Medical Technology Representative Credentialing Position Paper

MEDEC fully supports sound practical requirements that yield improved quality care and clinical outcomes, as well as a safe and confidential environment for patients, healthcare personnel and health care organization partners and stakeholders. While we support the concept of assuring credentialing, we believe that we must find an efficient way for vendors to respond without loss of productivity, duplicitous costs or risks to health technology company employee privacy. We support the creation of common national standards for the credentialing of medical technology industry representatives in an effort to ensure patient safety, privacy, high-quality and efficient care and access to medical technologies. read more

Value-Adds in Competitive Tendering Position Paper

Healthcare systems in Canada use tendering processes for the procurement of medical devices and diagnostics technologies. These tendering processes are becoming increasingly complex with growing requests for value-adds and are requiring a significant allocation of resources. The medical device industry is concerned about the direction of requests for these value-adds and the “uneven playing field” that may result due to them. This paper outlines MEDEC’s position regarding the definition of appropriate value-adds in a fair and transparent sourcing process. read more

Best Tendering Practices

This MEDEC position paper statement of principles is intended to offer MEDEC members and their customers/stakeholders a guideline for consistent non-binding, voluntary application for a code of conduct within the tendering process for medical devices. read more

Tracking Markers Intended to Simulate Unique Product Identifiers Position Paper

While the medical manufacturers support the principle of unique identifiers, they cannot support any tracking marker system that alters instruments. Adding tracking markers to instruments should not be done without the original manufacturer’s approval. Any change or permanent marking of an instrument ex-factory may require re-labeling via the applicable regulatory process for that product. read more

Positron Emission Tomography (PET) Position Paper

MEDEC is concerned that access to PET scanning remains limited for Ontario patients. Under the current Ontario Health Insurance Plan (OHIP), PET scanning is restricted to a select number of indications, which are mostly based on local clinical studies. We believe that appropriate use of PET scanning in Ontario should include additional indications as supported by current scientific and clinical evidence available from across a number of jurisdictions. read more

Patient Management Software Position Paper

In general, MEDEC supports the regulation of software as a Medical Device as outlined in Health Canada’s Notice of May 21, 2010. We are concerned about recent discussions which have indicated a change in the May 21 position particularly related to: Transmission of data in ‘real-time’; Middleware; EMR/EHR being exempt from regulation; and ASP exemption. The overarching assessment to determine the regulation of software as a Medical Device, like all medical devices should be based on the Manufacturer’s labeled indications for use of the product and functionality of the device. read more

Pandemic Planning and the Medical Device Industry

Health officials around the world are now monitoring the current H1N1 influenza outbreak and communicating with health care organizations and the public. A pandemic influenza outbreak expected to be a global threat will place a global surge demand on the need for specific medical supplies and equipment. read more
related resources

Health Technology Assessment

Health Technology Assessment (HTA) is used to inform decisions on the reimbursement, coverage, adoption and uptake of healthcare techonologies. HTA must be an enabler of patient access to new technology. The HTA process must be transparent, objective, and timely with an independent appeal process. read more

Bisphenol-A and the Canadian Medical Devices Industry

Medical devices are not currently the focus of Health Canada and Environment Canada's concern in regards to bisphenol-A (BPA), however, MEDEC is proactively monitoring this issue in order to prepare for any questions or concerns. read more

The Impact on Medical Devices in Canada with a Weak U.S. Dollar

In this current economy, the business facts need to be recognized in light of the strength of the Canadian dollar versus the U.S. dollar for manufacturers and distributors of medical device technologies in Canada. read more

Critical Issues in Canadian Orthopaedic Surgery

Orthopaedics is one of the greatest challenges the Canadian health care system faces. As Canada's population continues to age and grow, the demand for orthopaedic care will outstrip the supply of services. To this end, there are a number of strategies to tackle the mismatch between demand and supply. read more

