Prontuários eletrônicos na Atenção Primária: gestão de cadastros duplicados e contribuição para estudos epidemiológicos / Electronic medical records in primary care: management of duplicate records and a contribution to epidemiological studies

Resumo Analisaram-se os registros eletrônicos da atenção primária em saúde na cidade do Rio de Janeiro para duas doenças crônicas: hipertensão e diabetes, em um estudo de base populacional, com desenho epidemiológico transversal que considerou a população carioca que possuía "Equipes de Saúde da Família". O cálculo da taxa de prevalência foi estratificado por sexo e faixa etária, e a condição da doença foi mensurada pelos médicos de família nas consultas realizadas por estes, computando-se a CID-10. Excetuando-se as duas últimas faixas etárias (75 a 79 anos e 80 anos e mais), em que parece haver subregistro dos casos diagnosticados, observou-se uma associação positiva entre as taxas de prevalência e a faixa etária, em ambos os sexos. A geração de informações estatísticas objetivas e com confiabilidade é fundamental para a gestão no nível local, permitindo avaliar a dinâmica demográfica e as particularidades de cada território, e auxiliando no planejamento e monitoramento da qualidade dos registros dos cariocas cadastrados em cada unidade de saúde da família. Para isso, a gestão regular de registros duplicados nas listas de usuários cadastrados é fundamental para minimizar o sobreregistro de casos clínicos apontados nos prontuários eletrônicos.

Abstract Primary health care electronic medical records were analyzedin Rio de Janeiro for two chronic diseases, namely, hypertension and diabetes, in a population-based study with a cross-sectional epidemiological design that considered the Rio de Janeiro population enrolled in Family Health Teams. Calculation of the prevalence rate was stratified by gender and age group, and the condition of the disease was measured by family doctors in their visits using the ICD-10.Except for the last two age groups (75-79 years and 80 years and over), with apparent under-registration of the diagnosed cases, a positive association was found between prevalence rates and age in both genders. The generation of objective and reliable statistical information is fundamental for local management, allowing the evaluation of demographic dynamics and the peculiarities of each territory, and assisting in the planning and monitoring of the quality of Rio de Janeiro people's records registered in each family health unit. Thus, the regular management of duplicate records in the registered user roster is essential to minimize the over-registration of clinical cases reported in the electronic medical records.

Methodological description of clinical research data collection through electronic medical records in a center participating in an international multicenter study.

Data collection for clinical research can be difficult, and electronic health record systems can facilitate this process. The aim of this study was to describe and evaluate the secondary use of electronic health records in data collection for an observational clinical study. We used Cerner Millennium®, an electronic health record software, following these steps: (1) data crossing between the study's case report forms and the electronic health record; (2) development of a manual collection method for data not recorded in Cerner Millennium®; (3) development of a study interface for automatic data collection in the electronic health records; (4) employee training; (5) data quality assessment; and (6) filling out the electronic case report form at the end of the study. Three case report forms were consolidated into the electronic case report form at the end of the study. Researchers performed daily qualitative and quantitative analyses of the data. Data were collected from 94 patients. In the first case report form, 76.5% of variables were obtained electronically, in the second, 95.5%, and in the third, 100%. The daily quality assessment of the whole process showed complete and correct data, widespread employee compliance and minimal interference in their practice. The secondary use of electronic health records is safe and effective, reduces manual labor, and provides data reliability. Anesthetic care and data collection may be done by the same professional.

Structured reporting of prostate magnetic resonance imaging has the potential to improve interdisciplinary communication.

