RSTI FocalSpot > Summer 2012 by RSTI

SUMMER 2012

RSTI-TRAINING.COM

RADIOLOGICAL service TRAINING INSTITUTE > News from the Leader in Radiological Service Training > ISSUE 2012.3

27 YEARS OF Maximum Value for Your Educational Growth and Development

Cofounder’s Corner...............2 Testimonial: Pay Off.............5 RSTI Hits the Road...................6 Digital Upgrades.....................7 Calling All Students.............. 8 Hot in Cleveland.....................9 2012-13 Schedule....... 10-11 The Hidden Dangers........... 12 New Moodle Testing..........14 The Right FPD.......................17 Course Index........................ 19

INNOVATION ISSUE

ONLINE LEARNING

GROWS HERE!

Join us for after hours enrichment and extracurricular summer fun in the “green city on a blue lake.”

INDUSTRY SERIES

Hidden Dangers...Cont’d

Learn Hard. Play Hard.

the training business in our basement as Terry boldly went out and sold his dream. We were going to be the first independent radiological service training institute in the country. So we started, just the two of us. He sold and taught; I kept the books, although there was not much to “book keep” in the early days. Soon after we added John Perez, Larry Cornell and Manny Roman. Today, we are a much different company, but still continuing the work that he had envisioned prior to his death in 2008. Like most small companies we had our ups and downs and differences of opinion, but everyone that worked here in the past, always went on to “bigger and better” things. We must have been doing something right. All of our employees have been family and friends. Even our friends have become part of the RSTI family after a few months.

Cofounder’s Corner “All in the Family” It’s hard for me to believe that it has been 3 1/2 years since my husband, Terry Speth, Sr., passed away. Since I have spent all 27 years of our history involved with RSTI in one way or another, I thought that it’s about time you hear from me about our family business. Leaving a secure job at Picker X-ray and starting up your own business either took a lot of guts, or we were just young and stupid. Terry loved this business, and always knew in his heart that he could do a better job than Picker and could broaden the scope of radiological service training to hospitals, ISOs and other companies that needed basic training. Of course, I asked how we were going to pay the mortgage and buy groceries for three children and he kept saying, “not to worry.” Immediately he was on the road trying to get some business going on a “wing and a prayer.” To this day I remember those brave hospitals that booked business with us back in 1985. We started 2 | focalspot.SUMMER.2012

Once the business got growing rapidly we incorporated “fun” into everything we did. We started sponsoring skiing seminars, fishing seminars, annual RSTI symposiums and Christmas parties for all of our employees with their spouses. Terry always brought fun into the classroom with his bird calls and jokes of the day. Nothing warms my heart like hearing from our students. Here is one we just received that I want to share with everyone:

I just got through reading your article regarding Terry Speth and his great achievements. I was fortunate to receive my first course in x-ray by him early on in my career, followed by other top notch instructors at RSTI. I will always remember Terry, for the encouragement, commitment to success and advice. I am now an Imaging Specialist with Adventist Health. I have recommend RSTI to many of the onlookers watching me perform my job asking “how did you learn to do that?” Look forward to seeing you guys in the future for continued education.

Arcenio A. Villegas, CBET

Clinical Engineering (Imaging Specialist) Adventist Health Central California

As you know we distribute course evaluations after every class to make sure that we stay in touch with our students’ opinions on the course they have taken. We also ask them about such things as: classroom conditions, hotel accommodations, lunches provided, and transportation. Additionally, we try to interview at least one student privately for what we call a “testimonial.” We always get authorization for a picture and the testimonial itself, making sure that nothing gets printed that is not completely accurate. There is nothing like hearing about the RSTI Training Center from the other service professionals who have been here before you. Make sure you read the ones in this newsletter. Terry hired each of the instructors that are at RSTI today, except for one. He had an incredible knack for finding people that “could talk the talk and walk the walk.” Many qualified individuals applied for these positions over the years, but only a very few passed muster with Terry. That’s why when you attend one of our courses, you get a little bit of him in the process.

Notes from the Field Anna, I wanted to take a moment to say thank you for the training I received on the AMX 4. The facility, equipment, and instructor were fantastic and the training has allowed me to excel in my position out in the field. During a PM last week one of my coworkers asked if I had prior experience on the AMX 4 because I performed the PM “like a pro.” I can only attribute that to the quality of training I received at RSTI.  Thanks!

Amanda

Philips Healthcare Field Service Engineer

Next time you are in town, please stop by and say hello...I am here most everyday keeping the books and have been for 27 years.

Kathy Speth COFOUNDER & CEO, RSTI

If you have any stories about your experience at RSTI, we would love to hear them. Feel free to call Kathy or email kspeth@rsti-training.com.

