Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers Proceedings of a Workshop (2017) / Chapter Skim
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4 Options for Post-Market Surveillance
4 Options for Post-Market Surveillance
Pages 35-40
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From page 35... ...
The regulatory specifications include performance requirements as well as the criteria for the quality assurance program relevant to manufacturing respirators. Peterson noted that because NIOSH is author 35
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From page 36... ...
In the approval process, NIOSH first conducts an initial engineering review to ensure that the request for certification matches all of the accompanying documentation, including product drawings and the quality assurance system specifications. The product is then sent to the laboratory for testing, and concurrently NIOSH conducts a quality assurance review that delves into the manufacturing processes and procedures.
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From page 37... ...
Examples of nonconformance issues include performance failures, a failure to maintain quality control requirements, misleading advertising, and manufacturing under a private label without prior approval from NIOSH. What is important about the CPIP, Peterson explained, is that NIOSH oversees the investigation but it does not conduct the investigation.
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From page 38... ...
NPPTL disseminates information on standard test procedures through its website, issues letters to manufacturers on policy changes and clarifications, informs users about product failures or recalls, provides a certified equipment list and a trust source list through its website, informs all customers of new initiatives at NIOSH, and alerts stakeholders about other corrective measures that are under development. DISCUSSION A wide range of issues on post-market surveillance were discussed.
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From page 39... ...
Andrew Levinson said OSHA does have regulatory authority in that it can cite employers using non-NIOSH-certified respirators because that is a violation of OSHA standards and OSHA inspectors do enforce those standards. Elizabeth Claverie-Williams added that FDA has ongoing postmarket surveillance for all regulated medical devices, including surgical N95s.
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From page 40... ...
40 INTEGRATION OF FDA AND NIOSH PROCESSES that users are more likely to simply throw a defective one away and get a new one rather than report it. He suggested an effort to educate end users, safety professionals, and infection control practitioners on the need to report issues would be fruitful.
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