medical device reprocessing - mdrao.ca · mdr: out of the past—into the future • original plan...
TRANSCRIPT
Annual Conference September 8-10, 2013
Medical Device Reprocessing Out of the past—Into the future
Presented by : Barbara Bolding RN, BSN, MBA 09 September, 2013
Annual Conference September 8-10, 2013
MDR: Out of the past—into the future
• Original plan • Start with the current revolution in MDR
• Focus on the future of MDR
• Brief overview of the past
• What I found
• An amazing revolution in medical device reprocessing
• 1850-1900
• Origins of MDR as we know it • Science • Technology • Surgery
Annual Conference September 8-10, 2013
MDR: Out of the past
• Ancient times—before 500 CE (AD)
• Disinfection • Pitch, tars, aromatics (embalming)
• Moses—1450 BCE • Camp cleanliness—1st sanitary code • Fire for purification
• Greeks
• Hippocrates—460-377 BCE • Boiled water and medicated dressings for wound treatment
• Egyptians—300 BCE • Surgical instruments • Embalming and preserving
• Romans • Galen—130-200 CE • Boiled instruments when treating wounded Roman gladiators
Rome 2 CE
Aswan 300 BCE
Rome 2 CE
Annual Conference September 8-10, 2013
MDR: Out of the past
• Dark and Middle Ages—500s to 1300s CE
• Previous knowledge lost
• Academic surgeons, but few noteworthy contributions in the West
• Barber surgeons
• Amputations, dental extractions, setting fractures, blood letting
Annual Conference September 8-10, 2013
MDR: Out of the past
• Middle ages—1300 and 1400s
• Patient care was monastery based e.g.
• Hotel Dieu de Beaune 1443
• Hotel Dieu de Paris 1500
Ill patients on left Well patients on right
Annual Conference September 8-10, 2013
MDR: Out of the past
• Renaissance—1400s-1600s
• Plague 1350-1400 • PPE
• Denis Papin—1680
• “Digester” • Steam under pressure i.e. pressure cooker
• Antony van Leeuwenhoek—1683
• Microscope and microorganisms
http://archives.microbeworld.org/images/meetmicros/tools/tool_1_leuw-scope.jpg Perkins, JJ. Principles and methods of Sterilization 1956
Block, Seymour. Disinfection Sterilization and Preservation. Lippincott Williams & Wilkins. Philadelphia PA. 2001. p5.
Annual Conference September 8-10, 2013
MDR: Out of the past
• 1750-1850 Industrial Revolution
• Rise of large city-based hospitals to care for indigent poor
• Guys in London 1724
• Pennsylvania General in Philadelphia 1751
• Vienna General 1784
• Montreal General 1821
ard.bmj.com accessed 14 Oct 12
Vienna General Guys
collage.cityoflodon.gov.uk accessed 14 Oct 12
Annual Conference September 8-10, 2013
Medical Device Reprocessing: The 1st Revolution
Annual Conference September 8-10, 2013
MDR: The 1st revolution
• Mid to late 1800s
• End of the Industrial Revolution
• Modern concepts of sterilization linked to developments in
• Science—microbiology and chemistry
• Technology—pressure vessels, surgery
• Workplace—hospitals
• Extent and speed of change = Revolution
• Within 50 years
Annual Conference September 8-10, 2013
MDR: The 1st revolution SCIENCE
• 1840s—General anaesthetics for pain control • Nitrous Oxide 1842 • Ether 1842 (1846 demo of painless surgery at Mass. General) • Chloroform 1847
• 1862—Louis Pasteur • Germs cause disease • Heat kills germs
• 1867—Joseph Lister • Carbolic acid disinfects
• On fomites, incisions, hands of OR team • 1st antiseptic surgery • Reduced Berlin General Hospital infection rates from 90% to 15%
• 1881—Robert Koch
• 4 postulates relate microorganisms to disease • Pasteur’s contemporary and competitor
• Moist heat kills microorganisms better than dry heat
images.wellcome.ac.uk accessed 14 Oct 12
