Product Recall Initiative

November 11, 2010

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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

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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.

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Standardized Notification Template

95% Complete Reason for recall Product information Product label Depth of recall Actions required Sub-recall actions Product disposition Return response

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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 documentStep Three: Adoption Use of template & best practice Step Four: FDA Recommendation Submit template and best practice Step Five – FDA Collaboration

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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.