Security best practices under HIPAA

- Document Everything – look through the rule, pick out each standard and each implementation specification and create a chart that briefly describes how you are addressing each.
- Require and use strong passwords – teach your staff andcoworkers how to create them
- Limit systems access to those who absolutely need it for their jobs
- Create written policies and procedures detailing the requirements
- Provide regular (annual) training
- Audit your own compliance
- Check state law for breach/incident notice requirements
- Be afraid. These rules apply to the smallest medical practices and the largest healthsystems and health plans
- Information Security is a hot topic. New lawsare being passed constantly.
- HIPAA may not provide for a private right of action but novel legal arguments are beingtested
- A major breach in your information securitycan be a public relations disaster.
- The media will be quick to report an inappropriate release of significant amounts of PHI

What is Protected Health Information (PHI)?

Individually identifiable information collected ormaintained by a Covered Entity
- Can be oral or written
- Can be in any medium (electronic, printed, recorded)
- Includes simple demographic data
– just the fact that someone is your patient/plan member is PHI
- It’s still PHI if someone could reasonably figure out who the individual subject is.
- Sometimes a judgment call but best to be conservative

As per HIPAA guidelines following may receive PHI about an individual.
- The individual (must disclose)
- Anyone who has been authorized by the individual
- Anyone who is the individual’s Personal Representative
- Governed by state law but typically guardians, agents underPowers of Attorney, estate executors,
- Parent of an unemancipated minor EXCEPT if the minor has the ability to consent to the treatment (typically relates tomental health, substance abuse treatment and other sensitiveissues such as abortion and birth control.
- State law governs here. Know your state’s laws regardingPowers of Attorney, guardianships and executorships.
- Providers involved in the treatment of theindividual
- State and Federal agencies performing healthoversight activities (CE is permitted, but not required, to disclose unless state law requiresdisclosure).
- Other CEs when the disclosure is necessary tofacilitate Treatment, Payment or Health Care Operations

Invitro device and 510K related information resource

- Medical Device Guidance Documents - [http://www.fda.gov/cdrh/guidance.html ]
- CDRH Databases - [http://www.fda.gov/cdrh/databases.html ]
- Code of Federal Regulations - [http://www.fda.gov/cdrh/devadvice/365.html ]
- International Information - [http://www.fda.gov/cdrh/international/ ]
- Consumer Information - [http://www.fda.gov/cdrh/consumer/index.html ]
- Overview of Regulations - http://www.fda.gov/cdrh/devadvice/overview.html
- Is Your Product Regulated? - http://www.fda.gov/cdrh/devadvice/31.html
- Classify Your Medical Device - http://www.fda.gov/cdrh/devadvice/313.html
- How to Market Your Medical Device - http://www.fda.gov/cdrh/devadvice/3122.html
- Does Your Product Emit Radiation? - http://www.fda.gov/cdrh/devadvice/311.html
- Registering Your Establishment -http://www.fda.gov/cdrh/devadvice/341.html
- Listing Your Medical Device -http://www.fda.gov/cdrh/devadvice/342.html
- PMN = Premarket Notification 510(k) -http://www.fda.gov/cdrh/devadvice/314.html
- Device Exemptions 510(k) but with GMP - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
- Investigational Device Exemption (IDE) http://www.fda.gov/cdrh/devadvice/ide/index.shtml - Premarket Approval (PMA) Class III Devices http://www.fda.gov/cdrh/devadvice/pma/
- Quality System (QS) Regulation for Good Manufacturing Practices (GMP) http://www.fda.gov/cdrh/devadvice/32.html
- Device Labeling Requirements http://www.fda.gov/cdrh/devadvice/31.html
- Medical Device Reporting (MDR) http://www.fda.gov/cdrh/devadvice/351.html
- Device Recalls Corrections Removals http://www.fda.gov/cdrh/devadvice/51.html
- Importing Medical Devices into the U.S. http://www.fda.gov/cdrh/devadvice/391.html
- Exporting Medical Devices from the U.S. http://www.fda.gov/cdrh/devadvice/39.html

Four Basic Factors to Microbial Kill

EO Concentration

• Commonly 400 and 700 mg/l
• As EO concentration increases at a given temp and RH,
  –microbial inactivation (kill) rate increases
• Killing concentration required at the site where the microbes (BI’s) are located

Water Vapor (Humidity)

Required for EO to react with the critical cell molecules
• Generally measured as Relative Humidity

Temperature

• Kill rate increases with temperature
  –D-value decreases (time) with temperature
  –Exponential function
• For each 10°C (18°F) rise in temperature, the spore inactivation rate will generally double

Time

• Amount of kill increases with exposure (EO gas dwell) time
• 90 percent of surviving microbes are killed for each D-value time in gas dwell

D Value ?

