Call for Trusts to review instrument quality

Phil Daly and Tom Brophy from the department of clinical physics, Barts and The London NHS Trust, are urging other Trusts to follow their lead in implementing stringent quality assurance processes to ensure newly purchased instruments are fit for purpose, following research which identified quality issues in a significant number of devices. In a bid to evaluate the scale of the issue, Brophy et al. (2006) carried out a study of 4,800 instruments between January and June 2004 – some 15% were found to have problems.1 However, for individual manufacturers, the failure rate has been found to be as high as 35%.2 Furthermore, the latest reported figures show that some suppliers are continuing to sell substandard instruments, with 10% of instruments failing quality assurance tests in the first six months of 2009.3 In fact, the US Food and Drug Administration (FDA) shares the Trust’s concerns and previously issued a Public Health Notification in 2008, highlighting serious adverse events arising from fragments of medical devices left behind after surgical procedures.4 The notification highlighted the fact that nearly 1,000 adverse events related to unretrieved device fragments are reported to the FDA’s Centre for Devices and Radiological Health, each year – many of which are caused by surgical instrument failure.4-6

 Head technician, Tom Brophy, who has over 30 year’s experience of mechanical engineering, revealed that he had observed inadequate quality control procedures during visits to a significant number of manufacturing sites. However, he added that there is very little pressure on suppliers to improve performance, as so few Trusts employ dedicated expertise to perform systematic inspection of newly purchased instruments. “We have been speaking to the Medicines and Healthcare products Regulatory Agency (MHRA), the National Patient Safety Agency (NPSA), medical bodies and associations, as well as other Trusts, to bring this safety issue to the fore. Poor quality manufacturing is not an isolated problem and we need to ensure that suppliers who fail inspection tests are forced to ‘up their game’,” he told The Clinical Services Journal. The issue of poor quality instruments is not just about demanding better value for money from manufacturers, but also about improving patient safety, said clinical scientist, Phil Daly: “Not only is there a risk of litigation and increased costs due to repeat surgery to retrieve fragments left inside the patient, but the human costs are also significant,” he warned. In a recent paper, published in Medical Device Decontamination,3 Phil Daly, Tom Brophy and colleagues, from the departments of clinical physics and vascular surgery, highlighted the health risks of unretrieved instrument fragments – including the potential to cause an embolism.

This not only restricts the flow of vital oxygen and nutrients to the tissue, but may also result in a number of clinical problems – including pulmonary embolism, stroke or death.7-11 Even small particles have the potential to block critical vessels, they warned, while foreign bodies have been known to migrate through soft tissue into the venous system.3,9 Foreign bodies can also lead to the following clinical problems: