All Newsletters

VESTAGEN is a company worth taking a look at this year.  This Orlando Company has developed a new technology designed to help combat Hospital-Acquired Infections. 

Dec. 7, 2009 - Vestagen Technical Textiles announced its entry into the advanced performance textile arena with the introduction of the first of a new class of Nanotechnology-Based Healthcare Specialty Textiles.  The Orlando-based company will provide apparel and textile products for use in environments where biological contamination of clothing can occur.  Vestex, designed exclusively for the healthcare market, made its debut at the Institute for Healthcare Improvement’s 2009 National Forum.

Vestagen holds exclusive North American license to three patented Swiss technologies.  For the first time, these technologies have been blended to create a unique combination that can be applied to any single layer of fabric.  Vestex personal and professional wear repels fluids; has documented and registered antimicrobial properties impregnated in the clothing to resist contamination; rapidly kills microbes; is highly durable; minimizes odor and is naturally self cleaning.

“Infections are becoming more widespread in our society, and nowhere is that more evident than in our nation’s hospitals,” said Richard P. Wenzel, M.D., professor and former chairman of the Department of Internal Medicine at Virgina Commonwealth University Medical Center.  “This innovative nanotechnology-based textile may prove to be an important component in a hospital’s infection control efforts.”

According to the Centers for Disease Control and Prevention (CDC), health care-associated infections (HAIs) affect two million patients and claim nearly 100,000 lives each year.  With a per-patient cost of $15,000, these dangerous and preventable infections add approximately $30 billion annually to our nation’s health care tab.

“There is a clear and urgent need for our technology in America’s hospitals,” said Ben Favret, founder and CEO of Vestagen.  “It is well documented that medical textiles can become contaminated with dangerous pathogens, including the bacterium Methicillin Resistant Staphylococcus aureus (MRSA).”

In recent months, the issue of HAIs has come to the forefront of the health care debate.  In October, the U.S. Department of Helath & Human Services announced the award of $17 million to fund projects to fight HAIs.  The CDC and other government agencies has also called for more resources to focus on reducing and eliminating infections, one of the most common complications of hospital care.  Simultaneously, the American Medical Association is debating the future of doctors’ white coats, which have been criticized for unwittingly spreading infectous bacteria to patients.

“Vestagen is committed to providing advanced, antimicrobial, nanotechnology-based helathcare specialty textile products for our nation’s health care workers,” said Favret.  “We intend for Vestex, which combines protection, quality and comfort with traditional, identifiable styles of medical wear, to set a new technical standard for health care worker uniforms.”

The first line of Vestex apparel will include scrub pants and tops in a variety of colors, long sleeved T-shirts and lab coats.  They will be available in limited quantities this fall with a national roll-out in spring 2010.

About Vestagen Technical Textiles LLC

Vestagen Technical Textiles is an Orlando-based marketer and manufacturer of advanced performance textiles.  Vestagen is led by a skilled management team with nearly a century of combined experience in the health care, textile and apparel industries.  Backed by V-Ten Capital Partners, Vestagen is committed to creating innovative textile solutions.  For more information, visit www.vestagen.com

1. The cleared SS1’s circulation pump was a [redacted] pump. In 1999, the pump was changed to [redacted] pump. According to internal Steris documents, the original circulation pump failed for low flow performance and seal leakage that resulted in decreased SS1 reliability and consumer complaints. The change to [redacted] pump altered the flow rate, the now characteristics, and the flow through the lumen of the device. These changes significantly impact the function and delivery of the sterilant to and through an instrument.

2. The cleared SS1’s high pressure pump was an [redacted] pressure pump with a flow rate of [redacted]. In 1992, you developed a new model SS1, Model 90. This new model had a [redacted] high pressure pump with a flow rate of [redacted]. In 1995, as a result of consumer complaints of the Model 89 series high pressure pump leaking, your firm began installing pressure switches in the pumps to monitor the function of the high pressure pump. In 1998, your firm developed an “HP Pump Enhancement Kit,” and in 1999, began replacing the [redacted] high pressure pumps in the Model 89A1 and 90B1 series with the new [redacted] high pressure pumps. The changes to the high pressure pump altered the flow rate and flow characteristics in the SSI and through the lumen of the device. Therefore, these pump changes significantly impact the function and delivery of the sterilant to and through the device being processed.

