December 31, 2007

Need for Digital Mammography?

BY Dr. Keith J. Kaplan

These 2 stories appeared in Ireland in early November dealing with quality assurance issues in a hospital’s radiology department.  Stories have continued in the local press there about the continuing investigation on the matter.  A link is below for the story that appeared in RTE News on November 6, 2007.  What I find most interesting is request from the radiology department to hospital administrators requesting a digital mammography system to replace aging conventional film technology to provide the highest quality of diagnostic accuracy. 

While PACS systems for radiology are now in the majority of US hospitals, standards and concerns about digital mammography in this country have persisted.  A summary of the issues is available here from the American College of Radiology.  While adoption is taking place for digital mammography it appears to be slower than for other organ systems and studies in radiology, although undoubetedly mammography will follow. 

A New England Journal of Medicine in October 2005, showed no difference between digital and screen-film mammography in detecting breast cancer for the general population of women. However, it did find that digital mammography detected more cancers in women who were 50 or younger, premenopausal and perimenopausal, or had dense breasts.

Apparently the radiologists at this hospital thought enough of the technology to request from their institution forseeing these issues without it.  It begs the questions "Does newer technology, although controversial and perhaps with specific indications and more importantly, contraindications for use potentially allow for replacement of older technology?  Was the motive to obtain new equipment to replace older or enable higher quality diagnostic accuracy?  Would doing so have helped to eliminate the diagnostic errors?" 

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RTÉ News has learned that an eighth case of misdiagnosis has been uncovered at Midland Regional Hospital in Portlaoise, Ireland.

A woman who was told she had no cause for concern after breast cancer tests at the hospital has now been diagnosed with the disease after being re-examined by specialists at St Vincent’s Hospital in Dublin. The mother from Co Laois, who wishes to remain anonymous, said she was told by staff at the hospital in Portlaoise in July that her mammogram had indicated she was not suffering from cancer.

But after hearing about the HSE review of the work of a consultant radiologist in Portlaoise last September she sought a new appointment at St Vincent’s Hospital. She says she underwent a mammogram and breast ultrasound tests in October in Dublin and has now been told she has breast cancer.

The Minister for Health, Mary Harney, has said the report by the Health Service Executive on the misdiagnosis of cancer patients at the Midlands Regional Hospital will be published when it is completed at the end of the month.  She said it would be meaningless if the report was not published when it is completed at the end of the month.

But she said she wants to take advice in relation to whether, in the wake of what happened at Portaloise, other mammograms should be looked at again.

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The Midland Regional Hospital in Portlaoise was warned ten months ago that problems with mammography equipment meant ‘a huge potential for litigation’, in relation to delayed or wrong diagnosis of breast cancer.

However, the Health Service Executive has said it is satisfied that equipment in the x-ray department at the hospital operates within the normal quality assurance standards.

In a letter to hospital management, seen by RTÉ News and dated 13 December 2006, the radiology department advised that to deliver the highest standard of patient care it needed an imaging system, which could produce mammograms of the best possible diagnostic quality.

The correspondence expressed concern about the age of the mammography machine and advised that a digital system was needed instead of the film system, which at times was affected by dirt from the darkroom environment.

The letter warned that poor image quality could result in the missed or delayed diagnosis of a tumour, leading to reduced prognosis for a patient, or a false positive test resulting in patients having to undergo unnecessary surgery.

Flaws on the film system meant that patients had to undergo repeat x-rays, increasing the radiation dose and discomfort for them.

‘We are also concerned about the huge potential for litigation in relation to delayed or wrong diagnosis of breast cancer associated with using suboptimal imaging equipment’, the letter stated.

The HSE said a routine inspection on the machine last May did not include any identifiable faults.

Meanwhile, the HSE has said that six of the remaining 19 patients who were called back for a review of breast screening will require further assessment.

These patients have been contacted and will be seen at St Vincent’s University Hospital this week.

To date 3,026 mammograms carried out at the Midland Regional Hospital between November 2003 and August 2007 have been reviewed.

The HSE says that seven patients have so far been found to have symptoms of breast cancer.

There are to be statements in the Dáil on cancer care tomorrow morning, when Mary Harney will address the issue of shortcomings in Portlaoise Hospital.

Earlier in the Dáil, the Taoiseach indicated that misdiagnoses there may not have been due to any system failure.

Mr Ahern was pressed by Labour’s Eamon Gilmore on the issue of a consultant at the hospital having been placed on administrative leave, but said he would prefer to leave the facts to the official report which will be published later this month.

Story from RTÉ News:
http://www.rte.ie/news/2007/1106/cancer.html

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