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N95 Mask Requirements

Q: I attended the OSHA seminar in Lansing, MI earlier this summer and noted that when the N95 masks were discussed, the fit test consisted of making sure it stayed on the face when inhaling. The manufacturer lists more stringent fit testing criteria but I was wondering if that is necessary in an urgent care clinic setting. We infrequently have suspected TB patients and never treat TB at the clinics.

A: Thanks for your question. The exact requirements for N95 masks in low risk outpatient setting where suspected TB patients will not be treated, just triaged is a bit of a regulatory gray area right now so please let me do my best to explain...

There is "fit testing" and "seal checking". The seal checking sounds like what was described at the seminar you attended. The fit testing can be done in two ways either qualitative (using saccharin or bitrex test) or qualitative (using a machine to measure the N95 effectiveness) which I am assuming is the more stringent criteria you are referring to in the manufacturers recommendations.

According to the letter of the law as it's currently written, if an employee MUST wear a tight-fitting respirator, including one of the N95 type, for work duties the Respiratory Protection Standard (29 CFR 1910.134) applies.

The Respiratory Protection Standard requires you to do three main things:

1. Document the employee's medical clearance to wear a respirator.
2. Do an initial fit test using a qualitative or a quantitative fit test procedure with the size and make (brand) of respirator you plan to keep on hand.
3. Perform annual qualitative or a quantitative fit test fit tests.

Details about the employee's medical clearance to wear a respirator:
--Must provide a medical evaluation to determine employee's ability to use a respirator, before fit testing and use.
--Must identify a physician or other licensed health care professional to perform medical evaluations using a medical questionnaire or an initial medical examination that obtains the same information as the medical questionnaire.
-- Must obtain a written recommendation regarding the employee's ability to use the respirator from the physician or other licensed health care professional.
-- Additional medical evaluations are required under certain circumstances, e.g.: employee reports medical signs or symptoms related to ability to use respirator; physician or other licensed health care professional, program administrator, or supervisor recommends reevaluation; information from the respirator program, including observations made during fit testing and program evaluation, indicates a need; or change occurs in workplace conditions that may substantially increase the physiological burden on an employee.
-- Annual review of medical status is not required

Details on fit testing (initial and annual):
-- Two types: qualitative and quantitative
-- Most likely a qualitative fit test where the user reports a sensation (taste, irritation, smell) would be less expensive to administer. These tests use Saccharin, Bitrex, or Isoamyl Acetate (banana oil).
-- If you are interested in using quantitative test instead, the product pictured in this link (or similar) may be considered

Needless to say, all of the above represents a great deal of work for a respirator that isn't likely to be worn.

This is a concern that many Quality America customers have had, so in August I spoke with an official at the Federal OSHA Directorate of Standards. I asked him whether low risk outpatient facilities are required to have N95 for TB and pandemic flu and, if yes, if they have to follow the full requirements of the respiratory protection standard as far an medical exams, initial and annual fit testing.

He said that he wasn't sure what would be necessary as they were still working to come to consensus about it internally. He seemed to lean toward not having full requirements for outpatient care but mentioned that the Directorate of Enforcement had the policy right now. I asked if they had an estimated release timeframe for guidance and he indicated there was not one, just that when the policy was set it would be published.

I hope this helps. Here's another Quality America blog post you can check out for further guidance.

Posted by Quality America on September 26, 2007 | Comments (0)

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