Department of Veterans Affairs biomedical engineers at the National Center for Patient Safety (NCPS) examine medical devices for design, specifications, develop standards, and test devices. Very often, biomedical engineers are able to benefit from working side-by-side with clinical engineers to apply their engineering and managerial skills to healthcare technology.
In a prospective risk assessment, engineers consult with staff members at the VA including doctors, nurses, therapists, and technicians when the agency is procuring and acquiring medical devices.
For example, a prospective risk assessment was done on a complex medical device developed to help people with Parkinson’s stop shaking. Biomedical and clinical engineers conducted a review of a deep brain stimulator prior to its use at VA facilities.
After the review, the engineers determined that patients with such implants must be identified in the VA’s Computerized Patient Records System to ensure that contraindicated modalities are not used. A contraindicated modality is a medical term for a procedure such as an MRI that can cause an implant to heat up which may result in brain damage.
To prevent the potential harm that contraindicated modalities can cause a patient with an implant the fact that the patient has an implant must be recorded in the patient’s computerized record. When the information is noted in the electronic record, the clinical staff is prevented from admitting, scheduling, or treating a patient without getting approval from the physician who implanted the device.
However, in a retrospective risk assessment, engineers help to investigate, define, and solve problems associated with devices. Not all devices reviewed are sophisticated medical devices. For instance, some can be simple medical devices such as a pipette which can be used as an oral syringe to administer liquid medications.
In one case, a pipette was involved in a close call that concerned the correct dosage administered. At that point, a retrospective risk assessment needed to be to be conducted. As it happened, the scale on the pipette was read in the opposite way than a standard syringe would be read which caused confusion over the correct dosage. By assessing the situation, pipettes were replaced with safer and easier-to-read devices. A second alternative available would be to replace the liquid dosage with unit dose pills thereby eliminating liquid all together.
For more information, go to www.patientafety.va.gov.