Medical devices: continuing interest

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Medical devices and hospital equipment were the focus of special audits in 1999. This was a result of Y2K concerns when date sensitive devices were identified and remediated. Devices hit the radar screen again in December 2003 when the Health Products and Food Branch of Health Canada sent a letter to hospital administrators recommending they conduct an audit to verify that all medical devices had appropriate licences. A difficult period followed as hospitals struggled to obtain licence verification data from the Health Canada website and from manufacturers.

Medical devices are again a hot topic of discussion particularly concerning reprocessing procedures and policies. Over the next two years, several expert committees will report on these issues. Hopefully they will add significant expert advice and practical suggestions to assist hospitals in purchasing and processing medical devices.

Hospitals purchase equipment necessary for patient care. However, hospitals should not be held solely responsible for the selection of devices. In the rather unique environment of the hospital, independent medical staff has input and in some cases, direction over the choice of a medical device, its manufacturer and other important aspects. Governments have input as well.

Health Canada LicencesRegulatory oversight over medical devices is provided by Health Canada under the Food and Drugs Act. The 2003 difficulties were caused by the discovery that certain medical devices used by hospitals had not been licensed by Health Canada.

Health Canada classifies devices into four classes depending on patient risk. Manufacturers and importers are required to obtain a device licence for the importation or sale of all but the lowest class or category of risk.

Unlicensed devices may properly be sold to hospitals in two narrow categories. The first is a category of investigational testing. The second permits special access to devices in case of emergency or if conventional treatment has failed and licensed devices are unavailable or are unsuitable.

Hospitals are now encouraged to obtain satisfactory evidence from the distributor or manufacturer that a device has the required Health Canada licence. If hospitals discover that certain devices are not licensed, they should research the reason why and seek the appropriate medical and legal advice about implications for continued use. In some cases, the device may have been licensed, but the licence has lapsed. In other cases, the manufacturer may never have obtained a licence. The particular facts will be important.

Re-use and Reprocessing of DevicesRecently considerable attention has been devoted to the re-use of devices labelled as single use devices by manufacturers. Attention and debate has now broadened beyond this issue. After a variety of publicized incidents concerning reprocessed medical devices, the reprocessing issue has taken on a position of prominence. Hospitals continue to face practical problems including the discovery of decentralized reprocessing practices, complex designs of multi-use devices, difficult to clean devices, a lack of detail in some cleaning or sterilization instructions, as well as potentially conflicting information supplied by device manufacturers or manufacturers of processing equipment. These practical problems raise a desire, in particular instances, for validation of recommended protocols.

Spurred on by the Federal Auditor General’s Report in March 2004 recommending that Health Canada take action with respect to the regulation of the reprocessing of single use devices, Health Canada has formed an advisory panel on reprocessing of single use devices as well as re-usables. The panel had its first meeting in February 2005 and will continue to meet through the year. The panel’s recommendations are eagerly awaited.

The Ontario Hospital Association has had several conferences on the reprocessing issue. The Ontario Government has had its own initiatives through the Ministry of Health, as well as through Ontario Buys. Ontario Buys is examining back office integration projects, including a medical devices reprocessing group. The group will focus primarily on single use devices, but will hopefully examine re-usables generally. It is expected that the reprocessing of medical devices by third party reprocessors may be addressed by these various panels and study groups.

Purchase Contract WordingIn addition to these interesting technical and scientific issues, medical devices continue to raise the straightforward issue of value for hospitals. Hospitals are consumers. The distribution and sale of medical devices often involves standard form contracts, as well as electronic purchasing or procurement. Hospitals must continue to focus on the “message” and not be distracted by the “medium” of the procurement practice. Hospitals should use their purchasing power to ensure that they receive appropriate warranties and promises of performance that match their expectations. Hospital may want to require tenderers to provide pricing for reusable devices, rather than single use devices. Strategies such as combined purchasing units can add to hospital purchasing power and value in this area.

As more medical devices are developed for use in hospitals, the issues of re-use, reprocessing, government licensing and proper contracts can only become more important.