Table 5.
Identified risks to health and mitigation measures
| Identified risk | Mitigation measure |
|---|---|
| Instability, falls, and associated injuries | Clinical testing Training software verification, validation, and hazard analysis Wireless EMC and EMI testing Electrical safety testing Design characteristics Nonclinical performance testing and water/particle ingress testing Durability testing Battery testing Labeling |
| Bruising, skin abrasion, pressure sores, and soft tissue injury | Clinical testing Training Labeling |
| Diastolic hypertension and changes in blood pressure, and heart rate Adverse tissue reaction Premature battery failure | Clinical testing Training Labeling Biocompatibility assessment Battery testing Labeling |
| Interference with other electrical equipment/devices | EMC/EMI testing Labeling |
| Burns and electrical shock | Electrical safety testing Thermal testing Labeling |
| Device malfunction resulting in unanticipated operation (eg, device stoppage, unintended movement) | Clinical testing Nonclinical performance testing Training Software verification, validation, and hazard analysis Electrical safety testing Battery testing Water/particle ingress testing Wireless testing EMC/EMI testing Flammability testing Labeling |
| Use error | Clinical testing Training Labeling |
| Bone fracture (other than caused by falling)a | Training Bone density screening Pressure/torque monitoring Design characteristics Labeling |
| Long-term secondary effecta | Long-term clinical testing Surveillance program |
Notes: Adapted from Table 2 Identified Risks to Health and Mitigation Measures in FDA’s evaluation of ReWalk’s classification. Available from https://www.accessdata.fda.gov/cdrh_docs/pdf13/DEN130034.pdf.27 The entries in this table apply to other lower limb medical exoskeletons that claim being substantially equivalent to ReWalk™.
a
The last two rows contain additional risks that are not included in FDA’s original table. Bold entries are addressed in detail in this review.
Abbreviations: EMC, electromagnetic compatibility; EMI, electromagnetic interference; FDA, US Food and Drug Administration.