Policy & Procedure Document

Section 11B: SEC 11 — Intra-Operative Safety & Conduct (11.4, 11.5, 11.6, 11.7)

Independent Policies for Each Title

Operating Theatre Policy

POLICY 11.4 — Retained Surgical Item Prevention

Department Operating Theatre (OT)
General Hospital
Version & Dates Version: 1.0
Effective: //20__
Review: //20__
Owner OT Director/Chair + OT Nurse Manager + OT QPS Lead
Policy Code & Title OT-IO-11.4
Retained Surgical Item (RSI) Prevention: Count Reliability + Discrepancy Process
Related Policies: (Counts), SEC 6 (Stop-the-Line), SEC 3 (RCA/Sentinel), Policy 11.6 (Specimens), SEC 9 (IPC)

1.0 PURPOSE

1.1 Purpose Statement

1.1.1 To prevent unintended retained surgical items (RSI) by implementing a comprehensive, highly reliable system that combines:

  • a) standardized counting,
  • b) structured discrepancy response,
  • c) wound/cavity exploration expectations when applicable,
  • d) escalation and imaging triggers,
  • e) documentation discipline, and
  • f) a learning system to correct root causes.

1.1.2 To ensure the entire surgical team shares accountability for preventing RSI events; AORN emphasizes proactive risk strategies and team responsibility for resolution of discrepancies before the patient leaves the OR. (Aorn.org)

2.0 SCOPE

  • 2.1 Applies to all procedures performed in OT and OT-governed procedural rooms where any item could be unintentionally retained.
  • 2.2 Applies to sponges (all types), sharps, instruments, device fragments, and any “miscellaneous countable items” defined by OT count list.
  • 2.3 Applies from room setup through patient transfer out of the OR.
  • 2.4 Includes emergency and trauma cases with defined emergency modifications, but never eliminates the duty to reconcile items and document actions.

3.0 DEFINITIONS

  • 3.1 Retained Surgical Item (RSI): An item unintentionally left inside the patient after procedure completion.
  • 3.2 Count Discrepancy: Any mismatch between recorded counts and observed/verified items.
  • 3.3 Resolved Discrepancy: The missing item is found, verified, and reconciliation is documented.
  • 3.4 Unresolved Discrepancy: The missing item is not found after completing the standard search sequence; escalation actions including imaging are considered and documented.
  • 3.5 High-Risk RSI Case: Cases with increased RSI risk (e.g., emergency surgery, unexpected change in procedure, multiple teams, high blood loss, obesity, long duration, multiple cavities). (Risk factors used for heightened vigilance and documentation.)

4.0 POLICY STATEMENT

  • 4.1 RSI prevention is an OT patient safety priority. The facility shall apply standardized counting and discrepancy processes for every case. (Aorn.org)
  • 4.2 Counting is essential but not perfect; evidence cited in AORN RSI resources notes retained items occur much more frequently in discrepant cases than across all cases, supporting strict escalation for discrepancies. (Aorn.org)
  • 4.3 Any discrepancy triggers Stop-the-Line and cannot be dismissed by assumption or “clinical judgment” alone. The discrepancy process must be completed and documented.
  • 4.4 The patient shall not leave the OR with an unresolved discrepancy unless the escalation pathway (including imaging decision and documentation) is completed and approved by defined authority, with the surgeon informed and documentation completed. (aornjournal.onlinelibrary.wiley.com)
  • 4.5 RSI prevention requires an audit and learning system; all discrepancies (even resolved) are treated as near-miss events and analyzed for system improvements.

5.0 ROLES AND RESPONSIBILITIES

5.1 Surgeon/Proceduralist

  • 5.1.1 Participates in Time-Out/Sign-Out verification and acknowledges count status. (aornjournal.onlinelibrary.wiley.com)
  • 5.1.2 Stops closure/transfer progression when discrepancy is announced and participates in wound/cavity assessment when appropriate.
  • 5.1.3 Documents any wound exploration actions and communicates surgical findings relevant to discrepancy resolution.

5.2 Circulating Nurse (Discrepancy Coordinator)

  • 5.2.1 Initiates counts per and documents in real time.
  • 5.2.2 Announces discrepancy and initiates standardized search sequence.
  • 5.2.3 Coordinates escalation: charge nurse support, imaging request pathways, documentation, incident report initiation.