3. In December 1996, your finn made changes to the original software used in the device as cleared in 1989, in response to reports that customers were receiving high pressure pump alarms due to low facility water pressure. In response, you changed the software program to limit the operation of the high pressure pump to the sterilant exposure phase and the final drain. Because of this software change, the high pressure pump no longer runs during the final rinse phase. This action may affect removal of chemical residues from the processed devices and may pose a risk to the patient.

4. On August 19, 2002, your firm sent correspondence to all of your customers stating that it had changed the connector design on the Quick Connect Kits from individual components to one unit, in which all of the components are tethered together. The design change was initiated following microbiological testing failures related to the older, individual-component connectors. Additionally, new connectors were developed to facilitate the adaptation of the flow unit to the instrument to be processed. These changes to the connectors have a significant effect on the sterile fluid pathway and delivery of the sterilant.

5. The cleared SSI’s chamber volume was [redacted] After 510(k) clearance, your firm increased the chamber volume to [redacted] and then to [redacted] Along with this large increase in the chamber volume, the Sterilant 20 formulation was altered, with the intent of maintaining the final peracetic acid (PAA) concentration given the larger chamber volume. This large increase in chamber volume, which apparently also prompted a change in sterilant formulation, could significantly affect the ability of the system to sterilize by altering how sterilant is delivered and the concentration of ingredients in the sterilant.

6. Following the clearance of the 510(k), your firm added five additional [redacted] ingredients [redacted] and [redacted] to the formulation of the Sterilant 20. This change to the sterilant formulation could significantly affect safety or effectiveness of the device, specifically, the effectiveness of the active ingredient and its ability to sterilize, and by altering the stability of the sterilant.

FDA held a teleconference today at 1pm ET regarding the current issue with the Steris System 1 Processor used by many hospitals and endoscopy centers.  See yesterdays posting at InCo and Associates to view the recent letter sent to healthcare providers from the FDA.

If you are having problems coming up with an alternative call 808-282-5738 and we will help you come up with a solution.

The moderator for the teleconference call today was Theres A Toigo RPh, MBA from the office of Special Health Issues at the FDA.  The speaker was Timothy A. Ulatowski the Director, Office of Compliance from the Center for Devices and Radiological Health (CDRH).  You may listen to the call until January 6, 2010 by calling toll-free 866-421-5878.  For international callers call 1-203-369-0811.

The conference call began today at 1:12 PM EST.  More than 1000 people registered for todays calls.  The Q&A document will be updated on the FDA website.  There will be a transcript from this call on the FDA website in about a week.  FDA has posted three major documents that facilities should obtain fromt he FDA website related to the need to change product and/or the need to notifiy patients.

Early next week the FDA will issue more information to assist healthcare providers to come up with alternatives.  FDA notified Steris that they made change to the SS1 that could alter the safety of the Steris System 1.  These changes caused the system to not be FDA approved.  Steris stopped selling the Steris System 1.  There is a question on whether they notified the facilities of this issue.  Steris was supposed to be working with clients to transition to an approved product.  FDA has found that Steris was not doing this. FDA cannot assure that the Steris System 1 is safe to use for users or assure that the system is providing sterilization/disinfected.

The FDA notice applies to all Steris System 1 Processors, all models, all machines.  The FDA is asking for voluntary compliance with coming up with alternatives for patient safety.  This should be done immediatly.   FDA expects some facilities will continue using the Steris systems until they can come up with an alternative and provide proper staff training.  Do not interrupt providing diagnotic testing on patients.  FDA believes healthcare facilities should be able to come up with an alternation with the next 3 to 6 months.  FDA wants to be told of any obsticules to comply with this transition so they can assist individual healthcare facilities and healthcare associations.  This is not an opened timeline the FDA expects all facilities to transition to a safe alternative.

