Warung Bebas

Kamis, 15 Desember 2011

Wisata Kuliner Jakarta Terlezat

Ibu kota Jakarta merupakan salah satu pusat kota terbesar di Indonesia yang sangat ramai dikunjungi baik dari orang - orang dalam negri maupun dari luar negeri karena memang disana terdapat berbagai tempat wisata dan masakan kuliner yang harus dicoba. Wisata kuliner Jakarta memang terkenal enak dan lezat, karena masakan dari kota Jakarta terkenal khas dan tidak mudah dilupakan. Berikut adalah beberapa wisata kuliner jakarta yang harus anda coba ketika datang di Jakarta.

Wisata Kuliner Jakarta

1. Kerak Telor. Kerak telor ini memiliki cita rasa yang sangat khas sekali, yaitu sangat gurih sekali. Terbuat dari bahan dasar beras ketan putih, telur ayam atau bebek juga bisam udang goreng kering, bawang merah goreng, kelapa sangrai, cabai merah, kencur, jahe, merica, garam dan juga gulan pasir.


2. Ketoprak. Makanan ketoprak ini sangat mudah sekali dijumpai di beberapa tempat di Jakarta. Isi dari ketoprak ini adalah kupat/ lontong kemudian tahu, bihun, ketimun, tauge dan juga dilengkapi dengan bumbu kacang, kecap, bawang goreng yang membuat rasanya semakin nikmat dan lezat. Untuk mempercantik penampilannya tidak lupa juga biasanya diberikan krupuk berwarna - warni untuk menambah kesan makanan menjadi lebih ramai dan sedap.


3. Sayur Gabus Pucung. Kuahnya terbuat dari buah pucung atau keluwek, sehingga warnanya agak gelap, namun untuk masalah rasanya tidak usah ragu karena rasanya sangat enak dan segar. Sayur ini dipadukan dengan ikan gabus yang empuk dan gurih. Jangan sampai melewatkan kuliner yang satu ini ketika datang ke Jakarta karena rasanya dijamin akan membuat lidah anda ketagihan untuk terus memakannnya.


4. Soto Betawi. Makanan ini cukup populer di Jakarta karena memang rasanya tidak ada duanya. Terbuat dari campuran daging dan jeroan sapi serta kuah kental yang membuatnya semakin segar dan sangat gurih. Cocok bagi anda yang suka dengan makanan pedas dan panas.


Wisata Kuliner

Itulah beberapa wisata kuliner Jakarta yang patut anda coba ketika datang ke ibu kota Jakarta ini. Anda akan merasa ketagihan dan ingin mencobanya kembali karena memang resep masakan khas dari jakarta yang membuat semua makanan ingin selalu dikonsumsi. Semoga bermanfaat.

Medtronic Settles, Yet Again

And the march of legal settlements continues... Circling around the block and coming in front of the viewing stand again is device manufacturer Medtronic. 

The Latest Medtronic Settlement

As Bloomberg reported:
Medtronic (MDT) Inc., the world’s biggest maker of heart rhythm devices, agreed to pay $23.5 million to settle claims it paid kickbacks to doctors who implanted its pacemakers and defibrillators in patients, the U.S. Justice Department said in a statement.

Medtronic agreed yesterday to settle two lawsuits filed in federal courts in California and Minnesota accusing the company of violating the federal False Claims Act by paying physicians $1,000 to $2,000 for each patient who was implanted with one of the company’s devices, according to the Justice Department.

'Patients who rely on their health-care providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,' Tony West, assistant attorney general for the Justice Department’s Civil Division, said in an e-mailed statement. 'Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.'

As usual, Medtronic did not admit doing anything wrong:
Medtronic said in an e-mailed statement that it makes no admissions that the studies were 'improper or unlawful.' The company also said it established a reserve for the anticipated payment in the fourth quarter of fiscal year 2011.

