The Current Challenges in the North American Reprocessing Field and Proposed Solution!

The Current Challenges The Current Challenges in the North American in the North American Reprocessing Field and Reprocessing Field and

Proposed Solution!Proposed Solution!

By Colleen Landers By Colleen Landers

Registered NurseRegistered Nurse

Consultant Consultant

Objectives Objectives

• Define the major issues facing Define the major issues facing reprocessing departments. reprocessing departments.

• Provide options to solve these issues.Provide options to solve these issues.

• Refer to the standards that Refer to the standards that reprocessing departments require to reprocessing departments require to solve these issues.solve these issues.

ChallengesChallenges

• Cleaning and sterilization instructions. Cleaning and sterilization instructions.

• Turn around demands.Turn around demands.

• Sterilization extended cycles.Sterilization extended cycles.

• Staff orientation, education and Staff orientation, education and competency testing.competency testing.

• Weight of Sets.Weight of Sets.

• Loaner Sets. Loaner Sets.

• Flash SterilizationFlash Sterilization

Medical Procedures:Medical Procedures:

• First: Do no HarmFirst: Do no Harm

• New Millennium:New Millennium: Age of the Internet and Litigation!!Age of the Internet and Litigation!!(The Public are informed and demanding (The Public are informed and demanding more more

of HealthCare).of HealthCare).

Cleaning and Sterilization Cleaning and Sterilization of Medical Devicesof Medical Devices

• Medical Devices have become Medical Devices have become increasingly complex as more increasingly complex as more sophisticated and less invasive surgical sophisticated and less invasive surgical procedures are developed. procedures are developed.

• The manufacturers’ validated The manufacturers’ validated reprocessing instructions for these reprocessing instructions for these devices have not kept pace with the devices have not kept pace with the requirements listed in the Canadian and requirements listed in the Canadian and American standards. American standards.


• Along with this issue, the increased Along with this issue, the increased demand to do more surgical procedures, demand to do more surgical procedures, requires faster turn around of requires faster turn around of instruments to meet the surgical instruments to meet the surgical demand. demand.

• Concern regarding the safety of patients Concern regarding the safety of patients receiving healthcare in North America has receiving healthcare in North America has required the standards to be reviewed required the standards to be reviewed and requirements increased. and requirements increased.

Cleaning of Medical Cleaning of Medical Devices: Who is responsible Devices: Who is responsible for What??for What??• Manufacturer’sManufacturer’s validate that instrument can validate that instrument can

be reliably cleaned and sterilized/disinfected be reliably cleaned and sterilized/disinfected and is therefore re-usable.and is therefore re-usable.

• UsersUsers verify that cleaning & sterilization verify that cleaning & sterilization equipment is working properly and that in-equipment is working properly and that in-hospital cleaning & sterilization methods are hospital cleaning & sterilization methods are consistently performed and verified.consistently performed and verified.

Medical Device Specific Medical Device Specific Instructions for Instructions for ReprocessingReprocessing

What you don’t

Know?

Manufacturer recommended Manufacturer recommended cleaning that is not cleaning that is not validated!validated!

• ““Ivory Snow”!Ivory Snow”!

• ““No detergent”! No detergent”! (only sterile distilled (only sterile distilled water)water)

• ““Use regular hospital Use regular hospital cleaning protocol”!cleaning protocol”!

““Crud” IssueCrud” Issue

Patient-used (no side-panel):

un cleaned

Patient-used repeatedly;

side-panel removed

““Show Me the MONEY”!!Show Me the MONEY”!!

• STERILE Crud???STERILE Crud???- Acetabular reamers- Acetabular reamers- Electronic drill Hand pieces- Electronic drill Hand pieces

• No “infection” risk ? No “infection” risk ? What is the What is the issue?issue?

• Cost/Benefit: What is realistic???Cost/Benefit: What is realistic???

Sterile Crud ???Sterile Crud ???

• Foreign organic materialForeign organic material- Endotoxin (LPS) from dead bacteria- Endotoxin (LPS) from dead bacteria- blood and other organic debris from - blood and other organic debris from previous patient or from cleaning process previous patient or from cleaning process (e.g. enzymatic detergent residuals, water (e.g. enzymatic detergent residuals, water organisms etc).organisms etc).

• Adverse antigenic reaction to foreign organic Adverse antigenic reaction to foreign organic material (e.g. implants & LPS).material (e.g. implants & LPS).

• Foreign body: “Nidus” for endogenous Foreign body: “Nidus” for endogenous infection.infection.

[Xing et al. Accumulation of LPS by polyethylene particles decreases bone attachment to implants. J Orthopedic Res 2006;24:959-966]


• Health Care Facilities need to make sound Health Care Facilities need to make sound decisions when purchasing a reusable medical decisions when purchasing a reusable medical device. device.

• Documents that guide you are; Documents that guide you are; ISO 17664 Information to be provided by the ISO 17664 Information to be provided by the

manufacturer for reprocessing of a resterilizable manufacturer for reprocessing of a resterilizable medical devices. (CSA Z17664)medical devices. (CSA Z17664)

AAMI ST:81 Sterilization of medical devices; AAMI ST:81 Sterilization of medical devices; Information to be provided by the manufacturer Information to be provided by the manufacturer for the processing of resterilizable medical devices. for the processing of resterilizable medical devices.

Comply with ISO 17664 & AAMI Comply with ISO 17664 & AAMI ST81ST81

Validated Cleaning MethodsValidated Cleaning MethodsCoiled reamer

shafts

Crud from between coils

Alternative: solid shaft

Information provided by manufacturersInformation provided by manufacturers

• Adequate and appropriate cleaning and sterilization.

• Instruments with cannulation (lumens or holes) – these instructions need to be device specific – include ultrasonic. If the device retracts or requires disassembly – include pictures.

• Instruments with crevices (i.e. nuts, bolts, broaches, Instruments with crevices (i.e. nuts, bolts, broaches, cutting blocks) device specific.cutting blocks) device specific.

• Instruments that are hinged – (i.e. pliers, cutters, forceps) – instructions to include:– Cleaning brush size and type– Ultrasonic– Lubrication if required – type of lubricant that is recommended. is recommended.

Information provided by manufacturersInformation provided by manufacturers

• Flexible reamers – Instructions need to be device specific Flexible reamers – Instructions need to be device specific including pictures. including pictures.

• Manufacturers to give maximum number of reprocessing times Manufacturers to give maximum number of reprocessing times for implants (i.e. screws, plates) – how to identify when for implants (i.e. screws, plates) – how to identify when replacement is required.replacement is required.

• Manufacturers to review design. Cleaning tools should be Manufacturers to review design. Cleaning tools should be provided by manufacturers.provided by manufacturers.

• Ensure that when manufacturers update, revise and/or change Ensure that when manufacturers update, revise and/or change sterilization instructions for medical devices the new procedures sterilization instructions for medical devices the new procedures are communicated to the current users in a systematic are communicated to the current users in a systematic documented fashion.documented fashion.

WHY?WHY?