BACKGROUND: Effective interdisciplinary communication of imaging findings is vital for patient care, as referring physicians depend on the contained information for the decision-making and subsequent treatment. Traditional radiology reports contain non-structured free text and potentially tangled information in narrative language, which can hamper the information transfer and diminish the clarity of the report. Therefore, this study investigates whether newly developed structured reports (SRs) of prostate magnetic resonance imaging (MRI) can improve interdisciplinary communication, as compared to non-structured reports (NSRs). METHODS: 50 NSRs and 50 SRs describing a single prostatic lesion were presented to four urologists with expert level experience in prostate cancer surgery or targeted MRI TRUS fusion biopsy. They were subsequently asked to plot the tumor location in a 2-dimensional prostate diagram and to answer a questionnaire focusing on information on clinically relevant key features as well as the perceived structure of the report. A validated scoring system that distinguishes between "major" and "minor" mistakes was used to evaluate the accuracy of the plotting of the tumor position in the prostate diagram. RESULTS: The mean total score for accuracy for SRs was significantly higher than for NSRs (28.46 [range 13.33-30.0] vs. 21.75 [range 0.0-30.0], p < 0.01). The overall rates of major mistakes (54% vs. 10%) and minor mistakes (74% vs. 22%) were significantly higher (p < 0.01) for NSRs than for SRs. The rate of radiologist re-consultations was significantly lower (p < 0.01) for SRs than for NSRs (19% vs. 85%). Furthermore, SRs were rated as significantly superior to NSRs in regard to determining the clinical tumor stage (p < 0.01), the quality of the summary (4.4 vs. 2.5; p < 0.01), and overall satisfaction with the report (4.5 vs. 2.3; p < 0.01), and as more valuable for further clinical decision-making and surgical planning (p < 0.01). CONCLUSIONS: Structured reporting of prostate MRI has the potential to improve interdisciplinary communication. Through SRs, expert urologists were able to more accurately assess the exact location of single prostate cancer lesions, which can facilitate surgical planning. Furthermore, structured reporting of prostate MRI leads to a higher satisfaction level of the referring physician.

Methodological description of clinical research data collection through electronic medical records in a center participating in an international multicenter study / Abordagem e descrição metodológica do uso do prontuário eletrônico como forma de coleta de dados em pesquisa clínica em centro participante de estudo internacional e multicêntrico

ABSTRACT Data collection for clinical research can be difficult, and electronic health record systems can facilitate this process. The aim of this study was to describe and evaluate the secondary use of electronic health records in data collection for an observational clinical study. We used Cerner Millennium®, an electronic health record software, following these steps: (1) data crossing between the study's case report forms and the electronic health record; (2) development of a manual collection method for data not recorded in Cerner Millennium®; (3) development of a study interface for automatic data collection in the electronic health records; (4) employee training; (5) data quality assessment; and (6) filling out the electronic case report form at the end of the study. Three case report forms were consolidated into the electronic case report form at the end of the study. Researchers performed daily qualitative and quantitative analyses of the data. Data were collected from 94 patients. In the first case report form, 76.5% of variables were obtained electronically, in the second, 95.5%, and in the third, 100%. The daily quality assessment of the whole process showed complete and correct data, widespread employee compliance and minimal interference in their practice. The secondary use of electronic health records is safe and effective, reduces manual labor, and provides data reliability. Anesthetic care and data collection may be done by the same professional.

RESUMO A coleta de dados para pesquisa clínica pode representar um desafio em que sistemas de registro eletrônico em saúde podem facilitar o processo. O objetivo deste estudo foi descrever e avaliar o uso secundário de registros eletrônicos em saúde na coleta de dados para um estudo clínico observacional. Usamos o Cerner Millennium®, software de registro eletrônico em saúde, de acordo com os seguintes passos: (1) cruzamento dos dados das fichas de coleta de dados do estudo e dos registros eletrônicos em saúde; (2) desenvolvimento de método para coleta manual de dados não registrados no Cerner Millennium®; (3) desenvolvimento de interface de estudo para a coleta automática de dados nos registros eletrônicos em saúde; (4) treinamento de colaboradores; (5) avaliação da qualidade dos dados; e (6) preenchimento da ficha eletrônica de coleta de dados no fim do estudo. Três fichas de coleta de dados foram consolidadas em uma ficha eletrônica de coleta de dados no fim do estudo. Os pesquisadores realizaram análise qualitativa e quantitativa de dados diariamente. Foram coletados dados de 94 pacientes. Na primeira ficha de coleta de dados, 76,5% das variáveis foram obtidas eletronicamente, na segunda, 95,5%, e na terceira, 100%. A avaliação diária de qualidade do processo como um todo revelou dados completos e corretos, ampla adesão dos colaboradores e mínima interferência na prática profissional. O uso secundário dos registros eletrônicos em saúde é seguro e efetivo, reduz o trabalho manual e produz dados confiáveis. O cuidado anestésico ao paciente e a coleta de dados podem ser realizados simultaneamente pelo mesmo professional.

