Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.
Equipment and Supplies ; Medical Audit

According to the problems exist in the original ultrasound system, the study elaborates the design and application of the ultrasound audit workstation system, including the workflow, trace information recording, information management, audit data interaction, application effects, et al. This study points out that the system can optimize the ultrasound process, help to improve the quality and efficiency of ultrasound report audit as well as improve the efficiency of patients' ultrasound examination and medical treatment experience.
Humans ; Medical Audit

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
China ; Equipment and Supplies ; Medical Audit ; Quality Control

Operations Research (OR), also called Operational Research in the United Kingdom (UK), uses various computational tools for solutions to complex problems within a system. It deals with challenges in planning, scheduling, forecasting, process analysis and decision analysis. It also addresses individual components of the system. The methodology used for decisions based upon stochastic (random) processes can also be adapted for the common general medical ward round. Operational Research techniques add speed, efficiency, quality and consistency to the documentation in the case notes, and reduces the time taken for ward rounds. There is obvious benefit to the individual patient. It also acts as a learning tool which can be audited, and lends itself to research questions.
Humans ; Medical Audit ; Operations Research ; Quality Assurance, Health Care ; methods

Medical audit is vital to ensure continuous quality assurance and quality improvements. We did a retrospective study to ascertain the adequacy of clinical documentation and the factors hindering early discharge after an acute stroke in a restructured hospital. The medical records of all patients with acute stroke who died or were discharged from a restructured hospital in Singapore in January and February 1999 were reviewed retrospectively. Demographic data and the presence or absence of clinical documentation were noted. Factors hindering the discharge of patients at Day 5, Day 10 of stroke and at final discharge were noted and classified into: stroke-related, complications of stroke, medical-related and social factors. There were 101 patients in the study cohort, 55 males (54.5%) and 46 females (45.5%). The mean age was 67.9 years (SD 12.3). Documentation in Barthel scores (0%), presence of depression (0%), mental scores (1.0%), visual problems (10.0%), bladder continence (39.6%), admission functional status (37.6%) and dysphagia (52.5%) were deficient. The mean length of stay (LOS) was 13.0 (SD 14.2) days. The main factor hindering discharge at Day 5 (90.4%), Day 10 (95.2%) and at final discharge (82.1%) was stroke-related problems. Poor function (60.3%) and dysphagia (15.8%) were the 2 most common stroke-related problems hindering final discharge. Complications of stroke, medical-related problems and social reasons hindered final discharge in 10.8%, 17.8% and 2.9% of patients respectively. This audit revealed inadequacy in clinical documentation in patients with acute stroke. The main hindrance to final discharge of patients was stroke-related problems. The 2 most important stroke-related problems were poor function and dysphagia.
Cerebrovascular Accident/*therapy ; *Medical Audit ; *Medical Records ; *Patient Discharge ; Retrospective Studies

INTRODUCTIONThis study evaluated the efficacy of tinnitus retraining therapy (TRT) in habituating patients with tinnitus.

MATERIALS AND METHODSThis is a retrospective review of patients who underwent TRT in a tertiary referral Otorhinolaryngology unit. Patients were followed up with structured interviews with the aid of questionnaire forms. Habituation following TRT was evaluated.

RESULTSA total of 702 patients were included (55% male, 45% female). Habituation of reaction to tinnitus and habituation of perception were analysed. Average duration of follow up was 33 months. In total, 68% of patients described improvement in annoyance following TRT. Of these patients, 80% of them described habituation of perception as well. There was no statistical difference in gender and age between patients who did and did not respond to TRT. However, duration of treatment was significantly longer in patients who habituated (P <0.05). Patients who adopted treatment strategies recommended based on Jastreboff's TRT categories were also found to have higher success rates compared to those who refused.

CONCLUSIONThe goal of TRT is to achieve habituation of reaction to tinnitus. Habituation of perception is often a secondary result of sufficiently habituated response. From our study, more than two thirds of patients with tinnitus achieved habituation of reaction and of these, the majority also habituated to awareness of the tinnitus.

Female ; Habituation, Psychophysiologic ; Humans ; Male ; Medical Audit ; Qualitative Research ; Retrospective Studies ; Tinnitus ; psychology ; therapy ; Treatment Outcome

Since breast ultrasonography (US) has been used as an adjunctive screening modality in women with dense breasts, the need has arisen to evaluate and monitor its possible harm and benefits in comparison with other screening modalities such as mammography. Recently, the fifth edition of the Breast Imaging Reporting and Data System published by the American College of Radiology has suggested auditing methods for screening breast US. However, the method proposed therein is slightly different from how diagnostic performance was calculated in previous studies on screening breast US. In this article, the background and core aspects of medical audits of breast cancer screening will be reviewed to provide an introduction to the medical auditing of screening breast US, with the goal of helping radiologists to understand and identify potential ways to improve outcomes.
Breast ; Breast Neoplasms ; Female ; Humans ; Information Systems ; Mammography ; Mass Screening* ; Medical Audit* ; Methods ; Ultrasonography* ; Ultrasonography, Mammary

