RSTI FocalSpot > Spring 2012

SPRING 2012

RSTI-TRAINING.COM

RADIOLOGICAL service TRAINING INSTITUTE > News from the Leader in Radiological Service Training > ISSUE 2012.2

27 YEARS OF Maximum Value for Your Educational Growth and Development

President’s Letter..................2 Principle-Based Training......5 Monitor Calibration & QC.......6 Selecting the Right FPD........9 2012 Schedule.............. 10-11 Hidden Dangers............ 12-16 Course Index........................ 19 CRES Certification................ 20

THE KNOWHOW ISSUE

POWERED PRINCIPLED TRAINING State of OH Reg. No. 93-09-1377T ©2012 RSTI | Design by MossMedia

Our labs are energized with engaged learning on continuously upgraded equipment!

INDUSTRY SERIES The Hidden Dangers

THRIVING ALUMS A View from the Field

recognition and acceptance of his lifelong endeavor.

We worked with the local colleges and universities, as well as some online facilities, many times in search of one, very important part of his vision for RSTI. Terry used to ask me about my degree in Secondary Education, usually after a couple of beers at the local pub…He wanted to know what courses I took, how hard they were, and what the professors were like. You see, my friend, coveted the recognition that he believed until his last breath, came from a “baccalaureate” degree. Some nights that argument went on for hours, but in my mind he graduated Summa Cum Laude from the best University this world has to offer, “The University of Life Experience.”

You see Terry never realized that he had received multiple PhD’s along the way through his life of service to the medical industry. Take a look at his credentials: 1. PhD in Diagnostic Imaging Equipment Repair and Maintenance.

President’s Letter RSTI and Its Heritage The entrepreneur and visionary that started our training center in 1985 passed prematurely a bit more than three years ago at his home in Solon, Ohio. Terry had some favorite sayings, non-stop incredible stories and jokes and a love for education that rivals the finest Harvard PhD. When I would listen to him speak or teach, I was literally dumfounded by the extent of his accumulated knowledge base, but that was not the best part. He taught with the precision and skillset that only comes after making the subject matter your own and part of your life. He did just that.

What most people do not know is that my friend, Terry, always wished he had an accredited degree from a well-known college or university. His entire life he strove to provide academic credentials for his students and training institute.

Over the years we visited school after school in search of an alliance that, in his mind, would give global 2 | focalspot.spring.2012

2. PhD in Human Anatomy, Physics, Geometry and Mathematics.

3. PhD in X-Ray Principles, Properties and Use in Medicine.

4. PhD in Image Creation, Image Upgrade, Image Review, and Image Transfer.

I could continue, but I think you get the point on his personal accreditation and incredible acumen. In my humble opinion, my friend and partner over the last 10 years was a “freakin” genius, right up there with Dr. Einstein, Dr. Tesla, and oh yes, Dr. Roentgen. Was he a saint? Hardly…Did he make mistakes? Absolutely…You see he did whatever it took to nurture and protect his family, and often stood alone against all odds, right or wrong. If it took being dead right, he was game for that challenge too. As much as he loved his family, he also loved his “baby,” RSTI. He used every waking moment, thinking about how to nurture that baby for 25 years.

Around that passion, he was a great husband, great dad and great friend to those who took the time to know him well.

So what’s all the fuss about Big T at this point in time? Well, here are the reasons I have devoted this entire President’s Letter to the man who made all of this possible:

1. If he trained you personally I want you to know who you were privileged to work with at RSTI. I am here to tell you that his classes were something to treasure. Your Certificate from RSTI might be signed

by Terry Speth, but in truth you were taught by Terry Speth, PhD from the University of Life Experience.

2. If you were trained by our other instructors, you were still trained by Terry, because he taught everyone in our master instructor group. You see, being around Terry was like being around a bright star that just decided to go Nova. You had to be hit by his energy and his power in a way that will never leave you.

You know there is a Terry Speth Foundation that supplies funding for worthy students in need of financial assistance; however, what I am proposing is finding a school to honor Terry posthumously with an Honorary Doctorate in Diagnostic Imaging. This is a tedious task, especially since the world of academics is notoriously judgmental and moves like a tortoise. I will need support, not financial support, but written support of how this entrepreneur and visionary affected your life, whether you are newbie to the industry or have grown into a major position of authority in a hospital, ISO or 3rd party provider. I need to have 100 letters or emails to get started. Please take the time to drop me a line personally at RSTI or use my email, jmonro@rstitraining.com.