• Determined to prove predictable logarithmic death kinetics of challenge microorganisms (BIs) or natural bioburden
• “Decimal” Reduction Time - Measure of the biological organism’s resistance to the sterilant
• Time in minutes necessary to reduce (kill) a microbial population by one logarithm or 90%
• A Simple D-Value Calculation
  Time

-----------------------------

Log of Starting Population – Log of Final Population

Best practices in supplier Quality

Best Practice #1: Push Quality Upstream
• Deploy a web-based system and make it available to outsourcedmanufacturers
• They collect quality data and enter real-time into the quality system
• Quality data is instantly available to OEM quality engineers
• Process metrics are calculated by the system and pushed to quality
engineers every few hours
• Benefit: Engineers spend more time on working with
outsourced-manufacturers to improve process quality rather
than data collection and reporting

Examples -
Large Golf Manufacturer
• Sources components and clubs from dozens of suppliers worldwide.
• Also assembles clubs at multiple facilities around the world
• Process capability monitoring critical to keeping cost of poor quality

.low in an outsourced operation
• Benefits of implementing a web-based QMS at outsourced-manufacturer
• Data converted into information in a timely manner.
• Information is made available to all relevant parties while the
information is still fresh, thus enabling timely action.
• Engineers can address issues and take corrective action in time and
even before the lots reach the warehouse
• Cpk improved over 70% in 18 months

Best Practice #2: Streamline Audits

Other Audit Best Practices
• Clearly defined processes and metrics, so audit can discover unambiguous
process quality issues
• Audit process must incorporate the results of previous audits to track progress
against previous nonconformities
• There is a well defined process for root cause analysis and corrective actions
• Corrective and Preventive Actions are reported formally to all stakeholders

Best Practice #3: Live Supplier Scorecard

Key Metrics
• PPM of Components
• # of Corrective Actions Last Quarter
• Average Response and Resolution time for CAR
• # RMAs Processed per month
• MRB Inventory Levels
• Performance against benchmark

Best Practice #4: Closed-loop QMS

Stand Alone modules
• No Closed Loop Feedback
• No integrated process dashboard
Integrated closed-loop QMS
• Information flows easily from one module
to another
• Powerful drill down and drill across of analytics.

Best Practice #5: Calculating Cost of Poor Quality

COPQ 5% to 30% for most manufacturing companies
• Average COPQ is 20% for a manufacturer
• 1% for a six sigma company
• Over 25% for a three sigma company
• F50 company saved $1B/year in going from COPQ of 9+% to under 5%.

-Charge backs for additional cost incurred by the OEM due to
• Non-conforming components and materials
• Late deliveries from suppliers
• Introduce discipline and accountability

Best Practice #6: Build Business Case for QMS

Supplier Quality System is strategic to an OEM that outsources manufacturing
• VPs of Quality want to upgrade their Quality Systems but
can’t convince others about the investment
• Strategically linking quality with company objectives
• Defining before and after process maps
• Quantifying the value of infrastructure upgrade
• Getting buy-in from stakeholders

Framework for Defining Business Value

Savings From
• Cost Recovery
• Reduced Scrap
• Reduced Rework
• Reduced Inspections
• Reduced MRB Inventory
• Reduced Line Shutdowns
• Improved Equipment Utilization
• Reduced Warranty Recalls, Returns

What is OOS and how to avoid it ?

An OOS result is generated when a drug product undergoing release testing or stability testing fails to meet an expected result or specification. When this happens, the FDA requires a valid reason must be determined to invalidate the OOS result and therefore an investigation into the cause of the OOS result must be conducted.

OOS Related Inspection Questions
•Show me a list of OOS results from the last 6 months?
•What is the procedure for OOS situations?
•Are SOPs followed?
•Are initial investigations made in a timely manner?
•Are full investigations made in a timely manner (where necessary)?
•Are investigations documented properly?
•Are investigation findings subject to proper review?
•Does the procedure include root cause analysis, impact analysis, and corrective actions and preventive actions?

