Her last words were 'I'm choking'

ELAINE Basham was unfortunate in being in the wrong place at the wrong time. In 2000, the 33-year-old Down's Syndrome sufferer from Loftus, east Cleveland, was referred to the North Riding Infirmary in Middlesbrough to see a specialist about her breathing problems.

Her family were concerned that Elaine could only breath through her mouth because of enlarged tonsils and adenoids. Her GP suggested it might be worth seeing an ear, nose and throat specialist with a view to an operation.

Elaine, who was a much-loved, cheerful young woman who loved swimming, was assessed and a recommendation was made that she should have what was considered to be routine surgery to remove her tonsils and adenoids.

While the family waited for a date to be set for the operation, a sequence of events were taking place which would lead to her untimely death.

In January 1999, the medical journal The Lancet revealed that the mysterious 'prion' proteins thought to cause the human form of mad cow disease had been found in the tonsils of people who had died from variant Creutzfeldt-Jakob Disease (vCJD).

This sent alarm bells ringing at the Department of Health.

It suggested that patients undergoing a number of procedures, including tonsil surgery, might be at risk of catching this dreaded, incurable, fatal brain disease. This was because many hospital sterilisation units were not up to the task of destroying prions which might remain on surgical instruments.

At that time, only three years after the first confirmed vCJD case, there were doomsday predictions that up to 250,000 Britons could develop the brain disease, thought to be linked to eating beef from cattle with Bovine Spongiform Encephalopathy (BSE).

Dr Pat Troop, who was then deputy chief medical officer, took the matter very seriously. As the department's lead officer on variant CJD, she asked the Spongiform Encephalopathy Advisory Committee (SEAC) to do a risk assessment. The idea was floated that single-use, disposable instruments might have to be introduced to reduce the risk of transmission.

A small number of ENT surgeons were asked to try out available disposable instruments but in December 1999, they reported back that none of them found the single instruments as good as conventional tools. In February 2001, SEAC published advice which recommended that the Government should consider introducing disposable instruments for certain categories of surgery, including tonsilectomy. SEAC also recommended that hospital decontamination units should be upgraded.

In January 2001, the Department of Health announced that £200m was being made available to improve sterilisation facilities. Another £25m was being allocated to introduce new disposable instruments for tonsil and adenoid surgery.

Last week Pat Troop - now Professor Troop - told the Elaine Basham inquest jury the intention was to provide surgeons with disposable instruments "of normal quality". She explained that after seven companies provided samples of disposable equipment, contracts were awarded to two main suppliers.

To hold the fort until the new disposable instruments arrived, the health department bought in 3,000 sets of regular instruments from all over Europe. In June 2001, the new single-use instruments began to be used.

Almost immediately, surgeons around the country began reporting problems with the new equipment. Grant Bates, who was assistant secretary of the British Association of Otolaryngology, Head and Neck Surgeons (BAOHNS) at that time, told the inquest: "Usually, the quality was very poor. They were clumsy, we had lots of problems with them."

There were also reports that some diathermy forceps, a piece of equipment used to stop bleeding by applying heat to a surgical wound, were malfunctioning.

Prof Troop said: "At this time, the Medical Devices Agency followed up serious concerns, particularly concerns with diathermy and an apparent increase in the number of patients who were haemorrhaging after tonsillectomy and adenoidectomy."

On October 18, 2001, the MDA issued a hazard notice advising all NHS hospitals to review post operative haemorrhage rates and the use of electric diathermy forceps. A separate survey by the NHS Purchasing and Supplies Agency (PASA) confirmed that the main problem was with diathermy forceps which did not work properly. Prof Troop told the inquest that the two main manufacturers did respond to these complaints by improving the quality of instruments.

In June 2001 - five months before Elaine underwent surgery - two-year-old Crawford Roney, from Cheshire, was found dead in a pool of blood, several days after a tonsil operation at a private hospital which used disposable diathermy forceps. An inquest found that the boy died after inhaling his own blood following a delayed, secondary haemorrhage.

Closer to home, only three weeks before Elaine Basham's operation, an unidentified patient at the North Riding Infirmary needed intensive care treatment after being recalled to the operating theatre four times because of a post-tonsillectomy haemorrhage.

It was against this background that the fateful surgery to remove Elaine's tonsils and adenoids took place at the North Riding Infirmary on November 5.

During the operation, single use diathermy forceps were used to control bleeding in Elaine's throat. Things appeared to go well at first but about an hour and a half after surgery, Elaine was found to be haemorrhaging from the site of the operation. As doctors and nurses fought to save her life, diathermy forceps were again used to try to stem the bleeding.

Frank Martin, the senior consultant in charge of the surgical team, told the inquest that the forceps did not appear to be working properly. Instead he decided to over-sew the right-hand side tonsil bed.

A couple of hours later, Elaine was again returned to the operating theatre with severe haemorrhaging. Again, the diathermy heat treatment was applied. Once again, it failed to satisfactorily stop the bleeding.

Elaine suffered three cardiac arrests during the battle to save her life and her family believe there was a period when she was unable to breathe because of blood in her throat, compounded by the difficulty doctors had in providing a satisfactory air supply.

Just four days after her operation, BAOHNS sent a letter to the chief medical officer, Professor Liam Donaldson, expressing concern about single use instruments and the apparent increase in haemorrhages.

On November 15, at 4.30am, Elaine Basham died in the intensive care unit at James Cook University Hospital in Middlesbrough. Her last words to her mother, before suffering her first cardiac arrest were: "I'm choking."

The reaction to the Basham case was swift. The NRI immediately suspended tonsil operations and notified the Department of Health.

On December 14, Prof Troop instructed all ENT surgeons to revert back to using re-usable instruments.

Prof Troop told the inquest that the "balance of risk" for patients had changed because of the improvement in decontamination facilities in hospitals and the increase in reported problems with diathermy. Since that date, ENT surgeons in England have used traditional instruments.

A recent survey carried out by ENT surgeons in Middlesbrough showed that post-operative haemorrhage rates doubled during the period when disposable instruments were used and returned to normal after they were recalled.

At the end of the inquest, the Basham family solicitor, Richard Follis, told journalists: "There is little doubt that for nearly 12 months after the Government announced, amid a great d eal of publicity, that these single use instruments were going to be used, there were really serious doubts about the quality of the equipment that was being supplied and as a result of problems with equipment quality, as Professor Troop herself said, patient safety was compromised."

The only crumb of comfort for the Basham family is that Elaine's death brought an end to the use of single-use instruments in England.