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Maximizing SustainabilityThrough

Reprocessing Single Use Devices

Maximizing our Investment in Healthcare2011 CADTH Symposium Vancouver, BCApril 4, 2011

Dianne Trudeau Operations Leader Medical Device ReprocessingProvidence Health Care Vancouver, BC

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Today’s Topics

•Challenges in Healthcare

•Pathways to Sustainability

•Reprocessing

•What to Demand from a 3rd Party Reprocessor

•The Providence Health Care Story

•Summary

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Challenges in Canadian Healthcare

• Delivering quality care with less resources�Protecting patient safety

• Developing more environmentally responsible practices

�C3 – Cut the Carbon Community�Practice Greenhealth’s Clean Energy Solutions

• More responsible use of healthcare resources

• Need for new strategies and practices

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Nature of the Challenge

• Reducing wasteful behavior while maintaining high standards of care and safety

• Our challenge is to identify strategies that meet all criteria at once

Financial sustainability

Environmental sustainability

Patient care and safety

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A Window of Opportunity

•Maximize investment – evidence based practices

•Supply costs

•Innovative programs

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Pathways to Sustainability

"When an individual decides to recycle or dispose of waste differently, it has an impact. But when a hospital decides as an organization to go green, the impact is massive." (Dr. Makary, Johns Hopkins)

The researchers admit that reprocessing single-use devices often presents a perceived conflict between sustainability and patient safety, but it can satisfy both concerns and save money at the same time.

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Reprocessing Single-Use Devices (SUD)

•Reprocessing single-use devices is proven to produce substantial results

•Reprocessing in a medium-sized hospital can enable cost avoidance of $500,000 to $1 million per year in supply costs, allowing redirection of resources to patient care initiatives as well as new technology investments, research, or hiring more nurses

•The same program reduces medical waste by literally thousands of pounds

Saving hospitals hundreds of thousands of

dollars

Reduce waste by thousands

of pounds

Frees resources for investment in quality care

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Ongoing Adoption of SUD Reprocessing in Canada

Canada

•This strategy is still not widely adopted

•Lack of appropriate regulatory framework and lack of enough success stories

United States

•3rd party reprocessing has been broadly adopted as a practice for addressing the scarcity of resources in healthcare

•FDA controlled procedures and the adoption of reprocessing by most top hospitals (including Mayo, Johns Hopkins, etc.) presents a compelling story

•More than 50% of hospitals use reprocessing

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Safety of SUD Reprocessing

•All U.S. reprocessors undergo similar or stricter FDA scrutiny as original equipment manufacturers (OEMs)

•Over a decade of data shows that the use of reprocessed devices produces no added risk to patients and physicians – and that reprocessed devices fail less frequently than new ones

�Inspection and testing of every single device�Very rigid inspection & approval criteria�Only devices that can safely be reprocessed

(MAUDE database, GAO reports)

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Reprocessing

•Regulated by the FDA and comply with the same regulations as the OEM

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Reprocessing

Definition:•Process includes the cleaning, inspection, testing, repackaging & sterilization •Product must remain safe and effective for its appropriate clinical use, having the same quality, physical characteristics and performance

Examples:•Harmonic scalpels•Drill bits, burrs and saw blades•Electrophysiology (EP) catheters

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Reprocessing: The Process

How does a device get reprocessed?

•Products are returned to Reprocessor where devices are “ticketed”

•Obvious rejects, heavily soiled items or unapproved products are immediately eliminated from the cycle

2233

44

55

66

1

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Understanding Reprocessing

How does a device get reprocessed?

•Products are cleaned and decontaminatedaccording to item-specific protocols•All devices are uniquely coded to indicate number of reprocessing cycle•Devices are restored and tested to meet original FDA acceptance criteria, which may include both automated and manual processes•Devices go through a 2nd final clean process followed by packaging according to industry standards•Product goes through final inspection before product release

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Reprocessing: Addressing Myths

Common Myth: Reprocessing is not safe

FACTS:

•Reprocessed devices have separate FDA clearance

•FDA’s adverse event database contains over 6500 reports of patient deaths associated with original (un-reprocessed) devices since 2004

•According to the same database, no reports of deaths associated with the use of reprocessed devices

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Reprocessing: Addressing Myths

Common Myth: Reprocessed devices are not the same

FACT:

•Reprocessors must prove that a reprocessed device is equivalent to a brand new device

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Reprocessing: Addressing Myths

Common Myth: Reprocessed devices have no warranty

FACTS:

•Original manufacturers cannot warranty a device if it is reprocessed•Reprocessed devices must have a warranty through the 3rd party reprocessor

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Reprocessing: Addressing Myths

Common Myth: Reprocessed devices require informed consent

FACTS:

•Reprocessed devices are not investigational or experimental, so there is no legal, medical, or ethical reason for an informed consent•There is no increase in risk to the patient•Informed consent involves understanding of the procedure, not the devices being used

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What to Demand from a 3rd

Party Reprocessor…•Traceability

Make sure the reprocessor can trace device history

•Scientific and technological proficiencyAsk about how devices are selected, validated,

cleaned and tested•Resource commitment

Can the reprocessor commit resources to ensure program compliance, education, and logistics support?

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•ResultsDoes the reprocessor have a dedicated approach to ensure that the program delivers results ($ and waste reduction)?

•Program developmentCan we work with the reprocessor to continue to develop the reach and impact of the program?

•Safety/liabilityEnsure there is no added risk to patients or liability to healthcare providers associated with the program

•Hospital-centered modelDoes reprocessing add extra work to hospital staff – or does the reprocessor take care of all tasks?

…What to Demand from a 3rd

Party Reprocessor

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The Providence Health Care Story

•2004 - started researching reprocessing through phone calls & visits to 3rd party reprocessor customers & reprocessing facilities

•2005 - first BC program introduced within the Vancouver Coastal Health Authority

•St. Paul’s Hospital leads this effort

•Helped us push OEM prices down

•Reprocessing for us is a process of continued education and gradual program expansion

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St. Paul’s Hospital – 2010 outcomes

The Providence Health Care Story

01,0002,0003,0004,0005,0006,0007,0008,000

05/06 06/07 07/08 08/09 09/10 10/11

Pounds Diverted (lbs)

0

500

1,000

1,500

2,000

2,500

3,000

05/06 06/07 07/08 08/09 09/10 10/11

Cost Avoidance: Waste Disposal ($)

0

200,000

400,000

600,000

800,000

1,000,000

05/06 06/07 07/08 08/09 09/10 10/11

Estimated Cost Avoidance ($)

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Challenges:•Adopting a new technology/supply chain strategy•Buy-in from critical stakeholders:

�Senior Leadership�Surgeons�Nurses�Other Allied Services

•Effective collection and buy-back routines•Three critical success factors:

�Engagement�Education�Champions

The Providence Health Care Story

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Summary

•Reprocessing can be as safe and effective as the OEM, if the reprocessing is done by a licensed 3rd party reprocessor & certified by a regulatory authority (such as Health Canada or FDA).

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Questions

Dianne TrudeauOperations Leader, Medical Device Reprocessing

Providence Health Caredtrudeau@providencehealth.bc.ca

604 806 8093

Thank You