WWW.RSTI-TRAINING.COM | 3

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Testimonial: Investing In Your Career Proof RSTI Can Really Pay Off! Mark Manofsky, Philips Healthcare Before Mark decided to enter the medical industry, he was an avionics engineer for eighteen years. He worked for Boeing out of St Louis. Wanting to get out of the defense industry, he thought with his engineering degree, imaging would be a nice challenge and a great career choice. Once Mark realized he had several schools to choose from, he had to shop around to find the best fit for his education. He visited two training centers in Solon, OH. After visiting RSTI and speaking with Dale Cover, one of RSTI’s senior instructors, and seeing the impressive training labs and meeting RSTI’s friendly staff, Mark made the choice to attend RSTI’s X-Ray Certificate Series. “I felt I could get a great foundation and build a solid relationship with RSTI.” Mark said, “I thought I would have more room for growth at RSTI with the PACS and CT courses, as well as all the product specific classes.” Mark had moved back to Akron, OH ( just south of Cleveland). So it was easy to make the commute while attending classes. Mark’s imaging education started in May of ’06 and throughout the year he attended the entire X-Ray Certificate Series, Phases I-IV. He finished Phase IV in Oct ‘06 and started sending out résumés. In April of ’07, Mark was offered a position with Masterplan, “I felt that my RSTI training really piqued their interest.” He worked for Masterplan for over 4 years. Mark started working for Philips in July ’11. He works in the multi-vendor division. Mark’s RSTI education and his field experience make him a great asset to Philips. One of the reasons Mark changed jobs was the freedom to be his own boss as a field service representative. “Every day is different,” he says, “It’s not a lot of the same routine.” Mark recently attended RSTI’s AMX IV+ class. “We did a lot of troubleshooting which gives a great starting point when I’m out in the field on a service call.” He feels he is better prepared to service the AMX IV now.

Mark said, “The RSTI books and manuals are great reference materials, but nothing brings you knowledge like personal experience.” “I was very impressed by Anna’s ability to remember past students.” Mark appreciates the sense of familiarity at RSTI. He’s found the imaging field is very tight knit and a lot of people are willing to help share information or help troubleshoot when you have a problem. We at RSTI welcome students like Mark who take the initiative to carve out a lucrative career for themselves in the field of diagnostic imaging service. It is rewarding to see their successes and wonderful to have them return to RSTI after obtaining employment.

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RSTI Team Hits the Road AAMI 2012 Charlotte NC The AAMI 2012 Conference and EXPO in Charlotte North Carolina has come to a close. The underlying theme of this yearâ&#x20AC;&#x2122;s conference was information management to augment patient care or in other words, workflow management.

2012 Roadshow

At the expo there were many groups looking to quantify or record every bit of information possible; from tracking surgical instruments and the facilities property, to tracking and compiling patient data into a singular area.

FIME Aug 8-10..................Miami, FL

With the Imaging Service Engineer community being in the business of helping to create data (PACS/DICOM), this shows that our world is going to continually connect to an ever increasing amount of data collection environments. This is an exciting time to be in the medical service industry. Our world is evolving with many more exciting changes to be coming in the future.

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Portable X-ray Unit Digital Upgrades By Matthew J Mondello RSTI Instructor The use of film in all aspects of medical imaging is becoming more and more obsolete, let alone in portable x-ray systems. This along with the fact that there are some portables out there that are built to last and the cost to fully replace those that don’t last keeps climbing has caused a boom in the digital upgrade business. It is a cost effective solution to an aging technology and has many companies scrambling for your business. There are many factors to consider when deciding to go ahead with a digital upgrade. We are not going into depth on all of these factors but will touch on a few. The first deciding factor is going to be the budget that has been allotted for an upgrade. To help work within that budget, a couple options as far as detectors are concerned have been made available. Cesium Iodide and the Gadolinium Oxysulfide, “Gadox” for short, are the two options, the latter of the two being the more economical choice without too much sacrifice to image quality. The reviewing physician will have some input on this option, I’m sure, but it is none the less a better way to save money.

First Source Inc. http://www.fsimedicalimaging.net/dr_upgrade.html

Another feature to consider is the invasiveness to the existing system. Some digital upgrades leach into your portable like poison ivy through a tree’s branches. What seems like a harmless, neat relationship turns into a potentially irritating nuisance. Other upgrades are as simple as a connection to the user hand switch. In both cases there will need to be some interaction between the upgrade and the host system but being able to minimalize the interactions will be a benefit which brings me to my next point, the batteries.

The last major factor to consider is the availability of a wireless network within the normal work areas for a portable system. Since most of the digital upgrades work off of your standard 802.11 protocol, it would be a waste of money to install the upgrades on systems that are only used in “dead zones” of the facility. WIFI signal interference is one of the biggest problems noted by field techs.

There are two common methods for powering the digital imaging portion of your portable upgrade. One method is to tie the digital system directly into the batteries that power the system. This is a logical power option but does put added drain to your already taxed batteries. The second method is a separate battery system that runs the digital imaging upgrade independently of the host system. It will need to be charged separately as well but will not add strain to the existing batteries.

