Last Year in Sterilization and Infection Control News

2016 has come to an end and it’s time to reflect. As part of the disinfection and sterilization industry we have been following industry related news, shared on our blog in our monthly news updates. These are, in our opinion, the most important or interesting news for 2016:

 

Probably the biggest story of the year is the failure in some hospital Sterile Processing Departments (SPDs) to follow disinfection and sterilization guidelines. This has happened in Detroit, Washington, and Oregon, to name a few, and there are more.

 

260 Patients of PeaceHealth in Longview Warned of HIV, Hepatitis B and C Exposure

OregonLive – 05 April, 2016

The hospital discovered gaps in its sterilization documentation in late February.

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Records: Inspectors Missed Issues With Dirty Hospital Tools

CBS Detroit – 19 September, 2016

Records show state regulators who cited the Detroit Medical Center for lax compliance failed to find problems with dirty surgical instruments during an inspection last year.

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Dirty, Missing Instruments Plague DMC Surgeries

The Detroit News – 28 October, 2016

Reports, emails show years-long problem putting patients at risk.

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Instruments are becoming more specialized and complicated, which have also caused challenges in sterilization. During 2016 there were several cases of infection due to improper disinfection of gastrointestinal scopes:

 

Improper Disinfection Procedures May Have Exposed 293 Baystate Noble Patients to Hepatitis, HIV

Masslive.com – 22 January, 2016

The hospital has notified colonoscopy patients that the scopes used in their procedures may not have been properly disinfected.

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State Found Lapses in Infection Control at UCLA and Cedars-Sinai

Los Angeles Times – 15 May, 2016

Several studies and media reports have linked outbreaks of multi-drug resistant organisms (MDROs) to endoscopes without any findings of reprocessing breaches.

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This failure brought on the lawsuits against scope manufacturers:

 

Hospitals, Medical Centers Caught Up in Endoscope Infection Turmoil

Lawyersandsettlments.com – 28 November, 2016

While patients and doctors ask who is responsible for the endoscope infections that have reportedly led to multiple deaths in the past three years, officials have taken medical centers and medical device makers to task for putting the public health at risk.

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One solution was to make disposable scopes:

 

Cheaper, Cleaner and Safer? Hospitals Turn to Disposable Scopes to Fight Superbug Infections

Los Angeles Times – 20 December, 2016

In response to a series of superbug outbreaks around the country, some doctors and hospitals are trying out disposable scopes to combat the spread of antibiotic-resistant bacteria.

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The reported sterilization failures of medical instruments have many different reasons but one that emerged in all cases is the need for certified technicians. Sterile Processing Departments (SPD/CSSD) are the single most important entity in the prevention of hospital infection. Hospitals are standing up and taking notice of a historically overlooked profession. Hospitals requiring techs to be certified raises the bar for the profession, attracting more qualified candidates, reducing departmental turnover and hopefully increasing salaries. We can already see that SPD techs are becoming better problems solvers.

 

New State Hospital Certification law was born in Memphis

Memphis Business Journal – 21 April, 2016

A new law that will be signed soon by Gov. Bill Haslam will make Tennessee the fourth state in the U.S. to require sterile processing employees in hospitals to be certified.

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CS Certification Gains Momentum

Infection Control Today – 19 April, 2016

In light of the recent news articles making headlines in regard to improperly sterilized reusable medical devices, the issue of requiring certification of Central Service (CS) technicians has become more important than ever.

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Another positive trend is that tray packaging is going from wrapped to rigid containers.

 

The Case for Rigid Containers

Outpatient Surgery Magazine – 01 February, 2016

Did you know that the staple of sterilization known as "blue wrap" may soon be virtually extinct, elbowed aside by more cost-effective and more green-conscious rigid containers? That's definitely the trend.

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Hospitals have been focusing on instrument tracking systems:

 

Managing Surgical Instruments

RFID Journal – 22 May, 2016

RFID can improve patient safety and deliver cost savings to hospitals.

