Medical devices and the pediatric population - a head-to-toe approach.

: This review uses a head-to-toe approach, a standardized approach similar to the format used by clinicians during the physical examination, to highlight important differences between children, adolescents and adults. The assessment of a pediatric patient is significantly different from an adult and the heterogeneity of the pediatric population requires knowledge of the inter- and intra-subpopulation differences in growth and development for all organ systems. : A search of the English medical literature (PubMed and EMBASE) resulted in identification and review of articles that reported medical device use in the pediatric population based on specific organ systems.

Pediatric post-marketing safety systems in North America: assessment of the current status.

Purpose: It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use.

Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports.

Background. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified.

Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.

Background: Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S.

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective.

Medical devices are often overlooked as a contributor to adverse events. In clinical practice, physicians are aware of the potential for adverse effects from drug products, which are routinely included in differential diagnoses of patients' presenting complaints. However, physicians may not always consider that the use, misuse or malfunction of a medical device, and/or its components, may result in a patient's presenting signs and symptoms or lack of improvement.

Emergency department visits for medical device-associated adverse events among children.

Objectives: The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further.

Methods: ED medical record reports from the National Electronic Injury Surveillance System All Injury Program database from January 1, 2004, through December 21, 2005, were reviewed. MDAEs among pediatric patients were identified, and data were abstracted.

Device safety and effectiveness in the pediatric population: a US FDA perspective.

The US FDA recognizes that there are many challenges to ensuring that medical devices are used responsibly and safely in the pediatric population. Education plays a key role, and manufacturers and healthcare providers must be informed of medical device issues unique to the pediatric population. Healthcare workers and device manufacturers must recognize that adverse events may differ between the adult and pediatric population and among pediatric subpopulations.

Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007.

Purpose: Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002.

Methods: We analyzed reports in AERS received by FDA from January 1, 2003 to January 1, 2008 for overall numbers, age, gender, and seriousness of outcome in children and adults. Pediatric and adult age groups (<2, 2-10, 11-17, 18-50, and >50 years of age) were further evaluated for most frequently reported suspect drug classes and AEs.

Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.

Objectives: From January 1, 2005, through December 31, 2005, the Food and Drug Administration received 5 adolescent death reports associated with the use of insulin pumps, raising concerns about use of this device in this age group. To understand better the types of infusion pump-related problems in adolescents, we performed a comprehensive evaluation of insulin and patient-controlled analgesic pump-related adverse events reported for adolescents that were received by the Food and Drug Administration from 1996 to 2005.

Methods: A search for medical device adverse event reports from January 1, 1996 through December 31, 2005, involving insulin pumps or patient-controlled analgesic pumps used by patients who were aged 12 to 21 years was conducted in the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

Electronic prescribing reduced prescribing errors in a pediatric renal outpatient clinic.

Objective: To assess the effect of an electronic prescribing (EP) system on the incidence and type of prescribing errors and the number of error-free visits.

Study Design: This was a before-and-after study conducted in a nephrology outpatient clinic at an acute tertiary care pediatric hospital.

Results: A total of 520 patients had 2242 items prescribed on 1141 prescriptions during the study period.

Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems.

There is continuing concern that women who receive breast implants may be at increased risk for adverse reproductive outcomes or experience problems with breastfeeding. It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatalproblems. We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA's Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants.

Supply problems of unlicensed and off-label medicines after discharge.

A total of 709 unlicensed and off-label medicines were prescribed for 338 patients discharged from a paediatric hospital between 1 November 2003 and 31 January 2004. Thirty three per cent of patients had difficulty obtaining these medications in primary care which caused treatment disruption. The main problems were: (1) community pharmacies being unable to supply; and (2) GPs' refusal to prescribe.

Introducing Critical Care Outreach: a ward-randomised trial of phased introduction in a general hospital.

Objective: The purpose of the study was to investigate the effects of introducing a critical care outreach service on in-hospital mortality and length of stay in a general acute hospital.

Design: A pragmatic ward-randomised trial design was used, with intervention introduced to all wards in sequence. No blinding was possible.

Paediatric medicines research in the UK: how to move forward?

There have been numerous studies to show that many of the medicines used in children are used off-label or are unlicensed for use in children. When children are prescribed unlicensed and off-label medications, some people may see them as unknowing participants in informal and uncontrolled experiments. However, the licensing status of a drug can be seen as a by-product of the real issues: the safety, efficacy and quality of these medicines in the current licensing system.

Appendectomy during childhood and adolescence and the subsequent risk of cancer in Sweden.

Objective: Researchers have speculated that surgical excision of lymphoid tissue, such as appendectomy, early in life might confer an increased risk of cancer. In this study, we determined the risks of cancer for people who had appendectomy performed during childhood.

Methods: We studied the risk of cancer in a large Swedish cohort of children who had appendectomy performed during the period of 1965-1993.