There are several companies popping up in the digital upgrade market for portable X-ray systems. Most are jockeying for a position to upgrade your systems. Since most upgrades can be completed on average in about one day, it is important to keep in mind some of these factors that we have discussed. Should you have any questions about an upgrade or are looking to have a system upgraded, give us a call here at RSTI and we will be glad to help you meet your imaging needs! WWW.RSTI-TRAINING.COM | 7

Calling All Students By Terry Speth

RRRIIINNNNGGG – “Hello?” “Hi, this is Terry Speth with RSTI. You probably already know that RSTI provides the best independent service training available, but did you know that we also buy and sell imaging systems? I am calling to find out if your facility has any equipment that is being replaced now or in the near future. If you don’t have anything now, I would like to send you some information about how RSTI can be of assistance when you do.” We are planning on calling you soon to ask what pre-owned equipment your facility might have. It could be old equipment you want removed and disposed of, a machine you’re trading in for an upgrade or even an end-of-life machine. If you are a facility that has equipment in storage and don’t know what to do with it, you can turn it in to CASH! You’ve heard the phrase “One man’s trash is another man’s treasure,” right? You may be storing the perfect parts unit for someone. There is a great demand for pre-owned equipment overseas, too. If you don’t hear from us in the near future and you have some equipment you’d like us to take off your hands, we would love to hear from you. We can offer what no one else can, RSTI TRAINING CREDITS!!! Think of this as a way to enhance your training experience. Using your old equipment for training is a great way to get back to RSTI. So call us. We always love to hear stories about classes, student night out, or even bad jokes that our instructors told. If you want to come back for class and it is not in your budget, this is your answer. Training or CASH, whatever works best for you! Email Darrel Kile, or me, Terry Speth, a list of equipment, or piece of equipment you have available. It’s easy and won’t take much time. Usually we can tell you immediately what the value is and what we can offer you. If you are planning on removing rooms in the next few months, that’s great too. We can help you schedule the removal, de-install and/or pick up the equipment ourselves. We also can sell your machine for you on consignment.

I promise we’ ll be nice. See how harmless we look?

Terry Speth

Darrel Kile

tspeth@rsti-training.com 800.229.7784

dkile@rsti-training.com 800.229.7784

8 | focalspot.SUMMER.2012

Summer Events Cain Park Arts Festival Friday-Sunday, July 13-15 Cain Park 14591 Superior Road, Cleveland HTS

216-371-3000

Summer Events Hot in Cleveland!

Irish Cultural Festival

When attending RSTI, we want you to have the best learning experience possible. We also want you to have an enjoyable stay in our fair city and experience some of the fascinating multicultural opportunities you will find here.

Friday-Sunday, July 27-29 St. Sergius Russian Orthodox Cathedral 6520 Broadview Road, Parma

From our fabulous Metroparks system with miles and miles of hiking, biking and running trails to sandy beaches, lakes, rivers and fishing – there are plenty of activities for the outdoor folks to enjoy. There are numerous 5k, 10k, half marathon and marathon runs for those fleet of foot. Not to mention the Burning River 100, a 100 mile endurance race July 28-29! After all that activity you are going to be hungry. Cleveland boasts excellent restaurants including Iron Chef Michael Symon’s Lola, Lolita and B-Spot and Melt Bar and Grilled among many others you may have seen on the Travel Channel and the Food Network. We really are a foodie town and I encourage you to explore the huge variety of culinary experiences you will find here. Looking for something a bit more festive? Nothing says summer in America like festivals, and Northeast Ohio is no exception. Following is a list of some of the upcoming festivals that we hope you get a chance to enjoy on your next visit. We hope this helps you plan your next visit to RSTI and we look forward to seeing you this summer!

Friday-Sunday, July 20-22 Cuyahoga County Fairgrounds 164 Eastland Road, Berea

1-800-485-8013 Russian Festival

216-447-1015

Warehouse District Festival Sunday, Aug. 5 West Sixth Street Cleveland’s Warehouse District

216-344-3937

Cuyahoga County Fair Monday-Sunday, Aug. 6-12 Cuyahoga County Fairgrounds 164 Eastland Road, Berea

440-243-0090

Little Italy Feast of the Assumption Wednesday-Saturday, Aug. 15-18 Mayfield and Murray Hill roads Cleveland’s Little Italy neighborhood

216-421-2995

Romanian Festival Friday-Sunday, Aug. 17-19 St. Mary Romanian Orthodox Church 3256 Warren Road, Cleveland

216-941-5550

Egyptian Festival Friday-Saturday, Aug. 24-26 St. Mark Coptic Orthodox Church 2100 Pleasant Valley Road, Seven Hills

216-642-7692

Cleveland NATIONAL air show

Find more information on these events and so much more at PositivelyCleveland.com, CoolCleveland.com and Cleveland.com!

