Surgical infections related to dirty instruments receive graphic attention in the media, especially when applied to facilities involved with medical tourism. No one wants to be associated with these kinds of headlines because of the resulting loss of public confidence toward the facility or the country as a whole. How many potential clients have been dissuaded by these headline-grabbing situations?
In Canada, we pride ourselves on Quality Assurance standards that our Health Authorities and Private/ Public partnerships are measured against. In 2002, the International Society for Quality in Health Care (ISQua), the organization that “accredits the accreditors,” stated that “one third of healthcare standards worldwide have taken their lead from Accreditation Canada.”
One of our initiatives in 2007 (updated and revised in 2011), was the introduction of Best-Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semicritical Medical Devices in Health Authorities. Critical devices enter sterile cavities and need to be sterilized. Semi-critical devices come in contact with mucus membrane and intact skin, and need to be at minimum disinfected at high levels.
I work in the Quality Assurance and Patient Safety sector in Canada, where cleaning, disinfection and sterilization of critical and semi-critical medical devices are called “Reprocessing.
The definition of reprocessing is the steps performed to prepare used-medical devices for reuse (e.g., cleaning, disinfection, sterilization). Health facilities performing these tasks are called Medical Device Reprocessing Departments (MDRD).
The Best-Practices Guideline for Reprocessing is intended for healthcare providers to ensure that critical elements and methods of decontamination, disinfection and sterilization are incorporated into healthcare facility procedures. The document describes essential elements and methods in the safe handling, monitoring and assessment, transportation, and biological.
Best-Practice Guidelines applied to all areas that sterilize or disinfect medical devices…the expectation is 100 percent compliance.
decontamination of contaminated medical devices. There is an annual audit associated with these Best-Practice Guidelines applied to all areas that sterilize or disinfect medical devices. The expectation from the Provincial Health Authorities is 100 percent compliance.
Information in the document is consistent with or exceeds recommendations from the Public Health Agency of Canada (PHAC) and meets measures developed by the Canadian Standards Association (CSA). These references are used both by Accreditation Canada and its international branch for Qmentum surveys.
The Accreditation Canada Qmentum standard for Reprocessing of Medical Devices has 12 sections that cover high-performing reprocessing services:
• Complying with good reprocessing and sterilization practices
• Selecting, installing and maintaining safe reprocessing equipment
• Conducting safe and appropriate reprocessing and sterilization of reusable devices and equipment
• Monitoring quality and achieving positive outcomes
There are approximately 100 questions in the Qmentum standard.
The audit associated with these Best-Practice Guidelines has 15 sections and 356 questions. This allows the auditors, who are all professionals with backgrounds in the reprocessing of medical devices or infection-control fields, a greater depth of information related to the daily processes in the reprocessing departments or satellite areas, such as clinics that reprocess their own medical devices, but do not have trained reprocessing staff.
Best-Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices.
Selections from Best-Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices in Health Authorities that show the scope of the guidelines:
The best practices in the document are based on the assumption that health facilities already have basic infection prevention and control systems and programs in place. The document provides a number of recommendations for facilities regarding ways to implement best practices in the area of medical-device reprocessing.
The objective is to protect patient safety by ensuring that all health facilities are in full compliance with established standards for reprocessing of medical devices and patient-care equipment as described by PHAC and CSA.
Healthcare settings without Infection Control professionals are encouraged to work with organizations that have infection prevention and control expertise, such as academic health science centres, public health units that have staff certified in infection prevention and control and local infection prevention and control associations to develop evidence-based programs.
The document also states that:
Adequate resources should be devoted to infection prevention and control in health facilities. Resources are devoted to Environmental Services/Housekeeping in all healthcare settings including written procedures for cleaning and disinfection of client/patient/resident rooms and equipment; education of new cleaning staff and continuing education of all cleaning staff; and ongoing review of procedures.
There should be regular education — including orientation and continuing education — and support to help staff consistently implement appropriate infection prevention and control practices across the continuum of care. Education programs should be flexible enough to meet the diverse needs of the range of healthcare providers and other staff who work in the healthcare setting.
How Could this Affect You?
I have applied these Best-Practice Guidelines and the annual audits for one of the largest Health Authorities in Canada. Since 2007, when we began the audits across the 115 (now 176) sites, we have had a 40 percent increase in compliance throughout the region. That means there is a 40 percent less chance of a patient acquiring a surgical site infection due to an incorrectly cleaned, disinfected or sterilized medical instrument.
The audit identifies opportunities to improve practices and processes. There are checklists and standard procedures that can be recommended to assist with identified gaps in compliance.
As a result of staff engagement in the audit process, we have found staff to be eager to update knowledge and practical skills. They have a new pride and understanding of the importance of the work done in the MDRDs. The staff began to see themselves as a vital part of the patient-safety journey.
It reminds me of a story from 1961, when President Kennedy was touring the NASA facility and his entourage reportedly came upon a man mopping the floor in one of the hallways. The president stopped to chat with the man, shook his hand, and asked what he did at NASA. The janitor proudly addressed the young president by saying, “Sir, I’m helping to put a man on the moon!” When applied to MDRD staff, they are “saving lives” by ensuring all medical devices in their departments are reprocessed correctly.
With ongoing advances in surgical technology, medical devices are becoming increasingly complex, requiring dedicated, professionally trained staff to carry out the reprocessing procedures.
By applying Canadian Best-Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semicritical Medical Devices, facilities seeking to attract clients from Canada and elsewhere in the world could show they are exceeding expectations for Quality Assurance related to the reprocessing of medical devices. If potential clients ask questions about clean surgical instruments, you can confidently answer, “Yes, our Instruments are cleaned, disinfected and sterilized correctly!”
There are established procedures for receiving and responding appropriately to all international, national, regional and local health advisories in all healthcare settings. Health advisories are communicated promptly to all staff responsible for reprocessing medical devices and regular updates are provided. Current advisories are available from Public Health, the Ministry of Health, Health Canada and the PHAC websites as well as local regional infection prevention and control networks.
Where applicable, there is a process for evaluating personal protective equipment (PPE) in the healthcare setting to ensure quality standards are met.
There is regular assessment of the effectiveness of the infection prevention and control program and its impact on practices in the healthcare setting. The information is used to further refine the program.
About the Author
Janet Bristeir is trained as a Registered Nurse in England. She specializes in operating room nursing and the reprocessing of surgical instruments and devices. In Canada, she studied quality assurance as part of her Health Record Administrator training. Decades of clinical experience qualifies and allows her to bring a wealth of knowledge to quality assurance projects.
Bristeir works with facilities to ensure processes needed to produce clean, disinfected and sterile equipment are carried out to the highest quality standards. Located in Vancouver, British Columbia, Canada, Bristeir co-authored, with members of the Simon Fraser University Medical Tourism Research Group, published papers in 2011 and 2013. Bristeir works closely with the BC Ministry of Health. Bristeir is the CEO of Canadian Best-Practice Quality Audits Inc. www.canadianbestpracticequalityaudits.com.
