RE-PROCESSING
MEDICAL DEVICES

Medical device re-processing is a topic that has gained attention recently as an important element in patient safety and risk management strategies.

The significant role proficient re-processing plays in preventing infection has lately gained greater recognition, and there are now several initiatives underway to improve processes and to create common standards.

Attend this event and learn:

• The latest thinking and initiatives on re-processing
• What impact the CSA certification program will have on re-processing standards
• What standards should apply to loaned and leased instruments
• Lessons learned from Fraser Valley in attaining ISO status
• Why some hospitals go to third-party re-processors for SUDs
• What new software London Health Sciences is using to track devices for the purpose of infection and inventory control

PROGRAM CO-CHAIRS

Susan Springthorpe
Director of Research, Centre for Research on Environmental Microbiology (CREM)
University of Ottawa

Michael Lacatus
Manager, Sterile Processing Department, Mt. Sinai Hospital
President, Central Service Association of Ontario (CSAO)

INCLUDES THREE CASE STUDIES

ISO Quality Management System Standards in Reprocessing
– The Fraser Health Experience

Tracking Devices; Both for Re-Processing and Infection Control
– London Health Sciences

Improving Decision-Making, Communication and Collaboration about Sterilization Issues
– University Health Network

• Hospital Presidents, Vice-Presidents, CFOs, Risk Managers, Directors / Managers of Infection Prevention and Control
• Infection Control Practitioners
• Biomedical Engineers, Chiefs of Staff, Chiefs / Directors of Emergency Medicine, Nurse Managers and Practitioners, Clinical Care Managers, Clinical Educators
• Medical Device Manufacturing Presidents, Vice-Presidents, Directors of Product Development, Regulatory Affairs, Quality and Product Support

• Ministers, Deputy Ministers of Federal and Provincial Health Ministries
• Executive Directors of Healthcare Associations and Colleges
• Public Policy Analysts, Advisors, Researchers
• Partners, Principals and Associates from Legal Firms, and Consulting Firms Involved in Healthcare

Dear Colleague:

Maintaining and improving overall the quality of healthcare delivery in the hospital environment is critical to patient safety. Hospitals are being increasingly called upon to produce tangible results in the face of increasing budgetary pressure, exacerbated by the recent recessionary economic climate. In Ontario, the greater transparency to the public now demanded from hospitals by the new requirement to report key patient safety indicators places even greater pressure to improve those internal processes that have the greatest impact on results.

In this context, it is no surprise that sterilization and reprocessing of medical devices have recently gained greater recognition for the critical role they play in reducing the risk of nosocomial infections and contributing to successful outcomes for surgical patients. Until recently, this area was often overlooked by hospital administrators, despite its potential to pose significant risk for hospitals. With greater attention given to re-processing recently, there is increasing emphasis on the principles of quality system management for medical device reprocessing. This includes adherence to relevant standards of National or International origin, training and certification for technicians, and guidelines from provincial governments regarding re-processing of devices intended for single use (SUDs). Although some of these initiatives are still in the early stages, they hold great promise in establishing a clear way forward for hospitals to follow that will assist in achieving improved patient safety.

This conference, produced by Insight Information, will provide an important forum for interactive discussion of all the latest initiatives, their timely implementation, and the impact that these improvements will have on hospital operations, reprocessing technicians, on re-processing itself, and therefore on patient safety. We’re sure it’s one you won’t want to miss.

Sincerely,

Susan Springthorpe
Director of Research
Centre for Research on Environmental Microbiology (CREM)
University of Ottawa

Michael Lacatus
Manager
Sterile Processing Department, Mt. Sinai Hospital
President
Central Service Association of Ontario (CSAO)

MONDAY | DECEMBER 7, 2009

8:15 | 9:00

Registration and Continental Breakfast

9:00 | 9:05

Welcoming Remarks from Insight Information

9:05 | 9:15

Opening Remarks from the Co-Chair

Susan Springthorpe
Director of Research
Centre for Research on Environmental Microbiology (CREM)
University of Ottawa

9:15 | 10:45

Re-Processing Medical Devices: Improving Standards, Improving Patient Safety

Moderator: Susan Springthorpe
Director of Research
Centre for Research on Environmental Microbiology (CREM)
University of Ottawa