Sept 1-3 FEATURING THE BLUE ANGELS BURKE LAKEFRONT AIRPORT, CLEVELAND

216-781-0747

WWW.RSTI-TRAINING.COM | 9

RSTI 2012 Training Schedule June 25, 2012

TRAINING COURSE TITLE

July 2

August 23

July 9-20

Principles of Servicing Diagnostic X-Ray Systems (Phase I)

X-RAY CERTIFICATE SERIES

July 23Aug 3

Advanced Radiographic System Maintenance (Phase II) Advanced Fluoroscopic System Maintenance (Phase III)

NETWORKING & DIGITAL INFORMATION

Introduction to Networking & DICOM

MANAGEMENT

C.A.M. (Capital Asset Management)

July 9-20

Aug 20-31

1 Oct 1-12

Sep 17-28

###### Aug 6-17

Advanced Diagnostic Imaging System Analysis (Phase IV) PACS Engineer/Administrator Certification (Phase I) PACS Engineer/Administrator Certification (Phase II)

September

Aug 20-31

July 23Aug 3

July 30Aug 3

GE Advantx 1, Advantx E, Legacy, Compax 40

GE Definium Family: Definium 6000/8000, Discovery XR650/XR656, Optima XR640

PRODUCT SPECIFIC

GE Precision 500D R/F GE Revolution Family (XR/d 1X & 2X) GE Proteus (JEDI Generator) Philips Bucky Diagnost Private Practice X-Ray Systems GE AMX Portable (IV, IV+)

PORTABLES

Shimadzu Mobileart Portable Siemens Mobilett Portable Multi-Product C-Arm OEC 9600/9800 Multi-Product C-Arm OEC 9800/9900

C-ARM

C-Arm OEC 9900 Siemens Siremobile C-Arm Philips BV Pulsera C-Arm Siemens AXIOM Artis Family (FP)

CARDIAC

GE Innova Family (2100/3100/4100) Philips Integris Cath Lab System (Includes Generators) Analog Multi-Vendor Mammography (GE, Lorad, Siemens)

WOMEN'S HEALTH

Oct 1-5 Aug 20-31 Aug 20-31

I N D E P E N D E N C E

July 1618

July 30Aug 3

Sep 1719

L A B O R

Aug 6-10

Aug 6-17

D A Y

Aug 6-17

July 16-27

Lorad Multicare Platinum Breast Biopsy System GE Digital Mammography Family (2000D/ DS/ ESSENTIAL)

Oct 1-5

Sep 1014 Sep 10-21

Sep 10-21

Aug 27-31

July 23Aug 3

Digital Mammography (Hologic Selenia)

Sep 10-21

Lorad MIV Platinum and ACR Multi-Vendor Bone Densitometry

ULTRASOUND

Multi-Vendor Ultrasound

July 9-13 July 9-20

Principles of Servicing Computed Tomography Systems (Phase I)

Sep 24Oct 5

Advanced Computed Tomography System Maintenance (Phase II) GE Lightspeed CT GE VCT

Exhibits, Presentations And Special Notes 10 | focalspot.SUMMER.2012

July 23Aug 3 Aug 6-10

CABMET Aug 17-18 FIME Aug 8-10

CEAI Aug 22-23 NCBA Sep 12-14

MDEXP Oct 3-

Register Online or Call 1-800-229-7784 Please see the Registration Form on P.19 for tuition prices and details. October 8

Nov 5-16

Oct 15-26

January 31

14 Jan 7-18

Nov 26Dec 7

Nov 5-16

February 28

Jan 21Feb 1

Jan 7-18

Dec 10-21

March 25

Feb 25-Mar 8

Mar 11-22

Feb 4-15

Nov 5-7 Feb 11-15 Oct 22Nov 2 Dec 1014

Oct 22-26 Nov 5-9

Oct 15-19

Mar 1822

Nov 26Dec 7

Oct 22Nov 2 Oct 29Nov 2

Oct 22Nov 2

T H A N K S G I V I N G

Feb 18-Mar 1

Mar 4-15

Feb 25-Mar 1

Dec 3-5 Nov 2630

Nov 2630

Nov 26Dec 7

Dec 10-21

Nov 26Dec 7

C H R I S T M A S

N E W Y E A R S

Jan 28Feb 1

Jan 711

Mar 25-29 Jan 1418

Feb 4-15

Jan 2125

Feb 18-22

Mar 25-29

Mar 18-29 Mar 18-29

Dec 1721

Oct 8-19

Jan 21-Feb 1 Feb 4-15

Oct 15-19

Mar 4-8 Nov 5-16

Mar 4-15 Feb 18-Mar 1

Oct 8-19

Mar 4-15 Nov 5-16

Oct 812

PO -5

December

November

Nov 2630

FBS Oct 26-28

Feb 4-8

RSNA Nov 25-30

State of OH Reg. No. 93-09-1377T | WWW.RSTI-TRAINING.COM | 11

The Hidden Dangers

(Part 2 of 2 Part Series)