A physician-led initiative to improve clinical documentation results in improved health care documentation, case mix index, and increased contribution margin.

INTRODUCTION: Clinical documentation is the key determinant of inpatient acuity of illness and payer reimbursement. Every inpatient hospitalization is placed into a diagnosis related group with a relative value based on documented procedures, conditions, comorbidities and complications. The Case Mix Index (CMI) is an average of these diagnosis related groups and directly impacts physician profiling, medical center profiling, reimbursement, and quality reporting. We hypothesize that a focused, physician-led initiative to improve clinical documentation of vascular surgery inpatients results in increased CMI and contribution margin. METHODS: A physician-led coding initiative to educate physicians on the documentation of comorbidities and conditions was initiated with concurrent chart review sessions with coding specialists for 3 months, and then as needed, after the creation of a vascular surgery documentation guide. Clinical documentation and billing for all carotid endarterectomy (CEA) and open infrainguinal procedures (OIPs) performed between January 2013 and July 2016 were stratified into precoding and postcoding initiative groups. Age, duration of stay, direct costs, actual reimbursements, contribution margin (CM), CMI, rate of complication or comorbidity, major complication or comorbidity, severity of illness, and risk of mortality assigned to each discharge were abstracted. Data were compared over time by standardizing Centers for Medicare and Medicaid Services (CMS) values for each diagnosis related group and using a CMS base rate reimbursement. RESULTS: Among 458 CEA admissions, postcoding initiative CEA patients (n = 253) had a significantly higher CMI (1.36 vs 1.25; P = .03), CM ($7859 vs $6650; P = .048), and CMS base rate reimbursement ($8955 vs $8258; P = .03) than precoding initiative CEA patients (n = 205). The proportion of admissions with a documented major complication or comorbidity and complication or comorbidity was significantly higher after the coding initiative (43% vs 27%; P < .01). Among 504 OIPs, postcoding initiative patients (n = 227) had a significantly higher CMI (2.23 vs 2.05; P < .01), actual reimbursement ($23,203 vs $19,909; P < .01), CM ($12,165 vs $8840; P < .01), and CMS base rate reimbursement ($14,649 vs $13,496; P < .01) than precoding initiative patients (n = 277). The proportion of admissions with a documented major complication or comorbidity and complication or comorbidity was significantly higher after the coding initiative (61% vs 43%; P < .01). For both CEA and OIPs, there were no differences in age, duration of stay, total direct costs, or primary insurance status between the precoding and postcoding patient groups. CONCLUSIONS: Accurate and detailed clinical documentation is required for key stakeholders to characterize the acuity of inpatient admissions and ensure appropriate reimbursement; it is also a key component of risk-adjustment methods for assessing quality of care. A physician-led documentation initiative significantly increased CMI and CM.

Paro cardiorrespiratorio extrahospitalario. Realidad de un hospital terciario chileno / Out of hospital cardiac arrest events at an urban Hospital in Chile

Background: The incidence of out of hospital cardiac arrest (OHCA) is approximately 20 to 140 per 100.000 inhabitants. International registries, based on Utstein criteria have allowed standardized reporting of OHCA profiles and outcomes in different countries. We proposed to create a local OHCA registry. Aim: To assess the quality of the information about OHCA currently recorded in medical records according to Utstein guidelines. Material and Methods: A retrospective analysis of medical records of patients arriving in the emergency room of a public hospital with OHCA during a 3-year period. Data regarding the patient characteristics, event and outcomes were analyzed. Results: During the revision period, 317 patients arrived with an OHCA. None of the medical records had complete data on items that are considered a minimum requirement by Utstein guidelines. Mean age of patients was 63 years old, 60% were men, the most common arrest rhythm was asystole (43%) and 8% of patients were discharged alive. Conclusions: Data recorded in medical records is insufficient to inform the profile of OHCA. A prospective registry is currently being implemented based on the information provided by this study. This registry should optimize reporting and data analysis.

