Michael Causey, Editor & Publisher, eDataIntegrityReport.com

They say that change is about the only constant in life (we’ll leave out death and taxes for the sake of this discussion).

And we all got an excellent reminder of that earlier this month when the FDA smacked Boston Scientific by saying the agency would not speed up the review of manufacturing changes required for Boston Scientific to resume selling its implantable heart defibrillators.

 As first reported by The Wall Street Journal, the medical-device maker recalled all seven brands of its defibrillators in March after having failed to receive FDA approval for the manufacturing changes. The company had earlier told physicians that it expected the review to take less time than the typical 30 days, according to the WSJ.

 Boston Scientific submitted the changes to the FDA for approval on March 15 and 16, according to an email sent by a Boston Scientific sales representative to a physician on March 17 that was reviewed by WSJ.

What’s at the core of Boston Scientifics’ problem here? Well, at least part of it is change control failures. As noted in the Journal report, “The Natick, Mass., company’s failure to report the manufacturing changes to the FDA was the latest in a string of problems in following reporting requirements. The FDA is investigating the company’s failure in this recent case as well as past lapses,” an FDA official said.

But Boston Scientific is by no means the only company out there with a shaky hand on change controls. If you are reading this blog and your gut is starting to churn a little, you know who you are.

It may be time to review your change control program, right?

We thought it might help a little to review exactly what change control is, while we’re at it.

Good old Wikipedia defines change control within Quality management systems (QMS) and Information Technology (IT) systems as “a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.”

And that’s a great definition — as far as it goes. What it leaves out is what can go wrong when change control isn’t handled properly.

But we already know what the consequences are when change control isn’t properly managed, don’t we?

ADDITIONAL RESOURCES

For more on the FDA’s change control requirements, go here:

Boston Scientific sees it all a little bit differently. In a March 18 release the company notes that the FDA did recommend approval of an expanded indication of its heart medical devices. However, Boston Scientific has thus far declined to address the FDA’s decision not to review it more quickly.

AssurX will host a complimentary webinar on this important topic April 8, 2010 at 10am PDT. Click here to register.