Medizone Intl. (fka MZEIQ)

[Tane61]

The Marshall's "aggregate accrued and unpaid wages" - $1,506,772


Interesting exit timing for Edwin G.Marshall...


1) The U.S. EPA refused to regulate the MZEI ozone generating device...

...So MZEI is now touting their device as pesticide "application equipment" which the U.S. EPA DOES NOT REGULATE


MZEI (Aug 25, 2016)

...Medizone is now able to market & sell AsepticSure as an applicator in the US effective immediately

What is a Pesticide Device?

Pesticides are commonly thought of as chemicals. But we also have a role in regulating devices used to control pests. How a device might be regulated, however, depends on the device's specific design and function and whether it is used with a pesticide. A pesticide device is:

An instrument or contrivance (other than a firearm) that is used to destroy, repel, trap or mitigate (lessen the severity of) any pest such as insects, weeds, rodents, certain other animals, birds, mold/mildew, bacteria and viruses.

Note: Medical instruments or machines used to kill pests in or on living humans or animals are regulated by the Food and Drug Administration.

The Differences between Pesticide Devices and Pesticide Products and How They Are Regulated

Key differences between pest control devices, pesticide products and certain combinations can be summarized as follows:

Pesticide Product - contains a substance or mixture of substances that is intended to destroy, repel, prevent or mitigate (lessen the severity of) a pest. This includes substances that attract pests to lessen their impact, for example by attracting pests to a trap.

How Regulated: Must be registered unless it qualifies for an exemption.

Pesticide Device - works by physical means (such as electricity, light or mechanics) and does not contain a substance or mixture of substances to perform its intended pesticidal purpose.

How Regulated: We do not require registration for these. However, these devices are regulated in that “false or misleading claims” cannot be made about the effectiveness of devices. If a manufacturer is making claims about a device, they should have scientific data to back up the claims.
Some devices are not regulated. For example, any device that depends more upon the performance of the user than the performance of the device itself to be effective (such as a fly swatter) is not regulated. Also, traps for vertebrate animals are not regulated.

Combination - If an instrument, contrivance or appliance incorporates a substance or mixture of substances to perform its intended pesticidal purpose, then it is considered to be a pesticide product.

How Regulated: Must be registered unless it qualifies for an exemption.

Note: Pesticide application equipment that is sold separately from the pesticide itself is not a device or a pesticide. For example, a sprayer for a lawn herbicide that is sold separately from the herbicide is considered to be application equipment, which we do not regulate.

https://www.epa.gov/safepestcontrol/pesticide-devices-guide-consumers

----------

2) MEDIZONE FINALLY ADMITS OZONE CAN DAMAGE HOSPITAL EQUIPMENT

US EPA, Pesticide Product Label (excerpts)

Ozone can be corrosive. Repeated use of the AsepticSure TM Disinfection System can over time cause minor corrosive damage to ozone-sensitive materials or equipment. Ensure where possible that all such materials are removed from the environment before beginning an AsepticSure Disinfection Cycle (see Table 3).

WARNING: Because the gas formula is highly oxidative, care must be taken that the room to be disinfected be appropriate and compatible. Any sensitive equipment that may be adversely affected by ozone or hydrogen peroxide should be removed from the room prior to the start of a disinfection cycle.

Contraindications and Material Compatibility
WARNING: Ozone can be corrosive and is poisonous in high quantities.
Hydrogen peroxide at high concentrations can be corrosive.

Root Cause Investigation of Rubber Seal Cracking in Pre-filled Cartridges: Ozone and Packaging Effects.

LAY ABSTRACT: Pre-filled syringes/cartridges as primary packaging for parenterally delivered biopharmaceutical liquids contain multiple components, including a disk seal (septum) made of rubber materials. Cracking of rubber components may be cosmetically unacceptable and in extreme cases may compromise enclosure integrity. The septum, if not appropriately packaged, might crack under uncontrolled storage environment. The purpose of this study was to investigate the root cause of septum cracking and evaluate parameters/solutions to delay or prevent cracking from occurring. Custom-made chambers capable of tightly controlling ozone levels were assembled to deliberately create septum cracks. The results confirmed that ozone attack is the root cause of septum cracking during storage, and the stress-the result of crimping on the glass cartridge by the aluminum lined seal-made the septum particularly vulnerable to ozone attack. Ozone concentration as low as 10-40 ppb (levels routinely detected on a busy street) could crack the stressed septum in hours. [MZEI: Ozone concentration as high as 80000 ppb] Although the use of impermeable barriers could prevent cracking completely, this study suggested that any form of packaging barriers, including a highly permeable Tyvek® sheet, could postpone cracking by slowing down ozone diffusion and convection. This investigation will raise awareness of manufacturers of pre-filled cartridge/syringe parenteral products to storage and packaging requirements for the long-term physical stability of cartridge components as small as the rubber septum.

http://www.ncbi.nlm.nih.gov/pubmed/22293834


Understanding the link between ozone and rubber deterioration

One example where we commonly see failure of design is in medical devices. During initial testing, the parts may work fine. In field testing, however, there may be failures because the O-ring is exposed to ozone, which causes a degree of deterioration that leads to failure. At times, design engineers can even see this process act out even if they simply let the medical device sit on their office desk for an extended time.

www.applerubber.com/hot-topics-for-engineers/understanding-the-link-between-ozone-and-rubber-deterioration/

MZEI Canadian Distributors

Wood Wyant:

To prepare the room begin by removing all waste material, bedding, clothes and Optical Equipment...

Contamination Control Corporation:

All plastic and rubberized materials must be OZONE RESISTANT

----------

3) January 28, 2011

Joan Harrigan-Farrelly
Director
Antimicrobial Division
Office of Pesticide Programs
U.S Environment Protection Agency

Dear Ms. Harrigan-Farrelly:

On behalf of the Association for Professionals in Infection Prevention (APIC), the Society for Healthcare Epidemiology of America (SHEA) and the Association for the Healthcare Environment (AHE) formerly ASHES, we welcome the opportunity to comment on the topic of fogging applications for disinfectants. The issues are very pertinent to our organizations and we are responding collectively to reinforce our close agreement on mutual concerns, especially worker safety.....When used properly, HP also likely offers a greater margin of safety compared to other chemicals that can also be applied by vapor such as chlorine dioxide or ozone.(Davies A, 2011, in press JHI)

7. Are there any active ingredients that may be problematic for your facility as foggers?

Ingredients that affect OSHA exposure limits that may affect workers, especially agents such as formaldehyde or phenol-based agents, would be a concern. The latter were chemicals that stimulated investigation and ultimately specific recommendations against their use by CDC. Other chemicals such as chlorine dioxide and ozone also have many documented safety issues that would preclude their use in healthcare facilities.(Davies,JHI2011)

----------

Medizone International Announces Hospital Sterilization Initiative

10/01/2008 @ 8:35AM

PR Newswire (US)

"Mr. Edwin Marshall, Chairman and CEO of Medizone International stated, "With Dr. Shannon's leadership in this exciting new initiative, we anticipate being fully commercialized within 18 months."

-----

TO DATE, NOT ONE (1) SALE TO A HOSPITAL NOR ONE (1) HOSPITAL SERVICE CONTRACT HAS BEEN REPORTED, WORLDWIDE (The manufacture of the first production machine was announced back in April 2012)