Showing posts with label Medical Devices. Show all posts
Showing posts with label Medical Devices. Show all posts

Tuesday, January 29, 2013

Patient Safety Summit Breaks New Ground

The first annual Patient Safety Science and Technology Summit (PSSTS) was held in Dana Point, California on January 13 and 14, 2013. The two days were filled with presentations and panel discussions on several areas of patient safety.

Unlike many such conferences, this one expected a commitment from its more than 300 attendees to actually do something about increasing patient safety when they returned to their respective institutions.

The keynote address was given by former president Bill Clinton, who challenged those in attendance to follow through on their promises to actively promote patient safety in their institutions and achieve the summit’s goal of no preventable patient deaths by the year 2020.

Noted patient safety experts from around the world covered topics ranging from medical and nursing leadership to specific safety issues such as neonatal monitoring, medication errors, failure to rescue and inappropriate use of blood transfusions.

Family members of patients who died after medical errors presented their moving stories on video and in person.

The event was sponsored by the Masimo Foundation, the philanthropic arm of the Masimo Corporation, makers of medical monitoring equipment. Masimo’s CEO, Joe Kiani, teamed with patient safety guru, Dr. Peter Pronovost of Johns Hopkins to assemble the distinguished faculty.

A significant problem that the PSSTS identified is that most medical devices cannot communicate with each other because of interface issues. Nine major medical device manufacturers have pledged correct this and work on other areas of patient safety improvement in the future. In addition to Masimo, they include Dräger, GE Healthcare, Cerner, Zoll, Smiths Medical, Cercacor, SonoSite Fujifilm and Surgicount Medical.

I spent a few minutes with Mr. Kiani, who said, “Masimo will keep track of progress and expect follow-up results to be submitted.” This will apply to both corporate and individual attendee pledges.

Videos of all of the sessions including speakers, panels and Mr. Clinton’s address can be viewed here.

In the coming days I will discuss in detail some of the major areas covered by the summit.

Disclosure: I attended the meeting thanks to a grant from Masimo who had no input into anything written here.

Monday, April 2, 2012

CEO of Surgical Robot Maker “Spins” References to Favor His Product


In an interview on a website called MassDevice, Gary Guthart, CEO of Intuitive Surgical, maker of the Da Vinci surgical robot, offers many seemingly persuasive arguments regarding why the robot is revolutionizing modern surgery.

Here is an example of an interesting answer he gave to a question about a paper from the Journal of Clinical Oncology that said robotic hysterectomy was much more expensive than standard laparoscopic hysterectomy without demonstrable improvement in outcomes. Guthart said, “It turns out that the paper actually entirely misses the point, in that it compares laporoscopic [sic] to robotics, but the reality is that what's happening in the market is robotics are converting open procedures to robotic procedures.” 

The paper didn't miss the point at all. It made the point that standard laparoscopic surgery is equal to robotic hysterectomy except for its cost.

He went on to cite a paper in European Urology [full text here] that he said: “covers 20,000 minimally invasive prostatectomy surgeries – almost all of which are robotic – and it covers 60,000 open patients. What it shows is that a length of stay for the minimally invasive arm is reduced by 2 days and that complications – basically every complication they measure – are less with robotic than open and mortality is significantly less with robotics than open.”

The paper was a study of a Medicare administrative database and compared 19,594 minimally invasive radical prostatectomies [MIRP] to 58,638 open radical retropubic prostatectomies.

The word “robot” is mentioned only six times in the paper, mostly in the context of this sentence from the “Methods” section: “A unique designation for robotic assistance did not exist during the study period; therefore, we were unable to distinguish pure laparoscopic from robot-assisted surgery, and both were categorized as MIRP.”

It’s true that minimally invasive surgery resulted in shorter lengths of hospital stay and fewer complications in this paper but the patients in the minimally invasive group were both significantly younger and had significantly fewer co-morbidities, p for both < 0.001.

The skeptic community still awaits a scientifically valid study that proves robotic surgery is better than standard laparoscopic surgery for any disease.

Thanks to Nathan @NJHM for alerting me to the interview.


