Add the threat of a pandemic, such as with the 2009-2010 H1N1 influenza virus, and caregivers need to step up their battle gear. The CDC recommends in its revised Interim Guidance for H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel,² that healthcare workers who are in close contact with patients suspected or confirmed to have 2009 H1N1 influenza should wear a fit-tested, disposable N95 respirator; contrary to CDC’s isolation precautions which recommend the use of disposable surgical masks when caring for patients with seasonal influenza.¹

P2 cabinets and stations from TIDI Products

As hospitals and their suppliers struggled to meet demands for the more expensive N95 respirators in the wake of rising H1N1 deaths, questions began to emerge as to whether surgical masks could be substituted in first line use for routine H1N1 patient care.

In a letter to President Obama³ following the release of CDC’s Interim Guidance, leading scientific groups SHEA, APIC and ISDA, highlighted studies that proved no significant benefit to using N95 masks over surgical masks in preventing influenza transmission. The letter urged the Obama Administration to modify the federal PPE guidance as well as asked for a moratorium on the enforcement of OSHA’s requirement for healthcare facilities regarding the use of N95 respirators in relation to H1N1.

Featuring a playful design, DeRoyal’s Cosmic Nee-Noggs face shields can be worn by caregivers to help children feel more comfortable and less frightened.

While CDC did not make any changes to its revised Interim Guidance, it did respond with a series of Q&A documents^4,5 that addressed the new scientific evidence, at the same time reaffirming the need for respirators for close contact (within 6 ft.) of patients with known or suspected H1N1 and high-risk procedures, and also provided options for when supplies are short.

High-risk procedures include those that are aerosol-generating or that could increase inhalation of respiratory droplets such as bronchoscopy, sputum induction, endotracheal intubation, open suctioning of airways, cardiopulmonary resuscitation, and autopsies, noted CDC.²

OSHA also responded, issuing a statement along with its Enforcement Procedures for High to Very High Occupational Exposure Risk to 2009 H1N1 Influenza⁶ that "OSHA inspectors will ensure that healthcare employers implement a hierarchy of controls, and encourage vaccination and other work practices recommended by the CDC. Where respirators are required to be used, the OSHA Respiratory Protection standard must be followed, including worker training and fit testing," noting that, "where respirators are not commercially available, an employer will be considered to be in compliance if the employer can show a good faith effort has been made to acquire respirators."

Precept Medical Products’ Lite-Weight Thumb Loop Isolation Gown

Premier healthcare alliance has a variety of H1N1 resources posted on its Safety Institute website (www.premierinc.com/quality-safety/tools-services/safety/)⁷ with links to CDC’s Interim Guidance and Q&A, OSHA’s revised enforcement policy and other helpful information.

Even as several suppliers reassured customers of their ability to supply respirators and other PPE needed to comply with federal guidelines – in late November 2009, CDC acknowledged that a shortage of respirators could be anticipated at least through January 2010.⁸

CDC recommends the following broad-spectrum approach to conserving supplies of N95 respirators:⁵

• Minimize the number of individuals who need to use respiratory protection through the use of engineering and administrative controls;

• Use alternatives to disposable N95 respirators where feasible;

• Extend the use, and consider reuse of disposable N95 respirators; and

• Prioritize the use of N95 respirators for those personnel at highest risk of exposure.

Kimberly-Clark FluidShield PFR95 N95 respirator singles

CDC noted that "other classes of disposable respirators (e.g. N99s, N100s), which are similar in design and shape to N95s, can be considered. Alternatives to disposable respirators, such as powered air purifying respirators (PAPRs), or elastomeric half-mask and full facepiece respirators, can also be considered. PAPRs have the advantages of being more protective than N-95 respirators and the hooded designs can be worn with facial hair and do not require fit testing. PAPRs can also be cleaned and disinfected for reuse as indicated by manufacturers’ instructions."²

CDC also noted that "...in the context of supply limitations during the current pandemic, non-fit-tested disposable N95 respirators can be considered for personnel at lower risk of exposure or lower risk of complications from influenza until fit testing can be completed. This use will provide protection from droplets and splatter, as would facemasks, but also will provide some additional protection against small particle aerosols."⁸

Judson Boothe, marketing director, medical supplies, Kimberly-Clark Health Care, Roswell, GA, commented, "The precise impact of any pandemic is always a subject of speculation. When a facility begins its preparation for such events there are a few areas, which can be overlooked. One key area is the management of PPE."