5.3 Scrub Nurse/Technologist

  • 5.3.1 Maintains organized sterile field and countable item control systems (sponge board, sharps box, instrument organization).
  • 5.3.2 Participates in search of sterile field and instruments and confirms item accounting.

5.4 OT Charge Nurse

  • 5.4.1 Provides support personnel/resources during discrepancies and ensures policy compliance.
  • 5.4.2 Coordinates escalation to OT leadership when unresolved or when time pressure/conflict threatens compliance.

5.5 OT QPS Lead / OT Nurse Manager

  • 5.5.1 Ensures staff training, audits, and system redesign from discrepancy trends.
  • 5.5.2 Leads reviews of RSI events/near misses and ensures corrective action closure.

6.0 RSI PREVENTION SYSTEM REQUIREMENTS (FOUNDATION CONTROLS)

6.1 Standardized Count System (Interface with )

  • 6.1.1 OT maintains an approved standardized count process (initial/closure/final/relief counts) with consistent tools and documentation.
  • 6.1.2 Only approved radiopaque sponges are used when sponges may enter cavities, per facility rules.

6.2 Standardized Work Practices that Reduce RSI Risk

  • 6.2.1 Sponge control: no loose sponges; use sponge holders; keep used sponges visible and separated.
  • 6.2.2 Sharps control: sharps in sharps counter immediately after use; no sharps left under drapes.
  • 6.2.3 Instrument control: maintain instrument set integrity; account for detachable parts and device tips where applicable.
  • 6.2.4 Team communication: additions of countable items are verbalized and recorded immediately.

6.3 High-Risk Case Identification (Pre-Case)

  • 6.3.1 OT identifies high-risk cases in the briefing/huddle (emergency, high blood loss anticipated, obesity, multiple teams, long case, conversion risk).
  • 6.3.2 For high-risk cases, OT applies enhanced vigilance: reduced staff changes, deliberate count pacing, and explicit discrepancy readiness.

7.0 DISCREPANCY RESPONSE PROCESS (STANDARD “STOP-THE-LINE” PATHWAY)

7.1 Discrepancy Declaration (Immediate)

  • 7.1.1 When a discrepancy is identified, the circulating nurse states clearly: “COUNT DISCREPANCY — STOP.”
  • 7.1.2 The surgeon is informed immediately and acknowledges.
  • 7.1.3 Closure/exit activities pause until discrepancy actions are completed.

7.2 Standard Search Sequence (Required Order)

7.2.1 Step 1 — Sterile Field Search (Scrub-Led)

  • a) Scrub checks: instrument table, Mayo stand, sponge holders, sharps counter, kick bucket (as applicable), under instruments, and within drapes.

7.2.1.2 Scrub confirms whether any item could be hidden by pooled fluids, folded drapes, or discarded wrappers.

7.2.2 Step 2 — OR Room Search (Circulating-Led)

  • a) Circulating checks: floor around table, under table, waste bins (before removal), linen bags, instrument carts, suction canisters (as applicable), supply wrappers, and non-sterile surfaces.

7.2.2.2 If waste/linen already removed, escalation occurs immediately to locate those bags/containers before they leave controlled areas.

7.2.3 Step 3 — Surgical Site/Wound Check (Surgeon-Led)

  • 7.2.3.1 Surgeon inspects the wound/cavity as clinically appropriate based on risk and procedure stage.
  • 7.2.3.2 Surgeon communicates findings to the team clearly (“found/not found”).

7.2.4 Step 4 — Documentation Review (Two-Person Review)

7.2.4.1 Circulating and scrub review count sheet for:

  • a) additions after initial count,
  • b) relief changes,
  • c) multiple sponge types,
  • d) detachable components list,
  • e) count method or recording errors.

7.3 Escalation and Support

  • 7.3.1 If discrepancy persists after steps 7.2.1–7.2.4, the charge nurse is called to support search and to coordinate escalation.
  • 7.3.2 If the missing item is a sponge or item with high harm potential, escalation is immediate and not delayed.

