MDR Fundamentals

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. The requirements for best practice in medical device reprocessing are based on the Ministry of Health best practice document entitled Best Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices first published in 2007 and revised in 2011. POMDRA is based on the best practices outlined in this ministry document and are therefore not College standards and have been in place for some time. The best practice document is based on the Canadian Standards Association (CSA) for medical device reprocessing which aligns with best practices in both Alberta and Ontario.

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

The College wants to reassure physicians that the intent of the POMDRA initiative is not to impede physician office practices. During an assessment, if reprocessing deficiencies are identified, they will be communicated to the physician with guidance as to how those deficiencies should be corrected. Whether or not the physician’s current reprocessing practices can continue will depend on a number of factors. At the end of the assessment, physicians will be provided with options to correct the identified deficiency and a timeline to do so. Occasionally, a physician is asked to temporarily switch to disposable equivalents for the medical devices they use until the physician is able to review the results of the assessment and contact their medical supplier to obtain information on any equipment/supplies they are deficient in (for example, the purchase of biological indicators tests and biological test incubator). During this time, the physician may choose to move permanently to disposable medical instruments.

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

The goal of POMDRA is not to “fail” a registrant but rather identify mandatory requirements, provide guidance, and support physicians in making the necessary changes to continue providing safe services to their patients.

More than 4,000 physicians have identified on the 2017 Annual Licence Renewal Form that they reprocess semi-critical and/or critical reusable medical devices in their clinical office. It will take the College some time to reach them all. In the meantime, physicians who are reprocessing medical devices in their office are encouraged to review the information on the College POMDRA website to better understand the expectations. Physicians are advised to contact the College prior to making practice changes or decisions. 

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. The packaging on a single-use device will have the following symbol:

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 have 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 that 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, 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 is not an appropriate reprocessing area, neither is the washroom due to the potential for contamination).
 

What are MIFUs?

MIFU stands for manufacturer’s instructions for use. This is information on a particular medical device directly from the manufacturer. The MIFU for a reusable medical device provides information on:

  • which products are safe to use on the item (detergents, disinfectants and enzymatic cleaners)
  • instructions on how to reprocess the medical device such as, immersible or not, disassembly required, heat sensitivity
  • information on type of reprocessing required

Why are MIFUs important? 

Manufacturer’s instructions for use 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

What’s the concern about packaging reusable medical devices that are reprocessed by steam sterilization and what is “point of use”? 

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. 

Semi-critical reusable medical devices require, at a minimum, high-level disinfection. In a hospital setting, the practice of high-level disinfection (HLD) is achievable because hospitals have dedicated medical device reprocessing departments that can meet both provincial occupational health and safety requirements (WorkSafeBC) and reprocessing requirements described in the provincial best practice document. This is why hospitals can ensure that HLD is performed safely. Unfortunately in the community-based office setting, the lengthy and complex parameters of HLD are extremely difficult to perform. The College does not support HLD in community-based settings for reusable semi-critical and/or critical medical devices. This decision is based on an extensive review of current best practices including the BC Ministry of Health Best Practice Guideline for Cleaning, Disinfection and Sterilization in Health Authorities and WorkSafeBC. The expectation is that community-based physicians reprocess both their critical and semi-critical reusable medical devices by steam sterilization, provided this method has been validated by the manufacturer of these devices. If the medical device is not validated for sterilization in steam, the device must be replaced with a disposable alternative.

As with critical reusable medical devices, semi-critical reusable medical must be delivered to point of use packaged. This is to ensure the device is not contaminated or compromised until use. Common practice has been for physicians to steam sterilize an unpackaged semi-critical reusable medical device (for example a reusable vaginal speculum) and simply store it in a drawer until use. This practice increases the likely hood of contamination and increases patient risk of cross-contamination.

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, as well as inactivate the sterilant so that it does not work.

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.
  1. Enzymatic cleaners: Some detergents contain one or more enzymes, which are chemical substances that act on specific types of soil. Enzymatic cleaners work to dissolve dried soil without mechanical action and are recommended for pre-soaking of medical devices with tubes such as cannulated devices and heavily soiled devices.

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

How is cleaning performed?

