Frank’s Hospital Workshop – Free manuals and education

‘ In some developing countries, up to 50% of the medical equipment is unusable at any given time. In some hospitals, up to 80% of their medical equipment is inoperative… ‘
(World Health Organization, WHO)

Preface
The last ten years I have worked as a biomedical technician, consultant and trainer in five diverse developing countries. All these countries were very different, but the problems in the hospital workshops were similar:

 no spare parts for repairs and maintenance
 no technical manuals
 poorly or no trained biomedical technicians
 no (financial) support by the responsible authorities
 no technical support from the manufacturers
 lack of awareness of the advantages of preventive maintenance

Appropriate training for hospital technicians and simple equipment for hospital workshops would improve the situation easily. But unfortunately most countries still have not recognized the importance of the repair and preventive maintenance of hospital equipment.

I hope that this website can be a little support to all biomedical technicians in developing countries.
Here you find:

 all the documents about biomedical technology I have collected
 all the user and service manuals I have
 all training courses that I have developed and have held

About this site
http://www.frankshospitalworkshop.com is a private and noncommercial website which can be used for self-study. It is a collection of documents, experiences, best-practice procedures and teaching and learning materials about biomedical technology.

Acknowledgement and apologies
Thank you to all who actively support my website by providing documents and information. Special thanks to all the companies who allowed me to provide their equipment manuals. To those companies who do not want their documents to be made public I apologize and I will delete the material immediately upon request.

‘ On the average almost 80% of the medical equipment in government hospitals are not functioning and the number even reaches 98% in dispensaries in some regions. ‘

(Ministry of Health, Tanzania, 2008)

With greetings from Tanzania
Moshi, March 2013

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Training DVD locks up after equipment warranty is over?

I just had a call from an imaging engineer I know.  It seems that someone from his shop attended a Philips training school.  He returned from the school with a CD (or DVD) which had all of the service information on it.   It required a password to access the CD.   Well, when the warranty on the piece of equipment expired, the password to access the CD also expired, and Philips won’t issue another password.  Has anyone else heard of this?

Pat

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Medicare Proposes Ending Reimbursement for some PET Scans

As has been stated earlier – if a healthcare provider is depending upon past reimbursement rates to pay for future costs of medical devices, beware! CMS can change things almost at will.  Pat
Healthcare Business News

Limited funding

Plan for PET scans draws docs’ ire

By Jaimy Lee

Posted: March 30, 2013 – 12:01 am ET
In an effort to scale back use of high-priced imaging of questionable value in cancer treatment, Medicare has proposed ending reimbursement for post-treatment positron emission tomography scanning in prostate cancer patients and limiting its use to one scan for most other cancer indications.

Use of the technology, which involves injecting F-18 fluorodeoxyglucose (FDG) into the blood so the PET scan can identify regions of heightened metabolic activity, a sign of cancer metastasis, has grown sharply in recent years. The CMS, in giving preliminary approval to payments for the technology in 2005, required manufacturers and radiologists to establish a registry to monitor outcomes from its use.

The evidence garnered from that registry convinced the CMS that the scans provided no useful information for oncologists treating prostate cancer patients who had already completed their initial therapy, according to the March 13 proposed decision memo. “CMS believes at this point that the available evidence does not support the usefulness of FDG PET in beneficiaries who have completed initial treatment of prostate cancer,” the memo states.

The proposal drew fire from PET scan equipment manufacturers and the American College of Radiology, which represents physicians who administer and read the scans. “It’s a disappointment when something is not covered,” said Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, which represents imaging manufacturers. She expressed concern that the CMS’ recommendation will limit scans for patients who may require more than one study as part of their follow-up treatment.

Dr. Rathan Subramaniam, vice chair of the American College of Radiology’s nuclear medicine commission, said FDG PET imaging is useful for patients with aggressive forms of prostate cancer, including those with castrate-resistant prostate cancer, but agreed it is not as useful for patients with nonaggressive forms of the disease.

“Lumping it together (and) saying it’s not useful is not a good approach,” Subramaniam said. “It’s a valuable test in patients with aggressive prostate cancer. It should be funded.”

The recommendations are part of a broader effort by the CMS to evaluate what medical technologies it will reimburse through its coverage with the evidence development (CED) program, established under former CMS director Mark McClellan during the George W. Bush administration. The CMS says the program helps “address coverage of items and services that were believed to be promising but whose ultimate impact on Medicare beneficiary health outcomes remained unconfirmed.”

As part of the CED program, the National Oncologic PET Registry was established in 2005. The registry, which collects data from clinicians about PET scans and is managed by the American College of Radiology, last year requested that the CMS end data-collection requirements for FDG PET imaging used with cancer patients.

The CMS agreed, also proposing to end data collection for FDG PET scans in the March memo. An agency spokesman declined to comment further, citing the proposal’s comment period, which ends April 12.

