MDRA management is responsible for planning, documenting, and implementing the QMS. Management will select KPIs and monitor outcomes. Leaders are responsible for delegating the elements of the QMS to individuals for monitoring and ensuring that elements of the QMS are implemented and maintained.

MDRA management will also ensure that policies and other elements of the QMS are relevant to the requirements of the MDRA and the goals of the organization. Management will also be responsible for planning, documenting, and implementing the QMS.

Management is responsible for ensuring that regular audits of processes are performed to make sure that all policies and procedures are being followed. Audits can be performed by the healthcare organization’s infection prevention and control personnel or by an external auditor such as Accreditation Canada. The results of these audits are reviewed, and any non-compliance must be corrected.

Personnel

MDRA management will designate individuals to oversee different elements of the QMS. These designated individuals are responsible for monitoring the QMS and ensuring compliance.

All personnel in the MDRA will have defined and documented roles within the QMS. Personnel need to be aware of their roles, responsibilities, and functions within the QMS and must ensure that they fully understand these roles. Personnel must work within their functions.

MDRA personnel require comprehensive orientation, thorough training, and regular competency assessments. These must all be documented as part of the QMS. Orientation is crucial for new personnel to learn their roles in the QMS. Training ensures that personnel are knowledgeable in specific procedures within the MDRA and should be provided regularly, especially when there are changes to procedures or new equipment. Competency assessments are done annually and are important to ensure that personnel are aware of procedures and are compliant.

QMS Documentation

An important component of the QMS is documentation. Documentation is how the MDRA ensures compliance with regulations and standards. Every task performed in the MDRA must be documented. Documentation includes policies, procedures, and records.

An MDRA must have standard operating procedures (SOPs) in place for all processes performed in the department, as well as for contingency planning in case of emergency (e.g., loss of staff, loss of equipment, utility interruptions). The SOPs provide step-by-step instructions for personnel to complete reprocessing tasks. Personnel are required to follow the SOPs to ensure consistency in all products.

SOPs are developed by designated personnel who are knowledgeable in medical device reprocessing. They are created based on the requirements of standards and regulations, the healthcare setting’s policies, and the manufacturer’s instructions for use (MIFU) for specific equipment or devices.

SOPs and policies required by the QMS must be available to all MDRA personnel in either printed or electronic format. It is important for all personnel to be familiar with the SOPs and be able to refer to them as needed.

In addition, SOPs must also be reviewed regularly. The minimum review period is annually; however, SOPs may also be reviewed when there is an adverse event, an error, or changes in equipment or device MIFU. The review of SOPs is performed by experienced personnel who are knowledgeable about medical device reprocessing.

References

Government of Canada. (2021). Introduction to policy. https://www.canada.ca/en/heritage-information-network/services/digital-preservation/concepts-developing-policies/introduction-policy.html