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World Hepatitis Day

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Are your Signs Accurate?

Since 2010, World Hepatitis Day is observed on July 28th. The goal is to raise awareness of hepatitis as well as the prevention and treatment of the disease. According to the World Health Organization (WHO), an estimated 1.34 million people died globally from this disease in 2015. In comparison, numbers that high match those caused by tuberculosis, malaria, and HIV/AIDS. According to the World Hepatitis Day website, “Currently, 90% of people living with hepatitis B and 80% living with hepatitis C are not aware of their status.” We all need to be educated. This is not a disease found in just one country or in one particular ethnicity. Here is the chance to educate ourselves. Check out the website dedicated to the even this year at http://www.worldhepatitisday.org/en/about-us

Hepatitis is the inflammation of liver tissue. It is most commonly caused by a virus and there are five main ones commonly referred to as Types A, B, C, D and E. Types A and E are usually short-term (acute) diseases. Types B, C, and D are likely to become chronic. Note that Type E is very dangerous for pregnant women.

Listed below are some key facts about each type of Hepatitis taken from the WHO website. For more information visit http://www.who.int/hepatitis/en/

Key Facts of Hepatitis Types

  • Type A – transmitted through ingestion of contaminated food and water or through direct contact Continue Reading…
Packaging Infectious Substances

Infectious Substances Packaging

What Are Infectious Substances?

Infectious Substances are defined as substances which are known or are reasonably expected to contain pathogens, or micro-organisms including bacteria, viruses, parasites, or fungi which can cause disease in humans or animals. Section 1.4 TDG, IATA 3.6.2.1.1. They are split up into two separate categories. Category A which is capable of causing permanent disability, life-threating or fatal disease in otherwise healthy humans or animals. Category A infectious substances are either assigned UN2814 or UN2900 and are class 6.2. IATA 3.6.2.2. Category B substances are any other infectious substances that do not meet the criteria for inclusion of Category A. They are assigned the UN number 3373.

Packaging Infectious Substances

For Category A substances, Infectous Substances Affecting Humans or Animals Only, strict performance criteria should be met on the packaging including drop testing, puncture testing, a pressure testing, and a stacking test. The configuring is often referred to as the triple packaging system. When packaging Category A substances, you must start out with a leak-proof primary receptacle. If the substances are shipped at room temperature or higher, these receptacles must be made of glass, metal, or plastic. The primary receptacles must then be placed into a leak-proof secondary packaging, either wrapped individually or separated to prevent any contact.

Both the primary and secondary packaging must be able to withstand an internal pressure of at least 95 kPa. If Continue Reading…

Toxic
The Zika Virus — Public Health Crisis and Regulatory Puzzle

Zika virus – the name itself sounds exotic and dangerous. It is believed to be a serious risk for pregnant women. And it’s due to arrive in North America. Just how great a danger is this virus, and how should research and medical facilities prepare for the regulatory burden?

First of all, Zika is not a new virus. It has been known since the 1950s in equatorial Africa and Asia, but only recently has it appeared to migrate to new territories, including South and Central America, the Caribbean and Mexico. It is primarily a mosquito-borne illness, transmitted by the Aedes genus of mosquitos. Possibly climate change has increased the populations of these mosquitos in the areas where Zika is spreading. Aedes mosquitos are found in some parts of the U.S., and although they are not currently believed to be in Canada, they may spread as the climate warms. Person-to-person transmission by body fluids is possible, but this would be relatively rare compared to the mosquito vector.

Zika is classed in the Flaviviridae family of viruses, along with dengue fever, West Nile virus and the notoriously dangerous yellow fever. However, compared to these, Zika is usually a mild affliction. According to the Centers for Disease Control (CDC), only one in five persons infected with the virus shows any symptoms at all. For those who do fall ill, the symptoms Continue Reading…

Ebola Outbreak Puts Stress on Shippers of Infectious Substances

The headlines are frightening – Ebola virus, one of the most deadly viruses known, has broken out in several African countries. Medical authorities are concerned that it could spread beyond that region, carried by travellers all over the world. Laboratories in North America and Europe are on alert for patients showing suspicious symptoms. This, in turn, means that samples and specimens must be transported for testing and verification. How can the medical community deal with transportation of such high-risk materials?

Shipping biological substances training »

Ebola virus is considered a “hemorrhagic fever,” which affects the blood system. Its virulence is astonishing, with a fatality rate of between 50 and 90 percent. Combine this with the ability to be transmitted through casual contact, and the lack of specific vaccines or treatment, and it’s understandable why Ebola is such a feared disease. Therefore, it is all the more essential that transporters make sure that they comply with all legal and safety requirements.

Ebola virus is one of the few pathogens that is always classed as a Category A infectious substance, even in its uncultured form. The shipping description will be:

  • Identification number – UN2814
  • Shipping name – Infectious substance, affecting humans
  • Class – 6.2 (Infectious substances)
  • Packing group – Class 6.2 is not assigned packing groups

Procedures for shipping samples suspected of containing the virus will depend upon the regulations involved – the Hazardous Materials Regulations (HMR) for Continue Reading…

Shipping Infectious Substances – TDG

Transport Canada has posted a bulletin for shipping infectious substances (RDIMS#8210418).

In the overview, Transport Canada reviews what an infectious substance is: anything that is known or reasonably believed to cause disease in humans or animals. This substance can be in blood, body fluids, body parts, organs, tissue or cultures. The responsibility of the consignor is to: train, classify, package, mark/label, document, placard and have an ERAP in place, if necessary. In addition to the definition found in section 1.4 of TDG (Transportation of Dangerous Goods Regulations), the Public Health Agency of Canada (PHAC) has regulations that apply to lab safety and the import of human pathogens into Canada. Please keep in mind that provincial governments may have additional regulations in place.

Classification of infectious substances is generally done by a medical professional. If you know that what you want to ship is an infectious substance, then it is class 6.2. In TDG, under Appendix 3 in Part 2 is a listing of regulated infectious substances. This list is not exhaustive. If what you want to ship is not on the list, but exhibits the characteristics of an infectious substance, then it is class 6.2.

The authorized shipping names in TDG are:

  • Category A
    • UN2814 Infectious substance, affecting humans,
    • UN2900 Infectious substance, affecting animals
  • Category B
    • UN3373 Biological substance, Category B

UN3291 Clinical waste, unspecified, n.o.s., (Bio)Medical waste, n.o.s., or Regulated medical waste, n.o.s. are Continue Reading…

Must vs. May

In the regulatory world, things are not always as clear as they seem at first glance. One example of this is the use of the words must, may, shall and should. They seem pretty straightforward, but if interpreted incorrectly, they could lead you down the road of non-compliance, or leave you scrambling to comply with something that is not actually required.

Let’s imagine we are shipping an urgent package containing a sample of a virus that is included in division 6.2. We are shipping it by air according to the IATA Dangerous Goods Regulations. We have packaged the sample according to the regulations but when we go to label the package, we find that someone used the last label on the roll. We go hunting around the office to see if we can find more labels. The only 6.2 labels we can find are some that look similar to the ones we have always used, but they are not exactly the same. The labels that we normally use have text referring to notification to the public health authority in case of damage printed in the center. The labels we just found don’t have the text. Can we use them? Let’s see what the regulations say…

Section 7.3.15 of IATA shows a 6.2 label without the text. Below the picture of the label it states: "The Continue Reading…