Health Care facilities require a policy and procedure Health Care facilities require a policy and procedure requiring all information on reprocessing from the requiring all information on reprocessing from the manufacturer of the device prior to reprocessing; cleaning, manufacturer of the device prior to reprocessing; cleaning, decontamination, wrapping and sterilization.decontamination, wrapping and sterilization.

Required prior to purchase, lease, trial or evaluation or Required prior to purchase, lease, trial or evaluation or purchase.purchase.

Why? Why? To protect the facility from error and protect patients from To protect the facility from error and protect patients from

risk. risk.

POLICY PROCEDURE FOR ORDERING POLICY PROCEDURE FOR ORDERING REUSABLE MEDICAL DEVICESREUSABLE MEDICAL DEVICES

Requires the following;• Purchase approved by the Reprocessing Manager and

Infection Prevention and Control prior to evaluation, consignment, loaned/leased or purchases.

• Written manufacturer’s instructions for cleaning, wrapping and sterilization reviewed and attainable by Central Processing department before purchase.

• In-service for cleaning and sterilization shall be provided to all staff, prior to the medical device being placed in circulation for use on a patient.

POLICY PROCEDURE FOR ORDERING POLICY PROCEDURE FOR ORDERING REUSABLE MEDICAL DEVICESREUSABLE MEDICAL DEVICES

• The decisions to make changes to cleaning products, purchases of new equipment for surgical procedures, etc., shall be performed by a “Product Evaluation Team” endorsed by the OEM.

• All medical devices that will be loaned/leased, All medical devices that will be loaned/leased, used on consignment, evaluated or purchased used on consignment, evaluated or purchased will be reviewed and a decision made by the will be reviewed and a decision made by the Product Evaluation Team. Product Evaluation Team.

Why?Why?

To determine if the medical device can be To determine if the medical device can be cleaned and sterilized in the facility before cleaned and sterilized in the facility before evaluation, consignment, loaned/leased or evaluation, consignment, loaned/leased or purchased in the healthcare facility. purchased in the healthcare facility.

To ensure that the reprocessing will meet the To ensure that the reprocessing will meet the requirement for organism kill. requirement for organism kill.

To prevent risk to patients and staff.To prevent risk to patients and staff.

SolutionSolution• If healthcare facilities require staff to If healthcare facilities require staff to

reprocess medical devices then clearly reprocess medical devices then clearly written instructions with pictures are written instructions with pictures are required. required.

• In service of all medical devices given to the In service of all medical devices given to the reprocessing staff on the cleaning, wrapping reprocessing staff on the cleaning, wrapping and sterilization prior to the implementation and sterilization prior to the implementation of the device in the health care facility. of the device in the health care facility.

• Sound decisions, when purchasing the Sound decisions, when purchasing the medical device, to ensure it can reprocessed medical device, to ensure it can reprocessed in the facility to meet the best practices in the facility to meet the best practices required in the standards. required in the standards.

SolutionSolution• If increased numbers of surgical procedures If increased numbers of surgical procedures

are required then increase in instrumentation are required then increase in instrumentation to meet these demands is required. to meet these demands is required.

• Short cuts in reprocessing are a risk to Short cuts in reprocessing are a risk to patients! They are are not a means to meet patients! They are are not a means to meet the demand. the demand.

• All patients have the right to the same level All patients have the right to the same level of care and the same level of reprocessed of care and the same level of reprocessed instrument. instrument.

• ST79 covers these requirements as does CSA ST79 covers these requirements as does CSA Z314.3 and Z314.8. Z314.3 and Z314.8.

EXTENDED CYCLESEXTENDED CYCLES

Sterilization CyclesSterilization Cycles Typical steam sterilization method used in health care Typical steam sterilization method used in health care

arearethe dynamic air removal cycles.the dynamic air removal cycles.Typical cycles are:Typical cycles are:• 3 Minutes at 135 degrees C (2753 Minutes at 135 degrees C (275°°F)F)• 4 Minutes at 132 degrees C (2704 Minutes at 132 degrees C (270°° F) F)

Cycle is dependent upon specific sterilizer manufacturer.Cycle is dependent upon specific sterilizer manufacturer.Hospital sterilizers are only validated for these hospitalHospital sterilizers are only validated for these hospitalcycles. cycles. Gravity cycles rarely used today in healthcare facilities. Gravity cycles rarely used today in healthcare facilities.

Extended CyclesExtended Cycles

Up to 10 Up to 10 differentdifferent extended cycle times extended cycle times exist and the number grow daily!exist and the number grow daily!

These cycles are greater than the These cycles are greater than the standardstandard

hospital cycles.hospital cycles.Extended cycles are now being Extended cycles are now being

recommended byrecommended by

various device manufacturers.various device manufacturers.

e.g. Range of 5 to 40 minutese.g. Range of 5 to 40 minutes

Sterilizer Manufacturer Validated CyclesSterilizer Manufacturer Validated Cycles Gravity Displacement steam sterilizer Dynamic Air-removal

steam sterilizer

(e.g. Pre-vacuum steam

sterilizer)

Item Exposure time at

250oF (121oC)

Exposure time at

270oF (132oC)

Exposure time at

275oF (135oC)

Exposure

time at 270oF

(132oC)

Exposure

time at 275oF

(135oC)

Wrapped

instruments

30 minutes 15 minutes 4 minutes

10 minutes 3 minutes

Textile packs 30 minutes 25 minutes 4 minutes


Wrapped utensils 30 minutes 15 minutes 4 minutes


Unwrapped

nonporous items (eg

instruments)

3 minutes 3 minutes 3 minutes 3 minutes

Unwrapped

nonporous and

porous items in

mixed load

10 minutes 10 minutes 4 minutes 3 minutes

*This table represents the variation in sterilizer manufacturers’ recommendations for exposure at different temperatures. For a specific sterilizer, consult only that manufacturer’s recommendations. Dry times have not been indicated as this varies substantially depending upon the sterilizer manufacturer,

season and/or other site specific issues. Note: Extracted from AAMI DS2/ST79/2005-02-07

ProblemsProblems

Large sterilizers are designed toLarge sterilizers are designed toaccommodate loads of multiple devicesaccommodate loads of multiple deviceswith similar requirements for with similar requirements for

sterilization.sterilization. 1)1) Having only a small number of sets in a large sterilizer Having only a small number of sets in a large sterilizer

chamber increases the challenge to sterilization and the chamber increases the challenge to sterilization and the likelihood that air will not be completely removed from the likelihood that air will not be completely removed from the set being reprocessed. This may compromise sterilization.set being reprocessed. This may compromise sterilization.

2)2) It is inefficient to run a load with a single device that It is inefficient to run a load with a single device that requires a different sterilization cycle.requires a different sterilization cycle.

3)3) Sterilizing items in multiple loads does not allow Sterilizing items in multiple loads does not allow departments to meet the daily sterilization demands. departments to meet the daily sterilization demands.

ProblemsProblemsChanging the settings on sterilizerChanging the settings on sterilizerequipment, for each load, can lead toequipment, for each load, can lead tohuman error resulting in the human error resulting in the wrong cyclewrong cyclebeing selected.being selected.