Annual Conference September 8-10, 2013
MDR: The 1st revolution
TECHNOLOGY • 1838—Codman instrument company
• 1876—Charles Chamberland
• Protégé of Pasteur
• Modernized Papin’s “Digester” for sterilization
• Pressure steam sterilizer (temp to 120 C)
• Rack in the chamber holds items above the water
Papin 1680**
Chamberland*
* Perkins, JJ. Principles and Methods of Sterilization… 1956
Annual Conference September 8-10, 2013
MDR: The 1st revolution
WORKPLACE
SURGERY AND HOSPITALS
• 1820s—Operating Rooms appear in hospitals
• 1822 St. Thomas OR—London
• 1824 Massachusetts General OR—Boston
• Both with open amphitheatres
• Closed, once Semmelweis (1847) and Lister (1867) were accepted
The Ether Dome 1846 (Mass General)
St. Thomas
Annual Conference September 8-10, 2013
MDR: The 1st revolution
WORKPLACE
SURGERY AND HOSPITALS contd
• 1847—Ignaz Semmelweis • Handwashing reduces child-bed fever
• Compared wards of Physicians to Midwives • Used chlorinated lime
• Before Pasteur (1862)
• 1853-56—Crimean war—Florence Nightingale • Hospital sanitation
http://ldysinger.stjohnsem.edu/@themes/medicine/Semmelweis-mother.jpg
Annual Conference September 8-10, 2013
MDR: The 1st revolution
WORKPLACE
SURGERY AND HOSPITALS contd
• 1881—Koch—applied disinfecting properties of hot air, hot water and steam to OR
• 1885—Ernst von Bergmann—steam sterilization of surgical instruments & dressings
• 1889—William Halstead (and Goodyear)
• Surgical gloves
• Halstead (mosquito) forcep
von Bergman
von Bergman
Annual Conference September 8-10, 2013
MDR: The 1st revolution
SCIENCE
• Advances in surgery by late 1800s • Control pain • Reduce infection
• Types of surgeries expand
• New instrument designs required • Surgical instruments redesigned to withstand sterilization
• i.e. simple, steel, disassemble-able
Halstead mosquito
Nicolas Senn ~ 1885
Annual Conference September 8-10, 2013
MDR: The 1st revolution
TECHNOLOGY
• 1883—Radial, locking-arm door on sterilizer • Steam tight • Easy lock
• 1890—1st hospital steam sterilizer
• Rochester City Hosp • Sprague-Schulyer (later AMSCO) • Thermometer but no temp control • For dressings
• 1892—Hospital steam sterilizer at Roosevelt Hospital NYC
• Sprague-Schulyer • With pressure gauges and thermometer • For water, dressings and instruments
* Perkins, JJ. Principles and Methods of Sterilization… 1956
*
*
*
Chamberland 1876
Annual Conference September 8-10, 2013
MDR: The 1st revolution
Year Event
1820s ORs appear in hospitals
1838 Codman instrument company
1840s General anesthetics
1847 Handwashing—Ignaz Semmelweis
1853 Hospital sanitation in Crimea War—Florence Nightingale
1862 Germ theory—Louis Pasteur
1867 Carbolic acid as surgical disinfectant—Joseph Lister
1876 Modernized the “Digester”—Charles Chamberland
1881 Hot air, hot water, steam as disinfectants—Robert Koch
1883 Radial-arm sterilizer door
1885 Steam sterilized surgical dressings—Ernst von Bergman
1889 Surgical gloves—William Halstead (and Goodyear)
1890 1st hospital steam sterilizer—Sprague-Schuyler (later AMSCO)
Late 1890s Surgical instrument redesign
GA & Instruments
Infection Prevention
Sterilization
Annual Conference September 8-10, 2013
Medical Device Reprocessing in the 20th Century
Annual Conference September 8-10, 2013
MDR in the 20th century
TECHNOLOGY 1900s to 1930s
• 1885—early 1900s • Germany-many notable contributions re: steam
sterilization, chemical disinfection. • e.g. importance of saturated steam and air removal,
• Early 1900s
• Aesculap—rigid stainless steel and chrome plated sterilization drums with valves and vents.