What are Manufacturers Doing? Special Report by Mike Shouppe University of West Florida Finding manufacturer specific information on software development in medical devices has proven to be very difficult. I researched the best practices of three of the largest medical device manufacturers in the world: Philips, GE, and Siemens. After extensive searching of the internet, I found no information about any development methods (hardware, software, etc.) that pertained to Siemens products. Even after consulting with two local Siemens field engineers, a former Siemens employee, and their national support telephone line, I could not gather any information about their methods for quality assurance. Researching GE measures was equally difficult, although I was able to find information regarding GE’s method for overall (hardware and software) quality assurance. Identical to the software life cycle (Requirements—Design—Testing—Implementation— Maintenance), GE’s GAMP5 offers little benefit to the substance of this paper (GE 2011). Fearing an impasse at the summit of my research, I was pleased to learn about the methods Philips uses for software development. Though Philips uses common industry practices described in the FDA guideline to create high-reliability software ( just like GE and smaller manufacturers), Philips is the only manufacturer to publicly release their coding standards. Tying into the key point brought up by the FDA earlier (prevention of introduced defects), Philips lessens the chance of defects being caused by faulty or ambiguous code. The Philips Healthcare – C# Coding Standard (2009) is one of many such documents that specifies several aspects of code generation including naming, object lifecycle, control flow, object-oriented programming, exceptions, and coding style. Although many writers would not include code production methods in a paper on software validation and testing, I believe validation starts from the initial phase and lasts as long as the product is in use. What Philips has achieved with their Coding Standards is they have lessened the chance of defect introduction and have indirectly helped testing by decreasing the number of potential defects that will need to be fixed before release. 12 | focalspot.SUMMER.2012

First Source Inc. http://www.fsimedicalimaging.net/dr_upgrade.html

The future Medical device software (along with every aspect of health care) has advanced exponentially in the last two decades. We now have automated defibrillators that can analyze your heart rhythm and apply therapy autonomously when needed. Robots are assisting surgeons to perform microsurgical procedures that were unthinkable just a few years ago. Health care relies heavily on medical devices and the devices, in turn, rely heavily on software. Every player in the development of these devices should devote 100 percent of their resources to prevent adverse events, and we can see several examples of it with Philips’ Coding Standards and with the FDA’s newly established software division of the Office of Science and Engineering Laboratories ( Jones, Jetley, and Abraham 2010). The industry has come a long way since the Therac-25 incidents of the mid-1980s and will continue to make improvements to the quality of medical device software.

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ARTICLE References

Myers, G.J. (1979). The art of software testing. New York: Wiley.

fda.gov/MedicalDevices/DeviceRegulationandGuidance/ PostmarketRequirements/RecallsCorrectionsAndRemovals/ default.htm

Hetzel, W.C. (1988). The complete guide to software testing. Massachusetts: QED Information Sciences.

Rakitin, S. (2006). Coping with defective software in medical devices. Computer, 39(4), 40-45.

Leveson, N.G., Turner, C.S. (1993). An investigation of the Therac-25 accidents. Computer, 26(7), 18-41.

Germain, J. (2010). The gaping hole where auto software standards should be. TechNewsWorld. Retrieved from http://www.technewsworld.com/story/69571. html?wlc=1302135972

Jones, P., Jetley, R., & Abraham, J. (2010). A formal-based verification approach to medical device software analysis. eetimes. Retrieved from http://www.eetimes.com/ design/embedded/4008888/A-Formal-Methods-basedverification-approach-to-medical-device-softwareanalysis?pageNumber=0

U.S. Department of Transportation Federal Aviation Administration. (2003). Software approval guidelines. Washington DC: U.S. Government Printing Office.

U.S. Food and Drug Administration. (2002). General principles of software validation; Final guidance for industry and FDA staff. Washington, DC: U.S. Government Printing Office.

General Electric Company. (2011). GAMP5 â&#x20AC;&#x201C; a lifecycle management framework for customized bioprocess solutions. Retrieved from http://www.gelifesciences. com/aptrix/upp00919.nsf/Content/A8FF0950E1AB1DDEC12 5783B000435AF/$file/28989873AA.pdf

U.S. Food and Drug Administration. (1996). Code of Federal Regulations. 61(195).

Philips Healthcare. (2009). C# coding standard. Retrieved from

U.S. Food and Drug Administration. (2011). Recalls, Corrections and Removals. Retrieved from http://www.

http://www.tiobe.com/content/paperinfo/gemrcsharpcs.pdf

WWW.RSTI-TRAINING.COM | 13

Introducing Testing with Moodle Online Learning with a Global Reach! By Todd Boyland RSTI CIO & Instructor RSTI recently completed development of a web server that will be used by students for taking quizzes and exams. We developed this server around an open source e-learning platform called Moodle. Moodle is a Course Management System, or Virtual Learning Environment (VLE) that is currently being used by over 67,000 registered schools & colleges in 216 countries. A few of the major universities in the U.S. that use Moodle include: • Ball State University • Bowling Green State University • BYU • University of Illinois • Ohio University • University of Florida • George Washington University • Iowa State • Lehigh University • LSU • Michigan State University • Rutgers • Purdue • University of Nebraska • University of Rochester • University of Wisconsin

Students will now be able to get instant grading, feedback, and review of all course quizzes and exams, through their laptop browser. RSTI will soon be requiring students to bring their own laptops to training, although most already do. A testing laptop will be made available in the rare case that a student is unable to bring a laptop to training with them.