Thriving in the Field!

“I’m still employed by AGFA and because of your wonderful training I spent two weeks in Munich this year already. It seems they have me on a digital radiography track and I’m not switching off it. “

Stephen Calderwood

Agfa HealthCare Customer Support Engineer HE/FS Western Zone

________________________________

Another student makes good!

“One of your RSTI students is now employed

by Johns Hopkins. I got the job. I started the 2nd of March. Thank you to RSTI for giving me this opportunity. “

Matt Wilson

New Hire, Johns Hopkins

Jim Monro P re s ident & C O O

PS — RSTI and ECPI College of Technology in Charlotte, NC have just this month achieved a major milestone for Terry. We now have the first ever regionally accredited A.S. Degree in Diagnostic Imaging Service and Repair. This new associate’s degree is accredited by SACS. Next stop, a full B.S. degree for all those engineers in the field today!

Learn more at http://www.ecpi.edu/technology/medical-imaging-associate-degree

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Spring Into Principle-Based Training

By Dale Cover Spring is in the air but my thoughts are really set in summer mode. I am so ready to fire up the boat and take a cruise. There are just a couple issues to be dealt with though. The biggest is that last weekend I watched the first good size boat of the year attempt to make it up the river and slam hard aground, which reminded me the river is at least two months from being dredged for navigation.

Not to mention we will probably have at least one more significant cold snap before boating season really begins in late May. The docks still aren’t in; the engines are still winterized; the hull isn’t painted.

The point I’m trying to make is that even though I live 200 feet from where the boat gets put in and I could easily have it done, I have many necessary preparations before I can have a successful season. It is easy to make comparisons between my situation and getting started in the business of servicing diagnostic imaging equipment.

It sounds great to say we are going to drop all of our contracts and service the equipment in the imaging department ourselves starting next month. However, unless the personnel in the department are all five year plus veterans in imaging there may be a few things that need to be in place before taking on the job.

Training specific to the equipment may seem to be the most important thing when getting started but there is great value in principles-based training prior to the specific product training.

fluoroscopic systems, cardiac, vascular and special procedure rooms.

After I had a handle on the portables, radiographic and fluoroscopic systems, I would begin preparing to do at least first look service work on the Computed Tomography systems by taking RSTI’s Principles of Computed Tomography and Advanced CT Maintenance classes.

If I had multiple people in the department I would split them into different tracks after following the completion of the required X-Ray Phases.

Specialized tools and test equipment lists can be developed during training sessions.

This would be a good plan for anyone to successfully implement the personnel development needed to bring imaging service in-house, but there is still much more to know to manage the assets in the imaging department.

Capital Asset Management training seems like a natural program for the manager, but service engineers would also benefit from attending.

It is possible to bring imaging service in-house. In fact many facilities have. However, proper preparation is very important and it does take time. RSTI has been and will continue to be there to help you succeed in this endeavor.

If I were to develop a service department, I would start with X-Ray Phase I and II then either Phase III if Fluoroscopy is required, or PACS Phase I. Then I would look at the product specific training.

When considering product specific training, I would start with portables, mobile c-arms, ultrasound and radiographic systems (even if they are digital). Then I would continue with the bigger stuff like radiographic/ WWW.RSTI-TRAINING.COM | 5

Take Control of Monitor Calibration & QC These industry accepted standards help establish baseline requirements for monitors that include: DICOM GSDF (Grayscale Standard Display Function) calibration Luminance Resolution Reflection Geometric distortion

By Todd Boyland

Noise

RSTI will soon be introducing a new training course dealing with monitor calibration and quality control.

Our newest course, “Monitor Calibration and QC Program for Medical Displays,” is being designed to help implement an in-house calibration & QC program for medical monitors.

Glare

Display technology QC programs are critical in today’s radiology departments. A lack of diagnostic confidence resulting from poor display performance can have serious implications on a radiology department.

Today’s PACS can include hundreds of monitors spread throughout many departments, even remote locations.

How do we know that the same image being viewed in two locations appears the same to both physicians?

A well documented QC program will ensure all physicians within a workflow (even at different locations) are viewing the same image quality as their peers. Many departments hear that their display systems are “self-calibrating,” and can be falsely lulled into thinking QC is not necessary.