A case study on parsing chemotherapy related free-text data.

When modelling and simulating healthcare related processes, free-text data is often the only possible source of information. This data may contain vocabulary variations such as mistyped, misspelled and/or abbreviated words. This paper describes a semi-automated approach to free-text normalisation based on a combination of commonly used techniques and local expertise of medical oncology nurses. The approach emphasises the effectiveness of the vocabulary creation process through an interactive software application. When local knowledge is successfully captured, normalisation of large data sets can be done very rapidly with a high accuracy rate achieved. Furthermore, the techniques for localised normalisation can have significant benefits to free-text parsing accuracy when data is aggregated from multiple sites (hospitals). This research may lead to increased understanding of issues associated with chemotherapy related free-text data which in turn may impact patient treatment safety.

Risk factors for radiotherapy incidents and impact of an online electronic reporting system.

BACKGROUND AND PURPOSE: To ascertain the rate, type, significance, trends and the potential risk factors associated with radiotherapy incidents in a large academic department. MATERIALS AND METHODS: Data for all radiotherapy activities from July 2001 to January 2011 were reviewed from radiotherapy incident reporting forms. Patient and treatment data were obtained from the radiotherapy record and verification database (MOSAIQ) and the patient database (HOSPRO). Logistic regression analyses were performed to determine variables associated with radiotherapy incidents. RESULTS: In that time, 65,376 courses of radiotherapy were delivered with a reported incident rate of 2.64 per 100 courses. The rate of incidents per course increased (1.96 per 100 courses to 3.52 per 100 courses, p<0.001) whereas the proportion of reported incidents resulting in >5% deviation in dose (10.50 to 2.75%, p<0.001) had decreased after the introduction of an online electronic reporting system. The following variables were associated with an increased rate of incidents: afternoon treatment time, paediatric patients, males, inpatients, palliative plans, head-and-neck, skin, sarcoma and haematological malignancies. In general, complex plans were associated with higher incidence rates. CONCLUSION: Radiotherapy incidents were infrequent and most did not result in significant dose deviation. A number of risk factors were identified and these could be used to highlight high-risk cases in the future. Introduction of an online electronic reporting system resulted in a significant increase in the number of incidents being reported.

The need for harmonized structured documentation and chances of secondary use - results of a systematic analysis with automated form comparison for prostate and breast cancer.

INTRODUCTION: Medical documentation is a time-consuming task and there is a growing number of documentation requirements. In order to improve documentation, harmonization and standardization based on existing forms and medical concepts are needed. Systematic analysis of forms can contribute to standardization building upon new methods for automated comparison of forms. Objectives of this research are quantification and comparison of data elements for breast and prostate cancer to discover similarities, differences and reuse potential between documentation sets. In addition, common data elements for each entity should be identified by automated comparison of forms. MATERIALS AND METHODS: A collection of 57 forms regarding prostate and breast cancer from quality management, registries, clinical documentation of two university hospitals (Erlangen, Münster), research datasets, certification requirements and trial documentation were transformed into the Operational Data Model (ODM). These ODM-files were semantically enriched with concept codes and analyzed with the compareODM algorithm. Comparison results were aggregated and lists of common concepts were generated. Grid images, dendrograms and spider charts were used for illustration. RESULTS: Overall, 1008 data elements for prostate cancer and 1232 data elements for breast cancer were analyzed. Average routine documentation consists of 390 data elements per disease entity and site. Comparisons of forms identified up to 20 comparable data elements in cancer conference forms from both hospitals. Urology forms contain up to 53 comparable data elements with quality management and up to 21 with registry forms. Urology documentation of both hospitals contains up to 34 comparable items with international common data elements. Clinical documentation sets share up to 24 comparable data elements with trial documentation. Within clinical documentation administrative items are most common comparable items. Selected common medical concepts are contained in up to 16 forms. DISCUSSION: The amount of documentation for cancer patients is enormous. There is an urgent need for standardized structured single source documentation. Semantic annotation is time-consuming, but enables automated comparison between different form types, hospital sites and even languages. This approach can help to identify common data elements in medical documentation. Standardization of forms and building up forms on the basis of coding systems is desirable. Several comparable data elements within the analyzed forms demonstrate the harmonization potential, which would enable better data reuse. CONCLUSION: Identifying common data elements in medical forms from different settings with systematic and automated form comparison is feasible.