Advanced imaging, which includes PET scans as well as computed tomography and magnetic resonance imaging, has often been cited as a major contributor to rising healthcare costs.

A study published in the Journal of the American Medical Association in 2010 found that the rate of increase in imaging costs for Medicare beneficiaries with cancer outpaced the rate of increase in total costs among the same patients from 1999 to 2006.

During the same time period, PET scans for prostate cancer patients reported the most significant annual increase in mean imaging procedure counts, compared with seven other imaging modalities such as CT scans and bone-density studies, even though the overall mean-imaging procedure counts for PET scans were far fewer than other modalities.

PET scans are usually more expensive than CT imaging, which is the most common follow-up treatment for patients with prostate cancer, said Dr. Kevin Schulman, associate director of Duke University’s clinical research institute and a co-author of the 2010 study.

“Trying to make sure that technology is being used appropriately is a critical issue,” he said. “It’s the cost and the impact on the (Medicare) program that is driving attention.”

The CMS’ proposed decision would directly affect regional CMS contractors who may make differing determinations on whether to reimburse more than one post-treatment PET scan for cancer patients. In those cases, it could come back to a national coverage decision, Schulman said.

The CMS has “taken a look at PET scans almost continuously for the last decade,” Schulman said. “They are going to stay involved in advanced imaging for quite some time given the costs of imaging.”

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Radiosurgery system prices rise nearly 80%

Radiosurgery system prices rise nearly 80%

By Jaimy Lee

Posted: March 25, 2013 – 1:30 pm ET
The average cost of stereotactic radiosurgery systems has increased by about 78% during the past year, according to the most recent Modern Healthcare/ECRI Institute Technology Price Index.

The index gathers monthly and annual price data for about 30 supply and capital items purchased by hospitals and other healthcare providers, based on three-month rolling averages.

The average price point for radiosurgery systems was $4.9 million in January of this year, a 77.7% increase compared with January 2012 and a 4.3% increase compared with December 2012.


Kevin Lee, a senior analyst in the ECRI Institute’s healthcare technology advisory service, attributed the cost boost to interest in newer and more expensive systems, such as the TrueBeam STx platform developed by Varian Medical Systems, a Palo Alto, Calif.-based device and software manufacturer.

The system costs between $3 million and $5.5 million—the higher prices usually take into account the purchase of other options and add-on technologies, Lee said. Older systems such as Varian’s Trilogy system usually cost between $2 million and $3.5 million.

“That’s what’s influencing the average cost,” Lee said.

Academic medical centers and cancer centers are most likely to purchase the higher-cost systems.

Varian and Stockholm-based Elekta are expected to introduce new platforms this year and Accuray, based in Sunnyvale, Calif., recently launched a new version of its robotic system. The new platforms could lead to higher averages costs across the board for radiosurgery systems, Lee noted.

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Biomerieux Vitek 2 decontamination?

Hi all!

I don’t have much experience with the lab analyzers but just wanted to run it across you all to see if this sounds absurd or not.  We have a Vitek 2 that needs to be moved to a different location.  Biomerieux wants to charge us $6000 to decontaminate prior to the move…or if we cut a PO for a new piece of equipment they will waive the fee, sounds fishy to me!  Couldn’t our lab staff take care of the decontamination and then just have Biomerieux do the install at the new site?  Or anyone know of a company that could take care of the decontam for us…for a smaller fee?

Thanks in advance!

Sarah

Here’s a link to the manual -

http://www.frankshospitalworkshop.com/equipment/documents/automated_analyzer/user_manuals/Biomerieux%20Vitek%202%20-%20User%20manual.pdf

from TechNation March 18, 2013

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Intuitive Surgical (DaVinci) – unnecessarily adding cost to healthcare

Fool me once, shame on you; fool me twice, shame on me

The people at Intuitive Surgical, the folks who made a fortune by marketing robotic prostate surgery to men across America, can’t be having much fun right now.  They have been hoping to expand their business in obstetrics and gynecology.  But look at these comments by James T. Breeden, president of ACOG:

Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.

Robotic hysterectomy generally provides women with a shorter hospitalization, less discomfort, and a faster return to full recovery compared with the traditional total abdominal hysterectomy (TAH) which requires a large incision. However, both vaginal and laparoscopic approaches also require fewer days of hospitalization and a far shorter recovery than TAH. These two established methods also have proven track records for outstanding patient outcomes and cost efficiencies.

At a time when there is a demand for more fiscal responsibility and transparency in health care, the use of expensive medical technology should be questioned when less-costly alternatives provide equal or better patient outcomes. 

At a price of more than $1.7 million per robot, $125,000 in annual maintenance costs, and up to $2,000 per surgery for the cost of single-use instruments, robotic surgery is the most expensive approach. A recent Journal of the American Medical Association study found that the percentage of hysterectomies performed robotically has jumped from less than 0.5% to nearly 10% over the past three years. A study of over 264,000 hysterectomy patients in 441 hospitals also found that robotics added an average of $2,000 per procedure without any demonstrable benefit.  

