No. POMDRA uses best practices and guideline outlined in the Ministry of Health's Best Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices first published in 2007. Therefore, the standards applied by POMDRA have been in place for some time. The Ministry of Health’s best practice document is based on the Canadian Standards Association (CSA) document for medical device reprocessing, which are national standards. 

Community-based physicians are selected when they indicate through the Annual Licence Renewal Form that they reprocess reusable semi-critical and/or critical medical devices in their practice setting. Participants are also identified through the Physician Practice Enhancement Program when an assessor indicates that reusable medical devices are used in the practice. This initiative applies to all active physicians who practise in a community-based setting whether solo, multi-physician clinic, as well as long-term and short-term locums.  

Yes. The College has the authority to assess the professional performance of a registrant for the purposes of quality assurance under the authority of section 26.1 of the Health Professions Act, RSBC 1996, c.183 (the Act) and sections 1-19 and 9-1 of the Bylaws under the Act.  

The goal of POMDRA is not to shut down a registrant's practice but rather identify mandatory requirements, provide guidance, and support physicians in making the necessary changes so that they may continue to provide safe services to their patients.

As a quality assurance activity, information collected during the assessment process is confidential. Only in the event of risk of significant harm to the health or safety of the public can information be reported to a provincial health officer or a medical health officer under section 26.2 (2)(b) of the Health Professions Act.

A medical device is any instrument, apparatus, appliance, material or other article, intended by the manufacturer to be used for human beings in the delivery of care.

There are two types of medical devices:

1. Reusable – the manufacturer's instructions for use state on the packaging that a device is reusable. These devices can withstand cleaning, sterilization, disinfection and must be reprocessed to be safe for reuse on another patient.
2. Single-use – these devices must be discarded after use and must be dedicated to only one patient. Some packages may have the wording “single use disposable" while other packages may also have one of the following symbols:  

It is important to identify which medical devices used in your clinic setting must be reprocessed and which ones must be discarded. Depending on how and where a patient device is used, it may have different processing requirements; some need to be sterilized and some do not.

Manufacturer’s instructions for use (MIFU) are the written, validated information on a medical device that comes directly from the manufacturer. The device manufacturer has validated the steps necessary to prepare a device that is safe for patient use. The manufacturer is required to validate the device for cleaning, testing for function, packaging, and sterilization prior to the device being approved for medical use. If MIFU are not followed, patient safety may be compromised because the medical device could be improperly cleaned, packaged, loaded into sterilizer, disassembled or assembled, or sterilized using the incorrect type of sterilization process or cycle. MIFUs for reusable medical devices will follow national and provincial best practice reprocessing requirements.

Physicians should ensure that they have current, written MIFUs for all their medical devices, chemical products and reprocessing equipment (such as tabletop steam sterilizer/autoclave).

• item falling on floor
• sterile packaging is compromised (e.g. torn, wet, stained)
• a medical device is used on a patient

The steps performed to prepare contaminated/dirty reusable medical devices for re-use. There are many steps involved in reprocessing of a medical device. Every step must be followed as infectious agents can be transmitted from one patient to another via incorrect or inadequate reprocessing of medical devices.

Cleaning is the removal of contamination using friction, water, and detergents. All reusable medical devices must be cleaned first. Cleaning removes rather than kills micro-organisms. If an item is not cleaned, soil (e.g. blood, body fluids, dirt) can protect the micro-organisms from the action of the sterilization process making it ineffective. 

1. Detergents are chemicals that, when used in a solution with water, help clean devices. Only detergents compatible with the device/instrument must be used. Using the wrong detergent can stain the device and result in inadequate cleaning. Always follow the manufacturer’s instructions for use (MIFU) for both the product and the medical device.
2. Enzymatic cleaners: Some detergents contain one or more enzymes, which are chemical substances that act on specific types of soil. Enzymatic cleaners may be used during the cleaning step of reusable medical devices. Since enzymatic cleaners work to dissolve dried soil without mechanical action, they can also be used for pre-soaking medical devices with tubes such as cannulated devices and heavily soiled devices prior to the cleaning step.