7.4 Imaging Triggers and Decision Pathway

7.4.1 Imaging is considered when:

  • a) discrepancy remains unresolved after full search sequence,
  • b) there is suspicion of retained device fragment,
  • c) case type has high RSI risk and clinical suspicion remains despite “correct” reconciliation.
  • 7.4.2 Imaging request process follows hospital pathway (radiology on call/portable imaging).
  • 7.4.3 Documentation must include: time requested, type of imaging, result, and surgeon acknowledgment.
  • 7.4.4 AORN guidance highlights the need to resolve discrepancies and document unresolved discrepancies in the patient record. (aornjournal.onlinelibrary.wiley.com)

7.5 Unresolved Discrepancy (Last Resort Pathway)

7.5.1 If unresolved after search + imaging pathway (as applicable), the surgeon and OT leadership follow the facility-approved escalation decision framework, including documentation of:

  • a) item description,
  • b) actions performed,
  • c) imaging result,
  • d) final decision and responsible authority,
  • e) patient follow-up plan (as per clinical governance).

7.5.2 An incident report is mandatory.

8.0 SPECIAL SCENARIOS

8.1 Emergency Surgery

8.1.1 When immediate action is required for life/limb, initial counts may be delayed, but item control tools must be used from the start (sponge board, sharps box).

  • a) document “initial count not performed” with reason (emergency),
  • b) perform counts as soon as the patient is stabilized and workflow permits,
  • c) maintain best possible item control from the first moment (sponge board, sharps box).

8.1.2 Final count remains mandatory. If discrepancy occurs, follow discrepancy response pathway.

8.2 Staff Relief / Handover

8.2.1 Relief counts and handover documentation are mandatory per , because handoffs increase risk of communication failure.

8.3 Multiple Teams / Multiple Cavities

  • 8.3.1 One official count record is maintained; transfers of items between fields are verbalized and documented.
  • 8.3.2 Cavity closure counts are repeated per policy.

8.4 Devices with Detachable Parts / Fragments

  • 8.4.1 When detachable tips/components are used, the team accounts for them as “countable” items by local list.
  • 8.4.2 Any suspected fragment loss triggers immediate search and imaging consideration.

9.0 DOCUMENTATION / CONTROLLED RECORDS

  • 9.1 Count record with explicit discrepancy notes and actions.
  • 9.2 Discrepancy event record (search sequence, escalation, imaging actions).
  • 9.3 Surgeon documentation in operative note if required by policy for discrepancy/imaging actions.

9.4 Incident report for:

  • a) all discrepancies (resolved or unresolved),
  • b) any imaging performed for discrepancy,
  • c) any RSI event.

10.0 MONITORING / AUDIT / KPIs

  • 10.1 Discrepancy rate per 100 cases (by type: sponge/sharp/instrument/device fragment).
  • 10.2 % discrepancies with complete documented search sequence.
  • 10.3 Imaging utilization for unresolved discrepancies (trend).
  • 10.4 RSI events (target: zero).
  • 10.5 “Learning loop” closure: % corrective actions completed on time after discrepancy reviews.

11.0 REFERENCES (ENGLISH)

  • 11.1 AORN Retained Surgical Items (overview and prevention emphasis). (Aorn.org)
  • 11.2 AORN Preventing Retained Surgical Items (importance; discrepancy resolution responsibility). (Aorn.org)
  • 11.3 AORN Evidence Table Discrepancy cases have much higher retained item frequency than overall cases (supports strict escalation). (Aorn.org)
  • 11.4 AORN Guideline Quick View (documentation of unresolved discrepancies). (aornjournal.onlinelibrary.wiley.com)
  • 11.5 AORN RSI evidence resource (system approach including reliable counting and imaging considerations). (Aorn.org)

12.0 APPENDICES

  • 12.1 Appendix A — Discrepancy Search Checklist (Field → Room → Wound → Documentation)
  • 12.2 Appendix B — Imaging Request/Result Record (Discrepancy)
  • 12.3 Appendix C — RSI Near-Miss Report Template (Rapid entry)
  • 12.4 Appendix D — High-Risk RSI Case Briefing Prompt (Pre-Case)
Operating Theatre Policy