Check out the screenshot of the Moodle dashboard below...

A Map of Moodle Users Across the Globe!

Moodle eliminates the need for paper testing - just another way RSTI means green.

14 | focalspot.SUMMER.2012

documented, I browsed the Class 1 recalls that have been initiated since 2007 to see if the software defect trend continues to climb. A Class 1 defect is defined by the FDA as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death” (FDA 2011). There was a total of 43 Class 1 recalls of medical equipment between January 2007 and March 2011. Of the total amount of Class 1 recalls, 16 were attributed to software flaws increasing the percentage of software related recalls to over 37 percent. Table 1 lists information on the 16 FDA recalls along with possible adverse effects related to each one been initiated since 2007 to see if the software defect trend continues to climb. A Class 1 defect is defined by the FDA as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death” (FDA 2011). There was a total of 43 Class 1 recalls of medical equipment between January 2007 and March 2011. Of the total amount of Class 1 recalls, 16 were attributed to software flaws increasing the percentage of software related recalls to over 37 percent. Table 1 lists information on the 16 FDA recalls along with possible adverse effects related to each one

etc.), the FDA is specific on software requirements in the section on design validation. They state, “Design validation shall include software validation and risk analysis, where applicable. The results of the design validation…shall be documented in the Design History File” (21 CFR 820.30). Because manufacturers must have tangible proof of software validation, the FDA’s guideline should carry more weight than third-party guidelines.

Who Regulates? For medical devices, government regulation of all development including software is regulated by the FDA. To assist in the production of robust software in medical devices, the FDA has drafted a 43-page document to help instruct manufacturers on software development. The General Principles of Software Validation; Final Guidance for Industry and FDA Staff outlines principles that the FDA considers to be applicable to the validation of medical device software (FDA 2002). Because it is only a set of best practices and not a requirement, software developers are free to use an alternative approach as long as it satisfies the requirements of all applicable regulations. The specific “applicable regulation” the FDA is in reference to is the FDA’s Code of Federal Regulations Title 21 Section 820.30. At less than one page in length, it specifies that manufacturers must establish and document all design planning, input, output, review, verification, validation, transfer, changes and history for each medical device (21 CFR 820.30).

However, they only suggest that a level of confidence be developed that the device meets all requirements. This is not to say that all medical devices should share the same level of confidence. If an enteral feeding pump (used to supply nutrients to patients who

The FDA’s guideline covers all aspects of creating high quality software by using general validation and testing methods. According to the FDA, software validation is “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” (FDA 2002).

The FDA, like many software developers, acknowledges that developers cannot test forever and that zero-defect software rarely exists.

Though the regulation is applicable throughout the entire process of manufacturing (hardware, software, WWW.RSTI-TRAINING.COM | 15

Far Beyond Parts We respond to Engineers and Medical Professionals in crisis, with immediacy, thoroughness, and friendly care—largely because we believe in our role in the “care continuum.” Bottom line, we keep these medical devices in service—bettering the lives of healthcare professionals and the patients they serve.

CONNECT WITH A WORLD LEADER. CALL CLASSIC. FACEBOOK: SEARCH FOR CLASSIC IMAGING TWITTER: FOLLOW @CLASSICIMAGING REMADE IN AMERICA

LINKEDIN: linkedin.com/company/classic-diagnostic-imaging

16 | focalspot.SUMMER.2012

Selecting the Right FPD

(Part 2 of 2 Part Series)

Indirect vs. Direct Conversion By Larry Cornell

Which is the best? If image quality was the only consideration, it would appear that a-selenium would be the panel of choice. The MTF and QDE are superior and overall review of chest x-ray show radiologists prefer the image quality of direct a-selenium over indirect a-silicon Csi. The situation it seems, is that the other factors related to the panel are of equal importance. It appears that Csi panels produce a almost equal image quality and offers other important features such as size, cost, reliability, temperature sensitivity, and life expectancy. When all is added together, the panel of choice seems to be for now indirect a-Silicon Csi detector array. Panel manufacturers that use indirect conversion include GE (P&E), Thales, Philips, Siemens (Trexall), Samsung, Toshiba, and Varian. Direct conversion includes Fuji and Lorad.

Visit us atFIME! FIME August 8-10 Miami, FL Booth #2273 WWW.RSTI-TRAINING.COM | 17

RSTI Equipment

Squeezing Training Dollars

JOIN THE FUTURE OF CLINICAL TECHNOLOGY.

At the end of a fiscal year money is always hard to come up with. When it comes to training dollars, especially, ARAMARK experiencing significant engineers are onHealthcare the backTechnologies burners of is budget meetings. It’s easier than you thought to find your way to the growth, and we need oustanding people to join our team. training center.

