1 SARS – Clearing the Air Jerome J Schentag, PharmD University at Buffalo FailSafe Air Safety Systems Corp

2 SARS n Transmission: Person to Person via Aerosol droplets Health care workers have high rates of infection, especially ER, ICU, Procedures Up to 25% of SARS cases are HC workers Masks prevent transmission if worn continuously, and no hand to mouth contact…

3 SARS Inf Control- Points n Spread from infected patients to health care workers is a primary concern n Clearly, at least some Viral elements pass through or around surgical masks, N95 Masks and HEPA filters n Personal Negative Pressure units extract live virus from air and lower the inoculum. With UV light concomitantly, the virus extracted is completely eliminated.

4 Problem: Making Preparations for SARS’ Return n Vaccine Development n More N-95 Masks; protective clothing n Infected Patient Cohorting strategies n More Isolation Rooms ER Patients Clinical presentation non-specific –Personal Isolation for Unknown Respiratory Infections, immediately upon presentation.

5 Dual Approach to decontamination and containment Bedside and Mobile Isolation Systems Portable/Mobile Air Scrubbing Systems Model 07 Model 77

6 Model 07 and 77: Personal Isolation...Where You Need it

7 Technical Specifications n Air changes every six seconds (with each breath a patient takes) n Continuous Removal of all viral particles from air via HEPA/UV light n Greater than 100 feet per minute fume hood velocity at curtains (varying with opening during treatment) n Quiet Operation, soothing background white- noise for patient comfort n Cleaned Air is vented back into the room

9 Airborne Infection Control: Filtration Technology n Prefilter –Dust, Pollen, Smoke –Vapor n Filter –Fungi, Bacteria –HEPA > % reduction

10 Airborne Infection Control: UV Technology n Kills active and spore forms of microbial growth n UV on both sides of the HEPA filter n Cleans surfaces Cleans air

11 SARS Infection Control- Points n With personal Isolation Units: UV light on both sides of HEPA filters Air Changes at 700 CFM at every breath Cleaned Air is returned to the Room FDA equivalence 510K as Isolation Room –Unlike Isolation Rooms, the entire room is not contaminated when using these devices; All viral particles ejected by the patient are cleaned from the Room Air.

Negative Pressure rooms.. With current methods, the entire room is potentially contaminated by infectious droplets

13 SARS Infection Control - Points n Isolation Rooms: Problems Everything inside the room is contaminated by droplets and aerosols –Patient may take off mask, spreading droplets –Cleaning is labor intensive and must cover a large area Forces great reliance by Health Care Workers on protective gear. Venting to outside, vents live virus Filters without UV are contaminated with viral particles.

14 Comparisons with Negative Pressure Isolation Rooms n Major planning & construction efforts; esp. retrofitting n Cleaning and maintenance of a wide area during & between patients n Does not protect staff who must treat patient, unless patient always wears a mask n Requires complete protective gear for staff & visitors n Room costs for construction average $40,000 to $80,000 + n No external venting or construction required n Minimal cleaning protocol, 7000 hrs of continuous use on HEPA & UV lights n Confines virus to area inside the hood, protecting staff; covers a break in mask use. n Does not require protective gear to visit or enter room n FailSafe products average $3,500 to $29,500

15 Hospital wing or ER 77 Portable Isolation 07 Transportable Isolation

16 Problem: Procedures performed on SARS Patients n Intubation, bronchoscopy, airway manipulation, cleaning. n Use of O 2 via mask or T-tubes Humidified air expelled and surface is contaminated by droplets n Protection of Staff in a setting where mask on the patient does not address the source of contamination.

17 Personal Isolation during Procedures – CDC guidance Perform aerosol-generating procedures in an airborne isolation environment If the patient is in an airborne isolation room, perform the procedure in that environment. If an airborne isolation room is not available, the procedure should be performed in a private room, away from other patients. If possible, steps should be taken to increase air exchanges, create a negative pressure relative to the adjacent room or hallway, and avoid recirculation of the room air. If recirculation of air from such rooms is unavoidable, the air should be passed through a HEPA filter before recirculation as recommended for Mycobacterium tuberculosis.Mycobacterium tuberculosis Air cleaning devices such as portable HEPA filtration units may be used to further reduce the concentration of contaminants in the air. Doors should be kept closed except when entering or leaving the room, and entry and exit should be minimized during the procedure. Source:

18 SARS – Prevention vs Treatment n This device removes SARS and all other viruses from the air n It is not a treatment strategy (although it cannot be bad to reduce the airborne inoculum) n This is a device to lessen spread of SARS to other patients or to Medical Staff. A containment system

19 Air/Surface Purification Pre-Filter [Dust & Vapor] HEPA [99.97% >0.1micron] 700 to 2000 CFM UV irradiation OZONE oxidation

20 Problem: Decontamination in SARS environments n Units and rooms (including isolation areas) are surface contaminated with viral particles, some of which appear to remain infectious after hrs n Need coverage for inevitable breaks in infection control or failures of masks n Example: contaminated waiting room..

21 Integrated Technology Dust Vapor * Fungus Bacteria Virus Odor * Dust Vapor * Fungus Bacteria Virus Odor * PF F UVGI OZONE

22 Problem: Dealing with large numbers of Infected Patients.. n Not every patient needs personal isolation if there are many patients with the disease confined to an area. n It is necessary to protect HCWs and the other patients in settings of large numbers of SARS cases n Solution is an isolation wing or facility..

23 Fast setup of an isolation area for patients.. Pre-Filter [Dust & Vapor] HEPA [99.97% >0.1micron] 700 to 2000 CFM UV irradiation OZONE oxidation

24 ‘HOT’ Shelter 60 x 80 x 10 Tent

25 Hospital Wing Stk Rm HOT COLD Negative Pressure Room Positive Pressure Room

26 Travel - related SARS n Medical need – Bioterrorism,TB, Airborne Disease, SARS, and spreading during flu season A detained American Airlines jet sits on the tarmac in a cargo area of San Jose International Airport. (AP) First Line of defense is a mask on the suspect patient. Top-of-the-line defense is currently a negative pressure room.

27 Problem: Airplane landing with several febrile patients.. n Remove infected patients (07 transport Units) and admit them under continuous isolation (model 77 Units) n Manage these patients in ICU or ward under personal isolation units n FASS units to decontaminate the airplane with ozone

28 Summary  Cost effective, proactive solution for hospitals and other healthcare facilities to prevent the spread of airborne infectious diseases  Dual Use Technology (infection control and bio- terrorism); Airborne pathogens in general  Proven technologies – HEPA, UV and Ozone  Several Patents; FDA approval in USA  Equipment available in US, Canada, and (before end of 2003) in China