POLICY 11.5 — Patient Positioning & Pressure Injury Prevention

Department Operating Theatre (OT)
General Hospital
Version & Dates Version: 1.0
Effective: //20__
Review: //20__
Owner OT Nurse Manager + OT Safety Lead + OT QPS Lead
Policy Code
Related Policies: SEC 7 (Transfers), SEC 4 (Dignity/Privacy), SEC 8 (PACU handover interface)

1.0 PURPOSE

1.1 Purpose Statement

  • 1.1.1 To prevent perioperative pressure injuries and positioning-related harm (nerve injury, musculoskeletal injury, ocular/facial injury, device-related pressure injury) by implementing standardized positioning planning, execution, reassessment, and documentation.
  • 1.1.2 AORN emphasizes that all perioperative patients are at risk for pressure injury because they are immobile, placed on a relatively hard surface, and cannot feel or respond to pressure/shear during anesthesia. (Aorn.org)

2.0 SCOPE

  • 2.1 Applies to all OT cases from trolley→table transfer through patient exit.
  • 2.2 Applies to all positions, all specialty frames, and all patient populations.

3.0 DEFINITIONS

  • 3.1 Perioperative pressure injury: injury related to perioperative immobility, pressure, shear, moisture, or device compression.
  • 3.2 Positioning reassessment: periodic confirmation that protective measures remain intact during prolonged cases.

4.0 POLICY STATEMENT

  • 4.1 Positioning is a controlled safety procedure requiring planning, equipment readiness, team verification, and documentation.
  • 4.2 All patients are treated as at-risk; high-risk patients/cases require enhanced controls (support surfaces, padding, reassessment intervals). (Aorn.org)
  • 4.3 The circulating nurse coordinates positioning safety; surgeon and anesthesia provider participate in “final position safety confirmation.”

5.0 RESPONSIBILITIES

  • 5.1 Charge nurse ensures availability of approved positioning devices and adequate trained personnel.
  • 5.2 Circulating nurse leads assessment, positioning checklist, reassessment, and documentation.
  • 5.3 Scrub assists without compromising sterility.
  • 5.4 Surgeon confirms safe feasibility for exposure; anesthesia confirms airway/head/physiology considerations.

6.0 PROCEDURE

6.1 Pre-Position Risk Assessment (Mandatory)

  • 6.1.1 Assess patient risk factors (frailty, diabetes, vascular disease, obesity/underweight, neuropathy, edema, previous PI, limited ROM).
  • 6.1.2 Assess procedure risk factors (duration, steep Trendelenburg, prone spine, traction, rigid frames, anticipated blood loss).
  • 6.1.3 Identify device-pressure risks (ETT holder, ECG leads, IV tubing, urinary catheter, drains).

6.2 Positioning Plan and Team Confirmation

  • 6.2.1 Confirm intended position and planned changes.
  • 6.2.2 Confirm required pads/devices and safe handling approach.
  • 6.2.3 Confirm privacy controls (draping/exposure minimization) before induction/position change.

6.3 Universal Positioning Safety Principles

  • 6.3.1 Maintain neutral alignment of head/neck/spine.
  • 6.3.2 Redistribute pressure using approved surfaces and padding; AORN recommends using surfaces that redistribute pressure to reduce injury risk. (Aorn.org)
  • 6.3.3 Prevent shear/friction: lift rather than drag; use slide aids.
  • 6.3.4 Protect nerves: limit arm abduction; pad ulnar/peroneal risk zones; avoid compressive braces.
  • 6.3.5 Secure safely: safety strap without compromising perfusion; verify distal circulation as applicable.
  • 6.3.6 Ensure lines/tubes are not under the patient and not under tension.

6.4 Position-Specific Minimum Standards

  • 6.4.1 Supine: protect occiput, scapula, elbows, sacrum, heels.
  • 6.4.2 Prone: ensure no ocular pressure; neutral neck; protect face, chest, iliac crests, knees, toes; reassess face/eyes during prolonged prone cases.
  • 6.4.3 Lateral: protect dependent shoulder/hip; pad knees/ankles; stabilize.
  • 6.4.4 Lithotomy: synchronized leg movement; protect peroneal nerve; document start time and prolonged duration controls.
  • 6.4.5 Beach chair/sitting: prevent sliding; protect pressure points; ensure head/neck support.
  • 6.4.6 Trendelenburg: prevent sliding without injurious compression; protect arms/hands.