In the meantime it is important that all facilities utilize the biologicals required for the Steris System 1 Processor to assure everything is processed as well as possible.  But there is no assurance that this system is processing the instrutments safely for use on patients.

FDA encourages facilities to asked the alternative companies to show them the FDA approval letter and ask them if they have made any alterations to the system/product since they received the FDA approval.

FDA will post additional information early next week that list approved products that can be used as alteratives.  The FDA will assist healthcare facilities to come up with an alternative.

Many items are placed in the Steris System 1.  Identify what you are processing and check the manufacturers label on how each item is to be processed and decide what product(s) you will need to purchase for each item.  If the manufacturers label is not clear facilities are asked to call the manufacturer for assistance.  If the manufacturer cannot assist you call the FDA for assistance.

At this point this is not a recall of the Steris System 1.  The FDA is asking healthcare facilities to voluntarily comply with this transition and is giving healthcare facilities 3-6 months to transition.

How to communication with patients who have questions.  Check the FDA Q&A section.  There is no need to contact patients who have already been treated.

InCo and Associates Note:

It is important that if facilities are going to manual cleaning until an alternative is found that all employees should be trained extensively and monitored for following all procedures to prevent transmission of infections to multiple patients and/or the build up of biofilm on the instrutments which would lead to the disposal of the instrutments.  Manual cleaning is not the best option.

Back to Conference Call:

For physicians who do endoscopies the FDA does not recommend the interruption of performing procedures but to go to alternatives as soon as possible.

Is there compensation from Steris to healthcare facilities?  The FDA does not know and cannot respond to this question.

Important weblinks: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048303.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm

Questions can also be directed to Candace McManus, DrPH by email at candace.mcmanus@fda.hhs.gov or by telephone message at 1-877-260-3731

FDA Notice: Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations

Issued: December 3, 2009

Dear Healthcare Facility Administrator and Infection Control Practitioner:

The Food and Drug Administration (FDA) is providing this notice to inform you of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) and actions that you should take if you have this medical device in your facility. The SS1 is typically used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices.

STERIS Corporation (STERIS) has significantly modified the SS1, and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.

FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. Infections that occur after a procedure using a medical device reprocessed in the SS1 may be difficult to attribute to the SS1 and may go unreported. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device.

On May 15, 2008, FDA issued a Warning Letter advising STERIS that its changes to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (see http://www.fda.gov/ICECI/ EnforcementActions/WarningLetters/ 2008/ucm1048303.htm).As FDA stated in the Warning Letter, the changes made to the SS1 could significantly affect the safety or effectiveness of the device.

In response, STERIS stated that it would work with its customers to transition them to legally‑marketed replacements for the SS1. On January 20, 2009, STERIS advised its customers of this commitment and the steps that it would take to respond to FDA’s concerns. However, based on a recent inspection of STERIS and meetings with the firm, FDA is not satisfied that the firm has been working effectively to transition its customers to replacements for the SS1. FDA is therefore sending this letter to make recommendations on actions that you should take.

FDA Recommendations

If you have an acceptable alternative to the SS1 to meet your sterilization and disinfection needs, you should transition to that alternative as soon as possible to ensure continued patient safety. If you do not have an acceptable alternative to the SS1, you should promptly assess your facility’s patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.

For additional information, including information on FDA cleared or approved medical devices, see the “Questions and Answers” document on the FDA web site.

Please note that user facilities, including hospitals, are required to report suspected device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown (see http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequirements/ ReportingAdverseEvents/default.htm ). Also, FDA solicits voluntary reports of adverse events from healthcare professionals (see http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm ).

Contacting FDA

Answers to many of your questions are contained in FDA’s “Questions and Answers” document. In addition, FDA will host a call during the week of December 7 for healthcare facilities using the SS1. Healthcare facilities that wish to participate in this call should contact Heidi Marchand, Office of Special Health Issues, by phone at 301-827-4460 or by email at heidi.marchand@fda.hhs.gov. These facilities may also send an email to the NewsHealthCareProfs@fda.hhs.gov. E-mails and voice-mail messages should include the name of the healthcare facility, a point of contact at the facility, and a contact phone number and E-mail address.

