FAQs on MDR

Following is a compilation of questions and answers on key concepts related to medical device reprocessing (MDR) for the community-based physician office setting.

General

With the launch of POMDRA, has the College rolled out new practice standards?

No. POMDRA uses best practices and guideline outlined in the Ministry of Health 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. 

How does POMDRA choose participants?

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.  

Does the College have the authority to assess registrants on their medical device reprocessing practices? 

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.  

Can a registrant refuse to participate? 

Section 9-1(3) of the Bylaws indicate that a registrant selected for an assessment under this section must co-operate fully with the committee and its assessors, if any.
 

Can a physician fail the assessment, and if so, how does that impact his/her practice and office procedures? 

If during an assessment reprocessing deficiencies are identified, they will be communicated to the physician with guidance on how the deficiencies should be corrected; whether a physician’s current reprocessing practices can continue will depend on a number of factors. At the end of the assessment, the physician will be provided a report outlining the deficiencies, options to correct the identified deficiency and a timeline to do so. Occasionally, a physician may be asked to temporarily switch to disposable equivalents for their medical devices until they are able to purchase supplies (for example, biological indicator tests and biological test incubator) or equipment (sterilizer) to bring their medical device reprocessing to required standards. During this time, the physician may choose to move permanently to disposable medical devices.
 

Will the College shut down a physician's practice if it identifies some deficiencies in reprocessing? 

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.

How much time will I have to make POMDRA required changes to my reprocessing practice?

During a phone or on-site assessment, if reprocessing deficiencies are identified, they are communicated immediately to the physician or delegated staff person. The time allotted to correct a deficiency depends on the level of risk. Typically, one month is given to correct low and medium risk deficiencies. For high-risk deficiencies that require immediate attention, the MDR assessor will direct that the physician office ceases its reprocessing practices immediately until the matter is rectified. During this time, the physician office may be required to obtain disposable equivalents in order to continue performing procedures involving reusable critical and/or semi-critical medical devices. Some physician offices may opt to permanently switch to disposable medical devices.
 

Medical Devices

What is a medical device?

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:  

Why is it important to know what type of medical devices I have in my practice setting?

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.

What if a physician doesn’t have a dedicated physical space for reprocessing reusable medical devices? 

The Best Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices document states that the reprocessing of reusable medical devices must occur in a dedicated physical space for those activities. Practically, physicians are often limited with their physical space and do not always have the option of a dedicated space for reprocessing. While a space dedicated solely to reprocessing is ideal, the physical space can be a dual-purpose or multi-purpose room that is also used for other activities or procedures. The key is that during the time the space is used for reprocessing activities, it cannot be used for any other purpose simultaneously. For example, using a patient exam room is acceptable provided no patients are present when the steps of reprocessing occur.

The other best practice requirements are that in the reprocessing area, a one-way directional workflow is maintained (that is working from dirty to clean), work surfaces (such as counter tops and sink) are always cleaned and low-level disinfected prior to starting reprocessing activities, and there is no food or drink in the area. The staff kitchen and washroom are not an appropriate areas for reprocessing due to the potential for contamination.
 

What are MIFUs and why are they important? 

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).

When is a medical device considered contaminated?

A medical device is considered contaminated anytime there is potential that a device has contact with micro-organisms. Examples include but are not limited to:
  • item falling on floor
  • sterile packaging is compromised (e.g. torn, wet, stained)
  • a medical device is used on a patient

Reprocessing 

What is reprocessing?

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.

Why is the cleaning of reusable medical devices the first and most important step of reprocessing?

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. 

What products can I use during the cleaning step of my reusable medical devices?

There is a variety of products that can be used during the cleaning step to decontaminate reusable medical devices:
  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.
Remember that the cleaning product:
  • 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

Why do semi-critical reusable medical devices need to be steam sterilized like reusable critical 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.

Why do my reusable semi-critical medical devices have to be packaged in preparation for steam sterilization? 

The concept of “point of use” relates directly to how a medical device is delivered to the end user. Critical reusable medical devices must be sterilized and delivered to point of use sterile. This means that the item is packaged sterile, and remains intact in the package until it is to be used. As with critical reusable medical devices, the College requires that semi-critical reusable medical devices are also packaged in preparation for steam sterilization and remain packaged until point of use. 
 
Packaging both reusable semi-critical and critical medical devices ensures that physician offices are meeting national standards set out by the Canadian Standards Association (CSA). The CSA states that each package shall have an externally visible chemical indicator and an internal chemical indicator for the purpose of differentiating between processed and unprocessed packages and that packages shall be affixed with a load control label with at least the following information: name of item(s), date of sterilization, and load number with staff initials (only if more than one load a day is done).

In addition, packaging reusable semi-critical medical devices ensures that these devices are not contaminated or compromised until use. Past common practice has been for physicians to steam sterilize an unpackaged semi-critical reusable medical device (for example a reusable vaginal speculum) and store in an unsterile location (such as drawer in the exam room) until use. This practice increases the likelihood of contamination and increases patient risk of cross-contamination.
 

Sterilization 

What is sterilization?

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.

What type of sterilizer should I have for my clinical office?

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.

What is sterilization monitoring?

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.

What do I do if there is an unsuccessful outcome or breach during sterilization of reusable medical devices?

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

I have an arrangement with a physician/dentist in the same building to have my reusable medical devices sterilized by their sterilizer. Is this permitted?

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

References

  1. British Columbia Ministry of Health. Best practice guidelines for cleaning, disinfection and sterilization of critical and semi- critical medical devices in BC health authorities [Internet]. Victoria: British Columbia Ministry of Health; 2007 [revision 2011 Dec; cited 2017 Feb 15]. 136 p. Available from: http://www.health.gov.bc.ca/library/publications/year/2011/Best-practice-guidelines-cleaning.pdf
  2. Ontario Agency for Health Protection and Promotion (Public Health Ontario), Provincial Infectious Diseases Advisory Committee. Infection control for clinical office practice [Internet]. Toronto: Queen’s Printer for Ontario; 2013 [revision 2015 Apr; cited 2017 Feb 15]. 116 p. Available from: http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf
  3. Canadian Standards Association; Standards Council of Canada. Canadian medical device reprocessing. Toronto: CSA Group; 2018. 375 p. CSA Standard No.: CAN/CSA-Z314-18.