• Filters and rubber gaskets introduced in 1930s. • Aluminum replaces SS in the 1960s
• No widespread application in North America until early 1930s
• 1933—AMSCO and Castle • Temperature controlled steam sterilizers
• Earlier models were controlled by pressure
Perkins, JJ. Principles and Methods of Sterilization… 1956
Annual Conference September 8-10, 2013
MDR in the 20th century
WORKPLACE Up to 1930s • Reprocessing occurred in ORs
• Viewed as sterilization experts • Largest users of sterile supplies • Often produced sterile goods for entire hosp
• Rubber goods—gloves, catheters, tubings • Drapes and gowns • Gauze dressings • Glass syringes • Needles • Sutures • Instruments • Drugs • Solutions
• Sterilizers initially located in theatres
• As ORs became busier, sterilizers relocated to OR workrooms,
• Still supervised by OR nurses
Annual Conference September 8-10, 2013
MDR in the 20th century
WORKPLACE—St. Paul’s (Vancouver) reprocessing area 1910
Annual Conference September 8-10, 2013
MDR in the 20th century
• 1st CSRs (Central Sterilization Rooms) probably around 1920 • Product of
• Expanded OR workrooms • Military practices in WW1?
• Centralization for:
• Efficiency • Reduce duplication of equipment, supplies and effort
• Sharing limited resources • Steam sterilizers • Sets and trays
• Standardization • Product • Practices
• American College of Surgeons (Oct 1928)
• “Survey and Study of Surgical Dressings and Materials” • Recommended standards for dressings
Annual Conference September 8-10, 2013
MDR in the 20th century
• Earliest reference to CSR—1937*
• Preface indicates CSR concept had been around for about 20 years
• Scope of CSR services varied, depending on the facility
• Surgical supplies—gowns, gloves ,needles, sutures, drapes • All sterile supplies—OB forceps, rubber goods e.g. catheters, gloves • Sterile treatment trays • Blood collection and storage • IV and irrigating solutions • Infrequently used equipment—O2 tent, atomizers, crib sides, isolation equipment
• CSR nurse might accompany complex or emergency trays, and assist physician
• e.g. Gastric decompression, IV Therapy, spinal puncture
ACCESSED 18 SEPT 2012
Annual Conference September 8-10, 2013
MDR in the 20th century
• St. Paul’s (Vancouver) CSR 1940s
Annual Conference September 8-10, 2013
MDR in the 20th century
• SPH 1960s
Annual Conference September 8-10, 2013
MDR in the 20th century
• 1950s to 1990s
• Early 1950s— Ethylene Oxide sterilization used by hospitals
• 1956—Principles and Methods of Sterilization… by J.J. Perkins • Set the current standards and methods for reprocessing medical devices
• 1959—Prevacuum air removal sterilizer
• 1963—Glutarladehyde (Cidex®) approved as a liquid chemical sterilant by EPA
• 1969—Pulsing vacuum air removal sterilizer
• 1987—Blood and body fluid precautions (Harborview Medical Center, Seattle)
• 1989—Steris System 1®—liquid peracetic immersion
• 1991—Sterrad®—Hydrogen Peroxide vapour
Annual Conference September 8-10, 2013
Medical Device Reprocessing: The 2nd Revolution
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• Lots of the changes in MDR
• Equipment, products, instruments and sets
• In the past year
• Past 5 years
• Since you began your career
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• Examples of changes in MDR
• Minimally Invasive Surgery
• Instrument design
• Procedure relocation from OR to Diagnostic Imaging, cath labs, outpatients
• Chemical / low temperature sterilization methods
• Elimination of outdates
• Emphasis on competency through training and education
• Audits
• Centralization
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• Biggest and fastest change?
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• Biggest and fastest change?
• FOCUS ON PATIENT SAFETY
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• Clear to all that ensuring Patient Safety is our job
• Patients
• Health care administrators and executives
• Staff—inside and outside MDRD
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• What does Patient Safety mean in MDR?
• Reducing a patient’s risk for infection
• How do we do that?
• Strive to meet Best Practices / Standards
• Develop specific MDR Quality Systems to show that standards are being met
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• A word about “Quality Systems”
• Lots of names
• Quality assurance—QA
• Quality improvement—Q I
• Quality management system—QMS
• Substitute SAFETY for Quality
• A Quality System encompasses all the things we do to keep patients safe.
Annual Conference September 8-10, 2013
MDR: The 2nd Revolution
• In MDR, how do we keep patients safe?
