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NIOSH Respiratory Diseases Research Program

Evidence Package for the National Academies' Review 2006-2007

11.3 Certified Product Investigation Program

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Issue

Since July 1, 1982, the respirator program has been investigating reports of problems with MSHA/NIOSH and NIOSH certified respirators. These reports are from NIOSH audits of certified respirators, from regulatory agencies, and from users and manufacturers of respirators. Investigations have been systematically tracked since 1996, and total 350 investigations as of May 2006. The total includes # fatalities of employees who were wearing self-contained breathing apparatus at the time of their deaths. 

The goals of the program are to increasingly justify the user’s reliance on the NIOSH respirator certification program and to indicate to respirator manufacturers that NIOSH is sincere in its desire to increase the safety and reliability of certified respirators.

Approach

The protocol for handling a field report on a NIOSH-certified respiratory product consists of the following:

  • Receipt and logging of the field report
  • Classifying the report, and determining the urgency and importance
  • Allocating resources to investigate the report
  • Planning/organizing appropriate actions to resolve the report and prevent its recurrence
  • Implementing, controlling, and/or monitoring those actions
  • Closing the investigation and preparing resources for additional investigations

The primary role of NIOSH in a field report investigation is to monitor the manufacturer’s corrective actions. If the manufacturer cannot appropriately resolve the report, then NIOSH will offer them technical assistance. If necessary, and on rare occasion, NIOSH will take the actions necessary and within its power, to protect the worker. Such actions can include requiring the manufacturer to recall and appropriately retrofit their products, and requiring the manufacturer to stop the sale of the product as being NIOSH certified.

Outputs

350 investigations were conducted between 1996 and May, 2006.

Intermediate Outcomes

The respirator program and manufacturers work closely to resolve and correct performance failures and other issues associated with product.  NIOSH encourages users to contact NIOSH and the manufacturers concerning problems with NIOSH certified respirators.