"In the event of a pandemic, the availability of necessary supplies can fluctuate dramatically as we have recently seen with the onset of H1N1," noted Boothe. "With regard to how much PPE is really needed, the CDC recommends stockpiling enough supplies for the duration of a pandemic wave, which is estimated to last between six to eight weeks.

"By being a vertically integrated company, Kimberly-Clark has direct control over the manufacturing of its PPE products as well as other products," he added. "This allows us to increase or decrease manufacturing levels to help meet market demand. Beginning in 2007, we increased our PPE manufacturing capacity. This increased capacity allowed us to place more than 365 million facemasks and 1.9 billion gloves into the North American supply chain in response to the H1N1 pandemic this year."

GloveLock glove sealing tabs, from the Carpenter Group create a glove-to-garment seal with no adhesive-to-garment contact

According to Kaitlin Donohue, marketing manager, Tronex Company, which specializes in the manufacturing and distribution of disposable PPE, including garments (isolation gowns, lab coats, scrub suits, coveralls, bouffant and surgeon’s caps and shoe covers), masks and gloves, "our company prides itself with an order fulfillment rate in excess of 99%. Tronex has a proven inventory planning system that ensures consistent supply. When many suppliers were having trouble meeting demand, Tronex has been able to maintain a fulfillment rate of 99% for existing customers, while expending our business with good forecast and control.

Spectrum Surgical face shield with visor

"All Tronex factory partners have been with us for more than a decade," she continued. "We ensure that we understand our customers’ expectations and plan carefully with proper execution. Tronex is an Asian American owned company with a product category that is made in Asia. The cultural background, long-term experience in international logistics, understanding of global market conditions, and our operational excellence have enabled Tronex to ensure that we always have adequate supplies of PPE for all our customers."

"Recurring communication with our customers allows us to effectively forecast market needs," assured Jill Wells, medical marketing manager, TIDI Products LLC, Neenah, WI. Among TIDI’s line of P2 personal protection equipment are a variety of latex and non- latex gloves and impervious, SMS, and polycoated gowns.

Bullard’s EVA (Evolutionary Air) Powered air-purifying respirator

"The amount of PPE needed by facilities to protect their caregivers will obviously vary by staff size, number of patients and the level and severity of exposure within the community," said Boothe. "For this reason, facilities should take into account factors that would likely be present during a pandemic including increased number of employees and/or volunteers donning PPE, as well as a higher level of infection control precautions observed."

A portion of proceeds from the sale of Ansell’s Micro-Touch NitraFree exam gloves are donated to the Susan G. Komen for the Cure breast cancer foundation.

To help facilities determine how much PPE supplies they would need to stockpile, Kimberly-Clark developed the PPE Demand Analysis Tool. This dynamic analysis tool first begins with outputs from the CDC’s Flusurge.com program, which estimates hospital admissions. The tool then estimates outpatient visits utilizing the same planning assumptions. Combined with the facility’s current average PPE usage, this creates a baseline of information to estimate PPE usage rates per outpatient visit, per admission, per hospital bed and per employee, described Boothe.

Kimberly-Clark Health Care also recently launched the Protection Selection Tool, www.kcprotection
selection.com, an interactive website that assists medical personnel in purchasing PPE. The virtual healthcare model assists in selecting the most effective PPE by asking various questions concerning the procedure at hand and makes product recommendations.

