Safety moments4/16/2023 ![]() showed that although 37 UDFs were reported following nearly 12,000 orthopedic cases in two hospitals between 20, not a single patient suffered any untoward problems over a 12-36 month follow up period. These are certainly adverse outcomes that could be avoided altogether.Īlthough the FDA article released in 2008 discusses a wide range of untoward effects of UDFs, Pichler et al. Such reoperations incur additional associated risks and costs of emergency procedures which may bring about serious harm. Although no deaths appear to have occurred in this sample, serious harm was brought to 1 patient and 5 went on to have further operations to remove the foreign object. If the results of the above analysis are generalized, there may be as many as 262 faulty instruments related to patient safety incidents reported to the NPSA each year. UDFs pose a serious problem if the issue remains unattended. In doing so, evidence for the requirement of surgical instrument quality control can be determined. In this study, we aim to define and examine the problem of UDFs by observing the contribution of poor quality surgical instruments to reports of patient safety incidents made to the National Reporting and Learning System (NRLS) of the National Health Service (NHS) in England and Wales. Instruments purchased from certain manufacturers failed at a rate of 35%, suggesting that potentially one in every three instruments in some sets are of substandard quality. found that 15% of surgical instruments examined by medical and mechanical engineers failed to meet the appropriate British Standards (BS) guidelines. reported on a pilot study of a Surgical Instruments Service to assess the quality of instruments purchased by the hospital, remove those unfit for purpose, and inform the manufacturer. The alert also notes that with the increasing use of magnetic imaging modalities, the unrecognized presence of ferrous foreign bodies may cause tissue trauma or thermal injury. In the United States, the Food and Drug Administration (FDA) published an alert in 2008 stating that nearly 1000 incidents of retained pieces of broken instruments (unretrieved device fragments, UDFs) occurred each year, leading to a range of problems including local tissue reactions, infections, disability, and even death. ![]() Poor quality instruments fail and break and when used in an operation, the consequences to the patient can be disastrous. ![]() Problems arise, however, when these instruments do not live up to these expectations. Purchased from reputable suppliers, it is presumed that these instruments are of high quality and are usually put to use before any final user quality control is carried out. The quality of surgical instruments is heavily relied upon by surgeons to perform procedures to the highest standard. We suggest that forming a Surgical Instrument Quality Service at Trusts within the National Health Service (NHS) could prevent harm coming to patients, reduce cost, and improve the outcomes of surgical procedures. Poor reporting of patient safety incidents means that there may be as many as 1500 incidents a year of poor quality surgical instruments causing harm. Drillbits were the most commonly broken instrument.Ĭonclusions: This report is likely to only be the tip of the iceberg. Results: One hundred and sixty-one incidents were identified causing five reoperations, one incident of severe harm, six incidents of moderate harm, 35 of low harm, and 119 no harm incidents. The search revealed 2036 incidents, 250 of which were randomly selected and analyzed by a clinical reviewer. Methods: The NRLS was searched from August 2004 - December 2010. By examining the National Reporting and Learning Service (NRLS) database, the study aims to define the scale of the problem and provide evidence for the formation of surgical instrument quality control. Poor quality instruments may break intraoperatively leading to a failed procedure or causing harm to the patient. Objectives: Surgeons require high-quality surgical instruments to carry out successful procedures.
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