Control and Assembly
Control and assembly - principles

Control and assembly of reusable medial devices (RMD) takes place after cleaning and disinfection. Controls and assembled RMD’s are intended for use or sterilization.

Control (i.e., visual checks, technical functional tests, or both) are done before and after assembly of multi-component RMD’s or RMD compositions (for example surgical sets). 

A control and assembly workstation is adapted to needs (e.g., surface and light).


Specific attention is paid to RMD’s returning from maintenance and repair.

Controls and assembly of multi-components RMD’s, RMD composition consider an RMD manufacturer instruction for use (IFU)

Assembly of surgical sets are prepared in partnership with medical or surgical users. Agreed instructions specify:

  • The items belonging to the set and quantity of each item
  • The type of tray (mesh, perforated, thermoformed) and size (large enough to permit equal distribution of weight and metal mass)
  • As needed, the arrangement and protection accessories to be used (e.g., protection of sharp and fragile items, wedges to avoid shift or shocks during transport, tray liners, etc.)
  • As needed, the position of an RMD, as required for safe extraction at point of use

General rules apply:

  • Heavy instruments are placed in such a way that they will not damage more delicate items.
  • Items with concave surfaces broad, flat surfaces, or both, which may retain water are placed on edge.
  • For RMD’s with lumen, lumen ports are open.
  • Ratcheted instruments are unlatched. A description of the accessories needed to hold the instruments in the unlatched position is included.

Instrument identifiers and visuals assist to simplify the assembly of complex sets.

It is verified that:

  • Certificate of Compatibility of an RMD, and arrangement and protection accessories with the intended sterilization cycle are available.
  • Sterilizing agent has free access to all RMD surfaces. Tip protectors, if used, are permeable to the sterilizing agent, fit loosely, and are used according to the manufacturer’s written IFU. Only approved accessories are used. 
  • The weight does not exceed applicable occupational health and safety limits (maximum weight of an item, including packaging varies between 10 kg and 11 kg (25 lb) according to each country’s guidelines)

For basin sets, all basins are in the same direction and processed with lint-free, absorbent material between nested basins.

For textile, the product manufacturer is consulted for recommendations on the pack size, dimensions, and density that have been validated for the intended steam sterilization cycles. A pack is  prepared with freshly laundered textiles.

Control and assembly, and quality

Written control standard operating procedures (SOP’s) are prepared in accordance with quality management principles.  

Process validation of control and assembly manages that:

  • SOP’s are up-to-date, follow RMD manufacturers IFU’s, and are in-line with medical or surgical users expectations.
  • Training is executed and training certificates are available.
  • Occupational health and safety measures are in place.
  • Traceability is operational and effective.
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WFHSS recommendations for control and assembly

  1. Control and assembly Standard operating procedures (SOP’s) follow RMD manufacturer IFU’s and are in-line with end users expectations.
  2. Compatibility of RMD and protection accessories is verified.
  3. Control and Assembly process is implemented according to quality management principles and undergoes process validation .
Control and assembly flowchart
RMD after cleaning and disinfection

Used on patient or withdrawn from packaging

Go to Control & Assembly – Principles 

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Control and assembly

RMD or multi-component RMD or surgical set

Go to Control and Assembly – Principles 

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RMD ready for next step

Next step: use or sterilization

Go to Control and Assembly – Principles

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SOP prpeared in partnership with user

Go to WFHSS recommendation for Control and Assembly

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User feedback

Go to Control and Assembly and quality

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Bibliographic references -Control and assembly
  1. ISO 17664-1: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices (2017)

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Comments on WFHSS guidelines

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“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.

They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.

Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.

We wish you interesting reading!

On behalf of the Executive Committee

Dr Christine DENIS, President”  

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“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.

They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.

Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.

We wish you interesting reading!

On behalf of the Executive Committee

Dr Christine DENIS, President” 

Reusable medical device (RMD)

For the present guidlelines reusable medical device (RMD) means:

  • an item that is not intended by its manufacturer for single use.
  • A medical device designated or inrtended by the manufacturer as suitable for reprocessing.

The reprocessing of single use medical device is outside the scope of theses guidelines.
Medical device regulations vary between regions. Some items may not be registered as medical devices in some regions.

Sterilization

Sterilization is intended to renders the reusable medical device free from viable microorganisms. Sterilization is implemented on a clean RMD. Most common Sterilization process is steam. Low temperature sterilization processes are available for heat sensitive RMD

Disinfection :

Process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose (ISO 11139 : 2018) 

Cleaning :

Removal of contaminants to the extent necessary for its further processing or for intended use (ISO 11139 : 2018)  

Other definition: The first step required to physically remove contamination by foreign material, e.g. dust soil. It will also remove organic material such as blood, secretion, excretion and microorganisms, to prepare a medical device for sterilization or disinfection (WHO : 2016) 

Cleaning may be combined to disinfection in cleaning & disinfections processes (for instance in automated washer-disinfectors)

Tooltip Content

Sterilization :

Process used to render product free from viable microorganisms (ISO 11139 : 2018)

  • courthouse-3-1 Sterilization is intended to renders the reusable medical device (RMD) free from viable microorganisms.

Reusable Medical device (RMD) 

Medical devices wich are not single use i.e. which can be reused under appropriate reprocessing conditions, for an undelimited number of time or for a predetermined number of use.