WRHA Supply Chain New Technology Workshop Supply Chain Forum November 17, 2010

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1 WRHA Supply Chain New Technology Workshop Supply Chain Forum November 17, 2010 Prepared & Presented by: Gwen Connon, Contract Specialist, WRHA Contracting Services Sarah Kelso, Manager, Clinical Engineering, WRHA Louanne Mythen, Manager, Business Intelligence, Medtronic of Canada Guest Resources Health Canada and HealthPro

2 AGENDA A. INTRODUCTION B. DEFINITIONS OF NEW TECHNOLOGY WRHA Standard HealthPro CADTH Manitoba Health C. REGULATIONS/GUIDELINES HEALTH CANADA Establishment Licensing for distribution of all classes of Medical Devices Medical Device Licence for Classes II, III and IV Special Access D. WRHA NEW TECHNOLOGY INTRODUCTION PROCESS How is New Technology identified to the WRHA? WRHA Communication Implementation E. WORKSHOP INPUTS Define New Technology Examples of New Technology not considered in this Presentation Suggestions for managing New Technology while under contract

3 INTRODUCTION New Technology is a common procurement concern. What is considered New Technology? When does New Technology enter the picture? What are the rules around it? Today s workshop will explore this topic. The focus of today s discussion is relative to Medical Devices, but we welcome inputs relative to all New Technology discussions. Results will be shared with the new WRHA SCRC team for development.

4 CONSIDERATIONS Does the New Technology improve patient care, patient outcome, reduce patient risk, staff safety or enable management of the process? This process involves: Staying current with marketplace for general awareness Stakeholders who will be impacted? Is Licensing required? Evidence/Benefits Assessment/Budget Request for Information (RFI) / Request for Proposal (RFP) Product Evaluation/New Technology Education/Communication Contract Status Does the New Technology infringe on an existing contract? Typically marginal changes do not qualify as New Technology

5 DEFINITIONS OF NEW TECHNOLOGY Reference: WRHA Standard Contract Clause TECHNOLOGY CHANGE The WRHA has the option of adopting new technology, including new software upgrades, as it becomes available, and to terminate this Agreement, subject to the requirements, in whole or in part, should the Contractor be unable to meet the new technology, as may be introduced by the marketplace. This applies for the term of the Agreement. New technology is defined as instrumentation or services, which are not offered for sale as of the effective date of this Agreement. The WRHA reserves the right during the term of this Agreement to evaluate such new technology, including new software upgrades. If after evaluating such new technology, the WRHA is interested in utilizing this new technology, the WRHA shall inform the Contractor in writing and the Contractor shall have up to six (6) months to meet the new technology and present it to the WRHA. The WRHA shall purchase the new technology from the Contractor as long as the instrumentation and/or service is comparable, competitively priced and acceptable as reasonably determined by the WRHA. If the Contractor is unable to provide such new technology, then notice to the Contractor will be concurrent with the written notice of the six (6) month period. Vendor Suggested Enhancement New technology is defined as instrumentation or services, which would improve the safety and/or efficiency of the equipment or its use for staff and/or patients and was not offered for sale as of the effective date of this Agreement.

6 DEFINITIONS OF NEW TECHNOLOGY Reference: HealthPRO HealthPRO is a Canadian health sector group purchasing organization (GPO) NEW TECHNOLOGY GUIDELINES Supplier acknowledges that therapeutic or technological advancements may result in a product or service which is capable of being used in place of a product or service which is the subject of a contract. For the purposes of this clause, new technology is defined as: a) A product that was not available for sale at the time of the original posting of the applicable Request for Information/Request for Qualification and, b) A product that is not simply an iteration of a current product and, c) A product that, in the case of non-pharmaceutics, provides documented evidence of significantly improved patient care, patient safety or health care worker safety benefit.

7 DEFINITIONS OF NEW TECHNOLOGY Reference: CADTH The Canadian Agency for Drugs and Technologies in Health (CADTH) is a national body that provides Canada s federal, provincial and territorial health care decision makers with credible, impartial advice and evidence-based information about the effectiveness and efficiency of drugs and other health technologies. WHAT IS HEALTH TECHNOLOGY? any method or intervention used to promote health; prevent, diagnose, or treat disease; or improve rehabilitation and long-term care. Technologies include drugs, devices, diagnostic agents, equipment, and medical and surgical procedures. The definition also includes organizational and service systems that provide health care, such as telehealth. WHAT IS HEALTH TECHNOLOGY ASSESSMENT? An evaluation of the clinical effectiveness, cost-effectiveness, and broader impact of drugs, medical technologies, and health systems, both on patient health and the health care system.

8 REGULATIONS/GUIDELINES HEALTH CANADA Therapeutic Products Directorate ( TPD ) Medical Devices must comply with the Canadian Medical Devices Regulations. Health Canada Licensing is required to: import, sell, or advertise for sale medical devices in Canada. 1. Establishment Licenses for Distributors of Medical Devices (MDEL) - all classes Class I Devices Any person selling the device directly to a healthcare facility requires an Establishment Licence. This applies both to distributors and the manufacturer. Inspections for conformity to regulatory requirements including complaint handling and recall processes are conducted. 2. Medical Device Licenses (MDL) - Classes II, III, IV Any person selling the device directly to a healthcare facility requires an Establishment Licence except for the manufacturer who already holds the Device Licence for the product. The manufacturer is exempt because in order to hold the licence they need to have a quality system certified to ISO by a registrar accredited through the Canadian Medical Device Conformity Assessment System (CMDCAS). The ISO standard already covers postmarket requirements such as complaint handling and recalls, therefore, this is no need to require an Establishment Licence. CMDCAS audit reviews include conformity to Canadian regulatory requirements similar to the inspection carried out under Establishment Licensing.

9 WRHA NEW TECHNOLOGY INTRODUCTION PROCESS Clinician Identifies Patient Need OR Vendor Introduces New Technology No Existing Contract or No Open Tender Existing Contract or Open Tender Feasibility - An evaluation may be conducted - WRHA Resources are consulted I.e. Clinical Engineering, Facility Management, Medical Device Reprocessing, etc. Open Tender - managed by the rules of the tendering process - restricted to products offered by the tender closing date and time Contract - managed by the terms of the Contract I.e. New Technology clause - a limited evaluation may be conducted

10 WRHA NEW TECHNOLOGY INTRODUCTION PROCESS FEASIBLE PRODUCT POSSIBLE USAGE WRHA Internal Next Steps WRHA Product Review Evaluation & Standardization (PRES) Process - Confirm Need & WRHA Stakeholders Assess risk to proceed WRHA Clinical Engineering i.e. alerts, recalls, etc. Practice change may require further WRHA review & authorization Competitive Process as determined

11 WRHA NEW TECHNOLOGY INTRODUCTION PROCESS Implementation - WRHA Project Manager may be assigned for large regional initiatives Planning/Coordination - determine departments involved - determine product needs and volumes - product acquisition Education Nurse Educators - Determine end user needs - coordinate schedules with Vendor & end users Monitor Implementation for Reported Issues

12 WORKSHOP INPUTS Define New Technology Examples of New Technology not considered in this Presentation Suggestions for managing New Technology while under contract Questions?

13 Wrap Up Questions & Discussion Ground Rules 1. Respect confidentiality 2. Hypothetical situations only please Please remember to fill out your Evaluation Forms