6.5 Enhanced Controls for High-Risk Cases

  • 6.5.1 Use higher-grade support surfaces/padding and increase reassessment frequency.
  • 6.5.2 Document reassessment intervals (facility-defined; commonly every 2 hours for prolonged cases).

6.6 Intra-Operative Reassessment

  • 6.6.1 Reassess after table movement, major position change, traction adjustment, significant hemodynamic event.
  • 6.6.2 Document findings and corrections.

6.7 End-of-Case Checks and Handover

  • 6.7.1 Document position and devices used.
  • 6.7.2 Communicate any skin/pressure concerns to PACU at handover.

7.0 DOCUMENTATION

  • 7.1 Position and support devices used (headrest type, pads, straps, frames).
  • 7.2 Reassessment time stamps for prolonged/high-risk cases.
  • 7.3 Any positioning-related event/near miss or suspected injury.

8.0 AUDIT / KPIs

  • 8.1 % cases with complete positioning documentation.
  • 8.2 % high-risk cases with reassessment documentation.
  • 8.3 Perioperative pressure injury trend monitoring (QPS). (Aorn.org)

9.0 REFERENCES

  • 9.1 AORN pressure injury guideline takeaways (perioperative risk and support surfaces). (Aorn.org)
  • 9.2 AORN position statement (team responsibility; prevention starting before OR). (Aorn.org)

10.0 APPENDICES

  • 10.1 Positioning Safety Checklist (per case)
  • 10.2 High-Risk Positioning Plan + Reassessment Log
  • 10.3 Position-specific padding maps (supine/prone/lateral/lithotomy)
Operating Theatre Policy

POLICY 11.6 — Specimen Handling, Labeling & Transport

Department Operating Theatre (OT)
General Hospital
Version & Dates Version: 1.0
Effective: //20__
Review: //20__
Owner OT Nurse Manager + OT QPS Lead + Laboratory Liaison
Policy Code
Related Policies: SEC 6 (Two identifiers), Policy 11.2 (Wrong-site prevention), Policy 11.12 (Documentation)

1.0 PURPOSE

  • 1.1 To ensure specimens are correctly identified, labeled, documented, preserved, and transported to prevent mislabeling, loss, wrong-site description, and compromised diagnostic integrity.
  • 1.2 CAP guidance emphasizes specimen labels should contain at least two unique identifiers (e.g., patient name + ID number/MRN). (documentsuat.cap.org)

2.0 SCOPE

  • 2.1 Applies to all specimens collected in OT: pathology tissue, biopsies, frozen sections, microbiology specimens, foreign bodies when submitted, medico-legal specimens when applicable.
  • 2.2 Applies from sterile field collection through lab receipt.

3.0 DEFINITIONS

  • 3.1 Primary container: first container that holds the specimen.
  • 3.2 Two identifiers: patient full name + MRN/ID (or facility-approved second identifier). (documentsuat.cap.org)
  • 3.3 Chain-of-custody: documented control of specimen transfer steps (required for defined categories and critical specimens).

4.0 POLICY STATEMENT

  • 4.1 Every specimen container must be labeled immediately with at least two patient identifiers and accurate specimen description/site/laterality. (documentsuat.cap.org)
  • 4.2 No unlabeled specimen may leave the sterile field or OR.
  • 4.3 Specimen labeling requires a verbal verification/read-back between scrub and circulating nurse; complex site/orientation requires surgeon confirmation.
  • 4.4 Correct container/fixative/transport conditions must be used according to laboratory requirements.

5.0 RESPONSIBILITIES

  • 5.1 Surgeon identifies specimen source/site/laterality and orientation.
  • 5.2 Scrub protects specimen integrity and announces specimen details.
  • 5.3 Circulating nurse labels container, completes requisition/order, performs read-back, and ensures transport.
  • 5.4 Charge nurse supports escalation for discrepancy, delay, or loss.
  • 5.5 Lab/courier confirms receipt and reports issues.

6.0 PROCEDURE

6.1 Readiness

  • 6.1.1 Correct containers available (formalin, fresh, sterile microbiology, frozen section pathway).
  • 6.1.2 Labels and requisitions accessible.

6.2 Collection and Transfer

  • 6.2.1 Scrub receives specimen and protects integrity.
  • 6.2.2 Specimen transferred to circulating nurse in a controlled manner; no unattended specimens.