Tuesday, December 20, 2011

Electronic devices distract doctors. So do other things.


Another hand-wringing piece about the dangers of distraction by electronic devices, this time from The New York Times, prompts these comments.

According to the article, Dr. Peter J. Papadakos, an anesthesiologist and director of critical care at the University of Rochester Medical Center reportedly said he had seen nurses, doctors and other staff members glued to their phones, computers and iPads. It goes on to say the following:

“My gut feeling is lives are in danger,” said Dr. Papadakos, who recently published an article on “electronic distraction” in Anesthesiology News, a journal. [Anesthesiology News, a journal? Since when?]

This is interesting coming from an anesthesiologist, whose colleagues were notorious in the analog age for doing crossword puzzles and reading the [print] Wall Street Journal during cases.

Here, via the AHRQ, is a nice example of an adverse event that occurred because of a distraction. A resident forgot to place an order to stop warfarin because she was interrupted by a text. Curiously, the electronic computer order entry program, while described as being “robust,” did not alert anyone. When his INR reached 8.5 three days later, the patient developed a hemopericardium requiring surgery. It’s a little disingenuous to blame a text for this complication when a team of doctors apparently forgot that a patient was receiving one of the most dangerous drugs around.

The Times article described a malpractice case from Colorado. It involved a neurosurgeon who was making personal phone calls during an operation which left the patient partially paralyzed. Where were the OR staff and the anesthesiologist while all these calls were being made? I doubt that I could even make one personal phone call during a case in my OR without the supervisor, the medical director and risk management being notified.

There is no question that electronic devices can be addicting and distracting if you let them. So can many other things like thinking of sex, which men apparently do at least 19 times a day or so a recent study says.

I will admit that it annoys me when I am talking to a resident or PA and she pulls out her phone to read an incoming text. And I certainly agree that 99.9% of all emails do not need to be viewed immediately.

That does not mean we should electronic devices from hospitals. I think the ability to look up a drug instantly or review management of a problem on UpToDate at a patient’s bedside far outweighs the potential for distraction.

I wonder if the same debate took place when radios were first placed in automobiles?

Monday, December 19, 2011

iPads approved by FAA for use by airline pilots, not passengers

As reported by The New York Times and ZDNet last week, iPads are now approved by the FAA for use by pilots. iPad flight charts replace about 35 pounds of paper charts. Another story says that the iPads, which weigh about 1.5 pounds, will save some $1.2 million worth of fuel a year.

Supposedly fearing disruption of avionics equipment, the FAA has yet to approve iPad use for passengers when the planes are below 10,000 feet. Yet if I interpret the FAA correctly, pilots, using iPads while sitting directly next to the avionics, present no threat.

This reminds me of the still on-going controversy about the use of cell phones in hospital intensive care units. Cell phones have been said to interfere with monitors and ventilators. Many hospitals still have signs prohibiting cell phone use.

Research (e.g., here, here and here) shows that cell phones do not cause clinically important interference with medical devises unless placed within a minimum of about 3 feet, although a Dutch study claimed otherwise. However, that study used certain European cell phones which emit three times the energy of American phones. It is likely that iPads and other tablets do not cause problems either.

Yes, I realize that being unable to use one’s iPad for 30 minutes of an airplane flight is not really that big a sacrifice. And I would hate to be subjected to three hours of 200 people talking on their phones in a space as confined as an airliner. But one could make the same argument as that use regarding the replacing of paper flight charts with iPads. Let’s say 200 passengers brought iPads, Kindles or Nooks aboard instead of books. Wouldn’t that save a lot of weight and fuel too?

If it’s about being distracted during critical take-off and landing sequences, then the flight attendants should make all passengers put down their non-electronic books during those times too.

Bottom line: Rules that are irrational cause people to lose faith in authority. If this rule is not rational, people think maybe other rules [e.g., the 55 mph speed limit] are not rational either. As respect for authority decreases, chaos ensues.

UPDATE 12/26/2011:
New York Times reports electronic devices do not emit significant energy and are highly unlikely to affect avionics.