Debby Shapero Propp

1
TREATMENT OF MEDICAL DEVICE LICENSING ISSUES IN
PROCUREMENT DOCUMENTATION

• Debby Shapero Propp
• CESO 2004
• April 30, 2004

2
Whats the Benefit?

• Defining requirements early in the process helps
  ensure
• Hospitals 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_at_sympatico.ca
• debby.shaperopropp_at_shss.on.ca