6.3 Labeling Standard (Primary Container)

6.3.1 Label immediately after transfer.

6.3.2 Minimum label elements:

  • a) patient name,
  • b) second identifier (MRN/ID or approved),
  • c) specimen description + site + laterality/level if applicable,
  • d) date/time (per policy),
  • e) collector/OR identifiers as required. (documentsuat.cap.org)

6.4 Read-Back Verification (Mandatory)

  • 6.4.1 Circulating nurse reads aloud identifiers and specimen/site.
  • 6.4.2 Scrub confirms; surgeon confirms complex site/orientation.

6.5 Order/Requisition Matching

6.5.1 Requisition/order must match label exactly; mismatches are corrected before transport.

6.6 Special Categories

  • 6.6.1 Frozen section: marked and transported immediately; lab notified.
  • 6.6.2 Microbiology: sterile container; prompt transport; no formalin.
  • 6.6.3 Medico-legal: sealed container, chain-of-custody signatures at every handover.

6.7 Transport and Chain-of-Custody

  • 6.7.1 Use leak-proof secondary bag/box; separate paperwork from wet fixative.
  • 6.7.2 Specimens not left unattended in corridors.
  • 6.7.3 Receiving party documents receipt time and condition.

6.8 Discrepancy Handling (Stop-the-Line)

  • 6.8.1 Unlabeled or mismatched specimen: stop, isolate, correct with verification, notify charge nurse, incident report.
  • 6.8.2 Suspected lost specimen: immediate search protocol + notify surgeon/charge nurse/lab; document actions; incident report.

7.0 DOCUMENTATION

  • 7.1 Specimen log (case ID, specimen description, time, sender/receiver).
  • 7.2 Requisition/order record.
  • 7.3 Chain-of-custody form when required.
  • 7.4 Incident reports for mismatch, delay, loss, leakage.

8.0 AUDIT / KPIs

  • 8.1 % specimens with two-identifier labeling (target 100%). (documentsuat.cap.org)
  • 8.2 Specimen near-miss rate per 1,000 cases.
  • 8.3 Frozen section turnaround transport timeliness (trend).
  • 8.4 Leakage/damage incidents (trend).

9.0 REFERENCES

  • 9.1 CAP Practical Guide to Specimen Handling (two identifiers). (documentsuat.cap.org)
  • 9.2 CAP Uniform labeling manuscript (two identifiers + linkage within case). (documents.cap.org)

10.0 APPENDICES

  • 10.1 Specimen Labeling Checklist
  • 10.2 OT Specimen Log Template
  • 10.3 Frozen Section Rapid Pathway Form
  • 10.4 Chain-of-Custody Form
Operating Theatre Policy

POLICY 11.7 — Implant / Prosthesis Traceability (Stickers, Logs, Patient Implant ID)

Department Operating Theatre (OT)
General Hospital
Version & Dates Version: 1.0
Effective: //20__
Review: //20__
Owner OT Director/Chair + OT Nurse Manager + Supply Chain/Materials + Biomedical Liaison
Policy Code OT-IO-11.7
Related Policies: SEC 6 (Verification), SEC 9 (CSSD interface), SEC 3 (QPS/recall response)

1.0 PURPOSE

  • 1.1 To ensure every implanted device/prosthesis is traceable to the patient and procedure with complete identification data to support recalls, adverse event investigations, infection investigations, and patient follow-up.
  • 1.2 SFDA UDI requirements note implantable devices that include a patient implant card should contain device identification including UDI information.

2.0 SCOPE

  • 2.1 Applies to all implants/prostheses used in OT (orthopedic, vascular, mesh, plates/screws if classified as implantable by local governance, and any implantable devices brought into OT).
  • 2.2 Applies to stocked implants and vendor loaners.
  • 2.3 Applies from implant receipt into OR through documentation completion and patient implant identification output.

3.0 DEFINITIONS

  • 3.1 UDI: Unique Device Identifier system used to identify devices (UDI-DI/UDI-PI components depending on labeling).
  • 3.2 Implant Card: Patient identification information for implanted device; content requirements and exemptions may be defined by SFDA guidance documents.

