How often should a spike on a multi-use vial be replaced after use?

Spike Replacement on Multi-Use Vials

The provided evidence does not directly address spike replacement intervals for multi-use vials, but based on CDC infection control guidelines for related IV access devices and the principle of maintaining sterility, spikes should be replaced at least every 72 hours or immediately if sterility is compromised.

Evidence-Based Reasoning

Administration Set Replacement Standards

• CDC guidelines recommend replacing administration sets, including secondary sets and add-on devices, no more frequently than at 72-hour intervals unless catheter-related infection is suspected 1
• Needleless components should be changed at least as frequently as the administration set, with caps changed no more frequently than every 72 hours or according to manufacturers' recommendations 1

Multi-Dose Vial Sterility Principles

• Always use a sterile device to access a multiple-dose vial and avoid touching the access diaphragm 1
• Cleanse the access diaphragm with 70% alcohol before inserting any device into the vial 1
• Discard the multidose vial immediately if sterility is compromised 1

Contamination Risk Data

• Research shows contamination rates of 0.9-5.36% in multi-dose vials with variable handling practices 2, 3
• One study found contamination in a spike itself (Staphylococcus epidermidis), demonstrating that spikes can serve as vectors for contamination 2
• Studies with proper aseptic technique showed no contamination even with extended use, but this required strict adherence to sterile protocols 4, 5

Practical Algorithm for Spike Management

Replace the spike when:

1. 72 hours have elapsed since initial placement (extrapolating from administration set guidelines) 1
2. Any visible contamination or breach in sterility occurs 1
3. The vial itself reaches its expiration date or manufacturer's recommended discard time 1
4. The spike is touched or the sterility barrier is compromised 1

Critical Safety Measures

• Keep multidose vials away from the immediate patient treatment area to prevent inadvertent contamination by spray or spatter 1
• Never reuse syringes even if the needle is changed when accessing multi-dose vials 1
• Always use sterile technique and avoid touching the access diaphragm 1

Common Pitfalls to Avoid

• Leaving spikes in place indefinitely without replacement - this increases contamination risk over time 2, 3
• Failing to disinfect the access point before each use - alcohol disinfection is mandatory before every access 1
• Using multi-dose vials in high-risk patient care areas - keep them away from areas with potential splash contamination 1
• Not dating vials when opened - this prevents tracking of appropriate discard times 2, 4