On Thursday, three senators sent a letter urging the Office of Management and Budget to release a delayed rule to create a medical device identification system, Modern Healthcare reports.
Sens. Richard Blumenthal (D-Conn.), Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) sent the letter to Jeffrey Zients, OMB's acting director (Lee, Modern Healthcare, 2/9).
Background
There is no uniform labeling system for medical devices, making it difficult to track down problematic equipment used by hospitals and patients.
In 2007, Congress voted to support FDA's plan to create an identification system for the devices.
In July 2011, FDA sent its proposal to OMB for review, but OMB has yet to release a proposed rule based on FDA's plan (iHealthBeat, 2/7).
Letter Details
The lawmakers wrote, "Due to our strong desire for a robust post-market environment, we are very concerned with the delayed implementation of the [unique device identifier]."
According to the letter, OMB was expected to have reviewed and released a proposed rule within 90 days of having received FDA’s proposal (Modern Healthcare, 2/9).
The senators requested that OMB by March 1 provide:
- A comprehensive report on the status of the rule;
- A timeline for when the rule will be released
- A list of the reasons for the delay; and
- Whether any time extensions were granted (CQ HealthBeat, 2/9).