This course is designed to interpret the guidelines created by organizations like ACR (American College of Radiology) and AAPM (American Association of Physicists in Medicine). These guidelines can be used to create a customized display QC program for your facility.

6 | focalspot.spring.2012

Chromaticity Display artifacts

Topics covered in the course include: Current display technology for both “Diagnostic” and “Referral” monitors What defines a “medical grade monitor” Tools and equipment required for calibration and QC Automatic calibration support Manual calibration Enterprise QC management software R e c o m m e n d a t i o n s a n d r e q u i r e m e nt s f o r acceptance testing, performance criteria and testing frequency Look for details in the second half of 2012 for RSTI’s newest course, “Monitor Calibration and QC Program for Medical Displays,” which will most likely be a 3 day course offering.

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8 | focalspot.spring.2012

Selecting the Right FPD

Selecting the Right FPD

Digital radiologic imaging systems use a wide variety of flat panel detectors whose makeup is of a photostimulable storage phosphor (PSP). This is the material which is used to store/transfer the i age charge information. This includes amorphous selenium, amorphous silicon, charged coupled vice (CCD), and metal oxide semiconductor-field effect transistor (MOSFET). The purpose of this cle is to evaluate each of these materials and describe the advantages of each.

By Larry Cornell Digital radiologic imaging systems use a wide variety of flat panel detectors whose makeup is of a photostimulable storage phosphor (PSP). This is the material which is used to store/transfer the image charge information. This includes amorphous selenium, amorphous silicon, chargecoupled device (CCD), and metal oxide semiconductorfield effect transistor (MOSFET). The purpose of this article is to evaluate each of these materials and describe the advantages of each.

First, let’s see who uses what!

As you can see from the chart, most major DR manufacturers use the indirect amorphous silicon CsI input receptor as compared to the direct a-selenium method. It should be noted that all panels start with the amorphous silicon panel and then the panel is either layered with CsI (indirect) or a-selenium (direct) to act as the input substrate. The question now is why are there two choices and which one is best? (See Fig. A) As you view the major vendors on the chart, it seems that the indirect CsI layered amorphous silicon is the panel of choice. So why do Lorad and Fuji offer a-selenium FPD to their users instead?

Look for Part 2 in Summer FocalSpot!

First, let’s see who uses what.

Fig A

Detector Types used for Digital Radiography Technology

Vendor

Detector Indirect CsI

Flat Panel

GE Philips Siemens

a-Silicon Panel

What’s the Difference

Toshiba Direct a-Selenium

What’s the Difference The following shows the makeup Lorad of the two differ Fuji theirfollowing operation.

This the is followed a check list tha The shows makeup by of the two differen weakness and This allow toUsage choose which list panel Detector Types and their operation. isyou followed by a check thatis As you can see from the chart, most major DR manufacturers use the indirect amorphous silicon C weakness and allow you to choose which panel is input receptor as compared to the direct a-selenium method. It should be noted that all panels sta

with the amorphous silicon panel and then the panel is either layered with CSi (indirect) or a-selen (direct) to act as the input substrate. The question now is why are there two choices and which on With a-S best.

a-Silicon Array with CsI a-Silicon Array with CsI

tached to With a-Silic

Figview B the major vendors on the chart, it seems that the indirect CSI layered amorphous sili As you is the panel of choice.. So why does Lorad and Fuji offer a-selenium FPD to it’s users instead? the the tached to it

Conventional Phosphor Conventional Phosphor

What’s the Difference?

The following shows the makeup of the two different FPDs with a brief description of their operation. This is followed by a check list that will show you the strength and weakness and allow you to choose which panel is right for your application.

With a-Silicon FPD a layer of cesium iodide CsI is attached to the a-silicon array and when radiation strikes the input phosphor it gives off light like an image intensifier. The light output is transferred to the Amorphous Silicon Array and the equivalent charge is stored waiting transfer. Since the light is spread through the CsI, image quality (MTF) is primarily determined by the quality of the CsI layer. (See Fig. B)

(Part 1 of 2 Part Series)

CsI Crystal

intensifie the the inp the Amo intensifier charge is the Amorp charge is th s spread spread thr ly determ ly determin

CsI Crystal

Fig C

a-Selenium Flat Panel Detector a-Selenium Flat Panel Detector

With Amorphous Selenium FPD the radiation strikes the Selenium layer and the x-ray is converted to an electrical signal thus eliminating the conversion of light and the scatter created by the CsI. This produces a higher MTF and somewhat better image quality.

