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

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

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

Licensing Issues Medical Devices Regulations - wide scope, but not intended to regulate use of devices Medical Devices Regulations - wide scope, but not intended to regulate use of devices Compliance with regulations or enforcement? Compliance with regulations or enforcement? What do the Regulations say? What do the Regulations say? Medical Devices Reg. s 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 Rationale behind the documentation Health Canada Letter Health Canada Letterhttp://

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

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

Competitive Bidding Documents Competitive Bidding Documents Request for Quotations Request for Quotations  Use  Mandatory Requirement: licences for device & establishment in place or statement about exemption Request for Proposals 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

Agreements Often part of the competitive bidding document Often part of the competitive bidding document Sole source Sole source Due diligence (inquiries/searches - Due diligence (inquiries/searches - Representations and Warranties 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

Terms & Conditions Simple purchases, often low $ purchases Simple purchases, often low $ purchases PTC-0M - Specific document for medical equipment and devices 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 Licence Medical Device Establishment Licence Medical Device Establishment Licence any exemptions any exemptions PTC-01 - Standard purchasing document PTC-01 - Standard purchasing document  Safeguard wording similar to agreements

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

Contact Information Debby Shapero Propp / Ex

Medical Device Establishment Licence (Medical Device Reg. *S. 44) 44 (1) No person shall import or sell a medical device unless the person holds an establishment licence. 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 (2) Subsection (1) does not apply to (a) a retailer; (b) a health care facility; (c) ** in the case of Class II, III or IV medical device, the manufacturer of the medical device; (d) in the case of a Class I device, the manufacturer or the medical device, if the manufacturer imports or distributes solely through a person who holds an establishment licence. *Rationale for position in documentation/enforcement 1. Legal authorization re suppliers 2. Meeting regulatory requirements and ensuring certain procedures are in place if there is a problem with the device