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We don’t predict the future, but we definitely follow it. As medical technology progresses and becomes more innovative, the sheer variety of materials that need to be sterilized will most certainly increase. 3D printed medical devices will necessitate the same rigorous cleaning standards, but they will require some flexibility in how it’s done:

 

The First Transparent 3D-printed Skull Has Been Successfully Implanted

Extreme Tech –  27 March, 2016

As medical technology advances, the variety of materials that need to be sterilized grows. This 3D-printed skull is made of a plastic material polyetherketoneketone (PEKK, a thermoplastic) and is heat resistant which makes it suitable for high temperature sterilization in an autoclave.

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Duendoscope Tool3D Printed Medical Equipment Raises Questions

Vision Tiemes  – 2 November, 2016

As with any product used in the medical industry, the ability to clean and sterilize the material is crucial — better patient outcomes rely on it. 3D printed medical devices will necessitate the same rigorous cleaning standards, but possibly new and creative ways to achieve it. Radio frequency welding is one popular method of sterilization for medical and pharmaceutical companies.

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As a global company we follow the state of sterilization and disinfection in developing countries:

 

It's Not Easy Running A Hospital Without Running Water

NPR – 23 June, 2016

A third of hospitals in low and middle income countries may not have running water all the time.

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Who is to blame for Superbug DeathsAn Inside Look at a Hospital Located in an Airplane

Travel+Leisure – 04 July, 2016

It's a bird! It's a plane! It's a flying hospital! And in case you were curious, yes of course there's a sterilization area in this airplane hospital. The flying hospital has everything needed to perform six to eight eye surgeries for kids a day. Tuttnauer salutes the initiative of giving eyesight to kids in developing countries.

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Zika grabbed an important part of the titles in 2016, while Ebola was still in the news:

 

Who is to blame for Superbug DeathsBrazil Attempts to stop Zika Virus by Sterilizing Mosquitoes with Gamma Rays

International Business Times – 23 February, 2016

Global nuclear watchdog International Atomic Energy Agency (IAEA) has reportedly stepped in to help Brazil fight the Zika virus outbreak by sterilizing male Aedes mosquitoes with gamma rays, which will prevent the spread of the virus.

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Zika Outbreak: What You Need to Know

BBC News – 13 April, 2016

The World Health Organization has declared the Zika virus a global public health emergency. It is suspected of causing thousands of babies to be born with underdeveloped brains. This article includes complete information about the infection.

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Analysis of 1976 Ebola Outbreak Holds Lessons Relevant Today

National Institutes of  Health – 29 June, 2016

In 1976 the Ebola outbreak lasted 11 weeks and 280 deaths were reported. In the current outbreak there were 11,310 cases, and it lasted over two years. Analysis of the 1976 Ebola outbreak teaches us some lessons relevant for today.

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Guess How Many Zika Cases Showed Up At The Olympics?

NPR – 26 August, 2016

So far, it's looking like predictions from computer models were pretty much spot on: Zika wasn't a big threat in Rio de Janeiro during the Olympics.

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Sterilization is always important in Dentistry:

 

Health-care-associated infections, spore testing, and proper dental sterilization practices

Dentistry IQ – 29 January, 2016

The importance of the proper sterilization of dental instruments, supplies, and equipment used in patient care is a critical aspect of health-care delivery that directly impacts patient safety. Health-care-associated infections (HAIs) impose a significant economic impact on the US health-care system as a leading cause of mortality and morbidity, with annual medical costs from $35.7 billion to $45 billion.

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Who is to blame for Superbug DeathsInstrument Processing and Recirculation in the Dental Clinic

Dental Economics – 15 October, 2015   

Procedures involved in processing contaminated dental instruments continue to evolve as new technologies and products are developed to both maximize efficiency and minimize occupational risks. A series of complex multiple steps are required to accomplish cleaning and sterilization of instruments, including specialized equipment, adequate space, and qualified dental health-care workers

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Something Did Change: New CDC Documents Streamline Dental Infection Control

RDH Magazine – 17 June, 2016

These documents make doing what is right so much easier, as well as giving dentists more information on compliance and a compliance program for their office.

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This is it for our 2016 sterilization and infection control news summary. Now it’s your turn. What do you think are the most important or interesting news items of the year? Please let us know in the comments section below. Wishing you a happy, healthy and productive 2017!

Disclaimer: The views and opinions expressed in the referenced articles and blog posts are solely those of the original authors and other contributors. These views and opinions do not necessarily represent those of Tuttnauer, the tuttnauer.com staff, and/or any/all contributors to this site.

