Surveillance of Medical Device–Related Hazards and Adverse Events in Hospitalized Patients

Abstract

DVERSE DRUG EVENTS HAVE BEENstudied extensively, 1-7 but the computer-based techniques used to detect adverse drug events have not been used to identify medical device events. Although the US Food and Drug Administration's mandatory and voluntary medical device reportingprogramshaveplayedanessentialrole in identifying specific hazards associated with individual types of devices, 8-13 they are limited by underreporting and the absence of denominator data. The diverse arrayoftypesofmedicaldevicesandcomparable variety in potential problems associated with these devices 11,14-21 create challenges for the development and implementation of comprehensive surveillance programs. Human factors are more important than for drugs because devices have to be operated by a person, [22][23][24] and proper use depends on optimal design and instructions. [25][26][27][28] Because surveillance of adverse drug events was facilitated by the application of computer-rule-based methods for screening and detection, 5,29,30 we hypothesized that computer-based surveillance could facilitate recognition of

Triangulating case-finding tools for patient safety surveillance: a cross-sectional case study of puncture/laceration

“…This study is one of a small number to combine and compare the results of four or more detection tools applied to multiple linked datasets, and our findings are consistent with recent research showing the need to use more than one approach in patient safety surveillance 4 18 23…”

Error Producing Conditions in the Intensive Care Unit

“…The results show that devices with high criticality unfortunately have the highest ratings on the EPCs "shortage of time" and "unfamiliarity with the situation." This finding replicates results from Samore and colleagues 19 to a certain extent, but it also extends these by providing evidence that devices that are among the most important for patient safety also are the ones with the largest potential for patient hazards. Ironically, the use of these critical devices is especially compromised when nurses have to deal with significant challenges (e.g., unfamiliar situations) and are under high time pressure ("shortage of time").…”

Pattern of Medical Device Adverse Events in a Tertiary Level Hospital in Northern India: An Ambispective Study

“…So, Indian regulatory agencies should extend post-marketing monitoring to recipients (patients) rather than limiting it to healthcare professionals. Another study by Samore et al(2004) found foleys catheters (57%) and arterial catheters were the devices most commonly associated with MDAE in their study [19]. However, in the present study, no cases with these devices were reported.…”

“…But, none of the MDAEs that happened during the retrospective study period were reported to the same hospital's functional MvPI centre. The number of MDAE in our prospective study was lower than a previous study by Samore MH et al(2004), who detected 552 MDAE over 9 months [19]. However, their study was based on computer-ag-based surveillance while our study was based on spontaneous reporting approach.…”