While Ebola and Mers are still present, more general sterilization and infection control news can be found this month:
EE Times – 05 December, 2014
Inadequate instructions, component issues, and assembly errors -- those are but some of the causes behind recent medical device recalls and serious warnings announced by the FDA.
MedCity News – 09 December, 2014
Is the fear of hospital-acquired and other central line infections overblown?
Boomer Consumer – 05 December, 2014
The Washington Dental Commission has immediately suspended the license of a Renton dentist based on charges that he wasn’t following sterilization and infection control guidelines.
Mail Online – 12 November, 2014
NHS England said 22,000 people may have been put at risk over a period of 32 years by poor hygiene practices at a single dental surgery in the city of Nottingham in central England.
MERS is Still in the Headlines
Lapses in Infection Control Associated with Spread of Severe Respiratory Virus MERS, According to Study
Medical Xpress – 01 December, 2014
Little is known about the often fatal virus known as Middle East respiratory syndrome coronavirus (MERS-CoV), but researchers have identified gaps in infection control as a major culprit in all eleven published cases involving healthcare-associated transmission of the virus.
Arabian Business.com - 07 December, 2014
Stay away from camels is the latest recommendation in Saudia Arabia.
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.
The whole is greater than the sum of its parts, but some parts are certainly greater than others. The autoclave chamber, for instance, is the heart of the autoclave. Here the sterilization process occurs. The autoclave chamber must withstand extreme pressure and temperature. It often works day in, day out, 24/7. The autoclave chamber must treat a wide range of materials, such as metal, glass, and different liquids. And it must be built to produce reliable, consistent results, ensuring staff safety.
An autoclave chamber must be certified by the American Society of Mechanical Engineering (ASME) as compliant with its Boiler and Pressure Vessel Code (B&PVC) (or with PED – the Pressure Equipment Directive – if in Europe) and therefore safe. ASME certification is costly, complex, and time-consuming. So when an autoclave dealer says he’s in the process of obtaining a certificate, be patient and take into account that it can take six months or more.
Pressure Vessels Can Be Lethal
The B&PVC’s main object is to ensure the safety of the autoclave chamber. ASME has an outstanding safety record regarding pressure-containing components manufactured in accordance with the code.
Unfortunately the need for codes and regulations is best demonstrated by tragic stories of what happens when a pressure vessels fails.
This post explains ASME Boiler and Pressure Vessel Code and why it’s important.
ASME: Standing the Test of Time
In use for almost 100 years, the ASME Boiler and Pressure Vessel Code is one of the oldest mechanical codes. Adopted by law in the U.S., Canada, and many other countries across the world, it is arguably the most commonly used pressure vessel and boiler code today.
The video above demonstrates why strict measures are needed. The Boiler and Pressure Vessel Code uniquely ensure the safety of pressure-retaining structures. Over the years, ASME has developed a well-defined method of accreditation, monitoring, and inspection by three different bodies: ASME, the National Board of Boiler and Pressure Vessel Inspectors (NB), and Authorized Inspection Agencies (see below). This rigorous system makes B&PVC one of the most regulated engineering codes.
Tuttnauer and ASME
Tuttnauer is authorized by ASME to manufacture U- and S-stamped pressure vessels and power boilers, including autoclaves and steam generators. Furthermore, Tuttnauer’s autoclaves are authorized by and registered with the National Board (NB).
For over twenty years, Tuttnauer has produced thousands of autoclaves certified and stamped in accordance with the ASME Boiler and Pressure Vessel Code. The code covers all aspects of manufacturing operations regarding pressure-retaining items, including design, materials, welding, inspection, and testing. In accordance with the code, each pressure chamber is monitored, including inspection, testing, and tracing of all manufacturing activities.
Tuttnauer is authorized by ASME to manufacture pressure vessels and power boilers, including autoclaves and steam generators
Autoclave Chamber Manufacturing
- ASME, which authorizes Tuttnauer to manufacture pressure vessels and power boilers and certifies the finished products.
- The National Board, which commissions the Authorized Inspector and authorizes registration of autoclaves and steam generators in the NB archive.
- AI – an Authorized Inspector, employed by an Authorized Inspection Agency (AIA), who conducts third-party inspections and monitoring and is present during crucial manufacturing stages of each unit.
- In-House QC – Certified employees of Tuttnauer ensure that each application of the ASME seal accords with the B&PVC. Tuttnauer’s Quality Control Department is autonomous and has the authority and organizational freedom to verify that B&PVC requirements are met.
Robotic Welding of Autoclave Chamber
PED - ASME´s European Sister
PED, the European equivalent of the ASME Boiler and Pressure Vessel Code, aims to remove trade barriers regarding the supply of pressure equipment throughout Europe. The PED is based on Essential Safety Requirements (ESRs) that govern design, manufacturing, inspection, and testing. Tuttnauer is both PED- and ASME-certified.
Bottom Line: Make Sure Your Autoclave Chamber Is ASME-Certified
These four entities – ASME, the National Board, AI, and In-House QC – constitute the backbone of the Boiler and Pressure Vessel Code’s quality and safety assurance and control system, making the production of all such equipment a unique operation.
Next we’ll tell the tale of the making of an autoclave chamber from start to finish. And for our European readers, we’ll explain MDD and go deeper into PED. Stay tuned.
Donating an Autoclave to an Eye Surgery Hospital in Haiti
In October, Dr. Doug Villella, an optometrist and executive director of Vision for the Poor – an organization delivering eye care to low-income populations in Latin America and the Caribbean – contacted me about purchasing an autoclave for an eye surgery facility under construction in Port-au-Prince, Haiti. As Dr. Villella described Vision for the Poor’s mission, I knew a giving opportunity had come knocking at my door.
Vision for the Poor
Vision for the Poor has built five eye hospitals in Guatemala, Haiti, and Nicaragua, where native ophthalmologists and optometrists treat in excess of 100,000 patients each year. Using the model developed by India’s Aravind Eye Care Hospital (the largest such facility in the world, which has established the gold standard for sustainable eye care), Vision converts low-volume, inefficient eye clinics into high-volume, high-quality, self-supporting medical centers within one to two years.
The only obstacle to eliminating blindness in the world’s poorest regions is the prohibitive cost of hospital construction and equipment. Once a hospital is built, Vision for the Poor mentors the eye doctors and their staff until the facility is self-supporting. The hospital is owned and administered by a non-profit entity set up by Vision in each country. The cost-recovery model is simple: Patients who can pay subsidize the care of those who can’t.
Vision for the Poor helps eliminate avoidable blindness in Latin America and Haiti
It was hard to resist such a worthy cause, so with Tuttnauer’s backing, we decided to donate an autoclave. Tuttnauer is known for its cutting-edge sterilization technology, but for rural areas or developing countries, we often recommend the simpler semi-automatic autoclave, which is easier to operate and maintain. So we donated a Tuttnauer semi-automatic autoclave.
The semi-automatic autoclaves are often used in rural healthcare facilities
I was subsequently delighted to receive this thank-you note:
"On behalf of the poor, visually needy people we serve, thank you for the donation, which will be placed in the operating room at our new social-service eye hospital in Port-au-Prince, Haiti. With the support of Vision for the Poor, Visualiza and the International Eye Foundation, and using Visualiza and Aravind as models, Dr. Pierre DeCastro and Dr. Tania Medina are converting their private practice into a social-service eye hospital designed to reduce avoidable blindness in Port-au-Prince.
Your generous gift frees up scarce funding to help ensure the success of this project."
What a great way to end a successful year at Tuttnauer!