Questions can also be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, by email at candace.mcmanus@fda.hhs.gov, or by telephone message at 1-877-260-3731.

Sincerely,

Timothy A. Ulatowski
Director, Office of Compliance
Center for Devices and
Radiological Health
Food and Drug Administration

China must be alert to any mutation of changes in the H1N1 swine flu virus because the deadlier H5N1 bird flu (avium flu) virus is endemic in the country. WHO warned on Tuesday that H5N1 had erupted in pultry in Egypt, Indonesia, Thailand and Vietname, posing once again a threat to humans.  The most obvious ris is that H5N1 will combine with the pandemic (H1N1) virus, producing a flu virus that is as deadly as the former and as contagious as the latter.

Cover-ups by local Chinese goverment officials in 2003 during the SARS epidemic led to the dismissal of serval officials.  More than 300 people died in that outbreak.

China, the world’s most populous country, has reported around 70,000 cases of H1N1 and 53 death from the virus.

WHO reported more than 526,060 laboratory confirmed cases of H1N1 worldwide on November 15, with at least 6,770 dealths. WHO  has stressed for months that this is only the tip of the iceberg.

CDC warns about rise in serious pneumococcal disease. CDC said today that is is seeing a spike in serious pneumococcal disease, particularly in younger patients.  Anne Schuchat, MD, DIrector of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters that the CDC is seeing an increasing number of invasive pneumococcal disease cases around the country, but the numbers were particularly high in Denver at a time when pandemic H1N1 activity was peaking in the area. 

Health officials expect to see more pneumococcal disease when seasonal flu circulates, but the infections typically strike people who are older than 65.  In past pandemics secondary bacterial pneumonia infections particularly those involving Streptococcus pneumoniae, frequently contributed to illness and death.

This rise in pneumococcal disease is a stark reminder for high-risk groups to get the pneumococcal vaccine.  According to the CDC only about 25% of adults in high-risk groups who are younger than age 65 have received the vaccine.  CDC recently added people with asthma and smokers to the list of those who should receive the pneumococcal vaccine.

 Authority

Section 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain regulatory requirements for healthcare facilities in response to emergencies.  Two conditions must be met for the Secretary to be able to issue such “1135 waivers”:  first, the Secretary must have declared a Public Health Emergency; second, the President must have declared a National Emergency either through a Stafford Act Declaration or National Emergencies act Declaration.  If these conditions are met, then healthcare facilities may petition for 1135 waivers in response to particular needs, and only within the geographic and temporal limits of the emergency declarations.

Under Section 1135:

The Secretary may tailor authorities granted under Section 1135 waivers to match the specific situational needs, but the requirements that may be waived include those related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Active Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA).  These requirements provide important protections for patients during normal day-to-day operations, but they may impede the ability of healthcare facilities to fully implement disaster operations plans that enable appropriate care during emergencies.  For example, requirements under the Emergency Medical Treatment and Active Labor Act (EMTALA) would prohibit hospitals from certain rapid triage or sorting activities and prevent the establishment of off-site, alternate care facilities that could off-load emergency department demand.

• Waivers are permitted only to the extent they ensure that sufficient health care items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries in the emergency area during the emergency period.  The “emergency area” and the “emergency period” are the geographic area, in which, and the time period, during which, the dual declarations exist. 
• Permitted actions include the waiver or modification of conditions of participation, other certification requirements, program participation requirements, pre-approval requirements for health care providers; waiver of sanctions for certain directions or relocations and transfers that otherwise would violate the Emergency Medical Treatment and Labor Act (EMTALA); waiver of sanctions related to Stark self-referral prohibitions; modifications to deadlines and timetables for the performance of required activities; and waiver of sanctions and penalties arising from noncompliance with certain Health Insurance Portability and Accountability Act (HIPAA) privacy regulations.

