add share buttonsSoftshare button powered by web designing, website development company in India

5 Risk Management Response To Medical Device-Related Incidents

5 Risk Management Response To Medical Device-Related Incidents

1. Take care of the patient. This admonition is unnecessary for clinicians. Their first and highly-appropriate instinct is to push the equipment aside and focus on the patient. 

HTM professionals — best clinical field teams and biomedical equipment technicians may need to remind themselves that patients come first.

2. Report to Risk Management. When I ask risk managers about their biggest challenge, they often say it’s getting clinicians to report incidents promptly. When I ask HTM professionals, they say it’s not knowing that the device in their shop is there for incident investigation rather than routine repair. Make good reporting easy. Establish good communication between risk management and HTM.

3. Sequester the device. Put the equipment in a secure location so that it is not tampered with or inadvertently returned to service, especially if there is an expectation of legal action. The primary objective here is the preservation of evidence. Do not change the device settings. Save accessories and disposables (including packaging showing lot numbers). Plugin the device to maintain event logs.

4. Preserve patient data. This includes data within the medical device, printouts produced by the device, electronic and paper data in the patient record, and electronic data from networked medical devices stored centrally. Without these data, it’s difficult to get a clear picture of what happened. A thorough understanding of the event is essential to reduce the likelihood of its recurrence.

5. Investigate the incident. For some device-related incidents, HTM professionals within the organization have the appropriate skills. In other cases, the facility may wish to get additional expertise or an independent perspective. One option is to work with the device manufacturer — but note that the interests of the organization and the manufacturer are not identical. Another option is to work with an independent medical device expert.