TREATMENT OF MEDICAL DEVICE LICENSING ISSUES IN PROCUREMENT DOCUMENTATION

1. TREATMENT OF MEDICAL DEVICE LICENSING ISSUES IN PROCUREMENT DOCUMENTATION Debby Shapero Propp CESO 2004 April 30, 2004

2. What’s the Benefit? • Defining requirements early in the process helps ensure • Hospital’s needs are met • Regulatory requirements are met • Clearly specifies requirements to suppliers • Key to implementing hospital policies • Working Model • The SHSS Experience • Development of SHSS Documents • SHSS connection with Medical Engineering

3. Templates/Documentation Assess and consult Monitor and adjust Document

4. Licensing Issues • Medical Devices Regulations - wide scope, but not intended to regulate use of devices • Compliance with regulations or enforcement? • What do the Regulations say? Medical Devices Reg. s.26 ... no person shall import or sell a Class ll, lll or lV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, … Medical Devices Reg. s.44 (1) No person shall import or sell a medical device unless the person holds an establishment licence. (2) Subsection (1) does not apply to the importation or sale of a medical device by (a) a retailer; (b) a health care facility; ... • Rationale behind the documentation • Health Canada Letter http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/letter-healthcarefacilities_e.html

5. A Word About Templates • Advantages • Uniformity presented to the vendor community • Efficiencies achieved • Promotes safeguards • Disadvantages • Blind adherence • Promotes lack of ownership • Fails to be dynamic • Court will assume that you know your own document

6. Purchasing Medical Devices • Competitive Bidding Documents • Request for Quotations • Request for Proposals • Agreements • Supply of Products • Equipment Purchase and Installation Agreement • Terms and Conditions • Purchase Terms and Conditions • Purchase Terms and Conditions – Medical Equipment and Devices (“PTC-0M”)

7. Competitive Bidding Documents • Request for Quotations • Use • Mandatory Requirement: licences for device & establishment in place or statement about exemption • Request for Proposals • Use • Mandatory Requirement as with RFQ with a twist - if Bidder is in the process of applying for a licence • Statement about requirement of licence before being purchased • “Sell” in the Food and Drugs Act - broad and includes “offer for sale” • Currently have requested the position of Health Canada on this

8. Agreements • Often part of the competitive bidding document • Sole source • Due diligence (inquiries/searches - www.mdall.ca) • Representations and Warranties • Both the Supplier and the Equipment shall have received all applicable licensing under, and shall be in compliance with the Food and Drugs Act (Canada) and its regulations

9. Terms & Conditions • Simple purchases, often low $ purchases • PTC-0M - Specific document for medical equipment and devices • Purchasing issues • Issues unique & critical to medical devices • Licensing: satisfactory proof at the time of purchase as to: • Medical Device Licence • Medical Device Establishment Licence • any exemptions • PTC-01 - Standard purchasing document • Safeguard wording similar to agreements

10. Monitor Results and Feedback • Continue to monitor if any issues • Educate the staff • Prepare to adjust documents where necessary • Staff to exercise due diligence • Continue to work with management to obtain clear direction

11. Contact Information Debby Shapero Propp 416-576-1154 / 416-340-4800 Ex. 6528 debby.shaperopropp@sympatico.ca debby.shaperopropp@shss.on.ca