The supportability of medical devices

Abstract

Clinical Engineering (CE) and Health Technology Management (HTM) appears to be spending more time trying to get medical device manufacturers to provide support for inhouse servicing than ever before. Surveys conducted by AAMI in 2015 and CMBES in 2016 revealed that model-specific technical training and documentation were the top two priorities for this group of respondents. Many manufacturers and even healthcare institutions seem to minimize the value or even the existence of CE/HTM programs. It is important to note that these programs operate to save hospitals and healthcare money and also serve to provide quick and necessary support for healthcare technology in the clinical setting. They are now being challenged by many of their commercial partners. Almost every other acquisition of medical equipment now requires the need to negotiate support for inhouse services and is met with a balance of success and failure. It appears manufacturers are designing equipment without considering the customer’s option to service it. These customers include medium to large hospitals that have the capacity, economies of scale, and know-how to create and sustain CE/HTM departments. At the same time, there are many companies that provide good support for inhouse servicing. Their examples of appropriate support strategies may serve as a baseline for most other companies to make their products serviceable and to ensure CE/HTM is qualified and properly equipped to perform the required service. This paper highlights most of the issues surrounding the notion of Supportability in the CE/HTM world. These issues affect independent service organizations (ISOs) in a similar way. There are efforts to manage the supportability issue and ideas on how certain barriers might be dealt with. The paper attempts to recognize these and the rationale behind certain behaviors. There are standards and regulations, or an absence of them, which either help or hinder the issue.