Product Management and Device Safety Policy

1. Policy Statement

It is the policy of this organization that all vascular access devices, infusion products, and related equipment shall be selected, evaluated, inspected, and monitored through rigorous, evidence-based processes that prioritize patient safety and clinical outcomes. Product selection shall be driven by demonstrated clinical performance rather than cost alone or commercial relationships. All staff shall maintain current knowledge of products in use, and a robust system shall exist for reporting and investigating product defects, hazard alerts, and recalls.

2. Purpose

This policy exists to:

• Ensure that product procurement and device selection are driven by clinical evidence, patient safety outcomes, and interprofessional evaluation—not by cost alone or manufacturer relationships.
• Define the composition, responsibilities, and operating procedures of the interprofessional Product Evaluation Team.
• Mandate pre-use inspection of all infusion and vascular access equipment to identify defects or expired products before they reach patients.
• Establish a reporting-conducive environment where clinicians can easily and without fear report device problems, recalls, and hazard alerts.
• Define the organization’s response to supply chain disruptions to protect patient safety during product transitions.

3. Scope

This policy applies to:

• All clinical end users who select, order, insert, manage, or handle vascular access devices and infusion products.
• The interprofessional Product Evaluation Committee and all personnel involved in product procurement, formulary decisions, and clinical trials of vascular access products.
• Supply Chain, Pharmacy, Biomedical Engineering, Clinical Education, Infection Prevention, and Information Technology departments insofar as they participate in product management.
• All vascular access and infusion products including: peripheral IV catheters, midline catheters, PICCs, central venous catheters, implanted ports, intraosseous devices, antiseptic agents, dressings, securement devices, needleless connectors, extension sets, administration sets, and infusion pumps.
• All care settings within the organization.

4. Policy Requirements

4.1 Product Evaluation and Selection

4.1.1 Interprofessional Evaluation Team. The organization shall maintain an interprofessional Product Evaluation Committee (PEC) that includes clinical end users and indirect stakeholders. The PEC shall include, at minimum: nurses, infection preventionists, physicians, biomedical engineers, information technologists, pharmacists, and patient representatives. This diverse composition ensures comprehensive assessment across all dimensions relevant to product performance and safety.

4.1.2 Evidence-Based Selection Criteria. Products shall be evaluated across multiple dimensions: clinical application, performance, infection and complication prevention, safety, efficacy, ease of use, acceptability, reliability, and cost-effectiveness. Products shall be selected for evaluation based on: organizational quality indicators, internally and externally reported adverse event data, availability of new or safer products, current and emerging clinical evidence, and developing technologies.

4.1.3 Clear Evaluation Goals. The PEC shall define evaluation goals in advance of each product assessment, specifying what will be measured and the minimum parameters required for an evaluation to be considered successful. Goals may include: enhancing care continuity, reducing specific complication rates, improving clinician compliance with best practices, saving time, or standardizing use across the organization.

4.1.4 Risk-Benefit Analysis. Product selection shall be guided by risk-benefit analysis comparing patient risk of injury against indications for use. The PEC shall understand the intended organizational use of each product—such as reduction of infection, occlusion, or thrombosis—and compare this against manufacturer directions and product indications. Data collection tools shall be developed for analysis and ongoing monitoring of selected products.

4.1.5 Home Care Environment Assessment. For products intended for home care use, evaluation shall additionally assess: whether the device is designed for the home environment, whether reusable equipment can be properly cleaned and disinfected between uses, whether the product provides adequate feedback to assist patients and caregivers in identifying problems, and whether the product or technology will improve communication between home care patients and the healthcare team.

4.1.6 Education and Training. Comprehensive education and training for selected products shall be provided to all end users prior to product adoption. Manufacturer support may be utilized in product education when appropriate.

4.2 Ongoing Clinician Knowledge and Competency

4.2.1 Clinical end users shall attain and maintain current knowledge about developments and technologies relating to vascular access devices, infusion products, and equipment. This ongoing education ensures that clinical practice aligns with evidence-based recommendations and that staff can effectively utilize new technologies as they become available.

4.2.2 The Clinical Education Department shall incorporate product education into annual competency validation programs and shall provide timely education when new products are introduced or when significant changes to existing products occur.

4.3 Product Inspection and Quality Assurance

4.3.1 Mandatory Inspection. All infusion and vascular access equipment and supplies shall be inspected for product integrity and function before, during, and after use. This systematic inspection protects patients from product defects and enables early detection of quality issues.

