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TREATMENT OF MEDICAL DEVICE LICENSING ISSUES IN PROCUREMENT DOCUMENTATION

TREATMENT OF MEDICAL DEVICE LICENSING ISSUES IN PROCUREMENT DOCUMENTATION. Debby Shapero Propp CESO 2004 April 30, 2004. What’s the Benefit? . Defining requirements early in the process helps ensure Hospital’s needs are met Regulatory requirements are met

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TREATMENT OF MEDICAL DEVICE LICENSING ISSUES IN PROCUREMENT DOCUMENTATION

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  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

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