The initial comment period that asked for written responses has passed.  The FDA reports receiving 176 comments from industry groups, OEM’s, independent service companies, and individuals.

There is a very good article in this month’s DotMed’s HealthCare Business News.  The report includes many interesting comments from representatives of most of the interested parties.

 

The general arguments are predictable.  The OEM’s and their industry groups raise concerns about untrained and unqualified individuals working on equipment and the possibility of decreased patient safety.  The ISO’s and their industry groups counter that there is no data to support this claim and that, in fact, at least one independent study showed of 1,526 respondents surveyed only 12 respondents reported any adverse issues due to modifying the preventive maintenance procedures assigned by manufacturers.

 

OEM’s also argue that if they must maintain standards specified by the FDA, all others should be required to at least meet some minimum standards.  They also hope that some action by the FDA will help define new guidelines about their level of liability if equipment owners elect not to use their service groups for on-going work.

 

Although the FDA has not specifically stated why they have opened this docket item, the authors speculate that perhaps it was recent issues with endoscopy design and cleaning issues that prompted this action.  In any case, any action by the FDA is certain to effect the imaging community.

 

To read DotMed’s full article click here.