Understanding Systems and Procedure Packs

What Are Systems and Procedure Packs?

In the healthcare and medical device industries, systems and procedure packs (SPPs) play an important role in medical procedures. They are designed to simplify workflows, reduce setup times, and enhance patient safety. Understanding their definitions and applications is key to both regulatory compliance and operational efficiency.

Definition and Components

• A system refers to a combination of two or more medical devices or components that are intended to be used together to perform a specific function. These devices are compatible and are packaged or assembled by the manufacturer to function as a unified entity.
  Example: A surgical navigation system that includes imaging equipment, software, and surgical instruments.
• A procedure pack is a pre-assembled collection of medical devices, and sometimes non-medical products, that are intended to be used together for a specific medical procedure. These packs are often sterile and ready for immediate use in clinical settings.
  Example: A wound care pack containing sterile gauze, bandages, and antiseptic solutions.

Purpose and Use

• Systems are designed to ensure seamless integration and interoperability of devices. They are often used in complex medical procedures, such as surgeries, diagnostics, or therapeutic interventions, where precision and compatibility are critical.
• Procedure packs simplify the preparation for medical procedures by providing all necessary components in one package. This reduces the time needed for setup, minimizes errors in device selection, and ensures sterility for invasive procedures.

Regulatory Framework for Systems and Procedure Packs in the EU

Systems and Procedure Packs are regulated under the EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745). The MDR establishes clear requirements to ensure these combinations of products meet high standards of safety and performance, consistent with their intended medical purposes.

Key Articles Addressing Systems and Procedure Packs

1. Article 22 – Systems and Procedure Packs

   This article outlines the responsibilities of manufacturers who assemble and market systems or procedure packs. Key points include:

   • Assembly Requirements - the assembler of a system or procedure pack must ensure the compatibility and safety of all included components.
   • Verification of CE Marking - all devices included in the pack must bear the CE marking (if applicable), indicating compliance with relevant regulatory standards.
   • Assemblers must issue a declaration stating that:
     • The combination of products is safe and performs as intended.
     • The combination does not adversely affect the safety or performance of the individual components.
   • Traceability and Documentation - proper records must be maintained for each pack or system, ensuring traceability and regulatory oversight.
2. Annex I – General Safety and Performance Requirements (GSPRs)

   SPPs must comply with the GSPRs outlined in Annex I, which cover:

   • The safety and compatibility of components when used together.
   • The overall performance of the system or procedure pack in achieving its intended medical purpose.

Responsibilities of Assembler vs. Manufacturer

If the assembler simply combines CE-marked devices without modifying their intended use, they are considered the assembler and not the manufacturer. However, if any modifications or alterations to the intended use are made, the assembler assumes the role of the manufacturer and must comply with all requirements for manufacturing a medical device under the MDR.

Labelling and Instructions for Use

• Labelling Requirements: Systems and procedure packs must carry labels that include information about the individual components and their compatibility when combined.
• Instructions for Use: Instructions must be provided to ensure correct assembly, safe use, and understanding of any limitations or precautions related to the combination.

Post-Market Surveillance and Vigilance

Systems and procedure packs are subject to the MDR's requirements for post-market surveillance and vigilance, including:

• Monitoring the performance and safety of the products after they are placed on the market.
• Reporting incidents or adverse events involving the pack or system to relevant authorities.
• Updating the risk management file and technical documentation as necessary.

Ensuring Component Compatibility in SPPs

One of the most critical aspects of assembling SPPs is ensuring the compatibility of all components included in the pack. Component compatibility directly affects the safety, performance, and regulatory compliance of the SPP, as outlined in the EU MDR.

What Is Component Compatibility?

Component compatibility refers to the ability of individual items within a system or procedure pack to function together safely and effectively without compromising the performance or safety of the individual components or the overall system. This involves verifying both technical and functional integration.

Key Areas to Address for Compatibility

• 1. Functional Integration
  • Ensuring that all components in the system work seamlessly to achieve the intended medical purpose.
  • Example: A diagnostic imaging system must include hardware and software components that communicate effectively to produce accurate results.
• 2. Physical Compatibility
  • Verifying that components can be physically connected, assembled, or used together without issues.
  • Example: Syringes and needles within a procedure pack must fit together securely without leakage or functional failure.
• 3. Material Compatibility
  • Ensuring that materials used in different components do not interact in a way that could compromise performance or safety.
  • Example: A sterile drape in a procedure pack must not react chemically with the surgical instruments it covers.
• 4. Electrical Compatibility
  • For systems involving electronic devices, ensuring that components meet standards for electrical safety and electromagnetic compatibility (EMC).
  • Example: Ensuring that a medical device charger does not interfere with the operation of other electronic devices in a system.
• 5. Biocompatibility
  • Verifying that components that come into contact with the patient or user are biocompatible and meet relevant standards.
  • Example: The adhesive on a dressing in a procedure pack must not cause allergic reactions when applied to the skin.

Supply Chain Management for Systems and Procedure Packs

Effective supply chain management is essential for ensuring the quality, safety, and regulatory compliance of Systems and Procedure Packs. Given the complexity of sourcing, assembling, and distributing medical devices and components, maintaining a robust supply chain is crucial for achieving operational efficiency and meeting regulatory requirements under the MDR.

Supply chain management encompasses the coordination of all activities involved in sourcing, manufacturing, assembling, and delivering SPPs. For medical devices, the stakes are particularly high due to the potential impact on patient safety and compliance. Key objectives include:

• Ensuring the availability of high-quality components.
• Maintaining traceability across the supply chain.
• Mitigating risks related to delays, recalls, or non-compliance.
• Optimizing costs while maintaining regulatory and quality standards.

Best Practices for Supply Chain Management

1. Supplier Qualification and Monitoring

• Conduct thorough due diligence on suppliers, including audits, certifications, and quality control measures.
• Establish long-term relationships with reliable suppliers to ensure consistency and reduce risks.

2. Traceability Systems

• Implement digital tools to track and manage component data, including UDI information and batch-level tracking.
• Maintain documentation for all components, including technical files, declarations of conformity, and risk assessments.

3. Quality Assurance

• Perform incoming inspections to verify that components meet specifications and quality standards.
• Regularly review supplier performance and quality metrics to identify and address issues proactively.

4. Risk Management Framework

• Develop a robust risk management plan to address potential disruptions, such as alternative sourcing strategies and contingency plans.
• Monitor market conditions and regulatory changes that may impact the supply chain.

5. Collaboration and Communication

• Foster open communication channels with suppliers to address issues promptly and ensure compliance with evolving regulations.
• Collaborate on testing and validation processes to ensure component compatibility and overall product safety.