Editorial offbase

To the Editor:

Heaven forbid that the ” … FDA should mandate cleanrooms for critical medical device manufacturers … ” You seem to have missed the point of the GMP revision and the intent of FDA oversight in your May editorial.

The six year GMP revision process, authorized by the Safe Medical Device Act of 1990, was an effort by FDA to address two main issues: harmonization with the international quality system requirements (ISO 9001) and reduction of the number of injuries resulting from medical devices with design flaws. After review of years of data from trending MDRs and other sources during the 1980s, FDA found that one of the main reasons for device failure in the field was inadequate design. It took many years for industry and FDA to understand the market forces, which showed by 1989 that a revision was necessary. FDA also wanted to align the new regs with requirements in Europe, Australia, Japan and Canada and to reduce the need for device manufacturers to maintain different quality systems in different markets. Significant input from industry was solicited and incorporated into the new rule.

The focus of the new requirements is to offer manufacturers flexibility in deciding how to comply with the new rules. The objectives of controls are explained, and manufacturers have the opportunity to develop their own methods for implementing the requirements. Each manufacturer can select any process, any manufacturing environment, packaging system etc., which can be shown to produce a safe and effective device.

Given these facts, your conclusion that contamination control and cleanroom technology is somehow related to saving human lives seems like a stretch. Yes, controlling the environment is important in the manufacture of sterile devices, but there are a myriad of ways this can be accomplished. And this is the way it should be! Few instances of human harm have been attributed to non-sterile, dirty or otherwise contaminated devices resulting from an improper manufacturing environment. The new design controls will most assuredly reduce the number of human injuries much more effectively than your suggested “FDA mandate.”

The current FDA initiatives to work cooperatively with industry to ensure the safest, most innovative devices for U.S. consumption will accomplish more than restrictive mandates ever would. Let`s hope that continued voluntary cooperation will continue to the benefit of all mankind.

Anne F. Booth, Principal Consultant, Booth & Associates,

Publisher,

The Validation Consultant

Barrington, IL