(See Fig. C) WWW.RSTI-TRAINING.COM | 9

With With the Am Se the Sele electr electric light a light es aanh es a hig

RSTI 2012 Training Schedule April 18, 2012

TRAINING COURSE TITLE

April 2

9

16

May 23

30

Apr 30-­‐ May 11

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

X-RAY CERTIFICATE SERIES

7

14

21

June 28

MANAGEMENT

PRODUCT SPECIFIC

2

June 4-­‐15

PACS Engineer/Administrator Certification (Phase I) PACS Engineer/Administrator Certification (Phase II) June 25-­‐29

Introduction to Networking & DICOM C.A.M. (Capital Asset Management) GE Advantx 1, Advantx E, Legacy, Compax 40

*April 10-­‐20

Definium Family (5000, Sedecal Optima URS+ LP, Meridian X100/RadPro URS)

*April 10-­‐20

June 18-­‐29 June 18-­‐29

GE Precision 500D R/F GE Revolution Family (XR/d 1X & 2X)

May 21-­‐25

GE AMX Portables (IV, IV+) Multi-Product C-Arm OEC 9600/9800 Apr 23-­‐ May 4

Multi-Product C-Arm OEC 9800/9900

M E M O R I A L

June 4-­‐15 June 18-­‐29

June 18-­‐29

June 11-­‐15

C-Arm OEC9900 Apr 30-­‐ May 11

Siemens AXIOM Artis Family (FP)

CARDIAC

25

June 18-­‐29

Advanced Fluoroscopic System Maintenance (Phase III)

GE Proteus ( JEDI Generator)

C-ARM

18

May 14-­‐25

Advanced Radiographic System Maintenance (Phase II)

GE Discovery Family (Definium 6000, Discovery XR 650, Optima XR 640)

PORTABLES

11

May 14-­‐25

Advanced Diagnostic Imaging System Analysis (Phase IV)

NETWORKING & DIGITAL INFORMATION

4

May 14-­‐25

GE Innova (2000)

D A Y

I N D E P E N D E N C E D A Y

Philips Integris Cath Lab System (Includes Generators) Analog Multi-Vendor Mammography (GE, Lorad, Siemens) Lorad Multicare Platinum Breast Biopsy System

WOMEN'S HEALTH

GE Digital Mammography Family (2000D/ DS/ ESSENTIAL)

*April 10-­‐20

Digital Mammography (Hologic Selenia)

May 14-­‐25 June 4-­‐15

Lorad MIV Platinum and ACR

Ju 9-­‐

Multi-Vendor Bone Densitometry

ULTRASOUND

Multi-Vendor Ultrasound Principles of Servicing Computed Tomography Systems (Phase I)