Registro Sanitario, logros, debilidades y proyecciones al cierre del 2013 / The Health Registry, achievements, weaknesses and projections at the close of 2013

Se presenta un breve comentario acerca del trabajo desarrollado por el Registro Sanitario en el año 2013, con la finalidad de informar a los interesados en este tema sobre los logros, debilidades y proyecciones de trabajo que se ha trazado este colectivo de especialistas para los próximos años(AU)

A brief commentary is presented about the work done by the Health Registry in the year 2013, with the purpose of informing those interested in the topic about the achievements, weaknesses and work projections set by this team of specialists for the coming years(AU)

Using tablet technology in operational radiation safety applications.

Tablet computers have become a mainstream product in today's personal, educational, and business worlds. These tablets offer computing power, storage, and a wide range of available products to meet nearly every user need. To take advantage of this new computing technology, a system was developed for the Apple iPad (Apple Inc. 1 Infinite Loop Cupertino, CA 95014) to perform health and safety inspections in the field using editable PDFs and saving them to a database while keeping the process easy and paperless.

Surgical hospital audit of record keeping (SHARK)--a new audit tool for the improvement in surgical record keeping.

INTRODUCTION: Accurate and legible record keeping is a crucial part of good medical practice. Surgical Hospital Audit of Record Keeping (SHARK) is a new audit and teaching tool for junior doctors. The author has designed the tool, based on the Royal College of Surgeons guidelines, to anonymously score the different surgical teams' medical records within a hospital. It takes into account regular record keeping during ward rounds, together with the operation note and admission clerking. METHODS: The SHARK audit tool assesses 45 individual areas within surgical records. Fifteen points are apportioned for an initial surgical clerking, 13 for a subsequent record entry, and 17 for the operation note to give an overall score out of 45. It was implemented at 2 hospitals and used to educate medical students. RESULTS: The results were poor and improved with education at both sites. There was 80% total agreement with a κ coefficient for interobserver reliability of 0.6. CONCLUSION: This study shows that the SHARK tool is simple to use, repeatable, and reliable in improving record keeping.

Diagnostic and therapeutic problems of back pain syndromes and their distribution according to a colour coding system of flags.

BACKGROUND: Back pain poses a serious clinical problem in some cases, because under the clinical symptoms of back pain might be other hidden diseases. The aim of this study was to present difficulties in diagnosis and treatment of various diseases of the spine and 2. description to the flagship division, based on the traffic lights. MATERIALS AND METHODS: The clinical material is based on a group of 20 patients with diagnostic and therapeutic difficulties, among 1825 patients treated due to low back pain. Diagnosis was based on clinical examination and various imaging techniques. In the case of cancer biopsy was performed, and in specific and nonspecific infections of the spine treated surgically toward the microscopic examination of tuberculous granulation tissue or inflammatory. The diagnosis of osteoporotic fractures was based on the digital 3D CT. The studied group of 20 patients were divided according to color flag system. RESULTS: Among the analyzed patients 14 received red flag, 5 yellow and 1 black. The red flag has received seven patients with spinal infection, 3 patients with cancer and two with osteoporotic fracture, and 2 patients with low back pain due to an aortic aneurysm. Yellow flag received 5 patients with compensation claims. CONCLUSIONS: 1. In patients with back pain, diagnostic examinations should be administered according to a particular order. Clinical and radiographic examinations are basic tools which should be supplemented by the modern techniques of MRI and CT. 2. Histopathological evaluation of tissue preparations facilitates the diagnosis of an infection or tumour. 3. Classification according to colored flags are useful in clinical practice. It describes the degree of risk of serious illness and difficulties in therapy.