Examples of use of waivers:

• Hospitals request to set up an alternative screening location for patients away from the hospital’s main campus (requiring waiver of the Emergency Medical Treatment and Labor Act-EMTALA)
• Hospitals request to facilitate transfer of patients between ERs and inpatient wards between hospitals (requiring waiver of both EMTALA and HIPAA regulations)
• Critical Access Hospitals requesting waiver of 42 CFR 485.620, which requires a 25-bed limit and average patient stays less than 96 hours
• Skilled Nursing Facilities requesting a waiver of 42 CFR 483.5, which requires CMS approval prior to increasing the number of certified beds in a distinct part

Past instances where authority to grant Section 1135 waivers was enabled for recent disaster events include

• Hurricane Katrina (2005)
• 56th Presidential Inauguration (2009)
• Hurricanes Ike and Gustav (2008)
• North Dakota flooding (2009)

Q:  Why do this now; why can’t we wait until a hospital or region needs these 1135 Waivers?

            A:  The H1N1 epidemic is moving rapidly.  By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly.  1135 Waivers still require specific requests be submitted to HHS and processed, and some State laws may need to be addressed as well.  Adding a potential delay while waiting for a National Emergency Declaration is not in the best interest of the public, particularly if this step can be done proactively as the President has done today. 

Q:  Has the authority to grant 1135 waivers been granted before?

            A:  Yes, there are several instances where 1135 Waiver authority has been granted under the Stafford Disaster Relief and Emergency Assistance Act (vice National Emergencies Act) to help healthcare facilities cope with large patient burdens.  Recent examples include Hurricane Katrina (2005), Hurricanes Ike and Gustav (2008), and the North Dakota flooding (2009).  In addition, 1135 waiver authority has been granted previously as a precautionary measure, as in the case of the recent 56th Presidential Inauguration (2009).

Q:  Specifically, what will this NEA Declaration enable and what will this allow hospitals to do, if a waiver is requested and granted?

            A:  An NEA Declaration fulfills the second of the two conditions required for the Secretary of HHS to be able to grant 1135 waivers.  If requested, and HHS grants an 1135 waiver, healthcare facilities will be able to utilize alternate care sites, modified patient triage protocols, patient transfer procedures, and other actions that occur when they fully implement disaster operations plans.

Q:  Is the HIPAA Privacy Rule suspended during a national or public health emergency?

            A (from the HHS Office for Civil Rights website):  No; however, the Secretary of HHS may waive certain provisions of the Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.

What provisions may be waived

If the President declares an emergency or disaster and the Secretary declares a public health emergency, the Secretary may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule:

1. the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care (45 CFR 164.510(b))
2. the requirement to honor a request to opt out of the facility directory (45 CFR 164.510(a))
3. the requirement to distribute a notice of privacy practices (45 CFR 164.520)
4. the patient’s right to request privacy restrictions (45 CFR 164.522(a))
5. the patient’s right to request confidential communications (45 CFR 164.522(b))

When and to what entities does the waiver apply

If the Secretary issues such a waiver, it only applies:

   1. In the emergency area and for the emergency period identified in the public health emergency declaration.

   2. To hospitals that have instituted a disaster protocol.  The waiver would apply to all patients at such hospitals.

   3. For up to 72 hours from the time the hospital implements its disaster protocol.

When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol. 

Regardless of the activation of an emergency waiver, the HIPAA Privacy Rule permits disclosures for treatment purposes and certain disclosures to disaster relief organizations. For instance, the Privacy Rule allows covered entities to share patient information with the American Red Cross so it can notify family members of the patient’s location.  See 45 CFR 164.510(b)(4).

Learn More:  * See http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/katrinanhipaa.pdf for information on sharing information in emergency situations.

The U.S. has ordered 27.3 million more doses of  H1N1 Vaccine from Sanofi Pasteur, this brings the total government order of Sanofi vaccine to 75.3 million doses.  Sanofi said today that they will begin delivering pandemic H1N1 flu vaccine to the US by mid October.