CT

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

Exhibits, Presentations And Special Notes

10 | focalspot.spring.2012

Thru April 6 * Class starts Tues.(Easter) MD EXPO April 11-­‐13

VIP May 14-­‐18

AAMI Jun 2-­‐4

CMBES Jun 19-­‐22

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

July 9

16

August 23

30

6

13

July 9-­‐20

September

20

27

3

10

17

October 24

1

Aug 20-­‐31

8

15

November 22

29

Oct 1-­‐12

July 23-­‐ Aug 3

5

12

19

December 26

3

10

17

24

31

C H R I S T M A S

N E W

Nov 5-­‐17

Sept 17-­‐28

Nov 26-­‐ Dec 7

Aug 6-­‐17

Oct 15-­‐26 Aug 20-­‐31

Nov 5-­‐17

July 9-­‐20

Dec 10-­‐21 July 23-­‐ Aug 3

July 30-­‐ Aug 3 Oct 22-­‐ Nov 2 Oct 1-­‐12

Dec 10-­‐21

Aug 20-­‐31

Nov 26-­‐ Dec 7

Aug 20-­‐31 Sept 24-­‐ Oct 5

L A B O R

July 30-­‐ Aug 3 Aug 6-­‐10

Aug 6-­‐17

D A Y

Nov 5-­‐17 Oct 29-­‐ Nov 2 Oct 22-­‐26

Oct 22-­‐ Nov 2 Oct 15-­‐19 Sept 10-­‐21

Aug 6-­‐17

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

Dec 10-­‐21

Dec 10-­‐21

Y E A R S

Nov 26-­‐ Dec 7

Aug 27-­‐31 July 23-­‐ Aug 3

Oct 8-­‐19 Sept 10-­‐21

Nov 26-­‐ Dec 7

uly -­‐13

Oct 15-­‐19

July 9-­‐20

Nov 5-­‐17 Sept 24-­‐ Oct 5 Oct 8-­‐19

FIME Aug 8-­‐10

NCBA Sept 12-­‐14

FBFBS Oct 26-­‐28

RSNA Nov 25-­‐30

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

The Hidden Dangers The Current State of Validation, Testing, and Quality of Medical Device Software Special Report by Mike Shouppe University of West Florida Software has become a critical component of almost every medical device in use today. The shift from electromechanical to software embedded devices has allowed the health care field to advance exponentially.

However, coupled with the historically poor software development methods of the last few decades, we see that there still remains much work to improve the reliability of software in medical devices. This paper examines the current methods of software quality development, particularly testing and validation, being used in the medical device industry.

Why Test?

According to Myers (1979), software testing is the process of executing a program or system with the intent of finding errors. It can also be described as any activity aimed at evaluating an attribute or capability of a program or system and determining that it meets its required results (Hetzel 1988). These two fundamentals of software testing are extremely important in the production of high quality software. When embedded into medical devices, these fundamentals are even more important as defects can literally mean the difference between life and death.

Unfortunately, we have a multitude of software engineering flaws that teach us what not to do. Many of these flaws may have been found during validation, but were ultimately detected after patients were severely injured or killed. The most infamous medical software defects were introduced in the Therac-25 linear accelerator manufactured by AECL, or Atomic Energy of Canada Limited. These devices were responsible for overdosing at least six patients with more than 20,000 times the normal dose of radiation. This proved fatal for all but one woman who ultimately lost all motor function of her left arm. A paper written by Nancy Leveson and Clark Turner (1993) details the events that occurred between the users, AECL, and the US Food and Drug Administration. It was concluded that a single software flaw did not cause the deaths of at least 12 | focalspot.spring.2012

six people, rather it was caused by several separate software flaws. It was also later found, and documented in several internal FDA memos, that the Therac-25 subroutines that were responsible for the adverse events were created by a single programmer. The FDA also discovered little documentation along with no test plan. Coupled with the fact that AECL only tested the machine as a complete system with absolutely no unit or component testing meant that catastrophic failures should have come without surprise. The designers at AECL relied solely on the ability of software to safely treat critically ill patients. This was uncommon as all linear accelerators manufactured before (and since) have redundant hardware interlocks to prevent deadly accidents such as these. The medical industry learned from this mistake quickly. However, if the medical industry has learned anything from the lack of software development and verification is yet to be discovered.

Because of the Therac-25 incidents, the FDA increased their involvement in reviewing the development of medical device software including most recently a software laboratory within the Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEL) ( Jones, Jetley, and Abraham 2011). Hiring experienced software specialists by the FDA was inevitable as the content and complexity of embedded software in medical devices has consistently increased since the mid-1980s. Today, state of the art pacemakers may contain up to 80,000 lines of code while infusion pumps may have more than 170,000 lines of code ( Jones, Jetley, and Abraham 2011).

Because of the work of the OSEL, the FDA has become better prepared to deal with software defects. This is evident in the number of software related recalls that have been initiated by the FDA. The FDA’s analysis of 3140 medical device recalls conducted between 1992 and 1998 reveals that 7.7 percent of them are attributable to software failures (FDA 2002). Other studies (Rakitin 2006) show an increase of software failures between 1996 and 2006 at 21 percent.

Because FDA recall data is

...continued on Page 14

Date

Device

Reason for Recall

Possible Adverse Effects

2/17/07

LifeLine Automated External Defibrillators

Self-test software clears previous low battery alarms

Interruption of therapy during cardiac arrest

2/21/07

Alcon LADAR6000 Cataract Extraction System

Incorrect laser-power algorithm leads to ineffective treatment

Irreversible eye damage including blindness

6/6/07

Bayer Ascensia Contour Blood Glucose Monitoring System

Non-standard measurement units used for results (e.g. mg/dL vs. mmol/L)

Over/Underdosing of insulin

6/27/07

Baxa Corp. Exacta-Mix 2400 Rx Compounding System

Incorrect compounding levels of intravenous medicine

Medication overdose

8/24/07

Welch Allyn AED20 Defibrillator

Random communication error during treatment will not clear causing terminal failure of the device