4.0 POLICY STATEMENT

  • 4.1 No implant is inserted unless correct implant selection, packaging integrity, sterility status, and expiry are confirmed, and traceability capture is ready.
  • 4.2 Traceability documentation is completed before the patient leaves the OR or within the defined immediate post-op documentation window (not later than end of shift).
  • 4.3 Minimum traceability dataset includes patient identifiers, procedure, site/side, device description, manufacturer, model/catalog, lot/serial, expiry (if applicable), and UDI capture when available/required.
  • 4.4 Missing implant documentation is treated as a serious documentation defect and escalated.

5.0 RESPONSIBILITIES

  • 5.1 Surgeon confirms final implanted components and site/side.
  • 5.2 Circulating nurse leads traceability capture and documentation accuracy.
  • 5.3 Scrub preserves packaging/labels until captured; announces implant opening.
  • 5.4 Supply chain manages recall notifications and stock rotation; maintains implant log governance.
  • 5.5 Vendor rep (if present) provides technical support only within approved boundaries.

6.0 PROCEDURE

6.1 Pre-Case Implant Readiness

  • 6.1.1 Verify implant availability and correct size range.
  • 6.1.2 Verify packaging integrity and expiry.
  • 6.1.3 Verify CSSD release for loaner trays where applicable.
  • 6.1.4 Prepare traceability tools (stickers/UDI scan fields, implant log sheet).

6.2 Verification at Opening and Before Insertion

  • 6.2.1 Before opening, confirm: name/type, side/site match, size/model, expiry, packaging integrity.
  • 6.2.2 For laterality-sensitive implants, repeat confirmation immediately before insertion.

6.3 Traceability Capture (Stickers/UDI/Manual Entry)

6.3.1 Capture method follows facility system (sticker placement, barcode/UDI scan into EHR/registry, or manual entry with verification).

6.3.2 Minimum recorded elements:

  • a) patient identifiers,
  • b) date/time, OR room, surgeon, procedure, site/side,
  • c) manufacturer, model/catalog,
  • d) lot/serial and expiry if present,
  • e) UDI information when available/required.

6.4 Implant Log / Registry (Recall-Ready)

6.4.1 OT maintains an implant log (or EHR registry) designed for recall tracing and audit.

6.5 Patient Implant Identification Output

6.5.1 Provide implant identification information to the patient according to facility policy and applicable SFDA implant card requirements/exemptions.

6.6 Post-Insertion Reconciliation

  • 6.6.1 Circulating nurse confirms recorded devices match implanted devices.
  • 6.6.2 Unused opened implants are handled per returns policy and vendor/supply chain rules.

6.7 Recall / Safety Alert Response

6.7.1 Upon recall notice, supply chain uses implant log to identify affected patients and coordinates clinical communication; OT supports record retrieval quickly.

6.8 Nonconformity Handling

  • 6.8.1 Expired/damaged/missing label = do not use; isolate; notify supply chain and OT leadership.
  • 6.8.2 Missing documentation discovered post-op triggers immediate reconstruction from packaging/records and incident reporting if not resolvable.

7.0 DOCUMENTATION

  • 7.1 Implant traceability record in operative documentation (stickers/scan output/manual entry).
  • 7.2 Implant log/registry record.
  • 7.3 Vendor loaner documentation (receipt/release/missing items).
  • 7.4 Patient implant ID output record (implant card/discharge note reference).

8.0 AUDIT / KPIs

  • 8.1 % implant cases with complete traceability dataset (target 100%).
  • 8.2 Missing lot/serial/UDI capture rate (trend).
  • 8.3 Recall readiness drill performance (time to identify impacted patients).
  • 8.4 Loaner tray timing compliance (if applicable).

9.0 REFERENCES

  • 9.1 SFDA UDI Requirements (implant card includes device identification/UDI).
  • 9.2 SFDA guidance on implant card and exemptions (example document).
  • 9.3 SFDA REQ document annex referencing implant card information to be supplied.

10.0 APPENDICES

  • 10.1 Implant Traceability Form (Sticker/UDI Fields)
  • 10.2 Implant Log Template (Recall-Ready)
  • 10.3 Implant Verification Checklist (Pre-open / Pre-insert)
  • 10.4 Patient Implant ID Card Template (facility editable)

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