'We are happy that the investigation is behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes and cost effectiveness,' Marshall Stanton, vice president of clinical research and reimbursement for the cardiac and vascular group....
Previous Legal Settlements by Medtronic
Note that this is not the first time Medtronic has been accused of paying doctors (kickbacks, this time, which seem to be the ethical equivalent of bribes) to use its products. The Bloomberg report also noted:
In 2006, Medtronic agreed to pay $40 million to settle allegations that its Sofamor Danek unit violated state laws and the False Claims Act by paying sham consulting fees and providing lavish trips to doctors who used its products from 1998 to 2003.
Perusing the Medtronic file on Health Care Renewal also showed that Medtronic has had to settle other lawsuits alleging misconduct:

- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link here)
- In 2010, Medtronic settled multiple civil lawsuits for $268 million for allegations that it marketed an implantable cardiac defibrillator with faulty leads whose failures lead to 13 deaths (link here)

Cases of Apparent Conflicts of Interest Generated by Medtronics' Payments
In fact, paging through the Medtronic file on Health Care Renewal, we also found these cases of apparent conflicts of interest that Medtronic caused by making payments to or otherwise creating financial relationships with:

- FDA advisory board members (2007 link here),
- health care professionals who appeared on public television programs about heart disease and treatments of it (2007 link here),
- members of a non-profit organization which was supposed to guide the FDA regarding drug development  (2007 link here),
- prominent academic orthopedic surgeons who were in positions to influence other physicians' choices of orthopedic devices (2008 link here and 2009 links here, here and here),
- a military surgeon who wrote questionable articles about the supposed virtues of a Medtronic bone growth product (2009 link here),
- a top leader of US Veterans Affairs Department who objected to the appointment of an industry critic as US Surgeon General (2010 link here),
- spine surgeons apparently who could promote Medtronics' spine surgery products in (2010 link here) and who did not disclose all such payments when writing ostensibly scholarly articles on the subject (2010 link here)

So prior to the current settlement for "alleged" kickbacks, Medtronic had a long history of allegations that it had financial relationships with physicians who were in a position to promote the use of its products or its policy interests.

Why the Bad Behavior Continues

The latest settlement by Medtronic illustrates why the anemic approach by US government agencies to health care corporate misbehavior does not deter bad behavior.

- The punishment was a fine not large enough to have any effect on the finances of the corporation.. Such a relatively small financial penalty might just be seen as a cost of doing business by company executives.  (See these comments on the current case by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.)
-  The punishment was not a result of any specific bad behavior.  In this case, like many others, the corporation did not have to admit to anything.  This leads to the paradox of a punishment meted out for apparently nothing other than "alleged" actions, making it appear that the actual punishment was just a payment by the company to allow it to continue the sorts of actions that were alleged with impunity.  (Such punishments without clear crimes happen all the time in cases affecting the finance sector.  See a federal judge's condemnation of this practice here.) 
-  The punishment seems unrelated to the corporation's historic behavior.  In this case, there was no reference to the company's previous settlements, or the other allegations of questionable payments to physicians and health care decision makers in other circumstances listed above.  (Keep in mind that Health Care Renewal strives to present interesting cases, but does not have the resources to report on every single case of bad behavior by health care organizations.  Hence the list above of apparent bad behavior may not be complete.)
-  The punishment applied to the corporation as a whole, and hence may disadvantage many people, stockholders and corporate employees in particular, who had nothing to do with the alleged bad behavior.  On the other hand, those who authorized, directed, or implemented the bad behavior were not subject to any negative consequences. 

So why on earth would corporate leaders cease bad behavior which could increase revenues short-term and hence increase their compensation (e.g., in 2011, the Medtronic CEO received $9,624,709 according to the 2011 proxy statement), when the likelihood of any negative consequences for them appears to be near zero? 

This would be bad enough if the bad behavior only causes financial disadvantage for stockholders or corporate employees.

However, the bad behavior in question seems to repeatedly involve paying physicians and other health care decision makers in ways likely to influence their decisions in favor of Medtronics' products and corporate well-being.  Making decisions this way, however, is unlikely to be good for patients' and the public's health, as it is likely to lead to excess use of expensive tests and treatments that may have adverse effects, sometimes severe.  Thus patients may suffer unnecessary morbidity and mortality, and the public at large may pay far too much for medical care.

So will we see in our lifetimes honest, tough policing of health care corporate behavior?  Will the punishments start to fit the crime, and will they be significant enough to deter future misbehavior?  Why do we continue to accept government actions that seem more solicitous of the executives of big corporations than the public for whose benefit government is supposed to be run?  Where is the outrage?   

So, once more, with feeling.... in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.

