California's newly adopted H1N1 rules requiring widespread use of N-95 respirators by healthcare workers—perhaps the strictest in the country—has hospital officials "extremely nervous, because there's a nationwide shortage of these masks," says a spokeswoman for the California Hospital Association.
"Hospitals are expressing concern that if the pandemic is as bad (this season) as some people predict, hospitals could go through literally hundreds of thousands of these (N-95 respirators) a week, and you can't replace them because of the manufacturing shortage," says Jan Emerson, CHA's vice president for external affairs.
"We have one large Northern California Hospital that said they could easily see themselves going through 70,000 of these masks in one week," says Emerson, whose Sacramento organization represents more than 450 hospitals and health systems throughout the state.
"Hospitals now each have a supply," Emerson says, "but they don't know how many they're going to need. With CAL/OSHA's standard, it would likely increase the number of masks necessary. What I've been told is that a lot of hospitals have been told to get their orders in now to make sure that if they need them, they will be able to get them."
The concern is compounded because on Sept. 8 Cal/OSHA, California's version of the National Institute for Occupational Safety and Health, issued specific interim recommendations requiring use of the respirators in the process of caring for patients with suspected or confirmed pandemic H1N1 influenza in both outpatient and inpatient settings.
In theory, that means physicians in their clinical practices would have to adopt the use of the masks as well.
The recommendations say respirators such as N-95s, "should be used for hospitalized H1N1 suspected, probable and confirmed cases." And it "requires use of respirators when entering or working in areas where those patients are located."
Hospital officials for Northern California's Kaiser Permanente's Regional Infection Control Committee said in a recent paper that, "using methodology for calculating the current use of N-95 respirators and determining the current supply available to each medical center . . . we have determined that an extreme shortage of N-95 respirators exists at all medical centers."
The paper was signed by Stephen Parodi, MD, chief of infectious diseases and co-chair of the Kaiser Regional Infection Control Committee; David Witt, MD, chair of the National Healthcare Continuity Management; and Pancy Leung, RN, of the Regional Infection Control Committee.
The national shortage may be significantly exacerbated because NIOSH this summer revoked the certifications of 22 N-95 respirator products from two Chinese companies, Bei Bei Safety Co. Ltd and Jiangsu Teyin Nonwoven Fabrics Co., Ltd., or JTN.
For Bei Bei, those certifications or model numbers were listed as: TC-84A-4390, TC-84A-4391, TC-84A-4392, TC-84A-4520, TC-84A-4525, TC-84A-4560, and TC-84A-4562. "As of July 1, no Bei Bei Safety Company LTD (BBE) respirator model can be listed as NIOSH approved" and Bei Bei's respirator products "can no longer be manufactured, assembled, sold or distributed," NIOSH wrote in a July 1 notice.
For JTN, those certificates were numbered TC-84A-4244, TC-84A-4245, TC-84A-4380, TC-84A-4381, TC-84A-4382, TC-84A-4384, TC-84A-4385, TC-84A-4386, TC-84A-4389, TC-84A-4406, TC-84A-4407, TC-84A-4408, TC-84A-4490, and TC-84A-4501.
"As of June 22, 2009, no JTN respirator model can be listed as NIOSH approved," and no respirators with those numbers can no longer be manufactured, assembled, sold, or distributed," NIOSH said in a July 1 notice.
It could not be determined how many Bei Bei or JTN respirator models or products were recalled, or whether those products were sold under another brand name, or who purchased them and whether they are being replaced.
In Cal/OSHA's recommendations, N-95 devices should "generally be disposed of each time they are removed." If the employer is unable to assure a sufficient supply of respirators, "the employer should implement and document in writing the attempts to obtain respirators and measures the employer is implementing to conserve the respirator supply, which may include re-donning."
The masks are to be worn during "high hazard procedures including bronchoscopy, sputum induction, intubation and open circuit suctioning," Cal/OSHA added.