This can lead toThis can lead to devices being devices being weakened, destroyed or incorrectly weakened, destroyed or incorrectly sterilized in subsequent loads.sterilized in subsequent loads.

ProblemProblemPackaging for containment of devices or setsPackaging for containment of devices or setshas not been validated for use in extendedhas not been validated for use in extendedcycles e.g. reusable and single use wraps,cycles e.g. reusable and single use wraps,pouches, rigid containers and their filters. pouches, rigid containers and their filters.

– May not maintain sterilityMay not maintain sterility . .

– May not allow sterilization of all device surfaces May not allow sterilization of all device surfaces due to tightness of fitting, excessive metal due to tightness of fitting, excessive metal mass or layering of devices.mass or layering of devices.

Recommended SolutionRecommended Solution

Standardize to a minimum number of cycles Standardize to a minimum number of cycles e.g.e.g.

one extended cycle, the length of time to beone extended cycle, the length of time to bedetermined, in addition to the 3 or 4 minute determined, in addition to the 3 or 4 minute

cyclecycleroutinely used.routinely used.

• to allow BI and CI manufacturers to develop to allow BI and CI manufacturers to develop products specific to these cycles.products specific to these cycles.

• to decrease likelihood of human error.to decrease likelihood of human error.• to increase productivity.to increase productivity.• to decrease likelihood of sterilization failure.to decrease likelihood of sterilization failure.

Recommended SolutionsRecommended Solutions• When a device manufacturer develops When a device manufacturer develops

extended cycle recommendations, the extended cycle recommendations, the type of appropriate packaging to be type of appropriate packaging to be used used for the extended cycle for the extended cycle (reusable (reusable or single use wrappers, rigid containers or single use wrappers, rigid containers or pouches) should be included in the or pouches) should be included in the validation process.validation process.

• Packaging manufacturers should Packaging manufacturers should validate their products for extended validate their products for extended cycle times. cycle times.

AAMI TIR 31- Process Challenge AAMI TIR 31- Process Challenge Devices/test packs used for healthcare Devices/test packs used for healthcare

facilities.facilities.

• The standard extended cycles has been The standard extended cycles has been addressed in this AAMI TIR. addressed in this AAMI TIR.

• They include:They include: Pre Vacuum cycles 270 – 274 degrees at Pre Vacuum cycles 270 – 274 degrees at 10 or 20 minutes.10 or 20 minutes. Gravity 250 degrees 40 or 60 minutes. Gravity 250 degrees 40 or 60 minutes. Recommend Solid Load PCD and Hollow Recommend Solid Load PCD and Hollow Load PCD for each recommended cycle. Load PCD for each recommended cycle.

Proposed Chart for Extended Proposed Chart for Extended CyclesCycles

Standard Extended Steam Sterilization Cycle Times and Temperature

Cycle Type Temperature Time (minutes)

Dynamic-air removal

132°C - 135°C (270°F - 275°F) 10

Dynamic-air removal

132°C - 135°C (270°F - 275°F) 20

Gravity-displacement 121°C (250°F) 40

Gravity-displacement 121°C (250°F) 60

Recommended SolutionRecommended Solution • This will allow PCD manufacturers to develop This will allow PCD manufacturers to develop

PCDS for these cycles.PCDS for these cycles.• Adopted by the ST 8 - Hospital Steam Adopted by the ST 8 - Hospital Steam

Sterilizers so sterilizers validated for these Sterilizers so sterilizers validated for these cycles.cycles.

• Adopted as hospital cycles in ST79 –Adopted as hospital cycles in ST79 –Comprehensive Guide to steam sterilization Comprehensive Guide to steam sterilization and sterility assurance in health care and sterility assurance in health care facilities. facilities.

• Wrapping manufacturers can then test their Wrapping manufacturers can then test their wrap at these cycles.wrap at these cycles.

• CSA in Canada has agreed to also adopt these CSA in Canada has agreed to also adopt these cycles recommended. cycles recommended.

Conclusion Extended Conclusion Extended CyclesCycles

• Device manufacturers must work together, with other Device manufacturers must work together, with other manufacturers, to ensure that the recommended manufacturers, to ensure that the recommended extended cycle meets capabilities of the sterilizer, the extended cycle meets capabilities of the sterilizer, the packaging, and process monitors to be used.packaging, and process monitors to be used.

• Health Canada and the FDA, when reviewing pre Health Canada and the FDA, when reviewing pre market applications for devices will require the market applications for devices will require the medical device manufacturer to provide appropriate medical device manufacturer to provide appropriate ValidationValidation

• Packaging will be validated for these cycles. Packaging will be validated for these cycles. • Process monitoring device will be available for these Process monitoring device will be available for these

cycles.cycles.• Healthcare sterilizers will be validated for all of the Healthcare sterilizers will be validated for all of the

hospital cycles recognized as healthcare steam hospital cycles recognized as healthcare steam sterilization cycles. sterilization cycles.

Staff Orientation, Training Staff Orientation, Training and Competency Testing.and Competency Testing.

Reprocessing StaffReprocessing Staff

• Since the 1990’s with the advent of “Minimal Invasive Surgery”, instruments became complex and more difficult to clean.

• Simple instruments like kockers and criles made of stainless steel are no longer the norm.

• These changes brought larger challenges for cleaning, requiring knowledgeable staff that are current and trained.

• Staff now require greater education and critical thinking abilities in order to do the cleaning and reprocessing safely.

• Reprocessing departments require a Quality System

which requires monitoring and documentation. which requires monitoring and documentation.

Quality ControlQuality Control

Standards require Standards require Continuous supervision of personnel Continuous supervision of personnel

performance. performance. Competency testing.Competency testing. Supervision of work practices.Supervision of work practices. Ongoing verification of adherence to Ongoing verification of adherence to

policies and procedures. policies and procedures. Verification of reprocessing practices. Verification of reprocessing practices.

Quality SystemsQuality Systems• Deviations from normal operating procedures are Deviations from normal operating procedures are

identified, investigated and evaluated. identified, investigated and evaluated. • Corrective action required.Corrective action required.• Audits: Audits: Internal audits by knowledgeable staff to verify Internal audits by knowledgeable staff to verify

effectiveness of system. Audit reviews documented effectiveness of system. Audit reviews documented and corrective action taken.and corrective action taken.

Periodic external reviews to measure progress are Periodic external reviews to measure progress are recommended. recommended.

• Contractors or other organizations that perform Contractors or other organizations that perform functions that could effect quality systems then theyfunctions that could effect quality systems then they must demonstrate they will have adequate control must demonstrate they will have adequate control

andand supervisions so as not to effect quality system. supervisions so as not to effect quality system.

This Requires Educated This Requires Educated Staff with Critical Thinking Staff with Critical Thinking

Skills!Skills!• Challenge is to find these people and then to Challenge is to find these people and then to

maintain them in the field. maintain them in the field. • Orientation after they obtain a formal course Orientation after they obtain a formal course

requires months of supervision before they can requires months of supervision before they can function alone.function alone.

