Maximizing Sustainability Through Reprocessing Single Use Devices

Transcription

1 Maximizing Sustainability Through Reprocessing Single Use Devices Maximizing our Investment in Healthcare 2011 CADTH Symposium Vancouver, BC April 4, 2011 Dianne Trudeau Operations Leader Medical Device Reprocessing Providence Health Care Vancouver, BC 1

2 Today s Topics Challenges in Healthcare Pathways to Sustainability Reprocessing What to Demand from a 3 rd Party Reprocessor The Providence Health Care Story Summary 2

3 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 3

4 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 Patient care and safety Environmental sustainability 4

5 A Window of Opportunity Maximize investment evidence based practices Supply costs Innovative programs 5

6 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. 6

7 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 Frees resources for investment in quality care Saving hospitals hundreds of thousands of dollars Reduce waste by thousands of pounds 7

8 Ongoing Adoption of SUD Reprocessing in Canada United States 3 rd 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 Canada This strategy is still not widely adopted Lack of appropriate regulatory framework and lack of enough success stories More than 50% of hospitals use reprocessing 8

9 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) 9

10 Reprocessing Regulated by the FDA and comply with the same regulations as the OEM 10

11 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 11

12 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

13 Understanding Reprocessing How does a device get reprocessed? Products are cleaned and decontaminated according 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 2 nd final clean process followed by packaging according to industry standards Product goes through final inspection before product release 13

14 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 14

15 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 15

16 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 3 rd party reprocessor 16

17 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 17

18 What to Demand from a 3 rd Party Reprocessor Traceability Make sure the reprocessor can trace device history Scientific and technological proficiency Ask about how devices are selected, validated, cleaned and tested Resource commitment Can the reprocessor commit resources to ensure program compliance, education, and logistics support? 18

19 What to Demand from a 3 rd Party Reprocessor Results Does the reprocessor have a dedicated approach to ensure that the program delivers results ($ and waste reduction)? Program development Can we work with the reprocessor to continue to develop the reach and impact of the program? Safety/liability Ensure there is no added risk to patients or liability to healthcare providers associated with the program Hospital-centered model Does reprocessing add extra work to hospital staff or does the reprocessor take care of all tasks? 19

20 The Providence Health Care Story started researching reprocessing through phone calls & visits to 3 rd party reprocessor customers & reprocessing facilities 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 20

21 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 The Providence Health Care Story St. Paul s Hospital 2010 outcomes 3,000 2,500 2,000 1,500 1, /06 06/07 07/08 08/09 09/10 10/ /06 06/07 07/08 08/09 09/10 10/11 1,000, , , , ,000 Pounds Diverted (lbs) Cost Avoidance: Waste Disposal ($) 0 05/06 06/07 07/08 08/09 09/10 10/11 Estimated Cost Avoidance ($) 21

22 The Providence Health Care Story 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 22

23 Summary Reprocessing can be as safe and effective as the OEM, if the reprocessing is done by a licensed 3 rd party reprocessor & certified by a regulatory authority (such as Health Canada or FDA). 23

24 Questions Thank You Dianne Trudeau Operations Leader, Medical Device Reprocessing Providence Health Care