Cleaning must include the following steps:

  1. Manual friction
  2. Water
  3. Detergent or enzymatic cleaner approved for health-care use
  4. Completely immerse the device under the water to avoid splash or spray

What if I don’t have time to clean the medical device right away?

Pre-soak the device using an enzymatic cleaner. Keep the device moist in a designated container until cleaning can be performed.

How do I reprocess the non-critical reusable medical devices/instruments/equipment in my practice?

Non-critical (touches only intact skin) equipment should be cleaned of any visible soil, and then disinfected with a cloth and low-level disinfectant (LLD). Allow adequate contact time with the disnfectant according to the MIFU.

Following disinfection, the item should be rinsed or wiped with water, to remove residual disinfectant, and then dried before use.

Disinfectant wipes may be used for items that cannot be soaked, but it may be difficult to attain adequate disinfectant contact time. Disinfectant wipes may also be used by the primary care giver for cleaning small non-critical items between patients (e.g. stethoscope, blood pressure cuff).

The following requires LLD between use:

  • non-critical equipment (stethoscopes, blood pressure cuff, glucose meters, oximeters)
  • environmental surfaces (exam table, electronic thermometers, baby scales, and furnishings)
  • blood and body fluid spill

What are some examples of hospital-grade LLDs?

Hospital-grade disinfectants for use in the clinical office include:

  • alcohols (70–95% ethyl or isopropyl alcohol)
  • chlorine 5.25% sodium hypochlorite at 50,000 ppm (i.e. 1:50 dilution of household bleach)
  • calcium hypochlorite
  • phenolics (must not be used for toys or equipment that comes into contact with infants)
  • quaternary ammonium compounds (QUATs)
  • hydrogen peroxide enhanced action formulation

Can I reprocess my reusable medical devices using high-level disinfection (known as the cold sterilant method)?

In the community-based physician office setting, high-level disinfection (HLD) is not an acceptable method of reprocessing reusable medical devices. Although HLD kills micro-organisms effectively, the practice is problematic in the community-based setting for these reasons:

  1. There are WorkSafeBC ventilation requirements with some HLD products due to the toxicity of the products
  2. There are several required parameters for quality assurance that must be met in order to use HLD effectively

HLD is suitable for a hospital setting where there are strict parameters in place to correctly and safely manage the practice.

How do I safely transport dirty/contaminated medical devices?

  • Always use a designated container for dirty/contaminated equipment
  • Container should be cleaned and low-level disinfected after each use
  • Never transport clean and dirty/contaminated medical devices together in the same container

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.

For the community-based physician office, a tabletop steam sterilizer is the most common type of steam sterilizer.

What are the different kinds of tabletop steam sterilizers?

There are three types of steam sterilizers that utilize different methods to remove air from packages and the chamber.

  1. Pre-vacuum sterilizers (dynamic air removal)
    • Use a vacuum pump or water ejector to remove air from the chamber and packaged devices during the preconditioning phase and prior to sterilization
    • Operate at 132°C to 135°C
  2. Gravity sterilizers
    • Use gravity air displacement to remove air from the sterilizer chamber and packaged devices
    • Operate at 121°C or higher
  3. Steam-flush pressure-pulse
    • Use a repeated sequence of a steam flush and pressure pulse to remove air from the chamber and packaged items
    • Operate at 121°C to 123°C, 132°C to 135°C or 141°C to 144°C

Refer to the Checklist for Purchasing a Tabletop Steam Sterilizer for information on what to look for when buying a sterilizer for a clinical office.

What is sterilization monitoring?

Sterilization monitoring must be routinely performed to verify the effectiveness of the sterilizer and the sterilization process.

The types of sterilization monitoring required are as follows:

Biological Indicator (BI)

A BI is a test ampoule or spore-laden strip that provides a defined resistance to a specified sterilization process. Follow manufacturer’s instructions for both the BI and the sterilizer to perform test correctly:

  1. Use BI once a day on the first load sterilizer is used
  2. Once sterilized, the BI is removed from sterilizer and incubated in the BI incubator to see if the micro-organism will grow
  3. Interpret results of final readout
  4. Record results of final readout
  5. Medical devices can be used once final readout is obtained

Chemical Indicators (CI)

Chemical indicators indicate that the package has been processed through a sterilization cycle. Follow manufacturer’s instructions for both the CI and the sterilizer to perform test correctly. There are two types of CI: internal CI and external CI. Both are required.

