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Amendment requiring FDA to report on ISOs within 180 days goes to House vote

June 07, 2017
Parts And Service

8. The amendment also requires that the report address the current regulation by states, the Joint Commission or other regulatory bodies of servicing, with respect to devices by all entities including manufacturers, third party entities and hospitals.

Congressman Peters, in his remarks in support of passage of the amendment, noted that patients should not be taking a leap of faith and advised the committee he had hoped for a stronger measure. He also suggested that this amendment would "put us on a path to ensure patient safety."

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IAMERS President Diana Upton commented "IAMERS looks forward to a continued responsible dialogue with Congress, the FDA and stakeholders as to best practices to promote patient safety. We are hoping that the FDA will review and discourage the practice of some manufacturers to withhold equipment manuals, passwords, service keys and schematics."

Overall, those involved seem optimistic that the legislation could improve transparency and communication across different medical equipment stakeholder groups.

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