"Facilities should take into consideration their available storage onsite," advised Boothe. "Depending on its size, a facility may want to work with a distributor partner or even look into renting a storage facility that provides quick access to supplies when needed. Also, facilities should consider a system to rotate inventory to ensure product is not expired when needed."

Vystar Corp. and Alatech Healthcare are introducing the first exam gloves made with Vytex Natural Rubber Latex (NRL), a natural raw material that contains virtually undetectable levels of the antigenic proteins that can cause an allergic response, while retaining and improving upon the desirable qualities of latex.

For point-of-use accessibility, Kimberly-Clark’s PPE Dispensing System provides easy, organized storage and makes it easier for hospital staff to comply with CDC PPE recommendations. Modular and portable, the unit’s ergonomic design features easy-to-follow icons demonstrate proper donning techniques. The Kimberly-Clark PPE Dispensing System also reduces contamination of PPE apparel by dispensing gloves and masks with a spring-assisted mechanism to eliminate the need to reach into the box, among other features.

P2 cabinets and stations from TIDI Products mount on walls, doors, and glass to provide convenient point-of-use access to PPE.

"Making sure that PPE is easily accessible to healthcare workers is a simple but important step to help ensure that caregivers properly don and doff between each and every patient," advised Boothe. "Make sure that your staff knows the proper order in donning as well as doffing PPE. Improper removal, for example, can lead to cross-contamination to other patients as well as healthcare workers. One way is to provide easy-to-read posters at the location where PPE is kept that demonstrate the order of donning and doffing PPE," he suggested, adding, "Ongoing education about proper donning and doffing procedures is essential and should be facilitated on a regular basis; for this reason, Kimberly-Clark offers educational courses and resources at no cost to facilities."

The Personnel Protection Flu Kit from Alcavis HDC includes hand Sanitizer, N95 masks, bleach wipes, gloves, thermometer and tissues.

Wells, TIDI, remarked, "It seems as though some healthcare workers are not always cognizant of the fact that PPE offers a variety of levels of protection for different tasks at hand. Emphasis needs to be placed on consistent and correct usage of PPE for complete protection. Hospitals' protocols and standards should be adhered to relative to consistent and correct usage of PPE so healthcare workers have the appropriate protection at all times. PPE should have point-of-use access to comply with industry guidelines."

One barrier to compliance, added Wells, is that wearing PPE "is sometimes viewed as an annoyance because it [can be] hot and/or uncomfortable." To help encourage appropriate and conscientious PPE use among healthcare workers, Wells recommends comprehensive education and training on hospital procedures and protocols as to why protection is critical, and how to use it.

Chemotherapy-tested synthetic exam gloves from Innovative Healthcare Corp.

References:

1. CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: www.cdc.gov/ncidod/dhqp/gl_isolation.html

2. CDC Interim Guidance for H1N1Influenza in Healthcare Settings, Including Protection of Healthcare Personnel, Oct. 14, 2009: www.cdc.gov/h1n1flu/
guidelines_infection_control.htm

3. November 5, 2009: www.idsociety.org/WorkArea/
DownloadAsset.aspx?id=15676

4. CDC Questions and Answers about CDC’s Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel, December 1, 2009: http://www.cdc.gov/h1n1flu/guidance/control_measures_qa.htm

5. CDC Questions and Answers Regarding Respiratory Protection For Preventing 2009 H1N1 Influenza Among Healthcare Personnel, December 9, 2009: http://www.cdc.gov/h1n1flu/guidelines_infection_control_qa.htm

6. OSHA Instruction, CPL-02-02-075 - Enforcement Procedures for High to Very High Occupational Exposure Risk to 2009 H1N1 Influenza, effective date Nov. 20, 2009: www.osha.gov/OshDoc/Directive_pdf/CPL_02_02-075.pdf

7. Premier Safety Institute, Novel A (H1N1) Influenza website, www.premierinc.com/quality-safety/tools-services/safety/topics/swine-flu/index-Influenza-A-H1N1.jsp