Elaboração de um instrumento para coleta de dados de paciente crítico: histórico de enfermagem / Preparation of a critical patient data collection instrument: nursing record / Elaboración de un instrumento para recolección de datos de paciente crítico: histórico de enfermería

O objetivo deste estudo foi descrever a experiência de construção de um instrumento para coleta de dados para a documentação da primeira etapa do processo de enfermagem em uma unidade de terapia intensiva (UTI). Para esta construção, utilizaram-se estudos formulados com base na literatura sobre o cuidar/cuidado ao paciente crítico. O instrumento para documentação da coleta de dados, intitulado de histórico de enfermagem, foi avaliado e validado por enfermeiros assistenciais conforme: diagramação e dinamicidade no processo. Teve como norteador a Teoria das Necessidades Humanas Básicas. O uso do instrumento, no cotidiano dos enfermeiros, tem facilitado a implantação da primeira etapa do processo de enfermagem na UTI e direcionado a implementação das demais etapas. Com o seu uso, foi possível o registro organizado e direcionado dos dados, bem como a possibilidade de contar com informações imprescindíveis ao planejamento, execução e avaliação do cuidado profissional de enfermagem prestado ao paciente crítico.

This study described construction of an instrument to collect data to document the first stage of the nursing process in an intensive care unit (ICU). Its development drew on studies based on the literature on care/caring for critical patients. The instrument to document data collection (termed the Nursing History) was evaluated and validated by clinical nurses for layout and a dynamic process. It was guided by the Basic Human Needs Theory. Use of the instrument in the nurses’ daily routine has facilitated deployment of the first stage of the nursing process in the ICU, and steered implementation of subsequent steps. Its use made it possible for data recording to be organized and directed, and to make essential data available for planning, implementing and evaluating professional nursing care offered to critically ill patients.

El objetivo de este estudio fue describir la experiencia de construir un instrumento de colección de datos para documentar el primer paso del proceso de enfermería en una unidad de cuidados intensivos (UCI). Para esta construcción, se utilizaron estudios formulados con base en la literatura sobre el cuidar/cuidado al paciente crítico. El instrumento para documentación de la colección de datos, intitulado histórico de enfermería, fue evaluado y validado por enfermeros asistenciales como: diagramación y dinámica en el proceso. Tuvo como guía la Teoría de las Necesidades Humanas Básicas. El uso del instrumento, en el cotidiano de los enfermeros, ha facilitado el despliegue de la primera fase del proceso de enfermería en la UCI y dirigido la ejecución de los pasos restantes. Con su uso, fue posible el registro organizado y dirigido de los datos, así como la posibilidad de contar con datos esenciales para la planificación, ejecución y evaluación del cuidado profesional de enfermería prestado a los pacientes críticamente enfermos.

Creating an effort tracking tool to improve therapeutic cancer clinical trials workload management and budgeting.

Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.

Why patient summaries in electronic health records do not provide the cognitive support necessary for nurses' handoffs on medical and surgical units: insights from interviews and observations.

Patient care handoffs are cognitively intense activities, especially on medical and surgical units where nurses synthesize information across an average of four to five patients every shift. The objective of this study was to examine handoffs and nurses' use of computerized patient summary reports in an electronic health record after computerized provider order entry (CPOE) was installed. We observed and audio taped 93 patient handoffs on 25 occasions on 5 acute care units in 2 different facilities sharing a vendor's electronic health record. We found that the computerized patient summary report and the electronic health record were minimally used during the handoff and that the existing patient summary reports did not provide adequate cognitive support for nurses. The patient summary reports were incomplete, rigid and did not offer "at a glance" information, or help nurses encode information. We make recommendations about a redesign of patient summary reports and technology to support the cognitive needs of nurses during handoffs at the change of shift.

FDA adverse Event Problem Codes: standardizing the classification of device and patient problems associated with medical device use.

UNLABELLED: The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. METHODS: In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. CONCLUSIONS: Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.