Princess Health and More Short Circuits for Guidant. Princessiccia

Princess Health and More Short Circuits for Guidant. Princessiccia

Guidant ICD manufacturing problems

Gusty 06:44 Add Comment

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.

Princess Health and More Short Circuits for Guidant.Princessiccia

Princess Health and More Short Circuits for Guidant.Princessiccia

Guidant ICD manufacturing problems

Gusty 06:44 Add Comment

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.

Princess Health and "Naturopath" Takes the Fifth. Princessiccia

Princess Health and "Naturopath" Takes the Fifth. Princessiccia

complementary/ alternative medicine

Gusty 06:25 Add Comment

The Providence Journal has followed-up on the story of local "naturopath" John E. Curran. (See our previous post here.) Curran requested an administrative hearing at the state Health Department about its suspension of his "natural healing" practice. At the hearing, Curran refused to answer every question put to him, pleading the Fifth Amendment. In particular, he would not answer questions about three diplomas that he allegedly purchased from a "bogus college," nor the $2650 check he used to pay for them; a blue coat he wore at his practice, with a badge that read, "John E. Curran, ND, MD, MPH, PhD'; documents that identified him as an ordained minister, "a fugitive-recovery agent," and a member of the press; and a New York City Police badge with his name on it. Eventually, Curran ended the hearing, and agreed to accept the suspension of his practice. The Journal reported that investigations of Curran by the US Food and Drug Administration, Internal Revenue Service, Postal Service, and Attorney's Office are still pending.
Although Curran may be an extreme example, a quick look at the web will reveal all sorts of complementary and alternative medicine (CAM) practitioners making exaggerated claims about the benefits of their services. Reputable medical schools have allied themselves with CAM institutions which claim they can treat depression with acupuncture, and increase longevity with herbs (see previous post here.) The extent that spending on unproven, useless, and even harmful CAM treatments contributes to rising health care costs remains unexplored.

Princess Health and "Naturopath" Takes the Fifth.Princessiccia

Princess Health and "Naturopath" Takes the Fifth.Princessiccia

complementary/ alternative medicine

Gusty 06:25 Add Comment

The Providence Journal has followed-up on the story of local "naturopath" John E. Curran. (See our previous post here.) Curran requested an administrative hearing at the state Health Department about its suspension of his "natural healing" practice. At the hearing, Curran refused to answer every question put to him, pleading the Fifth Amendment. In particular, he would not answer questions about three diplomas that he allegedly purchased from a "bogus college," nor the $2650 check he used to pay for them; a blue coat he wore at his practice, with a badge that read, "John E. Curran, ND, MD, MPH, PhD'; documents that identified him as an ordained minister, "a fugitive-recovery agent," and a member of the press; and a New York City Police badge with his name on it. Eventually, Curran ended the hearing, and agreed to accept the suspension of his practice. The Journal reported that investigations of Curran by the US Food and Drug Administration, Internal Revenue Service, Postal Service, and Attorney's Office are still pending.
Although Curran may be an extreme example, a quick look at the web will reveal all sorts of complementary and alternative medicine (CAM) practitioners making exaggerated claims about the benefits of their services. Reputable medical schools have allied themselves with CAM institutions which claim they can treat depression with acupuncture, and increase longevity with herbs (see previous post here.) The extent that spending on unproven, useless, and even harmful CAM treatments contributes to rising health care costs remains unexplored.

Princess Health and "Slippery As Oiled Pigs". Princessiccia

Princess Health and "Slippery As Oiled Pigs". Princessiccia

Duke University Mismanagement quality Victor Dzau

Gusty 10:48 Add Comment

The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.

Princess Health and "Slippery As Oiled Pigs".Princessiccia

Princess Health and "Slippery As Oiled Pigs".Princessiccia

Duke University Mismanagement quality Victor Dzau

Gusty 10:48 Add Comment

The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.

Princess Health and Michigan Politicians Covet Large Blue Cross Surpluses. Princessiccia

Princess Health and Michigan Politicians Covet Large Blue Cross Surpluses. Princessiccia

Blue Cross

Gusty 10:35 Add Comment

The Detroit News reported that the Chairwoman of the State Senate Appropriations Committee is calling on Blue Cross Blue Shield of Michigan to voluntarily contribute some of its large and growing surplus to help state health care programs, or face loss of its tax exemption.
Michigan Blue Cross now has a surplus of $2.24 billion. According to the News, that is 800 percent of the mandated minimum amount.
The article noted that in Pennsylvania, after state politicians noted large surpluses being piled up by in state Blue Cross insurers, the Governor reached an agreement with the plans that they would contribute some of their reserves to state health programs.
Michigan Blue Cross spokeswoman Helen Stojic countered, "we spend tens of millions of dollars already reinvesting in communities."
On the other hand, Tom Clay of the Citizens Research Council of Michigan, noted, "you could make the argument that if the Blues are building up a reserve, they're probably charging more for insurance than they need to."
In my humble opinion, leaders of both not-for-profit insurers like some Blue Cross plans, and not-for-profit hospitals and academic medical centers need to refocus on their missions, or risk rude encounters with politicians who can find other uses for the money these institutions have been accumulating.