1 / 6

Product Recall Initiative November 11, 2010

Product Recall Initiative November 11, 2010. Team Members. Steve Huckabaa, Kettering Keith Lohkamp, Lawson Karen Conway, GHX Carol Stone, C.R. Bard Ann Bruns, BJC Lana Makhanik, VueMed Suzanne Alexander-Vaughn, Omnicell Phil Pettigrew, Denver Health Jeff Boran, Teleflex

cricket
Download Presentation

Product Recall Initiative November 11, 2010

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Product Recall Initiative November 11, 2010

  2. Team Members • Steve Huckabaa, Kettering • Keith Lohkamp, Lawson • Karen Conway, GHX • Carol Stone, C.R. Bard • Ann Bruns, BJC • Lana Makhanik, VueMed • Suzanne Alexander-Vaughn, Omnicell • Phil Pettigrew, Denver Health • Jeff Boran, Teleflex • Jan Domeyer Gibis, 3M • Linda Akiens Castiglioni, Mayo Clinic • Joe Sheil, Beth Israel Deaconess MC • David Hargraves, UPMC • Mary Jo Ellis, McKesson • Kevin Walters, O&M • Jean Sargent, USC • Randy Hayas, Orlando Health

  3. FDA Collaboration • Spring 2010 : FDA proposed creation of a joint workgroup of SMI, FDA, and HL7 professionals to explore/design the UDI database’s potential to address: • Standardized recall notification content and • Improved speed of notifications • FDA has initiated internal approvals for project . • Status of collaboration is uncertain. • UDI & GDSN formation place reasonable time expectations for collaboration to be months away.

  4. Standardized Notification Template 95% Complete • Reason for recall • Product information • Product label • Depth of recall • Actions required • Sub-recall actions • Product disposition • Return response

  5. Road Ahead Step One: Manufacturer Sub-Team • Final review of notification template by supplier subject matter experts/RA. Step Two: Provider Sub-Team • Create recall best practice document Step Three: Adoption • Use of template & best practice Step Four: FDA Recommendation • Submit template and best practice Step Five – FDA Collaboration

  6. Next Steps and Actions • Suggestions include: • Divide literature articles among members to review and extract key take-aways. • Provide a speaker to help understand what the government is looking for. • Select someone to intercept the CMS regulations that are due out soon, review and pull out key points for supply chain consideration and potential response during the comment period. • Start an SMI-member resource database for ACO information.

More Related