ADDENDUM (15 December, 2011) - On the GoozNews blog, Merrill Goozner called Medtronic's actions "a crime against science."

Rabu, 14 Desember 2011

A Sign of the Times

Every now and then, I venture out to go shopping at mainstream chain clothing stores.  Although I find it onerous, there are certain things I can't get at thrift stores.  For example, I can never find nice jeans.

The last time I set foot in these stores was about two years ago.  It was tough to find pants my size at that time-- many stores simply didn't sell pants with a 30 inch waist.  This year, it was even harder, since some of the stores that formerly carried 30W pants no longer did.  I managed to find my usual 30W 30L size in two stores, but I had a bizarre experience in both cases.   I put them on, and they were falling off my waist.  Since my waist size hasn't changed in two years, and my old 30W 30L pants of the same brand still fit the same as they did when I bought them two years ago, I have to conclude that both stores have changed their definition of "30 inches".  My new size is 28W 30L, which is tough to find these days.
Read more »

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall:


FDA Recall notice

Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
Recall Class: Class I [the most serious type of recall, see below - ed.]
Date Recall Initiated: October 18, 2011
Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510
All serial numbers are affected by this recall.

This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011.

Use: This product is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs.

Recalling Firm: Draeger Medical, Inc. 3135 Quarry Rd., Telford,
Pennsylvania 18969-1042

Manufacturer: Draeger Medical GmbH, Moislinger Allee 53-55_23558, Lubeck, Germany

Reason for Recall: The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station.

This product may cause serious adverse health consequences, including death.


Public Contact: Draeger Medical, Inc. 3135 Quarry Road Telford, Pennsylvania 18969-1042_215-660-2349

FDA District: Philadelphia

FDA Comments: On October 17, 2011, the company sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended.

Additionally, the company’s letter states that users should follow the instructions for Use of the Infinity Acute Care System Monitoring Solution. The Instructions for Use includes, "For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient's status." [That is, clinicians should work around the device's defects, which would seem to hold the computer's rights over the patients' rights -- rather than taking the device out of service immediately and having the vendor fix it - ed.]

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. Yes, acute care environments are not unpredictable, chaotic environments often moving a mile a minute. They are precisely the environment where everyone can sit around on their butts and leisurely hold, over pizzas and cokes, a committee meeting where each and every move can be discussed, just like in a software development shop ...

I also find the statement that this medical device was "distributed only to the Rush University Medical Center" remarkable. If true, it raises a number of issues that make me very uncomfortable:

  • How did the company's letter to Rush make its way to FDA? Whistle blower?
  • What testing was done by the manufacturer of this medical device before release to a live-patient environment?
  • Who approved this software "going live?" What due diligence was performed?
  • Was this a software beta test of experimental software on live subjects?
  • Did Rush University Medical Center have some sort of quid pro quo (e.g., financial arrangement) with the software company?
  • Did Rush seek IRB approval of this device?
  • Were patients presented with an informed consent process regarding its use in their care?
  • Were any patients actually injured or did any die as a result of this software?

The answers to these questions need to be sought by FDA.

-- SS

The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

"You should not have to work around something that is not in the way" - SS

Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences.

(Note: Part 1 of this series is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here. 2011 addendums: a post that can be considered part 9 is here, part 10 is here.)

Here is an addendum, part 10, from the FDA Maude (Manufacturer and User Facility Device Experience) Database. I do not know who wrote it or where it was from. It was received by FDA as indicated on 3 April 2011:


FDA MAUDE REPORT

CERNER POWERCHART

Event Type Other

Event Description

I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr).

In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise.

Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders.

With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders.

This design allows two distinct sources of error.

First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications).

Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa.

As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies.
[Workarounds - ed.]

I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns.

Brand Name CERNER POWERCHART COMPUTER
Type of Device NONE
Manufacturer (Section F) CERNER
Manufacturer (Section D) CERNER
Device Event Key 2081342
MDR Report Key 2045867
Event Key 1942844
Report NumberMW5020161
Device Sequence Number 1
Product Code LNX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/03/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?
Page Last Updated: 11/30/2011

I will let the FDA report speak for itself, with only one question:

When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety?

criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)

It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades.

An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting.

Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is here. We at Healthcare Renewal simply refuse membership on that team.

(Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?)

-- SS
 

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