• Due to the complexity of the instruments and vast Due to the complexity of the instruments and vast numbers of sets to master, this does not occur numbers of sets to master, this does not occur overnight. overnight.

• Ongoing education, competency testing of staff Ongoing education, competency testing of staff yearly, in service on all new medical devices is yearly, in service on all new medical devices is costly and time consuming. costly and time consuming.

• Staffing compliments must address release time for Staffing compliments must address release time for this to occur and is rarely considered when financial this to occur and is rarely considered when financial allocations are given to reprocessing areas. allocations are given to reprocessing areas.

Proposed SolutionsProposed Solutions• Require formal education as hiring practice. Require formal education as hiring practice. • Ensure the staff have job satisfaction. Ensure the staff have job satisfaction. • Provide ongoing education opportunities for staff.Provide ongoing education opportunities for staff.• Have internal audits be opportunities for Have internal audits be opportunities for

improvement.improvement.• Staff that know why they are required to do Staff that know why they are required to do

something do a better job. something do a better job. • Ensure you have detailed procedure cards for all Ensure you have detailed procedure cards for all

cleaning and reprocessing practices for all cleaning and reprocessing practices for all medical devices that are current and have medical devices that are current and have pictures to facilitate processes. pictures to facilitate processes.

• Provide opportunities for open houses in the Provide opportunities for open houses in the department so users understand the complex department so users understand the complex tasks the reprocessing staff deal with on a daily tasks the reprocessing staff deal with on a daily basis. basis.

Proposed Solutions!Proposed Solutions!• Offer opportunities for user staff to spend time Offer opportunities for user staff to spend time

in reprocessing. in reprocessing. • Offer opportunities for reprocessing staff to Offer opportunities for reprocessing staff to

view surgical procedures so they understand view surgical procedures so they understand the use of medical devices.the use of medical devices.

• Celebrate success! Celebrate success! • Teach staff to understand that an error is a Teach staff to understand that an error is a

learning opportunity as long as corrective learning opportunity as long as corrective action results. action results.

• Do customer service surveys and involve staff Do customer service surveys and involve staff in the results and solutions. in the results and solutions.

• Liaison staff between the operating room and Liaison staff between the operating room and reprocessing is a requirement, in order to solve reprocessing is a requirement, in order to solve issues rather then let them become issues that issues rather then let them become issues that break relationships. break relationships.

Proposed Solutions!Proposed Solutions!

• Reprocessing budgets must include release Reprocessing budgets must include release time for training and ongoing education. time for training and ongoing education.

• Auditing must be scheduled & documented!Auditing must be scheduled & documented!

• Recommendations must be documented, Recommendations must be documented, and addressed to improve process and action and addressed to improve process and action taken!taken!

Why knowledge is Why knowledge is Important?Important?

Weight of Sets!Weight of Sets!Imagine working in a Reprocessing Department or Operating Room where there is a maximum weight limit on instrument trays! Imagine that this maximum weight limit policy is routinely enforced!

Picture your staff no longer complaining about having to repeatedly lift heavy trays!

Imagine if you did not have to deal with wet pack problems or other sterilization concerns due to heavy trays!

This vision can come true by just saying “NO” to instrument trays that are too heavy!

WEIGHT OF SETSWEIGHT OF SETS

Heavy Sets!Heavy Sets!• No matter what the reason for an instrument set being on the heavy No matter what the reason for an instrument set being on the heavy

side, it can be a problem when it comes to the sterilization process.side, it can be a problem when it comes to the sterilization process. • Overweight sets and sets that do not have the metal mass evenly Overweight sets and sets that do not have the metal mass evenly

distributed can create concerns with adequate steam contact with distributed can create concerns with adequate steam contact with all surfaces. all surfaces.

• In addition, a problem with drying may result in the potential for wet In addition, a problem with drying may result in the potential for wet packs.packs.

• The Association of Preoperative Registered Nurses (A O R N ’s) 2006 The Association of Preoperative Registered Nurses (A O R N ’s) 2006 recommended practice for recommended practice for Packaging Systems states rigid container rigid container systems should be used according to manufacturers’ instructions. systems should be used according to manufacturers’ instructions. The approved sterilization method and cycle exposure times for The approved sterilization method and cycle exposure times for each rigid container system should be provided in the each rigid container system should be provided in the manufacturers’ data and instructions.manufacturers’ data and instructions.

• Your sterilization standards state “weight of a wrapped instruments Your sterilization standards state “weight of a wrapped instruments set should be no more then 16 pounds!set should be no more then 16 pounds!

• The sterilizers are validated for this weight. The sterilizers are validated for this weight.

Heavy SetsHeavy Sets

• Why? The more mass metal the more steam Why? The more mass metal the more steam forms water thus drying issues & wet packs. forms water thus drying issues & wet packs.

• The new CSA Z314.3 states the total weight The new CSA Z314.3 states the total weight with container cannot be over 10 kg/22 with container cannot be over 10 kg/22 pounds. pounds.

• Sterilization cannot occur unless the steriliant Sterilization cannot occur unless the steriliant can reach all surfaces of the instrument. With can reach all surfaces of the instrument. With multi layer sets users must verify that the multi layer sets users must verify that the steriliant will sterilize all medical devices in steriliant will sterilize all medical devices in all areas. all areas.

• Testing with BI’s has been done and failure Testing with BI’s has been done and failure has occurred. (User Alert- Problems with has occurred. (User Alert- Problems with process monitors for extended cycles) process monitors for extended cycles)

• If failure of any If failure of any BIs: report to BIs: report to medical device medical device manufacturermanufacturer

• Break down set to Break down set to smaller tray sets smaller tray sets and re-testand re-test

Instrument sets; Instrument sets; excessive weight & excessive weight & massmass

Ergonomic Concerns with Heavy Ergonomic Concerns with Heavy SetsSets

• In the hospital setting we see many injuries of staff due to repeated lifting of heavy instrument containers.

• The health and safety of healthcare workers should be protected through reasonable weight restrictions, especially when these trays must be lifted an average of 12 to 15 times each time the set is used and reprocessed.

• Instrument sets used for a surgical procedure are lifted on and off case carts, on and off surgical areas, in and out of instrument washers, onto and off of processing tables, lifted to be wrapped or containerized, into and out of the sterilizer, on and off storage shelves, etc.

• This repetitive lifting can be an ergonomic nightmare, particularly when the set weight exceeds 10kg/22 pounds or if there are several heavy sets.

• Studies have shown that repetitive lifting greater then 9kg will cause injury to staff such as shoulder, arm, back, neck.

• The statistics are showing that these heavy sets are making patients of our reprocessing and operating room staff.

Solution Say No!Solution Say No!• Write policy statement, “no instrument set, including

its package is to exceed 20 pounds.” Once we had the policy in place we could enforce it.

• SPD purchased a scale for the instrument room, and the weighed all of the sets that we owned that seemed heavy.

• We found about 25 sets that exceeded the 20-pound weight limit. The majority of hefty sets were orthopedic, and we also found some urology, neurology, cardiovascular and retractor sets that exceeded our weight limit.