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Season Greetings from Tuttnauer

It’s hard to believe that Holiday Season is just around the corner! 2016 is almost over. We’d like to take the opportunity to wish you a happy holiday season. We hope 2017 will be just as good if not better than 2016.

We invite you to keep the conversation going. Follow us on our social media channels: Facebook, Linkedin and Twitter, where you can get the latest industry trends and developments from Tuttnauer. And last but not least is our blog, where you are served with industry related top quality content. We have some great content lined up for 2017, so stay tuned.

 

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Sterilization by Gamma Irradiation: Nuke Those Bugs

The word radiation and radioactive are often associated with the horrors of Hiroshima and Nagasaki, and therefore have earned a negative reputation. Yet while the dangers of radiation are very real, they are a piece of the big picture of this scientific phenomenon. Actually, radiation’s benefits and contemporary applications are many, such as in medicine, communication, and science. In this post, we will focus on one specific application in the world of sterilization and infection control: that of radiation’s ability to kill harmful microorganisms. In other words, radiation can be used to sterilize medical and scientific equipment. But before we can understand this application, let’s review a short history of radiation.

Radiation is associated with Hiroshima and Nagasaki and has earned a negative reputation

History

The history of sterilization by radiation dates back to 1895 when X-rays were first discovered by W.C. Roentgen. In 1896 Henri Becquerel observed radiation emitted from uranium. And in 1898 Marie and Pierre Curie discovered several radioactive elements and first used the term “radioactive.” Marie received the Nobel prize twice in two different scientific disciplines even though she suffered from a blood illness attributed to prolonged exposure to radiation. She later died from this illness, known as aplastic anemia, at the age of 66. The damaging effects of radiation were not known at the time and therefore no safety measures were taken. Curie carried test tubes containing radioactive isotopes in her pocket, and stored them in her desk drawer, remarking on the faint light that the substances gave off in the dark room.

Pierre and Marie Curie in Action (Source: Wikipedia)

In 1958 the first commercial food irradiation plant was installed at Stuttgart, Germany, which processed spices. In 1963 the first gamma irradiator was installed in the US for the processing and sterilization of medical devices. In 1964 the Atomic Energy of Canada commissioned the first industrial cobalt-60 sterilization facility to sterilize surgical suture. Today, 40–50% of disposable medical products manufactured in developed countries are radiation sterilized and there are over 200 gamma irradiators worldwide in operation for a variety of purposes.

Ionizing Radiation

Ionizing radiation is a type of short wavelength radiation that carries enough energy to free electrons from atoms or molecules, thereby ionizing them. This article focuses on gamma irradiation, which is most commonly used for sterilization purposes.

The bottom line of how this works is that the ionizing radiation produces disruptions in sub-atomic particles involved in the formation of the microorganism. Simply put, this radiation causes damage to the genetic material - the DNA or the RNA - of the organism’s cell. If the DNA or RNA of a microorganism is damaged, the cell will die. In other words, radiation damages the hard drive of a bacterium, causing it to shut down for good. 

Gamma radiation is created by the decomposition of an atom

Decomposition and Gamma Rays

Let’s dive a little deeper in an attempt to explain how gamma ray radiation is produced. Every physical substance has natural energy levels, which can be increased or decreased artificially  in the lab. Gamma radiation is created by the decomposition of an atom. Gamma radiation is a natural radiation that is emitted from an atom or a molecule when its energy level drops. To take an extreme example, when radioactive uranium decomposes it releases energy to such an extent that it’s known as an atom bomb explosion (fission).

So now we understand that in fact every substance that decomposes emits some electromagnetic radiation, but not every electromagnetic radiation is fit for sterilization. Some substances are too powerful, uranium and plutonium for example. They might sterilize, but they will also kill everything else in the environment. Not exactly the desired outcome. So if uranium and plutonium are not fit for sterilization, what is? 

Cobalt: Not too Powerful, Not too weak

Gamma rays used for sterile processing are formed with the self disintegration of Cobalt-60 (60Co). Among thousands of gamma emitters only Cobalt-60 is indicated for sterilization processing. Cobalt-60 can be produced in a nuclear power reactor by the irradiation of 59Co (metal), with fast neutrons. 