  • Internal CI
    • Used to determine that adequate steam penetration has occurred

    • Inserted inside each package/wrapper to be sterilized
    • Internal CIs inside peel pouches can be read through the plastic once sterilization is complete
    • Internal CI in a wrapped package is read at point of use of the medical device
  • External CI
    • Some commercial packages/wraps may include an external CI; otherwise a separate external CI is required

Physical Monitors

At the end of each load, staff must review the printout and verify the following:

  • Time: ensure full duration of cycle
  • Temperature: temperature increase to steam
  • Pressure: adequate pressure has been reached

Once the operator has confirmed that these cycle parameters are present and correct, the operator must sign/initial the printout to indicate that verification was done. Retain the printout as part of the complete cycle record.

Newer models of steam sterilizers will have recording devices and printers built into them. Older models may not have printers, and some sterilizers may have been sold with a printer as an optional feature.

If you don’t have a printer:

  • Plan to replace it. The cycle documentation that a printer provides is now considered to be essential quality assurance information.
  • Check the sterilizer’s displays and record the sterilization time and temperature at intervals during each cycle.
  • Use a class 5 chemical integrator (internal CI) in each package

All quality assurance parameters must be documented. Keep log and the printout of each load.

What information do I need to document during sterilization?

Recording cycle test results is an important part of a quality assurance system. It is a permanent record confirming that all critical elements of the sterilization process were achieved and that the processed devices are safe to use for patients.

Documentation for each cycle must include:

  1. The date and time of the load, which is usually found on the printout
  2. Cycle number (if you run more than one cycle in a day)
  3. CI pass/fail – check the chemical indicators that are visible as you unload the sterilizer
  4. BI result when final readout is available for that day

What do I need to know when I am loading the sterilizer?

  • Do not stack packages on top of each other
  • Do not overload the sterilizer
  • Do not let packages contact the chamber wall
  • Use rack to place paper/package on their side
  • Place the plastic side of the pouch to face the paper side of the adjacent pouch
  • Place large items on the bottom shelf
  • Leave adequate space between pouches

What do I need to know when I am unloading the sterilizer?

  • Packages must be dry.
  • Newer sterilizers have a drying phase programmed into their cycle. Other models offer a drying phase as an option.
  • If your machine does not have a drying cycle, at the end of the cycle open (or crack) the door approximately 10 mm and leave the packages to dry.
  • Packages must be cool. Do not handle sterile packages until they are cool. Hot or warm packages still contain moisture, which can destroy the barrier quality of the package. The micro-organisms from your hands could easily contaminate the package.
  • Remember once dry and cool, the packages can be handled with bare clean hands (no gloves required).
  • Chemical indicator must pass. Check both the chemical indicators on the outside of the package as well as those that are visible on the inside of the paper-plastic pouches to ensure that the appropriate colour change has occurred.
  • Physical indicators must pass. Check the printout to ensure that the critical parameters (time, temperature, pressure) have been achieved. If parameters are not met, follow clinical office steps for a failed sterilization indicator.

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
  3. Record follow up actions
  4. Re-package
  5. Re- sterilize

How should I store sterile medical devices?

  • Storage area should be clean, dry and dust-free
  • Do not store liquids above sterile items
  • Do not store in corrugated cardboard boxes
  • Reprocess or discard if medical devices touch the floor, are wet or damaged
  • Do not store at floor level, on window sills or under sinks

Note: The shelf-life of a sterile package is “event- related” and remains sterile as long as the integrity of the packaging remains intact.

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.

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. Canad ian Standards Association. Medical device reprocessing in community health care settings. Mississauga: Canadian Standards Association; 2014. 94 p. CSA Standard No.: SPE 1112- 14.
  4. Canadian Standards Association. Decontamination of reusable medical devices. Mississauga: Canadian Standards Association; 2014. 97 p. CSA Standard No.: Z314.8-14.