• We put together a list and then asked the OR service leader for each area to help us eliminate some items in each set or to separate the sets.

Solution Say No!Solution Say No!• We then added a deadline of three weeks to

complete this project, knowing that if we set a deadline it was more likely to be completed in a timely manner.

• In some instances we were able to remove In some instances we were able to remove infrequently or unused instruments that were infrequently or unused instruments that were added to the set in case they were needed. We added to the set in case they were needed. We put these additional items in peel packs or small put these additional items in peel packs or small wrappers. wrappers.

• In other cases, such as cardiovascular (CV) sets, In other cases, such as cardiovascular (CV) sets, we separated the string instruments and the we separated the string instruments and the retractor and put them in separate smaller pans. retractor and put them in separate smaller pans.

Solution!• The number of pans is irrelevant to the outcome of the The number of pans is irrelevant to the outcome of the

procedure, as long as the correct items are readily available. procedure, as long as the correct items are readily available. Moreover, in addition to being readily available, the sterility Moreover, in addition to being readily available, the sterility assurance of each device had been verified, which is essential assurance of each device had been verified, which is essential for safe patient care. for safe patient care.

• SPD gets asked to add an instrument to a set, we ask if we SPD gets asked to add an instrument to a set, we ask if we can remove anything first. can remove anything first.

• Once the changes had been made, and the sterilization Once the changes had been made, and the sterilization process was verified, the surgeon’s preference lists were process was verified, the surgeon’s preference lists were updated to reflect the changes and the need to pick both updated to reflect the changes and the need to pick both parts of a set, since some were now in more than one parts of a set, since some were now in more than one package (i.e., trays are labeled A and B). In addition, we made package (i.e., trays are labeled A and B). In addition, we made sure the “pick list” made note of “just in case” items to be sure the “pick list” made note of “just in case” items to be picked that were taken out of sets and wrapped or peel picked that were taken out of sets and wrapped or peel packed separately.packed separately.

• We realize that even though surgeons may say they want We realize that even though surgeons may say they want everything in one pan, all they really want is to make sure everything in one pan, all they really want is to make sure they have what they need, when they need it. It doesn’t they have what they need, when they need it. It doesn’t matter if it is in one or more pans. matter if it is in one or more pans.

Weighing Sets and Limiting Weighing Sets and Limiting WeightWeight

.Fukushima Day Retractor set with one level wrapped separately

Instrument set being weighed

Solution!Solution!• Work with the manufacturers as users to educate Work with the manufacturers as users to educate

them that the weight is important and to aim for them that the weight is important and to aim for 10kg/22 pound weight. 10kg/22 pound weight.

• Users when making purchases start standing up Users when making purchases start standing up for the weight requirement to achieve sterility, for the weight requirement to achieve sterility, protect workers as our sterilizers are validated protect workers as our sterilizers are validated with 16 pounds of mass metal. with 16 pounds of mass metal.

• Health care committees when making purchasing Health care committees when making purchasing decisions this must be taken into account.decisions this must be taken into account.

• If we don’t say “NO” to overweight sets, you will If we don’t say “NO” to overweight sets, you will all be an occupational injury before you reach all be an occupational injury before you reach retirement age. retirement age.

• Remember we are humans not robots!Remember we are humans not robots!• Our body will react to abuse by breaking down!Our body will react to abuse by breaking down!• Why should we make reprocessing and operating Why should we make reprocessing and operating

staff suffer injury when we can divide sets into staff suffer injury when we can divide sets into reasonable weights? reasonable weights?

Loaner Specialty Loaner Specialty Equipment SetsEquipment Sets

Loaner Specialty Equipment Loaner Specialty Equipment SetsSets• Inventory issues!Inventory issues!

• Receipt on site 48 hours prior to Receipt on site 48 hours prior to scheduled surgical procedure.scheduled surgical procedure.

- Cleaning- Cleaning- Sterilization- Sterilization

• Quality Control for sets!Quality Control for sets!

Loaner SetsLoaner Sets• Healthcare facilities use loaned and shared medical devices for a

number of procedures for potential cost savings from not purchasing expensive devices in their inventory.

• Loaned and shared devices allow facilities to save on maintenance costs and keep up with changing technology.

• The biggest concern comes from those instrument sets that we do not own.

• Loaner sets come and go without written instructions, pictures, in service, etc. all not meeting ISO 17664, AAMI ST81, and CSA Z314.22 Management of Loaned, Shared, Leased Medical Devices.

• If you write your policy for your facility meeting these standards

you will eliminate the problems.

Problems!Problems!• Sets coming with no list of items.• No pictures.• No cleaning or sterilization instructions.• No in service.• Heavy sets.• Sets received in complete or soiled from previous user. • Come with no time to check and reprocess the sets

properly.• Sets received and not sure what is supposed to be in the

set. • All of these issues place the patient at risk of injury and

infection! • If manufacturers want your business then they will follow

your policy. • When doing the evaluation of which vendor you will deal

with use the standards to set policy to get all your concerns addressed.

Write Policy as a Solution!Write Policy as a Solution!Policy must address:Policy must address:

• Identify responsibilities as sender, receiver, qualifications Identify responsibilities as sender, receiver, qualifications and training of personnel, risk management, quality and training of personnel, risk management, quality management and insurance.management and insurance.

• Have a policy to cover emergencies related to loaned Have a policy to cover emergencies related to loaned and shared devices including the necessary signatures to and shared devices including the necessary signatures to designate that situation as an emergency.designate that situation as an emergency.

• Not accept Medical Devices unless they are licensed by Health Canada and FDA, and conform to codes and standards.

• Have procedures in place for sending, transporting and receiving of loaned and shared devices.

• Have in place mutually accepted written documentation, outlining the responsibilities of individuals during the transactions between senders and receivers.

Write Policy as a Solution!Write Policy as a Solution!

• In written form (e.g. in binders, manuals or monographs) and/or electronic format.

• In a central location so they are readily accessible and shall be updated as required.

• Documented and reviewed on a regular basis by the facility’s Infection Prevention and Control or Risk Management personnel, or their designates.

• Policies required for:Quality system!Quality system!Documentation!Documentation!

TransportationTransportation

• Check environmental and handling conditions Check environmental and handling conditions

required and transport accordingly.required and transport accordingly.

Routinely clean and maintain the trucks.Routinely clean and maintain the trucks.

Prevent physical damage, tampering and loss.Prevent physical damage, tampering and loss.

aintain records of devices transported.aintain records of devices transported.

Deliver the device to the next organization or Deliver the device to the next organization or facility at the contractually agreed time.facility at the contractually agreed time.

Solution to Loaner Set WeightsSolution to Loaner Set WeightsHow can you enforce the weight limit on those sets that weborrowed or that the company brought in for us to “use” aslong as we purchased their implants?

• The answer is in policy. The weight limit statement into your loaner policy then shared with the MDM representatives that had surgical instrument sets in our facility.

• Ask the MDMs to work with you to get their set weights down to 20 pounds. Some were very helpful and made suggestions on how we could divide the sets, while others took a little convincing and negotiating to get them to see that if they wanted us to sterilize their sets, they had to follow our policy.