Margaret Chan, director of WHO say that the overall clinical picutre of the pandemic H1N1 virus is reassuring, but health officials are concerned that a small group of paitents could  rapidly become severely ill.  These patients could overwhelm the intensive care units as the flu spreads.  She said the secon wave of the pandemic appears to be beginning.

The earliest results from testing of a pandemic H1N1 vaccine in children suggest that older children will get a good immune response with a single dose, but children younger than 10 may need two doses a few weeks apart.

More than 80% of workers feel pressure to come to work when sick, and 69% have received little direction from employers on pandemic H1N1, according to a survery released today.  The poll of 1,028 employees by Mansfield Communications found that 84% of workers believe the recession creates more pressure to show up to work sick.  Mansfield’s Rob Ireland said that employers need to communicate clearly about extended sick-leave policies and how to minimize disease spread.

Pandemic influenza refers to a global disease outbreak.  A flu pandemic occurs when a new influenza type A virus emerges for which people have little or no immunity, and for which there is no vaccine.  The disease spreads easily person-to-person, causes serious illness, and can sweep across the country and around the world in a very short time.  Such a virus is likely to have origins from avian viruses or possibly from other animal sources (e.g., pigs).  In the case of the current pandemic influenza found normally in pigs is causing illness in humans.  This virus is known as Novel H1N1 (swine flu).  Currently, the World Health Organization has elevated the Pandemic Level to Level 6.  This is the highest level for any Pandemic.

CLINICAL BACKGROUND INFORMATION

Historically, influenza has caused outbreaks of respiratory illness for centuries, including three pandemics in the 20^th century.  There are three types of influenza viruses: type A, B and C.  Only type A influenza viruses cause pandemics.  Seasonal influenza outbreaks can be caused by either type A or type B influenza viruses.  Influenza type C viruses cause mild illness in humans but do not cause epidemics or pandemics.  This newsletter is aimed at protecting healthcare workers during the current pandemic; therefore, the focus will be on the characteristics of type A influenza viruses.

Of the three types of influenza viruses, only type A is divided into subtypes.  Three different subtypes (i.e., H1N1, H2N2, and H3N2) have caused pandemics in the 20^th century. 

Seasonal, avian, and H1N1 (swine flu) can occur in humans. 

It is important to understand the basics of these three types of influenza. 

Seasonal influenza refers to the periodic outbreaks of acute onset viral respiratory infection caused by circulating strains of human influenza A and B viruses.  Seasonal influenza generally occurs most frequently during the winter months.  Between 5-20 percent of the population may be infected annually.  Each year, a trivalent influenza vaccine is prepared in advance of the anticipated seasonal outbreak and it includes those strains (two types A and one type B) that are expected to be most likely to circulate in the upcoming “flu” season.  Influenza vaccine is currently targeted toward those at greatest risk of influenza-related complications and their contacts, such as healthcare workers.

Avian influenza (H5N1), also known as the bird flu, is caused by type A influenza viruses that infect wild birds and domestic poultry.  The highly pathogenic H5N1 is one of the few avian influenza viruses to have crossed the species barrier to infect humans, and it is the most deadly of those that have crossed the barrier.  Most cases of highly pathogenic H5N1 infection in humans have resulted from contact with infected poultry or surfaces contaminated with secretion/excretions from infected birds.  Because all influenza viruses have the ability to change, scientists are concerned that highly pathogenic H5N1 avian influenza virus one day could be able to sustain human-to-human transmission.

Novel Strain H1N1, also known as swine flu, is caused by type A influenza viruses that infect pigs.  Novel H1N1 (referred to as “swine flu” early on) is a new influenza virus causing illness in people. This new virus was first detected in people in the United States in April 2009. Other countries, including Mexico and Canada, have reported people sick with this new virus. This virus is spreading from person-to-person, probably in much the same way that regular seasonal influenza viruses spread.