[A]n estimated $960 million to $1.9 billion will be added to the health care system if robotic surgery is used for all hysterectomies each year.

Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice. Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.

The stock market seems to be noticing:

6 comments:

nana said…

I remember when you were agonizing over whether/having to invest in robotic prostate equipment at the hospital because it was “all the rage” and the men would demand it and go elsewhere if not provided. Wonder if the outcomes are the same.

March 14, 2013 10:48 PM

e-Patient Dave deBronkart said…

From Facebook:

My extremely awesome urologist/surgeon Drew Wagner, who removed my kidney and adrenal gland laparoscopically *with bare hands*, says he does use robots sometimes. They’re extremely precise, not shaky, etc, for very fine work. The problem as Paul’s wording suggests, is that their marketing *increases* the amount of surgery, instead of just improving the quality of existing surgery. And since all surgery involves risk of harm, such marketing causes harm, IMO.

March 15, 2013 7:16 AM

Bill Reenstra said…

From Facebook:

It is my understanding that robotic procedures are always longer than comparable human (non-robotic) procedures. This increases the risk of infection of the open incision and risks associated with anesthesia.

March 15, 2013 7:17 AM

Beverly H Rogers said…

From Facebook:

Not only that you’ve got the learning curve for the surgeons learning to use the robot. Laparoscopic gyn surgery has been around for a long time.

March 15, 2013 7:17 AM

Barry Carol said…

This is another classic example of why doctors need to embrace knowing and caring about costs as an important part of their job. We need robust, user friendly price and quality transparency tools to help them do that with as little incremental demand on their time as possible.

March 15, 2013 7:43 AM

Jesse said…

Too bad unnecessary robotic surgery is not part of the choosing wisely campaign. Given the track record with Prostate surgery this (hysterectomy by robot) may become the norm as people vote with their feet based on the marketing hype. At our hospital we lost nearly all our prostatectomies to other institutions when we decided not to get a robot because there was no proven clinical advantage. Plus more and more residents are being trained primarily on the robot so if you don’t have one it becomes harder to recruit surgeons. Needless to say we now own a robot for surgeries.

March 15, 2013 8:05 AM

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Stryker has Neptune Problems (or their Customers Do)

Stryker slapped with FDA warning letter

By Damian Garde Comment | Forward | Twitter | Facebook | LinkedIn
The FDA issued Stryker a warning letter for improperly marketing devices, including Neptune.–Courtesy of the FDA

The FDA hit Stryker ($SYK) with a warning letter for failing to disclose a recall and selling devices without agency clearance.

Stryker revealed that the agency took issue with its quality systems and chided it for marketing the Neptune waste management system, among other devices, without attaining 501(k) clearance. The company didn’t disclose which recall irked the FDA or what other devices it sold without the agency’s OK, and a Stryker spokeswoman didn’t respond to a request for comment Tuesday.

The problems arose during a November inspection of Stryker’s Portage, MI, facility, the company said, and the FDA acknowledged that Stryker has already submitted corrective action plans to get clear of the warning. Stryker says it’s working with the agency to resolve the matter as soon as possible.

Just what the corrective process entails remains unknown. The FDA is generally sluggish to post warning letters on its website, and Stryker isn’t getting into any further detail. The company recalled Neptune last year, and the FDA applied its most-serious Class I designation to the move, but it’s unclear whether more recalls are coming as the agency cracks down on Stryker’s unapproved marketing of other devices.

- here’s the release

Stryker Receives FDA Warning Letter

March 12, 2013
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Kalamazoo, Michigan – March 12, 2013 – Stryker Corporation (NYSE: SYK) announced today that its Instruments division has received a warning letter from the U.S. Food and Drug Administration (FDA) related to observations made during a November 2012 inspection at its Portage, Michigan location.

The letter concerns quality system observations made during the inspection and cites Stryker for failing to notify the FDA of a product recall, and for marketing devices, including the Neptune Waste Management System, without a required 510(k) clearance. The letter acknowledged that Stryker Instruments has already submitted corrective action plans for the quality system and recall observations. The Company is fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit http://www.stryker.com.

Contacts

For media inquiries please contact:
Yin Becker, Stryker Corporation, 201-831-5000 or yin.becker@stryker.com

For investor inquiries please contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

Forward-Looking Statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system and the 2.3 percent medical device excise tax; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions, including the acquisition of Trauson Holdings Company Limited; and our ability to realize anticipated cost savings as a result of workforce reductions and other restructuring activities. Additional information concerning these and other factors are contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Read more: Stryker Receives FDA Warning Letter – FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/stryker-receives-fda-warning-letter#ixzz2NLtknH1A
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