4.3.2 Pre-Use Inspection Protocol. Before use, each product shall be visually inspected to confirm:

• Packaging is clean, dry, and intact with no tears, holes, or evidence of moisture infiltration.
• The product expiration date has not been exceeded.
• The product shows no visible signs of damage, discoloration, or physical defect.

Any product failing these criteria shall be removed from clinical use immediately without opening the package.

4.3.3 Management of Expired or Defective Products. Expired or defective products shall be:

• Removed from patient use immediately.
• Clearly labeled as “DO NOT USE — Expired/Defective” and segregated from usable inventory.
• Reported to the appropriate department within the organization (Supply Chain, Biomedical Engineering, or Pharmacy as applicable), to the manufacturer, and to authoritative reporting organizations as required.
• Retained and returned to the manufacturer when possible to enable thorough investigation of the failure mode.

4.4 Problem Reporting and Investigation

4.4.1 Recall and Hazard Alert Monitoring. Clinical staff shall monitor for product recalls and hazard alerts through the organization’s established surveillance processes. Supply Chain and Risk Management shall maintain a current log of active recalls and shall communicate relevant alerts to all affected clinical areas within twenty-four (24) hours of notification.

4.4.2 Structured Investigation. When investigating problems associated with medical devices, the organization shall use a structured, objective approach. Investigation shall distinguish between: device malfunction, user error, and problems with surrounding infrastructure. This distinction guides appropriate corrective action—whether additional clinician education or compliance and accountability review.

4.4.3 Reporting-Conducive Environment. The organization shall develop an environment that actively encourages and facilitates reporting of device problems. Barriers to reporting shall be identified and removed, including: fear of consequences, uncertainty about what to report, and lack of easy reporting mechanisms. Electronic error reporting shall be available and promoted. All adverse events or serious adverse events associated with vascular access devices or infusion products shall be reported to Risk Management, Quality Improvement, and authoritative reporting organizations as required.

4.4.4 Research demonstrates that clinicians may develop workarounds when products are problematic rather than reporting issues. The organization shall explicitly communicate that reporting device problems is a professional obligation and shall recognize staff who report concerns.

4.5 Supply Chain Disruption Management

4.5.1 Clinical experts, including Vascular Access Specialists and representatives from the PEC, shall participate in all product substitution decisions required during supply chain disruptions. Substitution decisions shall not be made by Supply Chain or Procurement alone without clinical input.

4.5.2 When familiar products become unavailable and substitutions are required, the organization shall ensure comprehensive planning for:

• Communication: Timely, clear notification to all affected clinical areas of the substitution timeline, rationale, and differences from the discontinued product.
• Education: Just-in-time training on differences in use, technique, or handling for the substitute product.
• Outcome monitoring: Enhanced surveillance of complication rates and clinical outcomes during the transition period to identify any safety signals associated with the substitute product.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through: quarterly PEC meeting completion and documentation review, tracking of product inspection failures and near-miss incidents attributable to defective or expired products, monitoring of recall notification response times, and tracking of device-related adverse event reporting rates.

5.2 Key Performance Indicators.

• PEC evaluation completion rate for all proposed formulary changes (target: 100%).
• Pre-use product inspection documentation compliance rate (target: ≥95%).
• Recall notification communication time to clinical areas (target: ≤24 hours of receipt).
• Device problem report submission rate (target: year-over-year increase indicating improved reporting culture).

5.3 Enforcement. Use of expired, recalled, or defective products after identification is a serious policy violation. Failure to report a known product defect or adverse device event shall be addressed through the progressive corrective action process.

6. Exceptions

6.1 In emergent clinical situations where no approved product is immediately available and patient safety requires immediate vascular access, an off-formulary product may be used. The clinical rationale shall be documented in the patient’s health record within two (2) hours, and Supply Chain shall be notified immediately to initiate formal procurement.

6.2 Supply chain disruptions requiring product substitutions without full PEC evaluation may be approved by the VAGC Chair and CNO jointly when timelines do not permit full committee review, provided that enhanced clinical monitoring is implemented during the transition.

7. Related Documents

• POL-003: Evidence-Based Selection and Clinical Monitoring Standards
• POL-008: Quality Improvement in Vascular Access
• POL-010: Evidence-Based Practice and Research in Vascular Access
• SOP-VA-034: Product Evaluation Committee Charter and Operating Procedures
• Conflict of Interest Disclosure Form (FORM-PEC-COI-001)
• Off-Formulary Product Request Form (FORM-PEC-OFR-001)
• Organizational Supply Chain Disruption Response Policy
• FDA MAUDE Database Reporting Requirements
• FDA MedWatch Program

8. Revision History