NEW FDA RULES MAY AFFECT SUPPLIERS TO MEDICAL OEMS

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ANAHEIM, CALIF. — Some medical plastics processors and suppliers are watching closely to see how new Food and Drug Administration good manufacturing practices rules will affect them.

The rules, most of which take effect in June, generally require that products be manufactured in a way that makes them safe and effective for their intended use.

N. Wayne Ladd, market manager for medical business in Eastman Chemical Co.'s specialty plastics unit, said resin suppliers are ``trying to understand what constitutes'' good manufacturing practices.

The Kingsport, Tenn., company may see more audits from original equipment manufacturers to check on product quality, he said.

Eastman recently was given a 70-page audit from a customer, Ladd said during a Feb. 11 interview at the Medical Design and Manufacturing West show in Anaheim.

The good manufacturing practices rules apply directly to the manufacturers of the medical devices, but those companies may ask for more information from their suppliers, such as processors and resin suppliers, according to Andrew Lowery, who heads the technical staff of FDA's Division of Small Manufacturers Assistance.

For example, several aspects of the new rules, such as purchasing controls, nonconforming product standards and design controls, may affect processors and suppliers, said Terrence Sullivan, a senior quality systems specialist with North Attleboro, Mass.-based Medical Device Consultants Inc.

Brian Meltzner, sales manager for Merrill's Packaging in Burlingame, Calif., said the new rules will not have much effect on his company, because it already works closely with suppliers and devises plans to monitor quality for each customer.