PURPOSE: The purpose of this study was to evaluate the efficacy of annual breast screening, which includes a mammography and a clinical physical examination. METHODS: From April 1995 to March 2000, we performed 51,170 annual clinical examinations and mammographies on 26,354 women, who wanted to undergo breast screening, at the breast center. Ninety-five breast cancers were detected during screening, and of these, only 76 breast cancers were operated on. The result were compared with 650 symptomatic breast cancers from the outpatient department (OPD). RESULTS: Of the 51,170 cases screened, the recall rate for further examination was 9.9% (n=5,066), and the biopsy rate was 2.1% (n=1,096). Ninety-five breast cancers were detected; a detection rate of 0.19%. Fourteen breast cancers were detected after more than 2 screening rounds. On the analysis of the medical audit data based on the screening mammographies, the positive predictive value, confirmed when a biopsy from a surgical consultation was recommended (PPV), was 8.6%. Further, 41 cases involving tumors found at stage 0 or I (54%). There were 25 cases of axillary lymph node metastasis (32.9%). These results were compatible with the ideal rates for medical audits, except for PPV and axillary lymph node metastases. The pathologic stages of the screened group were: 0, 22.4%; I, 31.6%; II, 40.8%; III, 5.2%, whereas those of the OPD group were 0, 3.4%; I, 27.4%; II, 52.8%; III, 15.5%, and IV, 0.8%. Early breast cancers were detected more frequently through screening than by the OPD (P<0.05). Breast conservation surgery was carried out on 32.9% (25 cases) from the screened group, but only 12.8% (83 cases) from the OPD group (P<0.05). CONCLUSION: Our breast cancer screening was properly performed. Further, these findings indicate that breast cancer screening using a clinical examination and a mammography is very effective in the early detection of breast cancer.
Biopsy ; Breast Neoplasms* ; Breast* ; Female ; Humans ; Lymph Nodes ; Mammography ; Mass Screening* ; Medical Audit ; Neoplasm Metastasis ; Outpatients ; Physical Examination

PURPOSE: Screening for breast cancer has constantly been increasing since the benefit of screening for breast cancers was established. The purpose of this study was to investigate the efficacy of annual breast cancer screening at one institution for 10 years by conducting a medical audit. METHODS: From March 1995 to July 2004, we performed 110,588 annual clinical examinations and mammographies on 58,024 women, who wanted to undergo breast cancer screening. Two hundred fourteen breast cancers were detected during screening, and one hundred sixty one of these patients were operated on. We then compared these results with the ideal rates for medical audits. RESULTS: Of the 110,588 cases that were screened, the recall rate for further examination was 12.1% (n=13,423). The biopsy rate was 1.01% (n=1,116). Two hundred fourteen breast cancers were detected for a detection rate of 0.19%. The percent of stage 0 cancer among all the cancer was 23.6%, stage I was 40.4%, stage IIa was 19.9%, stage IIb and IIIa were a combined 6.2%, stage IIIc was 3.1%, and stage IV was 0.6%. The positive predictive value (PPV) based on the abnormal findings on the screening examinations was 1.6% (PPV1). The PPV when a biopsy or surgical consultation was recommended was 15.1% (PPV2). The percent of tumor found as stage 0 or I was 64% (103/161). The tumor found as minimal cancer (stage 0 or tumor lesser than 1 cm) was 38.5% (62/161). There were 38 cases of axillary lymph node metastasis (23.6%). The number of cases of cancers found per 1,000 cases was 1.7. The prevalence of cancer found per 1,000 first examinations was 2.3. The incidental cancer found per 1,000 follow-up examinations was 1.2. The recall rate for further evaluation was 12.1%. These results were compatible with the ideal rates for medical audits, except for the recall rate, the PPV1, the PPV2, and the cancers found per 1,000 cases. CONCLUSION: On the base of these results, breast cancer screening was properly performed in this institution. Breast cancer screening using a clinical examination and a mammography is effective for the early detection of breast cancer.
Biopsy ; Breast ; Breast Neoplasms ; Female ; Follow-Up Studies ; Humans ; Lymph Nodes ; Mammography ; Mass Screening ; Medical Audit ; Neoplasm Metastasis ; Prevalence

OBJECTIVE: To evaluate the interpretive performance and inter-observer agreement on digital mammographs among radiologists and to investigate whether radiologist characteristics affect performance and agreement. MATERIALS AND METHODS: The test sets consisted of full-field digital mammograms and contained 12 cancer cases among 1000 total cases. Twelve radiologists independently interpreted all mammograms. Performance indicators included the recall rate, cancer detection rate (CDR), positive predictive value (PPV), sensitivity, specificity, false positive rate (FPR), and area under the receiver operating characteristic curve (AUC). Inter-radiologist agreement was measured. The reporting radiologist characteristics included number of years of experience interpreting mammography, fellowship training in breast imaging, and annual volume of mammography interpretation. RESULTS: The mean and range of interpretive performance were as follows: recall rate, 7.5% (3.3–10.2%); CDR, 10.6 (8.0–12.0 per 1000 examinations); PPV, 15.9% (8.8–33.3%); sensitivity, 88.2% (66.7–100%); specificity, 93.5% (90.6–97.8%); FPR, 6.5% (2.2–9.4%); and AUC, 0.93 (0.82–0.99). Radiologists who annually interpreted more than 3000 screening mammograms tended to exhibit higher CDRs and sensitivities than those who interpreted fewer than 3000 mammograms (p = 0.064). The inter-radiologist agreement showed a percent agreement of 77.2–88.8% and a kappa value of 0.27–0.34. Radiologist characteristics did not affect agreement. CONCLUSION: The interpretative performance of the radiologists fulfilled the mammography screening goal of the American College of Radiology, although there was inter-observer variability. Radiologists who interpreted more than 3000 screening mammograms annually tended to perform better than radiologists who did not.
Area Under Curve ; Breast ; Fellowships and Scholarships ; Mammography ; Mass Screening ; Medical Audit ; Observer Variation ; ROC Curve ; Sensitivity and Specificity