to name a few.
I’ll be posting each of the episodes over the next several days.
Happy New Year!
Happy New Year! I hope you had a very enjoyable holiday season and are ready to attack 2016. I’m looking forward to sharing more posts on a variety of exciting topics including: healthcare, innovation, leadership, teams, decision making, and human factors.
Happy Holidays from Human Factors MD!
Top 10 Health Technology Hazards for 2016
The ECRI Institute has published their annual Top 10 Health Technology Hazards for 2016. As noted in the brief, the list is published each year to identify:
“…potential sources of danger that we believe warrant the greatest attention for the coming year. The list does not enumerate the most frequently reported problems or the ones associated with the most severe consequences—although we do consider such information in our analysis. Rather, the list reflects our judgment about which risks should receive priority now.” (p. 2)
The list includes:
- Inadequate Cleaning of Flexible Endoscopes before Disinfection Can Spread Deadly Pathogens
- Missed Alarms Can Have Fatal Consequences
- Failure to Effectively Monitor Postoperative Patients for Opioid-Induced Respiratory Depression Can Lead to Brain Injury or Death
- Inadequate Surveillance of Monitored Patients in a Telemetry Setting May Put Patients at Risk
- Insufficient Training of Clinicians on Operating Room Technologies Puts Patients at Increased Risk of Harm
- Errors Arise When HIT Configurations and Facility Workflow Do Not Support Each Other
- Unsafe Injection Practices Expose Patients to Infectious Agents
- Gamma Camera Mechanical Failures Can Lead to Serious Injury or Death
- Failure to Appropriately Operate Intensive Care Ventilators Can Result in Preventable Ventilator-Induced Lung Injuries
- Misuse of USB Ports Can Cause Medical Devices to Malfunction
If you’re interested in getting your own copy, click on the image above or here.