Interruption of therapy during cardiac arrest

8/28/08

PhysioControl LifePak CR Defibrillator

GUI button for delivering shock is covered by another GUI component

Interruption of therapy during cardiac arrest

1/12/09

Alaris Medley IV Pump

Software fail-safe doesn’t detect free-flow condition of medication

Medication overdose

10/26/09

Stryker OR System II Surgical Navigation System

Software freezes or runs slowly during treatment

Injury or death due to wrong-site surgery

12/16/09

Abiomed AB5000 Circulatory Support System

Computer may shut down without any alarms

Rapid serious injury or death

2/22/10

Hospira Symbiq IV Pump

The “Check Flow Stop” alarm, which is designed to notify users of a free flow condition, may not function as intended

Interruption of medication therapy leading to injury or death

4/30/10

Alcon Research Constellation Vision Surgery System

Unintended error messages and non-responsive touchscreens.

Interruption of therapy leading to blindness

7/13/10

Carefusion Alaris PC IV Pump

Communication error freezes the main screen

Interruption of medication therapy leading to injury or death

8/24/10

Outlook 400ES Infusion

Communication error halts

Interruption of medication therapy

WWW.RSTI-TRAINING.COM | 13

The Hidden Dangers ...continued from page 12 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 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).

14 | focalspot.spring.2012

Though the regulation is applicable throughout the entire process of manufacturing (hardware, software, 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.

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.

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 cannot ingest food normally) fails, there is no chance the patient will be injured or killed immediately. On the other hand, if an infusion pump (used to deliver intravenous medications) infuses the incorrect dose, injury or death can occur in less than a minute. The FDA recognizes this difference in risk and provides instruction that based on the devices’ intended use “the software developer should determine the specific approach, the combination of techniques to be used, and level of effort to be applied” (FDA 2002).

...continued on Page 16

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The Hidden Dangers ...continued from page 14 What are manufacturers doing?

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.

The future Medical device software (along with every aspect 16 | focalspot.spring.2012

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.

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

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

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

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-based-verification-approach-to-medical-devicesoftware-analysis?pageNumber=0 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.

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

U.S. Food and Drug Administration. (2011). Recalls, Corrections and Removals. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequire ments/RecallsCorrectionsAndRemovals/default.htm

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

Germain, J. (2010). The gaping hole where auto software standards should be. TechNewsWorld.

Retrieved from http://www.technewsworld.com/story/69571.html?wlc=1302135972

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

General Electric Company. (2011). GAMP5 – a lifecycle management framework for customized bioprocess solutions. Retrieved from

http://www.gelifesciences.com/aptrix/upp00919.

nsf/Content/A8FF0950E1AB1DDEC125783B000435AF/$file/28989873AA.pdf

Philips Healthcare. (2009). C# coding standard. Retrieved from http://www.tiobe.com/ content/paperinfo/gemrcsharpcs.pdf

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Course Index & Registration Cancellation Policy

X-Ray Certificate Series

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

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

RSTI PACS Administrator/engineer certification

Phase I...........................................................................$4995 (for 2 weeks) Phase II..........................................................................$4995 (for 2 weeks)

Payment Due Policy

RAD & R/F Product specific

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 prior to the course start date. We also accept VISA, MasterCard, American Express, and Discover as a method of payment. All past due invoices will be assessed a late fee of 1.5% per month on any unpaid balances.

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 1, Advantx E, Legacy, Compax 40) GE Proteus XR/a.............................................................$3995 (for 1 week) Definium Family (DR)...................................................$9995 (for 2 weeks) (5000, Sedecal Optima URS+LP, Meridian X100/RadPro URS) Discovery Family (DR).................................................$9995 (for 2 weeks) (XR 650, Definium 6000, Optima XR 640)

Schedule Typically, courses run from 8:30 am-4:30 pm Monday through ­Friday. You will receive a 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 flight any time in the mid- to late-afternoon.

Cardiac CATH LABS

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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. We will notify you of this rate when you enroll; if you wish, we can add the full coverage package cost to your tuition.

Portable X-RaY

GE AMX Portables: IV and IV Plus.................................$2995 (for 1 week)

WOMEN’S HEALTH

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

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Mobile C-Arms

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Ultrasound

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.

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

Management

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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.

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