Focusing on the Health and Safety of Ontarians

In January 2007, MEDEC presented a Pre-Budget Submission as part of the annual Ontario pre-Budget consultations on two key issues affecting the government's ability to provide Ontarians with the highest quality care. This document is a summary based on the advocacy proposal, which was formally submitted to the Ontario Ministry of Finance's Standing Committee on Finance & Economic Affairs. read more

MEDEC Policy Summit on Cleaning & Sterilization of Reusable (Multiple-Use) Medical Devices

The MEDEC Policy Summit on Cleaning and Sterilization for Patient Safety was sponsored by the MEDEC Orthopaedic Committee on October 31, 2006. MEDEC supported this policy summit in order to continue and foster dialogue with the various stakeholders involved in cleaning and sterilization and to find solutions to the issues involved in the reuse of medical devices. read more

Provincial Variations in the Utilization of Implantable Cardioverter Defibrillators (ICDs)

Summary of results: there are significant provincial variations in the utilization of ICDs across Canada. The highest utilization of ICDs is in Newfoundland and Quebec. Provincial variations (above or below the Canadian average) have been sustained and are relatively consistent from 2002 -2005. read more

Self Monitoring of Blood Glucose for People with Type 1 and Type 2 Diabetes

There has been some recent debate in the diabetes care community regarding the importance and value of self-monitoring of blood glucose (SMBG) among people with Type 2 diabetes. read more

The Impact of Innovative Medical Device Technologies on Patient Safety Fall/Winter 2006

Patient safety must be a key focus of healthcare professionals and medical product manufacturers to ensure decreased adverse effects, decreased healthcare system costs, and improved patient outcomes. One mechanism that can help to minimize risk to patients is the appropriate use of medical devices and the adoption of innovative device technologies designed to enhance patient safety. read more

Economic Benefits of Treatment

Productivity gains from innovations in vision care abound – clearer vision, fewer complications, quicker recovery, and greater convenience. But Canadian health care policies threaten patient access to care and continued innovation in ophthalmic technologies. (Fall 2006) read more

Pandemic Influenza Planning and the Medical Device Industry

Health officials around the world are now stating that it is not a question of whether an influenza pandemic will occur but when. (Spring 2006) read more

The Storage And Handling Of Blood Glucose Test Strips

Research undertaken by MEDEC members who represent diabetes care device manufacturing companies suggests that further education among all parties in the supply chain (wholesalers/ distributors, sales representatives, pharmacies, and healthcare providers) is required to maintain product integrity by ensuring proper handling, shipment, and documentation procedures for blood glucose test strips.

Compliance with the Establishment License requirements of the Medical Devices Regulations is also a key expectation. (March 2006)  read more

Generic Product Registration Cards And PIPEDA Requirements

A few Canadian retailers have made recommendations to develop standardized or generic versions of warranty cards to replace company specific warranty cards.

Retailers would like to track customer warranty card information and potentially become involved in the centralized transfer of patient information to manufacturers of blood glucose meters. (March 2006) read more

The Impact on Canadian Manufacturers & Distributors of Medical Devices Costs Due to Raw Materials and Freight Fuel Surcharges

Market Conditions Impacting Medical Device Manufacturers (Winter 2005) read more

Cleaning and Sterilizing Reusable Medical Devices

Proper cleaning and sterilization of reusable devices in Canadian healthcare facilities is critical in preventing patient exposure to infectious agents. Communication and implementation of the manufacturers’ validated processes should be optimized with a view to developing best practise solutions that ensure patient safety. (Winter 2005) read more

The Vision Risk For Canadians

Advances in ophthalmic technologies improve sight for more cataract patients and increase economic savings – but Canadian healthcare policies threaten improvements (Winter 2005) read more

Cause for Concern: The Reuse of Single Use Medical Devices

Calls to light the practice of reusing single use medical devices (SUDs). This practice poses potentially serious and life-threatening risks to patients in Canada, by exposing them to infectious diseases and possibly malfunctioning devices. The reuse of SUDs is the practice of reprocessing the device for use on another patient.  read more

Briefing note on Cause for Concern: The Reuse of Single Use Medical Devices (Winter 2010) read more