Equipment VALUATION WORKSHEET OEM/Manufacturer ______________________

WE’RE HIRING:

Give •usTechnology a call about your used equipment that is for Date of Manufacture _____________________ Managers • Imaging Service Engineers (all levels) sale. If you are disposing any equipment now or in the • Senior Technology Managers • Biomedical Technicians (all levels) next few weeks, I can give you training credits towards Date of Tube ___________________________ a new class! It’s easy… fill out the short questionnaire WE OFFER: below, and fax it back to one of us: Terry Speth, or Gantry Slice____________________________ • Relocation Assistance • Technical Training Darrel Kile. We handle the purchasing of equipment, • Advancement Opportunities • Competitive Salaries and we can give you a good idea of the value of the Installed Y / N • Comprehensive Beneﬁts • Tuition Reimbursement equipment over the phone. It’s that simple! Floor Mount/Ceiling Mount_ _______________

THE BEST THE BUSINESS. Fax orJOIN e-mail yourTEAM info,INToday!

Software Level_ ________________________ Accessories / More Information_____________

Replace your Siemens Diagnostic X-Ray Tube with a New Varian!

OPTI 150

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Opti 150/30/50C Opti 150/40/82C Opti 150/40/73C Opti 150/40/80C

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Now Available! A New replacement for the Opti 150 housing:

Varian B-199

“All trademarked terms are property of the respective manufacturer.”

Siemens Trinity half page 2009.indd 1 18 | focalspot.SUMMER.2012

For more information go online for a datasheet, or contact your preferred dealer.

USA Contact Information Varian Interay 1-800-INTERAY TEL 1-843-767-3005 FAX 1-843-760-0079 E-mail interay.sales@varian.com

Europe Contact Information Varian X-ray Products Germany TEL 49-2154-924-980 FAX 49-2154-924-994 sales-xray@varian.com

12/9/09 10:26:55 PM

Course Index & Registration

X-RAY CERTIFICATE SERIES

WOMEN’S HEALTH

Phase I…………….……………………………………………................….….$4495 (for 2 weeks) Phase II…………………………........……………….………………… ……………….….$4695 (for 2 weeks) Phase III…………..……………………………….…………….……..……… ………….$4895 (for 2 weeks) Phase IV…………..……………………………………………….….……….….$49 ……….….$4995 (for 2 weeks)

Multi-Vendor (for 2 weeks) Vendor Mammography Systems...................................$5995 Systems........... Multicare Platinum.................................... .........................................................$2995 (for 1 week) (for 2 weeks) Hologic Selenia (DR) ...............................................................$12995 ............................. (for 2 weeks) GE Digital Mammography Family (DR) .................................$12995 ......... (2000D, DS, Essential) ..............................................$3995 (for 1 week) Multi-Vendor Bone Densitometry......

PACS Administrator/Engineer Certification Phase I…………….…………………………………........................... .............….….$4995 (for 2 weeks) Phase II……………………………………….………………….……… ……………..….$4995 (for 2 weeks)

Mobile C-Arms OEC 9600/9800.................................. ...................................................$6995 (for 2 weeks) (for 2 weeks) OEC 9800/9900..........................................................................$7995 9800/9900.................................. (for 1 week) OEC 9900.......................................................................................$4995 9900.................................................. Siemens Siremobile C-Arm Arm ........................................................$3995 (for 1 week) Philips BV Pulsera C-Arm Arm ............................................................$3995 (for 1 week)

RAD & R/F PRODUCT SPECIFIC GE Precision 500D………….……………………………………....……..….$9995 (for 2 weeks) GE Revolution Family: XR/d 1X & 2X (DR) …………….… ….…..….$9995 (for 2 weeks) GE Advantx Family..……….…………………………….…………… ……....….$5995 (for 2 weeks) (Advantx vantx 1, Advantx E, Legacy, Compax 40) GE Proteus XR/a .………………………….……………………..…… ……..………...….$3995 (for 1 week) GE Definium Family (DR)................................................ ................$9995 (for 1 week) (Definium 6000/8000, Discovery XR650/656, Optima XR640) Philips Bucky Diagnost….……………….……………………..……….. ………………..………...….$2995 (for 1 week) Private Practice X-Ray Systems….….……..……………..……….. ..……………..………...….$2995 (for 1 week)

Ultrasound Multi-Vendor (for 2 weeks) Vendor Ultrasound Systems...........................................$5995 Systems........

Management Capital Asset Management.........................................................$1995 (for 1 week) Management........................... Introduction to Networking & DICOM.........................................$1995 (for 3 days) DICOM.........