• Purchase additional instrument container or two to “house” the items removed from the vendor-owned sets.

(MDM – medical device manufacturer)

Solution to Loaner Set Solution to Loaner Set WeightsWeights

• Validated for sterilization by the MDM, and Validated for sterilization by the MDM, and even lighter by placing them in two containers, even lighter by placing them in two containers, we could use its sterilization process we could use its sterilization process recommendation. recommendation.

• Follow manufacturers instructions and conduct Follow manufacturers instructions and conduct your own sterilization verification testing per your own sterilization verification testing per AAMI’s recommendation on product testing.AAMI’s recommendation on product testing.

• When it comes to MDMs’ sterilization validation When it comes to MDMs’ sterilization validation testing, never take the representatives’ verbal testing, never take the representatives’ verbal word for it. Always ask for that information in word for it. Always ask for that information in writing directly from the MDM.writing directly from the MDM.

FLASH STERILIZATIONFLASH STERILIZATION

What is flash sterilization?What is flash sterilization?

Z314.13-01(CSA) – Emergency Sterilization –

Which now will be replaced by CSA Z314.3 – Why?

Flash sterilization - a special steam sterilization process designed and used for the emergency sterilization of surgical goods when proper sterilization cannot be done.

Flash SterilizationFlash Sterilization

“Flash sterilization, if used by facility policy, shall be used only for emergency sterilization (for example when a dropped instrument requires immediate sterilization).

Flash sterilization shall not be used to compensate for inventory shortages or scheduling problems.

Flash sterilizers will be biologically monitored minimally daily and all items traceable to the patient.”

Current practice!Current practice!Flashing total sets and implants is routine.

Quick rinse in a sub-sterile room or scrub-sink area -Uniform or scrub suit + sink is now contaminated

Excess flashing due to lack of inventory and scheduling practices.

Flash Sterilizers with no preventative maintenance

No verification of sterility of items being sterilized.

Instrument sets should not be flash sterilized. Flash sterilizers are only validated for 1-2 instruments.

The following conditions shall be met if you are flashing:a) there is an urgent unplanned need;b) there are documented procedures for this practicec) the physical layout and documented procedures assure

direct delivery of the sterilized item to the point of immediate use.

d) The flash sterilizers has routine preventative maintenance that is documented.

e) Staff trained in reprocessing practices and yearly competency testing.

Where do we need to be?Where do we need to be?

Where we need to be cont’dWhere we need to be cont’d d. Proper decontamination of instruments;

Performed in a separate room/environment

by people who are properly attired with PPE

(personal protective equipment). CSA Z314.8

e. Load documentation & monitoring system is

in place.

f. All flashed items tracked to the patient .

Measures to Avoid Flash Measures to Avoid Flash SterilizationSterilizationMeasure to avoid flash sterilization:Measure to avoid flash sterilization:maintenance of adequate inventories of medical maintenance of adequate inventories of medical

devices;devices;coordinating device reprocessing with surgical coordinating device reprocessing with surgical

schedules so that properly processed devices are schedules so that properly processed devices are available when needed;available when needed;

adherence to policies and procedures for loaned and adherence to policies and procedures for loaned and shared instrumentation (see Z314.22) so that devices shared instrumentation (see Z314.22) so that devices arrive in time for proper reprocessing; andarrive in time for proper reprocessing; and

education of medical staff and materials managers in education of medical staff and materials managers in the risks associated with flash sterilization the risks associated with flash sterilization

• Computerized booking systems that cannot be Computerized booking systems that cannot be converted to override inventory. converted to override inventory.

Why not Flash Sterilize?Why not Flash Sterilize?• SSterilization process itself can be similar to sterilization process terilization process itself can be similar to sterilization process

performed in reprocessing department but the lack of pre- and performed in reprocessing department but the lack of pre- and post- sterilization precautions introduces additional risks to the post- sterilization precautions introduces additional risks to the use of flashed devices. use of flashed devices.

• The facility has a responsibility to ensure that every patient The facility has a responsibility to ensure that every patient receives the same level of care; therefore should endeavour to receives the same level of care; therefore should endeavour to avoid the additional risks to patient safety associated with flash avoid the additional risks to patient safety associated with flash sterilization.sterilization.

• Remember that flash sterilizers are only validated for 1-2 Remember that flash sterilizers are only validated for 1-2 instruments, and should only be used for life and death situations instruments, and should only be used for life and death situations or loss of limb not routine for scheduling and lack of or loss of limb not routine for scheduling and lack of instrumentation. instrumentation.

CSA Standard Z314.3 “Flash sterilization shall not be used onCSA Standard Z314.3 “Flash sterilization shall not be used on

complete sets or trays of instruments.”complete sets or trays of instruments.”

What can be done to change?What can be done to change?

Develop policies based on CSA standards that bothDevelop policies based on CSA standards that both

SPD and OR staff could follow and live with!SPD and OR staff could follow and live with!

How do we do that?How do we do that?Research the CSA documents which are best practices in Research the CSA documents which are best practices in

reprocessing reprocessing Invite an expert to speak to the Peri-operative Policy and Invite an expert to speak to the Peri-operative Policy and

Procedure Committee about the CSA Standards. Procedure Committee about the CSA Standards.

ORNAC Standards are based on CSAORNAC Standards are based on CSA..

CSA Standards and ORNACCSA Standards and ORNAC

Are they mandatory?Are they mandatory?

Why are they written if hospitals can’t follow? Why are they written if hospitals can’t follow? Why write a policy based on CSA Standard Why write a policy based on CSA Standard that can’t be upheld due to resources that can’t be upheld due to resources available?available?

Do we bend the Standard to fit resources of the Do we bend the Standard to fit resources of the hospital?hospital?

Lots of great questions!Lots of great questions!

What can be done to change What can be done to change practices?practices?

Develop policies AND…..Develop policies AND….. Standardize practices throughout Canada for OR Standardize practices throughout Canada for OR

& SPD& SPD Identify staff competenciesIdentify staff competencies Develop an education planDevelop an education plan Decrease flash sterilization Decrease flash sterilization Share our resources Share our resources Be a leader!Be a leader! Provide every patient with the same level of careProvide every patient with the same level of care

Policies and ProceduresPolicies and ProceduresThe requirements for policies, procedures, documentation and The requirements for policies, procedures, documentation and

qualityquality

system are required.system are required.

If a flash sterilized medical device is used in a procedure, an incidentIf a flash sterilized medical device is used in a procedure, an incident

report shall be created that includes the following information:report shall be created that includes the following information: patient’s namepatient’s name physician’s namephysician’s name date and time the of procedure using the flash sterilized device date and time the of procedure using the flash sterilized device procedure it was used forprocedure it was used for reason that flash sterilization was neededreason that flash sterilization was needed results of physical monitoring and biological / chemical indicator results of physical monitoring and biological / chemical indicator

monitoring of the sterilizer and load.monitoring of the sterilizer and load.