The radioactive isotope is formed by neutron capture as shown in the following equation:
27Co59+ n→ 27Co60

Cobalt-60 is manufactured specifically for the irradiation process and is housed in specially designed chambers operating under strict standards and regulations. The gamma irradiation sterilization process does not involve sufficient energy to cause the treated products to become radioactive; it will only harm the microorganisms on the products. 

Will Cobalt-60 Live Life to the Fullest?

We all want to live our lives to the fullest, but when it comes to Cobalt-60, we are very satisfied with a half life. In order to understand gamma ray irradiation, we need to explain what the half-life of a radioactive substance is. It is the amount of time it takes for half of the atoms of the radioactive substance to decay. For example, if we start out with a 800,000 Curie of Cobalt-60, after 5.27 years 400,000 will remain. The amount of energy remaining after this period is not sufficient for sterilization; this is when the dose is returned to the production company, and they will replace it with a fresh new package of 800,000 Curie. This, of course, has a price tag, a very high one, well over $1 million!

Cold Process Sterilization

Currently, all industrial radiation processing facilities employ Cobalt-60 as the gamma radiation source. The reason why Cobalt-60 is the most suitable for radiation processing is because of the relatively high energy of their gamma rays and fairly long half-life which is  5.27 years.

A while ago we began the sterilization methods series with a discussion of methods that use heat and focused on autoclaving. We then continued to discuss non-heat methods: Ethylene oxide (EtO) and Formaldehyde that are used for sterilizing heat sensitive items. These two methods use a chemical agent to sterilize.

Just like EtO and formaldehyde, gamma irradiation is known as a ‘Cold Process,’ as the temperature of the processed product does not increase significantly. Therefore, it’s a suitable sterilization method for heat sensitive items. Gamma irradiation does not rely on humidity, temperature or pressure and can be applied to packaged goods.

Gamma irradiation is a physical/chemical means of sterilization, because it kills bacteria by breaking down bacterial DNA, inhibiting bacterial division. Energy of gamma rays passes through the equipment, disrupting the pathogens that cause contamination. These changes at the molecular level cause the death of contaminating organisms or render such organisms incapable of reproduction. The gamma irradiation process does not create residuals or impart radioactivity in the processed items. Complete penetration can be achieved depending on the thickness of the material.

Applications

Gamma sterilization is used to sterilize human tissue grafts: connective tissue allograft, such as bone, cartilage, tendons, ligaments, dura mater, skin, heart valves and corneas, which are widely used for reconstructive surgery in many clinical disciplines, including orthopedics, traumatology, neurosurgery, cardiac surgery, plastic surgery, laryngology, and ophthalmology. 

Sterilization by radiation is also used for sterilization of plastic syringes, hypodermic needles, scalpels, surgical blades, adhesive dressings and thermolabile medicaments. 

Other applications include: syringes, surgical gloves, gowns, masks, sticking plasters, dressings, ‘tetrapacks,’ bottle teats for premature babies, food packaging, raw materials for pharmaceuticals and cosmetics, and even wine corks. 

Another common application of sterilization by Gamma irradiation is food. Food sterilization by gamma irradiation is the process of exposing food to ionizing radiation to destroy microorganisms, namely bacteria, or insects that might be present in the food. 

Advantages

  • Gamma rays have a high penetration power so materials can be sterilized after filling them in the final container
  • The method is suitable for all types of materials such as dry, moist and even frozen items
  • The method is considered to be reliable and can be accurately controlled

Disadvantages

  • There is some risk involved since exposure to radiation may be harmful to workers
  • It can produce undesirable changes in medicine such as color, solubility and texture of the product
  • It can actually damage the material it’s meant to sterilize
  • It’s expensive

Summary

Using radiation for sterilization is great if you need to sterilize products that are heat and moisture sensitive and cannot be sterilized in an autoclave. However using ionizing radiation for sterilization isn’t always practical. Other reasons that this method is less popular is that it is very expensive and requires a warehouse-like processing facility. It can be very dangerous if used improperly. After all, if it can kill bacteria it can also kill humans. 

What’s your take? Let us know your thoughts about radiation sterilization in the comments below.

Dr. Mario Finkiel, Ph.D.
International Marketing Manager
Latin America and the Caribbean

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