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2	What Works Location, location, location Patient safety work is geographically connected Ad hoc meetings can be done in real time Consults are up-close and personal Work is unavoidably intermingled
3	What Works Organizational ownership Product level experts do care about what happens Understand quickly and immediately the problems being seen post market Positioned to ask the right questions to resolve the issue Learn from questions
4	OIVD Work Audit Jan 20 to Feb 28, 2006 55 pre/post market meetings
5	OIVD Work Audit HHE’s – 17 PMA issues – 14 (5 technical review; 9 AIP issues) Compliance letters – 7 MDR reports – 7 Other – labeling, import issues -- 10
6	Organizational Ownership -- subject specific work Flu problem – Roxanne Shively, Claudia Gaffey Women’s health problem – Veronica Calvin Problem with fungi or parasites – Freddie Poole Glucose problem – Pat Bernhardt POC problem – Arleen Pinkos, Carol Benson Coagulation problems – Josie Bautista
7	Organizational Ownership -- subject specific work TDM problem – Avis Danishefsky Instrument problem – Jim Callaghan Software algorithm problem – Mary Pastel Cytology problem – Louise Magruder, Max Robinowitz Genetics problem – Joe Hackett, Bob Becker, Maria Chan Etc.
8	What Works Knowledge management Information dissemination occurs At stand-ups At division meetings At management meetings Through teams organized to address issues – very product specific feedback assured At lunch, the men’s (women’s) room, etc.
9	Tools That Work Well -- Recalls Rapid dissemination of 48 hour notices Real time communication and meetings Nuanced expertise brought to bear (6 medical officers, a plethora of lab, industry, research scientists) Reviewers automatically included in important work Result in concrete actions
10	Recalls 2005 Class 1 – 6 Class 2 – 28 Class 3 – 44 Average days – 10 to 16
11	Recalls 2006 Class 1 – 1 Class 2 – 28 Class 3 – 24 Average days – 4 to 6
12	Recalls Result in knowledge gathering MDR analysis Literature reviews Professional outreach Changes in inspection plan; identification of problem players - MDR issue, general quality issue; total system failure Changes in inspection quality – briefings for inspectors or participation in inspections
13	Tools That Work Well – Ad hoc signals and risk communication Government partners CDC vancomycin resistant strep; Lyme disease problem; – MMWR, CDC panel, labeling changes, OCI investigation New York State – unapproved breath test, compliance letter CMS – Labotech Investigation
14	Tools That Work Well – Ad hoc signals and risk communication Trade Complaints High profile, high risk compliance letters to Roche (AmpliChip) Correlogics Natural link to pre-IDE; many follow-up meetings are joint
15	Tools That Work Well – Ad hoc signals and risk communication Consumer Complaints Strong tie to DSMICA for product specific queries; review staff learn what is being asked Compliance letters when unauthorized marketing is identified Providing information to CMS when FDA authority is limited Laboratory safety tips
16	Patient Safety Communications FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels FDA Issues a Public Message Regarding Drugs of Abuse Tests FDA Issues a Public Message on LifeScan Blood Glucose Meters Nationwide Alert on B-Sure Pregnancy Tests
17	Patient Safety Communications FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media Troponin: What Laboratorians Should Know to Manage Elevated Results Blood Human Chorionic Gonadotropin (hCG) Assays: What Laboratorians Should Know About False Positive Results Cautions in Using Rapid Tests for Detecting Influenza A
18	Industry Communications Warning letters – 2 Untitled letters – 2 It has come to our attention letter – 15 Other letters – 14
19	The Verdict Is Still Out -- MDRs Chemistry products are looked at by two chemists Hematology products by a hematologist Immunology products by an immunologist Microbiology products by a microbiologist Pathology products by someone with expertise in histopathology
20	MDR’s – FY 2006 Death – 16 Injury – 1325 Malfunction - 2554 Other - 416 Total -- 4314
21	The Verdict Is Still Out MDRs issues with quality of data and denominators Unsure if flecks of gold in the coal mine or if more fool’s gold then real LabSun/LabNet LabSun pilot during summer of 2003 – several interesting signals followed by fatigue Current plan to re-visit and re-focus (LabNet)
22	What Doesn’t Work Well Cataloguing of work and formalization of risk assessment Uncertain impact of feedback on premarket Poor connection to real world labs (not that we haven’t tried) – general reporting confusion (labs and companies)
23	One Clear Conclusion QSRs RULE Make most scientific sense as a basis for regulation – not equivalency but quality, verification, validation, control Connect to real world experience Result in clear regulatory actions
24	OIVD Surprising ongoing learning curve Untapped opportunities Come a long way Journey is not over
25	"Thank You" Thank You Donald St.Pierre don.st.pierre@fda.hhs.gov Ph. (240) 276-0484 Fax (240) 276-0664 www.fda.gov/cdrh/oivd