1. Staff—capable
2. Work space, equipment and supplies
3. Work instructions—comprehensive, documented, based on Standards
4. Process monitoring at critical points e.g. • Cleaning • Sterilization • Minimum effective concentration (MEC) of high level disinfectants (HLD)
5. Regular checks (e.g. supervision, audits) to see that • Procedures are being followed • Monitoring / testing results are within normal limits
6. Feedback and corrective action if things are not as they should be
7. Documentation of each part of the process
• Components of a “Quality System” by any name
Annual Conference September 8-10, 2013
MDR: Into the future
• What does all of this mean for MDRTs and MDR in the future?
• Don’t know the future, but we can predict trends:
• Technical knowledge
• Device and equipment complexity
• Computerization
• Safety and Quality assurance
• Centralization
• Responsibility and Professionalism
• View trends in terms of patient safety
Annual Conference September 8-10, 2013
MDR: Into the future
1. Technical knowledge • MDR is no longer just about steam sterilization
• Technical knowledge of reprocessing now includes: • Chemicals
• Cleaning • Disinfecting
• Water quality
• Sophisticated monitoring techniques • Sterilization chemical indicators • Cleaning efficacy • Minimum effective concentration of disinfectants
• Trouble shooting • Wet packs • Failed processes (e.g. positive BI)
Annual Conference September 8-10, 2013
MDR: Into the future
1. Technical knowledge of reprocessing contd.
• What does this mean for you and for patient safety?
• Standardized, comprehensive training for entry to practice
• Continual updating of knowledge and skills • Stay current
• Certification to confirm both
• CMDRT (CSA)
• Problem solving, critical thinking • Can’t predict every problem • Have to know the science and theory
• Start now
• Attend conferences and take back what you learn • Research studies and results • Standards and best practices
Annual Conference September 8-10, 2013
MDR: Into the future
2. Device and equipment complexity
• Reprocessing equipment
• e.g. sterilizers, washer disinfectors
• Single items, sets
• Difficult/impossible to clean
• Materials compatibility
• More reprocessing time required
www.intuitivesurgical.com
Annual Conference September 8-10, 2013
MDR: Into the future
2. Device and equipment complexity contd.
• What does this mean for you and for patient safety?
• Careful attention to manufacturers’ IFUs • Incorporated into work instructions
• Inservice and training from device and equipment vendors
• Need to ensure you get what you need to be safe
• Personal responsibility
• If you’re not sure, ASK
• Document reprocessing time esp. in Decontam
Annual Conference September 8-10, 2013
MDR: Into the future
3. Computerization
• Of equipment • On-board computers for complex equipment
• Newer equipment already there • e.g. washer-disinfectors, sterilizers
• Of information systems
• MDRD one of the last areas to computerize
• Item location (tracking) • Work instructions • Product labels • Monitoring / testing results for QA • Activity reports e.g. set utilization
• Tablets/iPads?
• Apps? • For information, problem solving?
From SPMs website Feb 07
Annual Conference September 8-10, 2013
MDR: Into the future
3. Computerization contd
• What does this mean for you and for patient safety?
• Continuous learning
• Potential changes
• Department practices
• Work flow
• Job duties
• Work schedules
Annual Conference September 8-10, 2013
MDR: Into the future
4. Centralization • Within a site (from numerous patient care areas)
• Within a region (from small volume, small centres)
• Reduces duplication, decreases fixed costs (e.g. sterilizers, washer disinfectors, IMS) • Automation
• Computerization
• Improves quality • Expertise and specialization/focus
• Best practices
• Decreases risk of failure and potential liability
• As hospitals focus on patient care, support services could be provided by a third party
Annual Conference September 8-10, 2013
MDR: Into the future
4. Centralization contd.
• What does this mean for you and for patient safety?
• Career planning, look ahead
• Possible specialization e.g. • Flexible endoscope reprocessing • OR instruments
• Skills to work with mechanization, automation, computerization
Annual Conference September 8-10, 2013
MDR: Into the future
5. Quality (safety) Assurance
• Can’t test the final MDR products (e.g. sterility of an instrument set)
• Focus on control of processes at every stage of MDR
• Trained staff—documented • Manufacturers’ Instructions For Use (MIFUs) followed
• Device • Equipment
• Work instructions—documented • Regular process audits—documented
• Documented verification testing where possible e.g.
