CLEANINGReusable Medical

Devices AAMI/FDA Medical Device Reprocessing Summit

October 11 -12, 2011 · Silver Spring, MD

“CLEAN”is defined several ways in the dictionary, one being…

“Free from contamination or disease”

While this definition fits well with how we in health care define cleaning reusable medical devices, there are many factors and challenges regarding “how to clean” and “how to verify” the cleaning process.

AAMI TIR30 defines cleaning as. . .

“Removal of contamination from an item to the extent necessary for further processing or for the intended use.”

AAMI TIR30 defines decontamination as. . .

“the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.”

AAMI ST79 defines cleaning as. . .

“Removal of contamination from an item to the extent necessary for further processing or for the intended use.”

AAMI ST79 defines cleaning as. . .

“In health care facilities, cleaning consists of the removal, usually with detergent and water, of adherent organic and inorganic soil (e.g. blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.”

AAMI ST79 Section 7 Cleaning and other Decontamination processes

“The written instructions of the device manufacturer should always be followed.”

AORN Perioperative Standards and Recommended Practices

“The manufacturer’s written instructions should be used to determine how to replicatethe validated cleaning and processing methods.”

It is best practice for health care facilities to have all of the manufacturer’s IFU and to place them inthe locations where they are readily accessible to those needing access, and to keep them updated.

MFG’s Instructions For Use

Herein lies a potential “patient safety concern” as not all HCFs have the MFG’s IFU for reprocessing all their reusable medical devices.

Many HCFs use (and prefer to use) a standardized cleaning procedure to keep up with the work load. While this is effective in cleaning visible soil, it may not be effective in cleaning non-visible soil,especially from complex devices.

Patient Safety Concern

EXAMPLE A - MFG’s Cleaning IFUOrthopedic Instruments

1. Submerge in enzymatic detergent.2. Flush port with 50 ml enzymatic detergent.3. Soak for 10 min in protein soluble detergent.4. Scrub with a soft bristled brush (agitate instrument

while scrubbing).5. Rinse with warm tap water (38-49 C)6. Flush port with 50 ml warm tap water.7. Place in bath of warm water (agitate by hand for at least

1 min). Repeat this process 2 additional times.

8. Ultrasonic for 10 min with neutral pH detergent (flush port with 50 ml prepared detergent before sonication).

9. Flush port with clean tap water (3 times).10. Rinse for at least 1 min with tap water.11. Dry with clean, lint free cloth.12. Inspect.13. Lubricate tip mechanism and

finger slot (do not lubricate flush port).

40 minutes?

EXAMPLE A - MFG’s Cleaning IFUOrthopedic Instruments

EXAMPLE B - MFG’s Cleaning IFUOrthopedic Instruments

1. Completely submerge instruments in enzyme solution and allow to soak for 20 min.

2. Rinse in tap water for minimum of 3 min.3. Ultrasonic clean for 10 min.4. Rinse in purified water for at least 3 min.5. Repeat sonication and rinse steps.6. Remove excess moisture from the instrument with

a clean, absorbent and non-shedding wipe.

50 minutes?

EXAMPLE C - MFG’s Cleaning IFUBiopsy Needle

1. Submerge in neutral pH enzyme solution for at least 20 min and flush vigorously.

2. Rinse under running warm water.3. Clean with a stiff nylon brush in neutral pH detergent.4. Rinse under running water. Vigorously flush under

pressure all lumens, holes and other areas.5. Disassemble devices.6. Ultrasonic for minimum of 10 min w/equipment

manufacturer’s detergent.

EXAMPLE C - MFG’s Cleaning IFUBiopsy Needle

7. Vigorously rinse with warm running water. Flush parts under pressure.

8. Perform second sonication for 10 minutes.9. Inspect.10. Vigorously rinse with deionized water. Flush lumens,

holes and other parts with deionized water under pressure.

60 minutes?

Lack of ResourcesThere is a concern that many HCFs do not have the resources to comply with complex reprocessing IFU. Simply stated; the physical space, environmental controls, turnaround time, skilled personnel and equipment requirements, are not always in place, not always understood, and often not appreciated.

Not all have ultrasonic cleaners.

Many, do not test them.

