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Derrumbamientos gammas de la cámara fotográfica, matanzas pacientes

por Loren Bonner, DOTmed News Online Editor | June 18, 2013
Infinia Hawkeye 4 SPECT/CT
from GE Healthcare.
A patient at James J. Peters VA Medical Center in the Bronx, New York, died on June 5 from injuries sustained while being scanned with a gamma camera. The camera apparently fell and crushed the patient.

According to information currently available, the gamma camera was an Infinia Hawkeye 4 SPECT/CT from GE Healthcare.

Benjamin Fox, a spokesperson for GE, told DOTmed News in an e-mail that GE Healthcare responded immediately upon being notified about the event "and is working with all appropriate government agencies to complete a thorough investigation."

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According to a report in the Wall Street Journal, the victim was a 66-year-old man. He was undergoing a procedure using the gamma camera when the apparatus collapsed and crushed him.

Because gamma cameras image gamma radiation emitting radioisotopes (that are injected into the patient), large and heavy panels of crystal insulated with lead are used to convert rays to light. They rotate around the patient.

A spokesperson for the medical center said the equipment was installed in 2006.

GE said it's the company's understanding that the gamma camera was not under a service contract with GE.

Officials are calling it a rare incident.

"This was a tragic incident, and our thoughts go out to the patient and his family. We are supporting the ongoing investigation into the cause of this incident," said GE.

GE has not yet been permitted access to the equipment and as a result, the company said they have not been able to determine the root cause of the incident.
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(1)

Theodore Warren

IT's Only Just Begun !

June 19, 2013 02:47

As Manufacturers continue to REFUSE TO SERVICE Instruments more than 7 years old as this obviously, Even Simple Maintenance of Electro-Mechanical Components as they used to Routinely in order to sell their Newer Instruments tragedies like this will be common place!

Not just major losses of Equipment as most are too Proprietary to have Serviced Privately By Experienced Engineers and Hospital Based Certified Medical Physicists anymore without Manufacturer Support, Ultra High Cost to Replace with Unnecessary Newer Models, still perfectly Viable and Safe to use if Maintained Properly, no Replacement Parts or Peripherals available but Bizarre Accidents like this will become prevalent, especially with the Huge Electro-Mechanical Components of these often HUGE 2 Ton Cameras or Older X-Ray, Fluoroscopes used in Angiograms and Arterial Stenting, Cancer Treatment etc.

IT will be interesting to find out how using "End of Life", Manufacturer "Officially discontinued Biomedical Equipment, after in many cases 7 years shakes out in Court! Should they be Officially Discontinued after the Manufacturer Refuses to Service Them, Not licensed or Allowed to Be Bought or Sold in the "Used Market" etc.

Are these highly expensive complex Instruments Still Legal to Use When Officially Discontinued by Manufacturers as is so common these days? Is the Manufacturer Liable for such Horrific Failures as this which NEVER WOULD HAVE HAPPENED if the Equipment was Properly INSPECTED and Tested as when still "Supported" by its Manufacturer? Given this latest Trend of Manufacturers to Prematurely Discontinue this type of Exotic Equipment that General "Techs" employed by the Owner would not have the slightest clue in Maintaining ?

In Light of this Totally Horrific and Unnecessary Tragedy Hopefully some Light will be shed on these Aspects as there is a LOT of OLDER Equipment Out there Still Being Successfully Used, Budget Cuts and Cuts in Insurance Reimbursements preventing already Financially Compromised Hospitals and other Medical Establishments from "updating" to New Equipment and Finally: Should Major Manufacturers be allowed to DISCONTINUE SERVICE arbitrarily after such a relatively short time of these Million $$ Mammoths knowing full well they are still being used worldwide ?

There is no doubt that these senseless tragedies will continue to increase as Similar Equipment Ages. For the Pt and family in this tragic Case hopefully justice will be served RIP

Ted Warren Ph.D.

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(1)

Adam Szopinski

Re: IT's Only Just Begun !

June 21, 2013 10:16

Truly accurate observation of the shortcomings of MFR greed and their insistence on making their own products obsolete in order to garner more business. As a materials manager of a surgical center, I can tell you firsthand accounts of the ridiculous nature of this practice. Perfectly fine equipment suddenly deemed obsolete and we are asked to purchase the 'improved' model. Well, we can't AFFORD the new model. And service contracts that tie your hands; once quoted a 5yr service contract for a laser that came in only $10K below the actual price of the unit!!! I suggested I'd might as well buy another unit to keep in storage.
Adam Szopinski

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Michael Blizzard

Re: IT's Only Just Begun !

