Although the FDA may prefer public comments, it is also allowing for private comments on this docket due to the possibility that confidential information may be useful in their evaluation but sensitive to the general public or a company’s competitors.

In an e-mail to HCB News, Diana Upton, president of IAMERS offered her own suggestions to people participating in the docket. "Answer the questions succinctly without criticizing the OEMs or the FDA. I believe they (FDA) are honestly trying to figure this out. Remember that the prime directive of the FDA is patient safety," she wrote.


Chris Nowak, an end user on the webinar panel, described this as an opportunity to create more transparent channels for educational and working relationships between OEMs and independent servicers, instead of continuing in "us and them" roles, which may hamper access to important documents and manuals necessary to ensure patient safety.

Jonathan Gaev, business line manager at ECRI Institute, said that similar initiatives were undertaken by the FDA in the late ’90s and that ECRI partnered with them in those initiatives and is happy to assist in the new docket.

Although nobody said it explicitly, many panelists seemed to suggest that the services provided by third-parties were right at home in an era of health reform, where value takes precedence.

“Hospitals are making buying decisions not just on a spreadsheet but they are visiting [servicing] facilities when they are looking at making a change from a manufacturer service – and they’re making more intelligent decisions because there is a tremendous cost savings that is provided by the third-party marketplace,” said one expert, who echoed others in that he would welcome the FDA in these discussions.

Still, not everyone is thrilled about the docket. One public commenter seemed to voice concerns that the docket implies certain accusations. "I don't think it is fair to just blame third-party vendors, ISOs or in-house programs. Yes, there are poorly trained biomed professionals in hospitals and in ISOs but OEMs also cut corners when it comes to generating more revenue," he wrote.

That person calls for "a solution to correct the problem rather create a monopoly in the health care market" in his comment.

The FDA docket will be open until May 3, 2016. The May issue of HCB News magazine will explore this issue in greater detail.

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