Device medical pdf surveillance

For the qualitative study, telephone interviews and device malfunctions, voluntary programs can encourage were conducted among 12 surgeons and four registered nurses practitioners to report hazardous situations and errors that did in two tertiary care hospitals in Ontario, Canada. Respondents not cause harm but have the potential to do so. An important were asked to discuss factors that influence the recognition, factor in the quest for improving the safety of medical devices reporting, and resolution of medical device-related incidents is broader immunity for error reports and a non-punitive according to their professional experience, as well as inter- For personal use only.

Numerous incentives can be used to improve the safety of medical devices. The hospital had an incentives for incident reporting would encompass protection established Center for Patient Safety with a mandate to from legal action and fear of criticism, blame, or disapproval.

These individuals, therefore, exist at the hospital. An effective medical device Proposed framework to improve surveillance system should incorporate multiple compo- the safety of medical devices nents that accurately document and assess the appropriate in a Canadian hospital context actions to reduce the risk of incidents, adverse events, and AMDEs have been found to occur In one study, newsletter distribution and recognize adverse events, incidents, or malfunctions associated information dissemination at monthly departmental meet- For personal use only.

These representatives report adverse events by Polisena et al Polisena et al, unpublished data, also associated with the use of medical devices to the Marketed revealed some frustration among frontline clinicians with the Pharmaceutical and Medical Devices Bureau of Health lack of feedback from their institution when they reported a Canada.

The reports sent help regulators to better character- medical device-related incident. The cycle consists of the contribute to a particular event, potentially mitigating risk following major steps: 1 receipt, screening, and archiving at an earlier stage. Hospitals benefit from timely new safety of incoming reports; 2 analysis of trends in aggregated information to make informed decisions concerning the Medical Devices: Evidence and Research submit your manuscript www.

Examples of fixed costs For personal use only. Also, the surveillance data Information technology staff would be on-call throughout can lead to the development of a conceptual framework of the implementation phase to resolve any potential errors or factors that influence device incident occurrence, recognition, answer questions from the intended users in order to ensure reporting, and resolution, thus leading to enhanced patient a seamless surveillance system launch.

In summary, the proposed surveillance system would facilitate the monitor- Critical incident analysis ing of device-related incidents and reduce the risk of adverse During the critical incident analysis phase, assigned hospital events or device malfunctions, leading to improved patient staff members from clinical, biomedical engineering, infec- care and decreased risk of health professional and institu- tion control, and other relevant departments must under- tional liabilities.

The termined time frame to a select group of hospital decision- framework provides investigators with a structured approach makers and health care professionals prior to its release on a For personal use only. These individuals would represent the demo- by outlining the main factors and related contributory factors graphics of intended users.

Items to be tested include data to for consideration. It is important to note that errors that do be collected by the surveillance system, such as the data not result in patient adverse events ie, near misses are not sources and collection methods, and procedures on data excluded from the analysis process.

The pilot test will not only collect feedback about the value of data collected and ease of use, but identify and correct any possible weaknesses in the system. To ensure Evaluation of proposed medical a smooth transition in the hospital, the implementation device surveillance system phase would be divided into numerous sub-phases, where Surveillance systems are dynamic and require acceptance the surveillance system would be installed in one hospital from intended users to render them successful.

Medical Devices: Evidence and Research submit your manuscript www. It is important to understand how care. We advise that direct costs of the surveillance system hospital decision-makers and health care providers plan to be calculated both in the planning and implementation phases use the surveillance data.

Data quality, timeliness, credibility, of the initiatives, while the benefits would be assessed in leadership, and persistence in data feedback processes were the implementation phase in order to evaluate the impact identified as additional important factors to surveillance of the safety of medical devices in the hospital.

Julie Polisena is funded by the vidual interviews or focus groups to solicit feedback on the Ontario Graduate Scholarship. The Disclosure evaluation would determine whether the surveillance system The authors report no conflicts of interest in this work. For personal use only. Questions might be, for example, Was the data collected in the system relevant and timely? Was it useful References for hospital administrators and health care providers? Was 1. Maisel WH. Medical device regulation: an introduction for the practicing physician.

Ann Intern Med. Would the hospital administrators 2. The rise of medtech [webpage on the Internet]. June 10, and health care providers continue to use the system? Are [cited January 2, ]. Accessed April 7, Adverse events in British system? Medical Device based on the surveillance data and patient records. Accessed November 11, Quality systems ISO [webpage on the Internet]. Ottawa: Health repeatedly due to human factors, then a training program Canada; Accessed February 26, National medical device postmarket this type of incident in a measurable way.

Conversely, if the surveillance plan. US Food and Drug Administration. Update and Next Steps. Ontario: Health Canada; Our assessment suggests that 9. Office of the Auditor General of Canada [homepage on the Internet]. Chapter a medical device surveillance program that combines an 6 — Regulating medical devices — Health Canada.

In: Jun status report of the Auditor General of Canada. Accessed March 15, Medicare and medical technology — the growing N Engl J Med. Qual Saf Health Care. The Medical Device Safety Act ;18 1 — Ethical issues associated with the Hong Kong: Xerafy; J Obstet Gynaecol Can. Accessed Adverse event reporting systems and safer November 11, Capsule Tech, Inc. Torrence ME. Data sources: use in the epidemiologic study of medical Risk? Strength of study evidence examined connectivity-is-waiting-worth-the-risk.

Accessed November 11, by the FDA in premarket approval of cardiovascular devices. Health Canada [homepage on the Internet]. Canadian Medical Devices Ottawa: Health Canada; The error may have been due to a poorly designed device, or it may have been used in a situation that promoted incorrect usage. Other users may make the same use error with similar or worse consequences.

You can help us identify these errors by reporting the actual events and near misses that occur at your facility. When reporting an adverse event, reporters often leave out details of the event that can be useful in identifying the factors or conditions that led to the event.

Reports are more helpful if you describe the scenario as concretely as you can. In programming a bolus before the concentration change, she misunderstood the default settings and accepted the bolus concentration as the final dose. As a result, the patient received a three-fold overdose.

In addition to a full description, other important and helpful information to include in the report is:.