Peter Weems, director of policy and strategy at MITA also mentioned QSR as a scalable solution to the issue and turned down the assumption that this docket is investigating an area in which there is no problem. The problem, said Weems, is the lack of accountability, not the safety record itself.

ISOs can talk about their safety record and the fact that they go “above and beyond for their customers” until the cows come home, he argued, but until there is verifiable information it's really just taking a company's word at face value.


Still, there is no denying the major business consequences of reshuffling the way things are done now. Presentations by Barbara Maguire, vice president, Quality and Geisinger Clinical Engineering, ISS Solutions, and Robert Kerwin, general counsel for IAMERS, emphasized the major repercussions new regulations could have on limiting the competitive options available to budget-conscious hospitals.

Kerwin went so far as to quote an alien in the 1996 blockbuster, Independence Day. When the film's fictional U.S. president asks a hostile captured alien what it wants the humans to do, the alien replied, "Die!" Kerwin uses the quote to make a lighthearted reference to what the OEMs may want third-parties to do.

It's a funny way of making a valid point. There may be more in the OEM's interest in imposing regulations on third-parties than simply ensuring patient safety — they would almost certainly profit from the changes.

The first day of the workshop did little in the way of offering solutions, but it did help to define the problem. Tomorrow the group will reconvene to talk about the possible challenges and benefits of implementing any changes.

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