End secrecy, save lives Public transparency Our issues:

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2 End secrecy, save lives Public transparency Our issues: Health care acquired infections medical errors improved oversight and information about physician care medical device safety

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4 Medical Harm: Response fails to align with scope of the problem 1 in 4 to 1 in 3 hospital patients; 27% Medicare; 9 million harmed annually Harm: Medication errors, burns, surgical errors, bedsores, falls, infections New estimate up to 400,000 deaths/year Preventable medical harm: not tracked so not included as a leading cause of death Resources devoted to prevention by hospitals, states & federal governments dwarfed by scope of this mostly preventable problem

5 Hospital infections by the numbers Nearly 2 million hospital patients are infected each year 1 in 20 hospital patients get an infection while there for treatment of something else Annually nearly 100,000 patients die from hospital infections National hospital costs related to hospital acquired infections: $45 billion average hospital cost of a serious infection following surgery: $57,000 (AHRQ) 76% of hospital infections were billed to Medicare (67%) and Medicaid (PHC4)

6 Safe Patient Project work 2003 Model bill: require hospitals to publicly report infection rates 30 states require; in 2012 hospitals from all states are reporting on Hospital Compare Variation among states WA is one that does more 2011 Model bill: require hospitals to publicly report medical errors; penalties for failure to report 26 states require hospitals to report; only 6 states require public reporting

7 Impact of Public Infection Reporting National (CDC) : 58 % drop in central line associated bloodstream infections in ICUs Period of time during which more than half of the states required disclosure of that measure : 41% reduction of ICU CLABSI 17% surgical site infections 7% catheter associated urinary tract infections

8 Impact of Public Infection Reporting States Pennsylvania: 8% drop in infections between 2006 and In 2010, hospitals posted a 24% decrease in CLABSI rates from 2009, preventing 525 infections. New York: many hospitals decreased certain surgical infections from ; 39% reported zero infections for hip surgery; significant reductions documented in NY for CLABSIs. Director of NY Dept of Health's bureau of health care associated infections: "I do believe it is because of reporting." Colorado: 43% decrease in CLABSIs in adult ICUs from and similar decreases in neonatal ICUs and long term acute care hospitals; These data suggest that public reporting of infections may enhance individual facilities accountability and focus on reducing infections.

9 Physician Safety Oversight & Information 2009 state model Physician Profile Disclosure Act (CO) Information available varies by state Disciplinary orders Competency issues National Practitioner Data Bank Public Use Data File Change federal law publish names State work CA: Monitoring board meetings; Public participation, oversight of surgical centers, substance abusing doctors WA: More information to and participation by patients

10 Medical Device Safety Incredibly fast growing market American public assumes complex and high risk implants are tested for safety Over 90% of devices are cleared for sale through fast track process that only requires the manufacturer to show it is similar to an existing device, called a predicate Not required to provide clinical studies for safety 78% of Class III devices are cleared this way The predicate can even be a device that has been recalled for safety reasons FDA cannot ask if the new device has addressed the safety issues

11 Medical Device Safety cont d No unique identifier for tracking devices yet No national registries fragmented, professionals control, not public Poor systems for collecting adverse events FDA can order studies but limited enforcement tools for the highest risk, long timelines, data is not readily available to public

12 Actions to a million consumers signed up through all of our campaigns 12

13 Story Collection Page 13

14 Stories Fundamental to campaign 1 st story ask in 2003: 37 stories By 2011: had collected over 3000 stories 1 st story ask for hip & knee replacement in summer 2013 garnered nearly 3000 stories Identify strong voices Interviews for media Lobbying and testifying Boots on the ground in many states

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16 NETWORKING!

17 Why are we in Seattle? Campaign to get warranties for hip and knee implants Seattle is a major market high volume Consumer advocates on the ground Providers focused on improving quality and safety Collaborations promising for action

18 We began with a hip replacement and just sort of riffed off of that. New Yorker, February 2012

19 Medical device warranty campaign

20 Reasons for warranty campaign for hip and knee Implants Weak Regulation not clinically tested Implanted in the body How long the device will last is not in writing Patients are not given information about the manufacturer and model of the device

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22 Make devices safer Goals of campaign Make device makers accountable for performance Provide a warranty similar to other products Inform patients of true lifespan of implants

23 Targets: Six top selling hip and knee implant makers Zimmer, DePuy (Johnson & Johnson), Biomet, Smith & Nephew, Stryker, Wright Medical More than 58,000 consumers sent more than 350,000 letters to the six largest hip and knee implant makers in the United States asking them to warranty their products.