The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.
== Phase 2: Deeper dive Dive - Design History File Review ===== Scenario ===Client wishes to acquire a ureteral stent company. Dolcera provides the following Design History File (DHF) review.=== Review: Design Input ===
Verify if design input documents are sufficient and also verify if these input documents have been adequately linked to the product performance specifications.
=== Review: Product Performance Specifications (PPS) ===
Verify that design inputs correlate adequately to the specifications and that appropriate design verification and validations (DV&V) are performed. Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans. Verify that product performance specifications correspond to appropriate design output documents.
=== Review: Risk Management documents ===
Review Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation. Verify that DFMEA links appropriately to the PPS. Also verify that appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA. Similarly verify that PFMEA links appropriately to the process validation protocol acceptance criteria and that in-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA.
=== Review: Design Output documents ===
Drawings would be reviewed for completeness. We would recommend that Company X perform a First Article Inspection in order to verify the dimensions on the drawings.
=== Review: Manufacturing documents ===
Review manufacturing procedures, component specifications, raw material specifications, in-coming and in-process inspection procedures for completeness. Review linkage between component and raw material specifications and appropriate in-coming inspection procedures. Ensure inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials. Review of calibration records and preventive maintenance records would be also performed. This would also include a review of the in-process / incoming inspection test methods and related test method validations.
DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports would be reviewed. This would also include a review of the design test methods and related test method validations.
=== Potential DHF Review Outcomes ===
Based on a review of the above DHF documents a potential outcome for the uretral catheter acquisition project could involve the following:
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.