Signs and Symptoms of H1N1 (swine flu)

The symptoms of novel H1N1 flu virus in people are similar to the symptoms of seasonal flu and include:

·         fever

·         cough

·         sore throat

·         runny or stuffy nose

·         body aches

·         headache

·         chills  

·         fatigue

 A significant number of people who have been infected with this virus also have reported diarrhea and vomiting.  Also, like seasonal flu, severe illnesses and death has occurred as a result of illness associated with this virus.

High-Risk Groups

A person who is at high-risk for complications of novel influenza (H1N1) virus infection is defined as the same for seasonal influenza at this time.

• Children younger than 5 years old.
• Adults 65 years of age and older
• Persons with the following conditions:
  • Chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological (including sickle cell disease), neurologic, neuromuscular, or metabolic disorders (including diabetes mellitus)
  • Immunosuppression, including that caused by medications or by HIV
  • Pregnant women
  • Persons younger than 19 years of age who are receiving long-term aspirin therapy
  • Residents of nursing homes and other chronic-care facilities.

Transmission of Influenza

Transmission of novel influenza A (H1N1) is being studied as part of the ongoing outbreak investigation, but limited data available indicate that this virus is likely transmitted in ways similar to other influenza viruses.  Seasonal human influenza viruses are thought to be transmitted between persons primarily through large-particle respiratory droplet transmission (e.g., when an infected person coughs or sneezes near a susceptible person).  Transmission via these large-particle droplets requires close contact between source and recipient persons because droplets do not remain suspended in the air and generally travel only a short distance (<6 feet).  Contact with contaminated surfaces is another possible source of transmission and transmission via small-droplet nuclei (also called “airborne” transmission) might also occur, but the contribution of these modes of transmission to influenza epidemiology is uncertain.  Because data on the transmission of novel H1N1 viruses are limited, the potential for ocular, conjunctival, or gastrointestinal infection is unknown.  Since this is a novel influenza A (h1N1) virus in humans, transmission from infected persons to close contacts might be common.  All respiratory secretions and bodily fluids (diarrheal stool) of novel influenza A (H2N2) cases should be considered potentially infectious.

Close contact, is defined as having cared for or lived with a person who is a confirmed, probable or suspected case of novel influenza A (H1N1), or having been in a setting where there was a high likelihood of contact with respiratory droplets and/or body fluids of such a person.  Examples of close contact include kissing or embracing, sharing eating or drinking utensils, physical examination, or any other contact between persons likely to result in exposure to respiratory droplets.  Close contact typically does not include activities such as walking by an infected person or sitting across from a symptomatic patient in a waiting room or office.

Trea 

CDC is currently investigating cases of respiratory illnesses in the states of California and Texas.  The individuals who have become ill are between the ages of 7 and 55.  63% of the cases are male.  Treatment for anyone suspected of having this illness (swine influenza) are oseltamivir and zanamivr.  Symptoms of the illness include cold symptoms, fatigue, loss of appetite and fever.  Individuals should see their physician to have a nasal culture tested for influenza and stay at home until symptoms have passed, usually 5-7 days.  Travel to the affected areas in Mexico is being discouraged.

16oo cases of swine flu reported in Mexico with 103 deaths.  Cases reported in the US include 7 in California, 2 in Kansas, 1 in Ohio, 8 in NYC (among a group of students who recently returned from Mexico), 2 in Texas.  Cases have also been reported in Canada, British Columbia, Nov Scotia, France, Spain, Scotland, and Israel.

Protecting yourself and your family:  Stay away from large groups of people.  Stay at least 6 feet away from individuals who have a respiratory tract infection.  Wear a mask if you have to be close to someone with a respiratory tract infection including someone who is living in your house.  If you are experiencing a fever greater than 100 try to get an influenza culture done and take antiviral medication within 48 hours of onset of symptoms.  Antivirals may not help if not started within 48 hour of onset of illness.

Person infected with the swine flu should be considered infectious up to 7 days after onset of symptoms.  People who are continue to be sick after 7 days should be considered infectious.  Especially children.