For example, many HCFs do not know which or how many of their devices require ultrasonic cleaning?

Survey organizations; such as, TJC, CMS and AAAHC should provide stricter audits of health care facilities for compliance with MFG’s reprocessing IFU.

Survey Organizations

June 15, 2009 - Update on The Joint Commission's PositionBased on discussions with experts in the field, professional organizations, and government organizations, The Joint Commission has decided to refocus its survey efforts on all of the critical processes included in sterilization.

If a complete and effective process of sterilization is used, it will be considered an effective sterilization method.Therefore, surveyors will review the critical steps of disinfection and sterilization to determine if the process is appropriate.

And, now they are!

Here is a brief overview of the 3 critical steps of reprocessing:1. Cleaning and decontamination. All visible soil must be

removed prior to sterilization because steam and other sterilants cannot penetrate soil, particularly organic matter. Manufacturers’ instructions are available for all instruments; these include directions for the cleaning and decontamination process. Some smooth metal instruments may be easily brushed clean, while complex products may require disassembly and special cleaning techniques. Many manufacturers specify that an enzymatic soak be used as well.

2. Sterilization. Most sterilization is accomplished via steam, but other methods are also available. Steam sterilization of all types, including flashing, must meet parameters (time, temperature and pressure) specified by both the manufacturer of the sterilizer, the maker of any wrapping or packaging, and the manufacturer of the surgical instrument. In addition to these instructions, physical, chemical and biological controls must be used as designed and directed by their manufacturers.

3. Storage or return to the sterile field. Each newly sterilized instrument must be carefully protected to ensure that it is not re-contaminated. For full steam sterilization cycles, packs of instruments are wrapped and sealed. Instruments subjected to steam sterilization using methods other than full cycle sterilization may be transported in “flash pans” or other devices specifically designed for the prevention of contamination during and after the steam process.

In summary, Joint Commission surveyors will focus on all of the critical steps and the integrity of the sterilization process.

The Centers for Medicare & Medicaid Services (CMS)has recently revised their Survey and Certificationdocument to include more stringent audits in the areasof infection control and sterilization.Areas of emphasis include:

• Compliance with nationally recognized standards/documents.• Formal training in areas of infection control and sterilization.• Compliant cleaning, sterilization and monitoring procedures.• Established criteria for flash sterilization.

Reference:CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009.

The Accreditation Association for Ambulatory Healthcare (AAAHC) added an infection control chapter to their standards handbook.

Infection control highlights included:

“Adhering to standards, guidelines, and manufacturer’s instructions for cleaning, disinfection, and sterilization of instruments, equipment, supplies, and implants.”

Reference:OR Manager Magazine, Volume 26, Number 2, 2010.

July 20, 2011 - Joint Commission OnlineFocus on sterilization and high-level disinfection processes

In an effort to ensure that patient safety is maximized, accredited organizations that perform sterilization or HLD are encouraged to review their processes in detail.

Comparison of organizations policies and procedures with relevant guidelines will help organizations make sure that their processes are up-to-date.

July 20, 2011 - Joint Commission Online

Beginning in 2010, surveyors have spent additional time during surveys evaluating the cleaning, disinfection and sterilization processes.

Earlier this year, Joint Commission surveyors received in-depth training on sterilization processes. This education was provided in collaboration with AAMI and included a review of all aspects of the AAMI ST79 guideline on steam sterilization.

Strict compliance with MFG’s validated reprocessing IFU is a critical aspect of patient safety.

While each of us here today knows and respects this statement; it is important to recognize that many HCFs may not have the resources to comply with complex cleaning IFU. Add to this challenge “a lack of cleaning verification” and it is easy to conclude, that patient safety is a real concern!

CONCLUSION

Chuck HughesGeneral ManagerSPSmedical Supply Corp.6789 W. Henrietta Road · Rush, NY 14543 USA(800) 722-1529 · E-mail: chughes@spsmedical.com

Chuck is the General Manager and lead educator for SPSmedical which provides validation testing services to medical device manufacturers, along with sterilization consumables and on-site sterilization audits to health care facilities. Certified as a Health Education teacher, he has worked for over 25 years in the manufacturing industry and is a corporate member of numerous organizations, including AAMI and CSA where he contributes to writing standards.

Thank You!