July 13, 2013 10:57

I totally agree. The financial stress many health systems are under will significantly increase these types of unfortunate incidents. CMS is constantly cutting reimbursments for diagnostic imaging. Third party service contracts offer cheaper maintenance and equipment will be used way longer before its replaced. Dr Warren is correct..this is only just the beginning.

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Bill Schimmer

Inappropriate write-up

June 21, 2013 10:16

Dear Dr. Warren;
Your assumptions completely reject current GMP policies used by Biomedical Engineers industry wide. They demean the efforts of those departments to maintain a high level of patient safety and provide users with equipment that maintains budgets and procedurral ability. I reject your assumptions and assert that your article is designed to simply start a controversial dialogue.
Let's instead wait for the official report and identify means to provide patients, confidence that they can be diagnosed safely and accurately.

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(1)

Jonathan Berg

Assumptions

June 21, 2013 10:16

Wow - that's a lot of assumptions to make. Who said GE refused to service the unit? My understanding is that the VA typically takes over equipment service after the inital warrantee expires, using their own internal biomed engineers.

Hopefully the investigation will determine if it's a manufacturing defect, service deficit, material or mechanical failure.

It's a shame and the nightmare of any NM technologist.

Jonathan Berg, M.S., R.T.(R)(CT), CNMT, PET

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Brian Tunell

Infinia Hawkeye 4 incident

June 21, 2013 10:17

According to reports, this equipment was serviced by GE, and although it is seven years old, the Infinia Hawkeye 4 has not been EOL'd. It's still for sale by GE.

Whether it was serviced by GE, or a factory trained in-house Imaging group, it sounds more like a catastrophic failure of a detector mount, or the floor anchors (if the Gantry actually fell).

Either way, these terrible incidents do happen, even without human interaction.

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(7)

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Theodore Warren

G.E. And Other Biomedical Manufacturers Have Discontinued

June 24, 2013 05:09

MOST Biomedical Instruments have "DECLARED after 7 years "End of life", End of Service, "Sundowners etc. G.E. Is not the only in fact they are one of the better companies but Care Fusion, Natus who are "declaring" Their Products ENG OF LIFE after 7 years REFUSE TO SUPPORT THEM IN ANY WAY INCLUDING BASIC SERVICE, ROUTINE REPAIRS, RE-CALIBRATION,REPLACEMENT OF ANY ELECTRONIC OR ELECTRO-MECHANICAL COMPONENTS OR PARTS, EVEN "FLOW METERS" FOR PFTS which HAVE TO BE REPLACED q6 months or the machine senses their age and will not turn on. There are 100s perhaps 1000s of these STILL USEFUL Excellent Instruments in use Worldwide originally made by Viasys, another Brilliant Biomedical Engineering Company that Care Fusion bought out and immediately cut off supplying any type of Service Which My Firm Took Over for our Clients that are still using them. This "Flow Meter" which a Pt sitting in a PT Box like a telephone booth would respire through this tube when Open, when closed he would respire in the Closed Box with Measured amounts of 3 gases, 2 inert and when exhailing sensors in the "box" would sense the Volume of Air displaced by the movement of the chest, compare it to the Inert Volume used and the Instrument would provide accurate Information about the Capacity of the lower, Posterior of the lung (which a Spirometer cannot do). To make a long story short, Care Fusion DISCONTINUED sale of these highly Proprietary breathing tubes which Viasys sold for $ 250 before and NOW,being unavailable RENDER THE STILL TOTALLY USEFUL, ACCURATE, SAVE AND VIABLE INSTRUMENT USELESS.

We finally found one company in Italy that actually bought up large quantities of these "Flow Meters" and selling them now at $2,500- $4,000. Care Fusion has still not come up with an adequate replacement for the device and many Pulmonologists and Cardiologists etc still have them laying around USELESS! Care Fusions never Version is totally inferior and ridiculously OVERPRICED AT OVER 100k.

I doubt very much if the G.E. GAMMA CAMERA in question is still being supported as well as other Mammouth Radiological Equipment as well still WIDELY USED WORLDWIDE, still selling USED and unsupported at (I saw an ad in dot met for one) $130,000. Unlike Other Radiological Equipment that EMITS Radiation these Gamma Cameras may not be subject to the Federal, State and City scrutiny, mainly concerned with testing Emissions to see if minimal standards of Emission and Protection to Pt, Tech, other Offices are protected from dangerous RADIATION EXPOSURE.

THEY DO NOT CHECK THEM FOR MECHANICAL SAFETY NOR CAN ANYBODY WITHOUT THE SAME TRAINNING AS AIRLINE METALURGICAL SPECIALISTS HAVE TO EVALUATE THE METAL FATIGUE ROUTINELY. MECHANICAL AND AREONODICAL ENGINEERS TO EVALUATE THE HYDROLICS AND OTHER COMPLEX SYSTEMS OF PASSENGER JETS Q 6 MONTHS ETC ETC.