• must be used according to manufacturer’s recommendations for dilution, temperature, water hardness and use
• must be used according to the product’s material safety data sheet (MSDS)
• must be approved for use in health-care settings—household detergents must not be used on medical devices

The College requires all community-based physician offices to steam sterilize their reusable semi-critical medical devices provided that they are validated to be reprocessed by steam by the manufacturer’s instructions. 

This decision is based on a comprehensive review of both national and provincial standards, as well as WorkSafeBC requirements. Past practice in both health authorities and community-based physician offices was to reprocess reusable semi-critical medical devices by high-level disinfection (HLD), which involves soaking the reusable medical devices in a high level disinfectant product. In a hospital setting, the practice of manual HLD may be achievable safely because hospitals have dedicated medical device reprocessing departments that can meet both provincial occupational health and safety requirements (WorkSafeBC) and meet the lengthy and complex HLD requirements described in the provincial best practice document. Due to complexity of accurately performing HLD and its higher occupational safety risk, most hospitals have moved away from the practice of HLD as a method of reprocessing reusable semi-critical medical devices.

The College states that in the community-based physician office setting, if the semi-critical or critical medical device is not validated for sterilization in steam, the device must be replaced with a disposable alternative. Always consult the manufacturer’s instruction for use (MIFU) for more information.

The practice of steam sterilizing both reusable semi-critical and critical medical devices helps to ensure patients are receiving the same standard of care whether they are visiting a hospital or a community-based physician office.

Sterilization is the elimination of all forms of microbial life (bacteria, viruses, fungi). Sterilization can be achieved in a number of ways. One of the most common ways to sterilize reusable medical devices is steam sterilization which is sterilization by steam under pressure.

The table top steam sterilizer is the most common and practical type of steam sterilizer for the community-based physician office. A table top steam sterilizer usually has a chamber volume of less than 42.5L and generates its own steam. It is the steam under pressure that kills all micro-organisms that may remain on a device after cleaning and renders the device “sterile”.

There is a variety of table top steam sterilizer models available; however, only those licensed by Health Canada can be used in physician offices. Refer to the Checklist for Purchasing a Tabletop Steam Sterilizer for more information.

Sterilization monitoring must be routinely performed and documented to verify the effectiveness of the sterilizer and the sterilization process. The types of sterilization monitoring required are as follows:

• Biological Indicator (BI)
• Chemical Indicators (CI)
• Physical Monitors

For more detailed information on sterilization monitoring refer to the POMDRA Assessment Tool for Steam Sterilizattion. For sterilization load record samples, see Additional Resources.

If any of the indicators fail—physical parameters and/or chemical indicator and/or biological indicator—the failure must be investigated. Follow these steps:

1. Do not use the items in the load
2. Report to medical director or delegate
3. Record follow up actions
4. Re-package
5. Re-sterilize

The gold standard is that reprocessing of reusable medical devices should be performed in the clinical office where the devices are used.

If a physician office chooses to use an off-site/out-of-office sterilizer to reprocess their reusable medical devices, the following considerations must be applied:

• Off-site reprocessing is only acceptable if the off-site sterilizer is in a hospital or another physician office that has undergone (or will undergo) a physician office medical device reprocessing assessment. The rationale for this is that BC hospitals undergo routine medical device reprocessing audits which follow the Ministry of Health’s Best Practice Guideline for Cleaning, Disinfection and Sterilization in Health Authorities to ensure that reprocessing practices meet the recommendations as outlined in the document. In addition, hospitals undergo a regular federal evaluation process though Accreditation Canada, which includes a detailed audit of the hospital’s medical device reprocessing department.
• Off-site reprocessors may also be other physician offices that have undergone (or will undergo) the physician office medical device reprocessing assessment. For other health-care professionals (e.g. dentists), the College does not oversee their MDR practices and therefore they are not acceptable as off-site reprocessors for physician use.

Therefore your MDR options include the following:

1. Switch all reusable medical devices to single-use equivalents
2. Purchase a tabletop steam sterilizer for the reprocessing of reusable medical devices including adherence to all requirements described in the provincial best practice document for steam sterilization
3. Obtain access to another physician’s tabletop steam sterilizer where this physician office has undergone or is willing to undergo the College physician medical device reprocessing assessment