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Trends

Disinfection of semi-critical medical devices is still often carried out at point of use while reprocessing of critical instruments and most sensitive semi-critical devices is increasingly centralized.

It is indeed recognized that on time delivery of sterile and functional devices relies on the perfect execution of a complex sequence tasks that are best performed by a specialized service with adequate production skills and infrastructure

Quality of device reprocessing is crucial for patient safety. It also a key contributor to the operational efficacy and reputation of hospital.

Role of sterilization department Manager

Sterilization Manager responsibilities are broad: technical diverse and subject to constant evolutions

  • Establish the device reprocessing strategy with hospital management (subcontract all or part of sterilization activities, share with other facilities, maintain reprocessing internally, define the devices under responsibility of sterilization department).
  • Justify and obtain the adequate human and material resources from hospital management.
  • Structure, adapt the sterilization premises (architecture, air, water).
  • Organize reprocessing operation (point of use processing, cleaning & disinfection, control & assembly, packaging, sterilization, storage) and flows, in partnership with surgical department (in particular for point of use reprocessing).
  • Ensure conformance with applicable regulation & standards, guidelines.
  • Implement or supervise the implementation of the quality management system, process validation recording of activities and traceability
  • Draws up the organization chart, job descriptions, recruit, assign responsibilities and delegations (e.g. for load release or authorization to use pressure vessels) supervise evaluations.
  • Organize the education and training curriculum of employee and periodic assessment of knowledge and update as needed.
  • Ensure that adequate occupational health & safety (weight, exposure to chemicals, spills)
  • Manages employees and often the medical device reprocessing process, as well as occupational health and safety considerations. May also have an assistant to support these duties.
  • Daily adapt to activity variation, change and unavoidable challenges without compromising patient safety
  • Negotiate supply and maintenance contracts. In the event of subcontracting, participates in specifications and agreements.

To execute this complex array of tasks, the sterilization manager must have technical and management skills,

Technical knowledge
  • Microbiology and hygiene
  • Device reprocessing principles and technologies (chemistries, and equipment)
  • Surgical activities and various categories of medical devices
  • Architecture, air, water quality
  • Regulation, standards and guidelines
Management skills
  • Human resources (recruitment, education, assessment, occupational health & safety)
  • Quality management principles and risk assessment, process validation principles
  • Project management
  • Activity monitoring, key performance indicators (KPIs)
  • Budget and administrative

Whatever the initial education of the sterilization manager, complementary education will be required to acquire this broad range of skills.

explanations

Some countries request a specific high-level qualification such as pharmacists in some western European countries or nurses.

Supervisors

In larger services several supervisors will assist the sterilization manager to ensure execution of task according to procedures and run daily activities or by holding specific roles such as production planning or quality management.

The quality Manager belongs to the sterilization department or can be external (e.g. quality management service of the hospital)

  • Develops, implements, monitors and continually improves the quality management system (QMS)
  • Ensures compliance with best practices, regulations, customer needs and alignment with sterilization Manager objectives
  • Identifies opportunities for process improvement and leads initiatives to enhance quality.
  • Provides training on quality standards, procedures, and best practices to employees.
  • Analyzes customer complaints, non-conformances, supervise vigilance declaration to authorities.
  • Implements corrective actions and verifies that they are adequate.
  • Organizes audits, present findings and action plans to management.

Employees

The number of employees of the centralized sterilization department is adapted to the size of the hospital and level of activity.

The job description is available and ensures that the role played within the broader organization is well understood. It may outline of the knowledge that the employees is expected to continuously update.

Job description
  • Responsibilities and tasks to be performed.
  • Education, qualifications required (country dependent)
  • Skills and aptitude.
  • Functional relationship.
  • Physical, chemical and infection risks.
Knowledge to be updated
  • Principles of sterilization and disinfection.
  • Good sterilization practices.
  • Safety and hygiene of premises and personnel.
  • Quality assurance systems.
  • As needed operation of pressurized equipment.
  • Knowledge of instrumentation.

Infection prevention and occupational health & safety measures are clearly communicated and periodically reviewed with staff. Their application is carefully monitored.

Infection prevention
  • Hand disinfection.
  • No nail varnish, gel nails, acrylic inserts.
  • No jewelry on hands and arms.
  • Coverage of hair and beards.
  • No make-up that could generate particles.
  • Behavior of in the event of contagious disease.
  • Eating, drinking smoking prohibited outside designated areas.
  • Access and circulation rules.
Protective measures
  • Protective equipment (masks, goggles, gowns, aprons) against splashes of contaminated liquids or chemicals.
  • Handling of contaminated and sharp devices.
  • Vaccinations obligations.
  • Waste handling.
  • Behaviour in the event of an accident.
  • Weights handling.
  • Prevention of musculoskeletal risk by appropriate gesture.
explanations

Additional protective measures may be defined for specific pathogens (e.g. prion)

There is a process in place to ensure continued competency. Periodic assessment, training and continuing education are documented.

explanations

Assessment consists of verifying the acquisition of knowledge and skills appropriate to the duties performed Depending on the field, the assessment may be carried out by the sterilization manager or supervisors, or the quality manager. Education should include updates on new equipment and technologies. If formal courses from recognized institution are available, staff should be encouraged to take them.

The employees in charge of transport are members of the sterilization staff, of another department of the healthcare facility, or are employed by an external service provider. They must have received specific training on the consequences and risks associated with their activities.

Human resources and quality management

  • A quality management system is in place. Quality policy and objectives are communicated throughout the organization.
  • Job description, Standards operation procedures (SOP), work instructions, Occupational health & safety measures are available and communicated.
  • Training ensures that employees are qualified for their job and knowledge checks are periodically performed

Recommendation of WFHSS

  1. More and more sterilization and reprocessing of the most critical devices is centralized and placed under the responsibility of a Manager with high and broad technical and management skills.
  2. The central sterilization Manager organizes reprocessing activities and resources in accordance with hospital policy and best practices, applicable regulation and quality management principles.
  3. Supervisors and employees have clear assignments, skills and knowledge adapted to their role. Knowledge checks are periodically reviewed and updated as needed
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