Cardiac CATH LABS Philips Integris R/F Cath Lab System........................... .......................$9995 (for 3 weeks) Siemens Axiom Artis (DR) .................................................. .............$14995 (for 2 weeks) GE Innova 2100/3100/4100 (DR) .............................. ................$14995 (for 2 weeks)

CT (Computed Tomography) Phase I..........................................................................................$4995 (for 2 weeks) ...............................................$5995 (for 2 weeks) Phase II..................................................... GE LightSpeed Multi-Slice.................. .......................................................$7995 (for 2 weeks) GE VCT....................................................... ..................................................$5295 (for 1 week)

Portable X-RAY GE AMX Portables: IV and IV Plus..................................... .....................$2995 (for 1 week) Shimadzu MobileArt Portables…….............................................$2995 ...............$2995 (for 1 week) Siemens Mobilett Portables........................................................$2995 (for 1 week)

Effective 6/1/12 Effective 06 0 6 /01/2012

Cancellation Policy - Tuition is only refundable if cancellation is received in writing by RSTI at least 14 calendar days prior to the course or seminar date. da Allow 30 days for receipt of the refund. Registrants who cancel within 14 days of the course or seminar eminar date will have the tuition transferred to another course or seminar on a space available basis. In the event that a co course does not attain our minimum enrollment, RSTI may postpone it. Paid tuition will remain on account to be applied to the rescheduled resche class.

Payment Due Policy - Payment for all courses and/or seminars is due three full weeks in advance of the course start date. Purchase orders are accepted, but also must be paid one week acce prior to the course start date. We also accept VISA, MasterCard, ard, American Express, and Discover as a method of payment. All past due invoices will be assessed a late fee of 1.5% per mon month on any unpaid balances.

Schedule - Typically, courses run from 8:30 am-4:30 4:30 pm Monday through Friday. You will receive a detailed detailed schedule when we confirm your registration. You should schedule your incoming flight to arrive Sunday afternoon or evening. On the last Friday, class ends at 12:00 noon. You may schedule your return flig flight ht any time in the midmid to late-afternoon. Full Coverage Package - You are responsible for expenses you incur while attending courses. However, RSTI has negotiated a reduced package rate that includes 12 nights hotel accommodations, transportation between the hotel and training center, breakfast, and lunch. lunch. We will notify you of this rate when you enroll; if you wish, we can add the full coverage package cost to your tuition. Course Materials - In addition to specially designed manuals and daily course handouts, you will also receive where appropriate:

• •

Document package of the lecture Flow diagrams

• •

Troubleshooting charts Performance evaluation forms

Class Photograph Certificate of Completion

Due to copyright issues, some courses require that students bring their own manuals. These may include, but are not limited to, Operators Manual, Service Manual and Schematics. We will advise you of this when you enroll.

Make checks payable to: Radiological Service Training Institute (RSTI)

• •

Tuition and Full Coverage Package rates are subject to change. Please confirm rates with our Registrar when you enroll.

HOW TO REGISTER: Phone 440.349.4700

•

Fax 440.349.2053

•

www.rsti www.rsti-training.com/register

How to register: Phone 440.349.4700 • Fax 440.349.2053 • www.rsti-training.com/register MAIL COMPLETED FORM TO: RSTI 30745 Solon Rd. Solon, Ohio. 44139 Mail completed form to: RSTI 30745 Solon Rd. Solon, Ohio. 44139 Course Name

Dates

1._________________________________________________________________

Course Name

_______________________________

Dates

_______________________________ 2._________________________________________________________________ 1. ____________________________________________________________________________________________ __________________________ ___________________________________________________________________

________ Full Coverage Package (Yes or No)

2. ____________________________________________________________________________________________ Title __________________________ Name of class attendee ____ ____ ____ ____

________ Bill my organization P.O. ________ Full Coverage Package (Yes or No) ________ Registration fee enclosed: $________ Bill my organization. P.O. No. __________________________ ________ Bill my credit card: _____MasterCard _____Visa Registration fee enclosed: $ __________________________ _____AMEX _____Discover Bill my credit card: ___ MasterCard ___ VISA

___________________________________________________________________ __________________________________________ Company/Organization Phone Name___________________________________________________________________ of class attendee Title Address Fax ___________________________________________________________________ Company/Organization Phone City State Zip ___________________________________________________________________ ________________________________________ Email Address FAX

Exp Date __________ Number: __________________________ ___ AMEX ___ Discover Signature (required): ______________________________ ___________________________________ Number: _________________________ Exp. Date: __________

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Signature (required):___________________________________

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WWW.RSTI-TRAINING.COM | 19

CRES Certification RSTI has made it easy for you to become CRES certified. Our CRES self-study package is a powerful tool to help you focus on specific certification objectives. There are nine different criterion-referenced modules that give a comprehensive review of subjects covered on the exam. The nine modules are entitled: • Anatomy and Physiology • Radiographic Physics • Electricity and Electronics • Radiographic Equipment Applications • Fluoroscopic Imaging • Radiographic Circuit Operation • Regulations and Laws • Technical Problem Solving • CRES Exam Review

Mastering these topics will enable you to succeed on the final CRES Certification Exam. With RSTI’s self-study CRES package you can learn anytime, anywhere, at your convenience and on your schedule. The modules contain both practice exams with answers and exams which can be returned to RSTI for grading. We are offering a 20% discount off of the list price of $398. The sale price is $318.40.

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30745 Solon Road Solon, Ohio 44139