• Periodic review incident reports to help identify ways to reduce the Periodic review incident reports to help identify ways to reduce the need for flash sterilization.need for flash sterilization.

Policies Policies Flash sterilization process is composed of several phases thatFlash sterilization process is composed of several phases that

are critical to achieving and maintaining sterility. are critical to achieving and maintaining sterility.

These phases include:These phases include:

a)a) transport of contaminated devices to decontamination transport of contaminated devices to decontamination areaarea

b)b) disassembly and decontaminationdisassembly and decontamination

c)c) preparationpreparation

d)d) loading the sterilizerloading the sterilizer

e)e) sterilization proceduressterilization procedures

f)f) monitoring and recording of cycle parametersmonitoring and recording of cycle parameters

g)g) unloading and aseptic transfer of items to the sterile unloading and aseptic transfer of items to the sterile field.field.

Personnel RequirementsPersonnel Requirements1. All aspects of emergency steam sterilization require 1. All aspects of emergency steam sterilization require supervised staff that are knowledgeable, trainedsupervised staff that are knowledgeable, trained personnel wearing appropriate attire, including personalpersonnel wearing appropriate attire, including personal protective equipment.protective equipment.

2. Personnel must have demonstrated expertise in 2. Personnel must have demonstrated expertise in medicalmedical

device reprocessing and in the use and application of device reprocessing and in the use and application of thethe

steam sterilization process.steam sterilization process.

3. Control of bio burden and containment of contaminants 3. Control of bio burden and containment of contaminants are essential to the sterilization process. are essential to the sterilization process.

Personnel Requirements Personnel Requirements 4. The health care facility administration to ensure that 4. The health care facility administration to ensure that

operators of all steam sterilizers used for flash operators of all steam sterilizers used for flash sterilization in the facility are trained.sterilization in the facility are trained.

5. Education documented with ongoing competency in 5. Education documented with ongoing competency in the operation of steam sterilizers.the operation of steam sterilizers.

6. Staff are aware of the hazards associated with steam 6. Staff are aware of the hazards associated with steam sterilizers.sterilizers.

7. Monitoring and maintenance of sterilizers required. 7. Monitoring and maintenance of sterilizers required.

Flash Sterilization PersonnelFlash Sterilization Personnel• Flash sterilization personnel must be responsible for Flash sterilization personnel must be responsible for verifying verifying

exposure time and temperature, and for aseptically exposure time and temperature, and for aseptically transferring the sterilized items to the point of use. transferring the sterilized items to the point of use.

• Personnel engaged in the processing of items for flash Personnel engaged in the processing of items for flash sterilization require an initial orientation and on-the-job sterilization require an initial orientation and on-the-job training, including instruction in the following;training, including instruction in the following;

a) sterilizer operation and monitoring (sterility assurance)a) sterilizer operation and monitoring (sterility assurance) b) the parameters of steam sterilizationb) the parameters of steam sterilization c) basic microbiological principlesc) basic microbiological principles d) the health care facility's infection control and prevention d) the health care facility's infection control and prevention policies and procedurespolicies and procedures e) decontamination of medical devices e) decontamination of medical devices

Flash Sterilization PersonnelFlash Sterilization Personnel f) monitoring of sterilizationf) monitoring of sterilization

g) preparation of the incident report g) preparation of the incident report

h) action to be taken if there is a failure during reprocessingh) action to be taken if there is a failure during reprocessing

i) unloading and transfer to the sterile field.i) unloading and transfer to the sterile field.

The facility shall assign specific responsibility to a The facility shall assign specific responsibility to a staffstaff

member or position for the maintenance of quality member or position for the maintenance of quality systemsystem

documentation relating to flash sterilization, includingdocumentation relating to flash sterilization, including

documentation of staff training, and the collection, documentation of staff training, and the collection, reviewreview

and retention of flash sterilization incident reports. and retention of flash sterilization incident reports.

Work Area for Flash SterilizationWork Area for Flash Sterilization • The steam sterilizer used for flash sterilization shall be The steam sterilizer used for flash sterilization shall be located in a restricted-access area immediately adjacent to located in a restricted-access area immediately adjacent to

the area where the sterilized items will be used in patient care. the area where the sterilized items will be used in patient care.

• The sterilizer shall not be located in the operating room The sterilizer shall not be located in the operating room theatre, and shall not be near any potential source of theatre, and shall not be near any potential source of contamination, such as sinks, hoppers, linen, or trash disposal contamination, such as sinks, hoppers, linen, or trash disposal areas. areas.

• Sterile storage shall not be located immediately adjacent toSterile storage shall not be located immediately adjacent to the sterilizer used for flash sterilization. the sterilizer used for flash sterilization.

• Flash sterilization must be carried out in a clean environment.Flash sterilization must be carried out in a clean environment.

• Devices processed by this method must be transferred and Devices processed by this method must be transferred and handled as little as possible as may not be protected by handled as little as possible as may not be protected by packaging before or immediately after the sterilization packaging before or immediately after the sterilization process.process.

Work Area Work Area • At least one flash sterilizer in the OR suite shall be on the At least one flash sterilizer in the OR suite shall be on the

emergency power system. emergency power system.

• The facility shall have written validation from the sterilizer The facility shall have written validation from the sterilizer manufacturer that it is suitable for flash sterilization and manufacturer that it is suitable for flash sterilization and specifying the size of loads for which it has been validated.specifying the size of loads for which it has been validated.

• All instruments shall be cleaned and decontaminated prior to All instruments shall be cleaned and decontaminated prior to sterilization by trained staff wearing appropriate PPE. Refer sterilization by trained staff wearing appropriate PPE. Refer to Z314.8. Saline shall not be used. Before they are to Z314.8. Saline shall not be used. Before they are cleaned, general operating instruments shall be separated cleaned, general operating instruments shall be separated from delicate instruments or devices requiring special from delicate instruments or devices requiring special handling. handling.

Work Area Decontame Work Area Decontame

• Soiled items shall be contained during the transport Soiled items shall be contained during the transport from the point of use to the decontamination area. from the point of use to the decontamination area.

• They shall be cleaned immediately. They shall be cleaned immediately.

• Gloves and appropriate PPE shall be worn when Gloves and appropriate PPE shall be worn when handling soiled items. handling soiled items.

• Containment may be accomplished by any means Containment may be accomplished by any means that adequately prevents inadvertent personnel that adequately prevents inadvertent personnel contact with or exposure to the soiled items during contact with or exposure to the soiled items during the transfer.the transfer.

• Reusable transportation containers shall be cleaned Reusable transportation containers shall be cleaned and decontaminated after each use.and decontaminated after each use.

Sterilization Sterilization • High-temperature saturated steam must come into High-temperature saturated steam must come into

direct contact with all surfaces of all items. direct contact with all surfaces of all items. • Air removal, steam contact, and drainage of condensate Air removal, steam contact, and drainage of condensate

are enhanced by proper positioning and by the use of are enhanced by proper positioning and by the use of perforated or mesh bottom trays. Items to be sterilized perforated or mesh bottom trays. Items to be sterilized may be placed inmay be placed in

(a) protective organizing cases(a) protective organizing cases (b) open trays(b) open trays (c) rigid sterilization container systems (c) rigid sterilization container systems (d) single wrapped trays(d) single wrapped traysClosed container system is preferred, to minimize the Closed container system is preferred, to minimize the

chance chance of contamination occurring between sterilizer and patient.of contamination occurring between sterilizer and patient.