Ann-Marie Assang
Manager, Central Processing
Toronto General Hospital, UHN

Julie Polisena, MSc
Research Officer, HTA Directorate
Canadian Agency for Drugs and Technologies in Health (CADTH)

Valerie Zellermeyer
Program Director, Perioperative Services
St. Michael’s Hospital

In the past five years, Canada has seen major developments in policies regarding the reprocessing of both single-use medical devices (SUDs) and reusable ones. Advisory committees at the Provincial and Federal levels, technology assessment agencies, Provincial and Territorial Health Ministries, and Health Canada have all issued guidance to health care facilities and device manufacturers. The topics of greatest interest have progressed far beyond the old question of whether a hospital should reuse SUDs, which used to be a decision left up to the judgment of each facility. This session will review the current developments with respect to:

• New Provincial directives on reuse of SUDs
• New accreditation standards for hospital reprocessing
• Adequate reprocessing instructions from manufacturers
• Manufacturer validation of reprocessing instructions
• Problems with cleanliness of loaned or leased reusable devices
• Manufacturers specifying non-standard sterilization cycles
• Impact of improvements on infection rates
• Increasing collaboration between the hospital community and manufacturers

10:45 | 11:00

Networking Coffee Break

11:00 | 11:45

CSA’s National Certification Program for Medical Device Reprocessing Technicians

Miles Murphy
Product Manager, Personnel Certification
Canadian Standards Association

• Certification and career planning and management
• Candidate admission requirements
• Program curriculum and competency development process
• Testing methodology

11:45 | 12:30

How to Treat Loaned or Leased Devices – What Standards for Re-Processing Apply?

Lorna Coutoulas
Coordinator/Educator Sterile Processing Department
Southlake Regional Health Cantre

• Processing of loaner/leased medical devices – before and after use
• Partnership between Reprocessing Department, Operating Room and vendor
• Manufacturers instructions and interpretation
• Time lines for receiving loaned medical devices
• Transportation of loaned medical devices
• Staff education and training
• CSA Standard Z314.22

12:30 | 2:00

Networking Luncheon

2:00 | 2:45

ISO Quality Management System Standards in Reprocessing
– The Fraser Health Experience

Sheila Konishi
Senior Director, Reprocessing Services & Surgical Supply Logistics
Fraser Valley

• ISO 9001:2008 – What is it?
• The big question – Why do it?
• Getting started – First steps
• “Audits R Us” – Challenges along the way
• Benefits of the journey
• Lessons learned – The journey continues…

2:45 | 3:00

Networking Refreshment Break

3:00 | 3:45

Extended Cycles

Linda Jakeman
Sterile Processing Consultant
Nova Scotia Department of Health

• Why Extended Cycles
• What is validation?
• What are manufacturers required to do?
• What are Reprocessing Departments required to do?
• What does CSA and AMMI require?
• What are Standard Cycles?

3:45 | 4:30

Best Practices and Challenges in Re-Processing European Instruments

Lorna Coutoulas
Coordinator/Educator Sterile Processing Department
Southlake Regional Health Centre

Ian Pequegnat
Manager
Steris Canada Inc.

The criteria for deciding what cycle parameters to be used for instrument processing, including extended cycles.

• Sterilization validation of extended cycles in North America, specifically the 18 minute European cycles
• European cycle parameters including 18 minutes for prion inactivation
• Process monitoring – challenges
• Multiple cycles in healthcare facilities and possible consolidation of loads
• European standards adopted by CSA including ISO 11140, ISO 1766, ISO17664, CSA Z314.3, CSA Z314.8, CSA/ISO Z17664, CSA Z314.1, CSA Z314.22
• Medical device licensing in Canada

4:30

Conference Adjourns

TUESDAY | DECEMBER 8, 2009

8:15 | 9:00

Continental Breakfast

9:00 | 9:15

Opening Remarks From the Co-Chair

Michael Lacatus
Manager, Sterile Processing Department
Mt. Sinai Hospital
President
Central Service Association of Ontario (CSAO)

9:15 | 10:15

Collaborating with Manufacturers to Improve Validation

Moderator: Michael Lacatus
Manager, Sterile Processing Department
Mt. Sinai Hospital
President
Central Service Association of Ontario (CSAO)

Glen Frecker
Supervisor, Medical Engineering Surgical Support
Toronto Western Hospital, University Health Network

Marilyn Mah
Manager, Central Processing Department
Toronto Western Hospital, University Health Network

Surgical instruments have become more complex the past few years because of rapidly developing technological advances in surgical procedures. Often medical devices are designed for the health care provider to improved access and reduce trauma. The high technology often results in smaller instrumentation with multiple joints, ball and socket design, and many intricate moving parts.

