The wait for information must go on for a North-East family whose daughter died after an operation using controversial instruments. Health Editor Barry Nelson investigates.

WHEN 33-year-old Elaine Basham was booked in to have her tonsils and adenoids out, her family was expecting a straightforward minor operation. Elaine, much-loved, fun-loving young woman who overcame Down's syndrome to win a clutch of swimming medals for her country, was told that the surgery was needed to overcome long-standing health problems.

The surgical team at the now closed North Riding Infirmary in Middlebrough opted to use recently introduced disposable surgical instruments on the recommendations of the Department of Health.

Concerns that patients undergoing ear, nose and throat operations might be exposed to the theoretical risk of cross-contamination from conventional surgical instruments was behind this move.

As ever, patient safety was the most important factor as far as surgical procedures were concerned, particularly at a time with the threat from the human form of mad cow disease, variant Creutzfeldt Jakob Disease (vCJD).

But only a week before Elaine's operation on November 5, 2001, the Department of Health put out a hazard notice to all ear, nose and throat surgeons after reports that some surgeons were experiencing difficulties in using the new disposable instruments. Surgeons were reported to be concerned about the quality of some of the instruments, particularly equipment featuring built-in electric elements designed to cauterise bleeding, a process known as 'diathermy'.

As they watched Elaine going into theatre, her family would have been horrified to learn that, five months earlier, two-year-old Crawford Roney from Cheshire died after surgeons using similar instruments removed his tonsils.

Surgeons at the private Alexandra Hospital in Cheadle, Cheshire, used instruments with a heating element in line with national guidelines. A few days after the operation, Crawford's father found him dead in bed. An inquest found that he died after inhaling his own blood.

At first, the operation on Elaine Basham went according to plan, but surgeons experienced difficulties in staunching bleeding, despite using instruments with elements designed to cauterise bleeding wounds. She was re-admitted to theatre but the bleeding started again and, during efforts to control the haemorrhaging, Elaine suffering a cardiac arrest.

Her family, who were by her bedside as she fought for her life, were told their daughter had suffered irreversible brain damage. Elaine died on November 15, ten days after what was supposed to be a straightforward operation.

Alarm bells began to ring at the Department of Health after Elaine's death, the second within a few months involving the new disposable diathermy instruments. And, on December 4, the Department sent out a circular to all surgeons in England advising them to stop using the instruments.

A few weeks later the Department of Health went even further, issuing a statement that on the "balance of risk" surgeons should go back to using reusable, traditional instruments. This was in spite of an estimated £25m a year being invested by the Government in purchasing a range of new single-use, disposable surgical instruments.

According to a spoksman for the Department, back in December 2001, the priority had always been patient safety and before disposable instruments were introduced, tests concluded that they were of satisfactory design and quality.

However the spokesman admitted: "Following the introduction of single-use instruments there was an increase in adverse incidents from tonsillectomies."

Single-use diathermy equipment was identified in a joint investigation by the Department and the Medical Devices Agency as a potential factor in the increased numbers of adverse incidents.

An MDA 'hazard' notice about disposable diathermy instruments was issued in October 2001, but it was only after further reports of problems suggesting a continuing risk to patients that the Department of Health suspended the use of the diathermy single-use instruments for toonsil and adenoid operations.

All of this was little consolation to the Basham family who faced their first Christmas without Elaine.

Julie Basham, Elaine's mother, told The Northern Echo at the time: "I cried for 24 hours solid after Elaine's death".

She remains convinced that her daughter might still be alive if the authorities had acted more promptly.

Nearly four years after Elaine died they still want to know what precisely happened at the North Riding Infirmary that day and why the disposable instruments continued to be used, despite previous reports of problems.

The family and their legal representatives, Alexander Harris, were encouraged when, after many delays, it was announced that a full inquest with a jury would be held on Teesside.

But hope turned to despair when the inquest, due to take place in February, was cancelled a week before.

The family were just steeling themselves for the ordeal of a full inquest starting on July 25 when they received the news that, due to an administrative error, the inquest would have to be adjourned again.

Elaine's mother is now in her late 60s and wonders whether she will ever find out what really happened to her daughter.

While the jury inquest is expected to clarify whether the throw-away instruments contributed to Elaine Basham's death in any way, the national situation is confusing for patients in different parts of the UK.

In 2003, two years after surgeons in England were told that they should not use disposable diathermy instruments in ENT operations, the National Institute of Clinical Excellence, or NICE, issued new guidance which confirmed earlier concerns.

Based on information provided by ENT surgeons around England from experience gained in 12,000 operations, NICE advised English surgeons not to use the controversial disposable instruments.

The study found that the risk to patients increased when equipment featuring electrical elements to reduce bleeding were used.

Worryingly for patients in England, the review found that about ten per cent of surgeons were still using the disposable instruments, despite contrary advice from the Department of Health.

Surgeons in Scotland, Wales and Northern Ireland are still being advised to use the disposable instruments in tonsil and adenoid surgery after separate investigations suggested that there was no increased risk to patient safety.

Solicitor Richard Follis, representating the Basham family, believes that the full jury inquest will provide an insight into whether the introduction of disposable instruments was a mistake by the Department of Health.

Depending on the outcome of the inquest, this could lead to calls for a public inquiry into the use of disposable surgical instruments.

Catalogue of tragedy

October 2001: A Department of Health 'hazard notice' is circulated to English surgeons warning them of problems with new disposable surgical instruments used in ear, nose and throat operations.

November 5, 2001: Elaine Basham from Loftus undergoes surgery to remove her tonsils and adenoids at North Riding Infirmary, Middlesbrough.

November 15, 2001: Elaine dies due to haemorrhaging which triggers heart attacks and brain damage.

December 4, 2001: The Department of Health tells all English surgeons to stop using new single-use instruments because of reported problems.

December 21, 2001: The Basham family tells their story exclusively to The Northern Echo.

April 2002: It is revealed that a two-year-old boy died in Manchester after disposable instruments were used to remove his tonsils five months before Elaine Basham's operati on.

March 2004: A review of 12,000 ear, nose and throat operations carried out by the National Institute for Clinical Excellence found that disposable instruments increased the risk for patients.

July 2003: The Teesside coroner orders a jury inquest into Elaine's death and a date is fixed for February 2005.

February 2005: The Basham family is told that inquest cannot go ahead. A week later a new date of July 25 is set.

June 2005: The Teesside coroner's office informs the Basham family that the inquest is postponed for a second time. No date is fixed.