Who is protecting us? CDC N95 mask for H1N1

indigo girl · Nov 6, 2009

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/nov0509respirator.html

What a mess. It looks like Dr. McIntyre still believes that her study correctly shows the superiority of the N95 to the surgical mask. Too bad she was not present to defend her research. SHEA is determined to get rid of the N95 as the routine protection. SHEA is also saying that this study influenced the IOM decision but because it was not yet published, McIntyre who was on that committee says it did not. IOM only looked at published studies.

Better read the whole article to make sense of this. SHEA probably won't give up until they get OSHA and CDC to change the level of protection.

Raina MacIntyre and colleagues first presented their findings at a medical conference in mid-September, reporting that N-95s, compared with no respiratory protection, reduced the risk of confirmed influenza in hospital workers by 75%, whereas surgical masks had no protective effect. The findings were hailed by some experts as a landmark in a field where few clinical studies have been done.
But at the Infectious Diseases Society of America (IDSA) annual meeting last week, MacIntyre's team presented a new analysis of their data, made at the request of peer reviewers. The reanalysis excluded the control group of unprotected workers. The result was that workers who wore N-95s still appeared to be better off than those with surgical masks, but the differences were no longer statistically significant.
Some press reports and critics of the study—which has not yet been published in a journal—characterized the reanalysis as a retraction of the earlier report. Critics also suggest that the study influenced the recent recommendation by the Institute of Medicine (IOM) that healthcare workers should wear N-95s when caring for H1N1 patients. MacIntyre was a member of the committee that wrote the IOM report, issued in September.
But MacIntyre says the reanalysis was not a retraction. She asserts that the study results still indicate a real difference in levels of protection, but the changes requested by the peer reviewers left the study "underpowered" to show significance. Further, she says the IOM panel considered only published studies in making its recommendations.

(hat tip FlaMedic)

indigo girl · Nov 10, 2009

http://infectiousdiseasenews.com/article/50386.aspx

SHEA remains determined to get rid of the N95 mask as your best protection from swine flu. This time they wrote to the White House. Good grief!

I do not have a warm and fuzzy feeling about SHEA and these other organizations. Let them be at the bedside in a surgical mask. What they do not mention in their letter is that the IOM made the recommendations not based on McIntyre's study since it has not been published yet. It was based on other evidence.

This seems like a war of wills. The doctor representing the 3M Company called it "The Holy War" at the CIDRAP Conference I attended in Minneapolis.

Three national health organizations wrote President Barack Obama today, requesting the administration issue an immediate moratorium on federal guidelines that require the Occupational Safety and Health Administration to enforce the use of fit-tested N95 respirators among health care workers treating patients with suspected or confirmed influenza A H1N1.
The letter, composed by experts from the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA) and the Association of Professionals in Infection Control and Epidemiology (APIC), follows a retraction last week by the Australian researchers who authored a preliminary report suggesting N95 respirators offered significant benefits over surgical masks, after data from another study indicated both offer equal protection from disease transmission.
Surgical masks offer several advantages, the letter stated, including being more readily available, more practical to implement, more likely to be worn and less costly than N95 respirators. “Permitting OSHA to continue to enforce a policy that is not grounded in science will force healthcare facilities to waste time and resources working to comply with a flawed requirement when they instead should be working to enact measures that will have a beneficial impact on patient care and worker safety during this national emergency,” they wrote.

(hat tip pfi/prrs)

3rdcareerRN · Nov 12, 2009

In case you are responsible for buying N9x respirators for yourself or others, here is an excellent new set of info from the CDC:

http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource.html

"Welcome to the NIOSH trusted-source page for respirator information. This information may be regarded as a trusted source to verify which respirators are approved by NIOSH, how to get them and how to use them. "

indigo girl · Nov 12, 2009

IOM committee member comments

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/nov0509respirator.html

Dr. Bonnie Rogers of the University of North Carolina at Chapel Hill, vice-chair of the IOM committee, agreed that the committee did not rely on the MacIntyre study--or another recent clinical comparison study that had not yet been published--in reaching its conclusions.
As noted by Rogers, the IOM report states, "Without having the full details of the studies the committee could not draw conclusions from either study. Clinical effectiveness data are thus quite limited and conflicting at this time." Given the limited and conflicting clinical evidence, the committee based its recommendations on the experimental evidence of airborne transmission of flu viruses and the fit characteristics of N-95s compared with medical masks, the report adds.
Rogers commented, "I find that our recommendations are solidly based on the scientific evidence, particularly that related to filtration and fit. This was entirely exclusive of the Loeb and MacIntrye abstracts as is stated in the Letter Report, as the science for these studies was simply not available for the committee to review and debate."

lamazeteacher · Nov 12, 2009

Thanks, indigogirl for putting some rational observations about the various groups involving themselves in this exertion of wills. It reminds me of the sarcastic quip, "Who died and made you Queen/King?" when new organisations press their beliefs on other longer standing organisations.

When I worked last as an Infection Control Nurse, in 2004, SHEA and IOM, weren't on the scene. The four groups making position statements for the wearing of surgical masks, makes me wonder who and what is behind such diversity in thinking. Following the money, I imagine it's the cost of N95 masks, with the need for teaching given nurses and doctors to fit them properly, and possibly lack of compliance with wearing N95s properly, that drives them. We all know just how compliant with P&Ps doctors are.

I haven't seen the numbers in the Australian study or the reason for their turn around. I did listen to a doctor giving and getting calls with a lot of misinformation about the mode of transmission of H1N1, on talk radio. He has an amazingly high consistent listener base, and yesterday he was questioning the political pressure involved in decisions about the credibility of some research, and refusal to give credence to others. It seems medical opinion is not involved in final decisions about medical research......

The use of masks for surgical staff performing surgery has been called a "ritual", promoting a false sense of security, and decades ago, studies showed that post surgical infection rates were unchanged, whether or not masks were worn. I don't know the number of cases involved any more, but I have been taught that where research is concerned the higher "n" is the better, and "double blind" is best. It may be presumed that anyone feeling the urge to cough while doing surgery without a mask, would be more likely to step back, turn away, or stifle it.

One wonders why so much money goes for research, the results of which get lost as it were, on the "cutting room" floor, by politicians who have limited background in biochemical research.

Certainly the sudden release for use of GlaxoSmith Kline's H1N1 vaccine yesterday had no good explanation for the delay in allowing it to be used, other than the money that went to other companies who were unable to keep up with their contracted amount of vaccine, yet were given time to get whatever they had could muster going, while Glaxo's 11,000,000 doses languished in a holding fridge......

So do ask your representatives in government, what priorities they set for keeping up with the demand for vaccine, which I think had to do with the release of GlaxoSmithKline' products. It was getting very uncomfortable for those on the "hot seat" to continue that stand. It sure makes you wonder who's in charge there at the FDA!