This session will explore how risk can be minimized for patients through partnerships between instrument vendors/manufacturers and the hospital for successful patient outcomes.

• Have instrument manufacturers been receptive to feedback from hospitals?
• Validation of the cleaning process by manufacturer – do they go far enough?
• Instrument manufacturer re-validation to comply with most commonly recognized sterilization temperature and time parameters
• TWH’s experience with fractionated steam validation

10:15 | 10:30

Networking Coffee Break

10:30 | 11:30

Third-Party Re-Processors – Why Some Hospitals Go This Route for SUDs

Bill McInerney
Co-ordinator, Sterile Processing Department
Victoria Hospital, London Health Sciences Centre

• The history of SUD re-processing
• Provincial recommendations on re-processing SUDs
• Using third-party re-processors for SUDs
  • the economics of re-use
  • cost savings involved
  • safety to patient
• Health Canada licensing
• Risk assessment needed on SUD re-processing

11:30 | 12:30

Tracking Devices; Both for Re-Processing and Infection Control

Terry Robb
Corporate Manager, Sterile Processing
London Health Sciences Centre

• Out of crisis – control
  • a brief over view of the London CJD experience
  • how a tracking system could have changed the picture clinically and financially
• The business case
  • clinical and financial justifications for Tracking Systems
• The purchase decision
• Successful implementation
  • managing change and employee and customer expectations
  • standardized nomenclature – the challenge and the reward

12:30 | 1:45

Networking Luncheon

1:45 | 2:30

Managing Risk and Potential for Liability in Re-Processing

Mitra Nadjmi
Risk Management Specialist
Healthcare Insurance Reciprocal of Canada (HIROC)

• Threat of infection in overall risk management strategy
• Re-processing as major part of patient safety strategy
• History of litigation in Canada connected to medical device re-processing and in other jurisdictions
• Legal issues surrounding loaned instruments
  • who is responsible for cleaning them between uses?

2:30 | 2:45

Networking Refreshment Break

2:45 | 3:30

Improving Decision-Making, Communication and Collaboration about Sterilization Issues

Ann-Marie Assang
Manager, Central Processing
Toronto General Hospital, UHN

• Patient safety
• Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation that are unclear, non-specific or unattainable
• There was a need to define what it means institutionally to meet standards and provide safe patient care
• Continuing to support the advancement of surgical technology
• One multi-site organization’s experience in managing sterilization challenges
• The development of the RMD Matrix
• The elements of the tool as well as an illustration of how it is used
• The key benefits of the RMD Matrix
• How the use of the Matrix has facilitated transparent decision-making, communication and collaboration about sterilization issues across the sites will be described

3:30 | 4:15

When it Makes Sense to Re-Process and When it Doesn’t

Shawn Kenny
Manager, Sterile Processing Department
St. Joseph’s Healthcare, Hamilton

• Factors to consider in determining the threshold of cost effectiveness of re-processing
  • the base cost to re-process
  • the original cost of the item
  • environmental considerations for low cost re-useables
  • allocation of costs; which department pays?
  • the cost of third-party re-processors for SUDs
• The impact improved standards may have on improving the cost-effectiveness of re-processing certain types of devices

4:15 | 5:00

Conserving Resources and Generating Savings with Innovative Re-Processing Technology

Abdool Karim
Manager, Regional Processing Center
Sunnybrook Health Science Center

• Challenges faced to increase capacity by over 30% by adding 3 new OR’s, Centralization and transfer of services from Women’s college
• Replacing old infrastructure that were costly, low morale, high WSIB claims and extensive repairs
• Flat budget
• State of the Art Technology that was not yet approved and first Installation of its kind in North America. Meets or exceeds standards
• Outsourcing considered but was not competitive
• Cost savings of over $300,000 yearly
• Overall benefit to patient care by re-channeling of savings

5:00

Register 3 delegates for the main conference at regular price at the same time and you’re entitled to register a fourth person from your organization at no charge. For other group discounts, please call 1-888-777-1707. All discounts must be redeemed when booking, discounts will not be valid or applied after this time.