STERILIZATIONSTERILIZATION The health care facility shall follow the device manufacturer’s The health care facility shall follow the device manufacturer’s

instructions, including those forinstructions, including those for

time and temperaturetime and temperature load size (including any necessary adjustments to time or load size (including any necessary adjustments to time or

temperature with relation to load size)temperature with relation to load size) maximum loads (by weight or by number of instruments)maximum loads (by weight or by number of instruments) load configurationload configuration Each flash sterilization cycle shall be verified by the health care Each flash sterilization cycle shall be verified by the health care

facility through actual testing of loads configured as specified facility through actual testing of loads configured as specified in the manufacturer’s instructions. in the manufacturer’s instructions.

SterilizationSterilization

If flashing will occur for life, limb or organ emergency disaster If flashing will occur for life, limb or organ emergency disaster then then

after cleaning, items shall be placed in a perforated or mesh after cleaning, items shall be placed in a perforated or mesh bottom bottom

instrument tray and arranged in the following manner:instrument tray and arranged in the following manner:

(a) instruments and devices with concave surfaces shall be (a) instruments and devices with concave surfaces shall be positioned with the open side down;positioned with the open side down;

(b) all hinged instruments shall be opened, without engaging the (b) all hinged instruments shall be opened, without engaging the ratchet, and shall be placed on racks or stringers as needed;ratchet, and shall be placed on racks or stringers as needed;

(c) items with easily removable parts shall be disassembled;(c) items with easily removable parts shall be disassembled;(e) for complex instruments (e.g., air-powered instruments), the (e) for complex instruments (e.g., air-powered instruments), the

instructions of the device manufacturer shall be followed;instructions of the device manufacturer shall be followed; (f) l(f) lumens of tubing, suction devices, and needles shall be umens of tubing, suction devices, and needles shall be

moistened with pyrogen-free water immediately prior to moistened with pyrogen-free water immediately prior to steam sterilization. steam sterilization.

Do Health Care facilities meet these Do Health Care facilities meet these requirements?requirements?

Auditing of healthcare facilities across the nation will show that Auditing of healthcare facilities across the nation will show that mostmost

do not meet these requirements.do not meet these requirements.

Most:Most:

a)a) Wash instruments in scrub sinks or small sink in between OR Wash instruments in scrub sinks or small sink in between OR theatres. theatres.

b)b) Decontame areas not under negative pressure Z314.8Decontame areas not under negative pressure Z314.8

c)c) Maintenance on these sterilizers not done, sterilizers not Maintenance on these sterilizers not done, sterilizers not cleaned, records not kept. Some so old should be replaced. cleaned, records not kept. Some so old should be replaced.

d)d) Staff not trained to reprocess and do not have competency Staff not trained to reprocess and do not have competency testing or required education. testing or required education.

It goes on and on!It goes on and on!

Acrobat Document

Notice from Ministry Ontario of Notice from Ministry Ontario of Health re Flash SterilizationHealth re Flash Sterilization

Do you meet all these requirements?Do you meet all these requirements?

IF NOT YOUR FACILITY NEEDS IF NOT YOUR FACILITY NEEDS

TO TAKE ON A PROJECT TO TO TAKE ON A PROJECT TO

IMPROVE PROCESSIMPROVE PROCESS!!

Implement to improve patient care!Implement to improve patient care!

Set up a Quality Improvement ProjectSet up a Quality Improvement Project Joint Quality Assurance/Accreditation Project –Joint Quality Assurance/Accreditation Project – Sterile Processing Department and Surgical SuitesSterile Processing Department and Surgical Suites

Called The “Flash” Project.Called The “Flash” Project.

Must have buy in from all parties!Must have buy in from all parties! Why do it? Best Practices are provided in the CSA Why do it? Best Practices are provided in the CSA

standards and every facility should be aiming for these standards and every facility should be aiming for these practices.practices.

Accreditation will now be examining flashing practices Accreditation will now be examining flashing practices as a part of their review. as a part of their review.

Reprocessing Reprocessing Challenges!Challenges!

• I have touched on a few challenges but I have touched on a few challenges but there are many more. there are many more.

• Reprocessing is complex, always Reprocessing is complex, always changing, and a very demanding changing, and a very demanding profession! profession!

• It requires ongoing education, and It requires ongoing education, and knowledge that is current.knowledge that is current.

• Staff with critical thinking skills, Staff with critical thinking skills, knowledgeable is required.knowledgeable is required.

• Reprocessing staff must be the patient Reprocessing staff must be the patient advocates!advocates!

Change can be accomplished!Change can be accomplished!

• Working together for the betterment of the patient we Working together for the betterment of the patient we can all meet best practices in reprocessing as can all meet best practices in reprocessing as

• Remember!Remember!

You could be that patient having a surgical procedure and You could be that patient having a surgical procedure and

would you want a totally processed instrument or a would you want a totally processed instrument or a flashedflashed

one?one?

I know what I would want and so do you!I know what I would want and so do you!

Remember!Remember!

We never know when we will require treatment in the facility we work at!

Always advocate for all patients!

When any reprocessing staff or their family require care, we want to know that the instruments are the best quality and meet standards!

What Can We do?What Can We do?Raise the bar in reprocessing!Raise the bar in reprocessing!

Ensure all patient’s are not put at Ensure all patient’s are not put at risk during their hospital stayrisk during their hospital stay!!

PARTNERSHIP:

OPTIMAL PATIENT CARE REQUIRES WORKING

TOGETHER!

References:References: • AAMI ST 79 Comprehensive guide to steam AAMI ST 79 Comprehensive guide to steam

sterilization and sterility assurance in a health care sterilization and sterility assurance in a health care facilitiesfacilities

• AAMI TIR 31 Process Challenge devices/test packs for AAMI TIR 31 Process Challenge devices/test packs for use in health care facilitiesuse in health care facilities

• CSA Z314.3 Effective Sterilization in Health Care CSA Z314.3 Effective Sterilization in Health Care Facilities by the Steam Process Facilities by the Steam Process

• CSA Z314.8 Decontamination of Reusable Medical CSA Z314.8 Decontamination of Reusable Medical DevicesDevices

• CSA Z314.22 Management of Loaned, Shared and CSA Z314.22 Management of Loaned, Shared and Leased Medical Devices Leased Medical Devices

• Just Say No by Rose Seavey RN, MBA, CNOR, ACSPJust Say No by Rose Seavey RN, MBA, CNOR, ACSP

• Best Practices for Cleaning, Disinfection and Best Practices for Cleaning, Disinfection and Sterilization in Health Care Facilities Sterilization in Health Care Facilities

Let’s all provide every patient Let’s all provide every patient with the care that we all would with the care that we all would

like to receive!like to receive!

QuestionQuestions!s!