Think of all the HUGE Fluoroscopes used in Angiogram's, Basic X Ray Equipment, Instruments used for CA Treatment, Gamma Guns, MANY OTHER SIMILIAR DESIGNS which are BASICALLY THE SAME, WITH A PATIENT BEING SURROUNDED BY 2 LOADS = TO TWO or more "HONDAS" Emitters and Collectors being operated by a "Joy Stick" or other control with the touch of ones finger controlling these huge mammoth components SUBJECT TO THE SAME FORCES AS 747S, exactly the same forces as in Jet Engines inspected every 6 months or GROUNDED for METAL FATIGUE, CHANGED IF EVEN A MICROSCOPIC CREAK IS FOUND IMMEDIATELY!

The not equal of course but the PHYSICS IS! The Constant circling around a table, bending Metal Shafts back and forth, up and down... FOR YEARS WITHOUT INSPECTION! Complex Mechanics, Gears, Hydraulics, Bolts, Brackets subject to the SAME forces. You have to be CLUELESS if you think they do not have to be inspected and REPLACED even if working perfectly apparently which probably some MAINTENANCE STAFF can ACCOMPLISH BASICALLY but this is on an entirely DIFFERENT LEVEL OF EXPERTISE. The Manufacturer SHOULD KNOW and at least SHOULD RECOMMEND these Regular Inspections but Highly Trainned Personnel or at least Licensed Techs who go out and Check them Regularly! SUPPORTED OR NOT. This ALL has to be Tested in the Original Design and known before Licensed. THe Radiological components ARE and usually Strictly Tested by Federal and Local Officials for Safety SUPPORTED OR NOT by the manufacturer. These Instruments, Even if Declared "End of Life" are still LEGAL to use, Be Bought and sold, Maintained by AMATEURS.

The Manufacturers are DEFINATELY AWARE OF THESE PROPRIATARY FACTS and hopefully have them TESTED by Experts while the Instrument is under Service Contract. This is Engineering 101. Summarily declaring them "End Of Service" yet perfectly Legal and Medical Ethical To Buy and Sell in the Used Market by the FDA is an ACCIDENT WAITING TO HAPPEN. I see it all the time with Older Instruments, some with CRTs, Declare End Of Life but still being used by our Clients the 12,000 Volts Needed for Raster with a CRT over years, causing the Insulation to deteriorate and the Current Flying around even near the Patient Connections Looking for a ground to flow into, easily potentially arcing and the Patient the best "Ground" around go figure!

Question is SHOULD THESE INSTRUMENTS THAT ARE BEING DECLAIRED SUMMARILY "END OF SERVICE OR END OF LIFE BE ALLOWED TO BE USED WITHOUT MANUFACTUERER SERVICE OR SUPPORT ? We find ourselves more and more doing compiled revisions rather than Consulting for our Clients, Mostly without Manufacturer Support but We are Mostly all Certified Medical Physicists, Graduate Biomedical Engineers and Med Pros. About 1/2 the Biomedical Products being used are over 7 years old, perfectly Viable and Safe, Accurate etc.

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Prabhu Ethiraj

Patient death crushed under Infinia Hawkeye 4 SPECT/CT from GE H

July 04, 2013 08:41

Unbelievable. It is an incomplete narration of events. Infinia Hawkeye 4 SPECT/CT from GE Healthcare is a versatile machine. I am having a near 10 years old MPR SPECT Millennium Gamma Camera, which is fully functioning till date and properly maintained by the GE Engineers. Often the machine down time is few hours for some trivial soft ware issues and are immediately attended to. Possibly the said centre had compromised on the quality of medical personnel handling such sophisticated equipment. Please don't pass on judgements without having a complete picture of the incident, comprehensively considering the incident as a whole, in the interest of patient safety and comfort.

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Rocco Cuteri

Not the first time patient crushed by Gamma Camera

July 05, 2013 11:23

There was another case a few (more than 10) years back, I believe in Milwaukee, where a single detector camera being used to do a WB bone fell on a patient. I don't precisely remember the brand. This system had the gantry moving on the track, rather than a fixed gantry/moving table. The tech hit "home".The gantry moved to the head of the track and the head was rotating to the home position. The tech had left the step-stool right where the head wanted to be. As it came down on the stool handle, rather than stopping because of the resistance, it continued to rotate, lifting the gantry off the track and the gantry fell on the patient, killing them. The service reps were around in a few days putting yellow triangles all over the system, pending a permanent fix.

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