• BI results • Cleaning efficacy • In-house product qualification testing for sterilization
• Trays • Sterilizer loads
Annual Conference September 8-10, 2013
MDR: Into the future
5. Quality (safety) Assurance contd
• What does this mean for you and for patient safety?
• Responsible for following written procedures • Ensure they are available
• Expect regular process audits
• It’s not you, its patient safety
• Monitor processes whenever possible • Measure, test, check displays • Know what you’re doing
• Expected result • What to do with an unexpected result
• Document all activities
• Make the time for it
Annual Conference September 8-10, 2013
MDR: Into the future
6. Responsibility
• Expectation by public and by employers that MDRTs will:
• Be “answerable/accountable for actions within their control”
• Specified in job description and /or job duties e.g.
TYPICAL DUTIES AND RESPONSIBILITIES:*
In accordance with the principles of infection control, decontamination, sterilization, and aseptic technique, and established policies, procedures and safety standards: Receives, sorts, disassembles, cleans, decontaminates, sterilizes, assembles, wraps and reassembles all medical devices, trays, carts, supplies and equipment related to the Operating Room (OR) and/or other areas of the hospital; *CSA PUBLIC REVIEW 2012-08-28 Z314-MDR DRAFT 3
Annual Conference September 8-10, 2013
MDR: Into the future
6. Responsibility contd
• What does this mean for you and for patient safety?
• You need to ensure that you have appropriate knowledge, skills and abilities to ensure safe outcomes • Identify your gaps • Act to fill them
• Requires an active response • Can’t wait for others e.g. employer, to do it for you (passive) • May include:
• Asking for clarification or explanation • Seeking certification • Participating in Inservice • Further education and training • Supervised practice
• Part of professionalism…
Annual Conference September 8-10, 2013
MDR: Into the future
7. Developing professionalism
• Five characteristics of a profession:
• Specialized knowledge and training
• Mandatory examination for licensure
• Code of ethics includes individual responsibility, obligation to the public
• Regulated by statute
• Authority delegated to a regulatory body/association
Annual Conference September 8-10, 2013
MDR: Into the future
7. Developing professionalism contd.
Characteristics of a profession What does this mean for you?
Specialized knowledge and training • Attend and/or support College programs
• Participate in continuing education
Examination for licensure • Obtain certification e.g. CSA
• Encourage others
Code of ethics includes responsibility • Develop a “responsible” mind-set
Regulated by statute • Monitor activity in the US e.g. New Jersey (2004), IAHCSMM
Authority delegated to an association • Become involved in local, provincial and/or national reprocessing association formation and development
• Use association to lobby for change
Annual Conference September 8-10, 2013
MDR: Into the future
• Current revolution and future directions
• Technical knowledge
• Device and equipment complexity
• Computerization
• Centralization
• Safety and Quality assurance
• Responsibility and Professionalism
• Focus on PATIENT SAFETY
Annual Conference September 8-10, 2013
MDR: Into the future
• Look where we’ve come from
• Since medical devices were first reused, MDR has been changing
• We’re in the midst of another revolution in MDR
• Science, technology, and workplace
• Perceptions and attitudes
• Happening quickly
• Scope and speed • Can be overwhelming
• Can also be exhilarating
• There’s no going back
Annual Conference September 8-10, 2013
MDR: Into the future
• Maybe we can’t go back
• But we can choose how to respond
• Future will be:
• Changing
• Challenging
• Exciting
Annual Conference September 8-10, 2013
• It’s a great time to be in medical device reprocessing Thanks Barbara Bolding
MDR: Into the future
Annual Conference September 8-10, 2013
MDR in the 20th century
• 1950s to 1990s
• Early 1950s—Ethylene Oxide sterilization used by hospitals
• Previously
• McCormick sterilized spices
• Libraries fumigated books (killed silverfish)
• Device sterilization arose from germ warfare science in WW II
• Fort Detrick—Dr. Charles Phillips
• ETO to sterilize delicate germ warfare lab equipment
Annual Conference September 8-10, 2013
MDR in the 20th century
• Manual ETO sterilization
• When 12 hours have passed, remove the packages and ventilate them.
• Items used on the human body must be ventilated for 72 hours.
• Discard the bags and empty ampoule in the ordinary rubbish...