Avoid Analytical Instrument Related OOS

•Regular method re-validation
•Instrument qualification (initial, after changes, after repairs etc)
•Operator qualification
•Qualification of reference material and reagents(stability, purity, accuracy)
•Preventive maintenance for equipment and computer hardware (seal, lamps)- based on usage
•Trend charts of critical instrument and method parameters

Avoid Product Related OOS

•Process analytical technology
–Get a good understanding of the process
–Uncover and fix critical process parameters
–Reduces process variability
–Can interfere in production process based on results of intermediate steps
•Setting meaningful specifications
–Set specifications based on mature process not on pilot results or ‘tentative’ registration specifications
–Update specifications based on experience and statistical evaluations

JGCP Audit Requirements

1 -Per Article 2, Audit is defined as “an investigation conducted by a sponsor or postmarketing sponsor, or one that a sponsor-investigator appoints a designated person
to determine whether the clinical trial or postmarketing clinical trial is conducted according to this Ministerial Ordinance (No. 36) and the protocol or postmarketing protocol
to ensure the reliability of the technical documents collected by the clinical trial or postmarketing clinical trial.”

2- When the sponsor-investigator appoints an individual within the same medical institution to conduct the audit, said individual must be a third party who is not involved in the clinical trial.
3 -The sponsor-investigator may also appoint a third-party organization outside of the medical institution to conduct the audit.


4-Article 21, Clause 6:
"Procedures concerning auditing plan and duties" refer to a plan and procedure that the sponsor-investigator prepares to guarantee that the audit is properly conducted.


5 -This documentation must include:
+ Selection of the auditor (including the qualifications for the auditor)
+ Name of the auditor who will audit the clinical trial
+ Specific methods of auditing

+ Handling of auditing report and audit certificate.

6- Article 31. Audit (by sponsor)
- The sponsor shall prepare an audit plan as well as the operating procedures for the related duties, and conduct audits in accordance with the audit plan and the operating procedures.
- Auditor to be independent of those in charge of medical device development or monitoring.
- Audit report to document the matters confirmed in the audit and an audit certificate to verify that the audit has been conducted. Submit report and certificate to the sponsor.

7 -Article 42. Audit (sponsor-investigator)
-The sponsor-investigator shall prepare an audit plan as well as the operating procedures for the related duties, and conduct audits in accordance with the audit plan and the operating procedures.
-Auditor shall not be engaged in the clinical trial at the medical institution where the clinical trial is conducted (including its preparation and management) or in monitoring.
-Audit report to document the matters confirmed in the audit and an audit certificate to verify that the audit has been conducted. Submit report and certificate to the sponsor-investigator and the head of the medical institution.




8 -An audit on individual clinical trials shall be conducted by deciding on:
+ the subject of the audit, i.e. medical institution and other facilities engaged in the clinical trial
+ the timing of the audit taking into account the
* importance of the clinical trial for application to the regulatory authorities
* number of subjects
* type and complexity of the clinical trial
* level of risk posed by the clinical trial to subjects,
* various issues discovered through monitoring.


9 -The auditor is required to
+ visit the medical institution and other facilities engaged in the clinical trial as necessary
+ directly access the source documents to confirm that the clinical trial is being properly conducted and the reliability of the data is fully ensured.

Japan good clinical practice rules

Ministry Ordinance 36 issued in 2005
Based on ICH6 and closely aligned with ISO 14155
Parallels the Drug GCP (MHLW Ordinance 28)
6 Chapters, 79 Articles
- Chapter 1. General Provisions
- Chapter 2. Criteria for Preparations for Clinical Trial
- Chapter 3. Criteria for Clinical Trial Management
- Chapter 4. Clinical Trial Criteria
- Chapter 5. Criteria for Reevaluation Documents, Etc.
- Chapter 6. Criteria for Sponsoring Clinical Trial, Etc.
Audit requirement discussed mostly in Articles 21, 31 & 42
JGCP requirements have many similarities to those the US and Europe.
Largely due to MHLW participation in ICH and the ICH Guideline for GCP (E 6)
Closely aligned with ISO 14155 Parts 1 & 2
Basic functions of the Sponsor, Investigators, Informed Consent, Record Retention, and IRB’s are nearly identical to requirements currently in place for the US.

JPAL Laws, Ordinances and Notifications

The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005)MHLW Ministerial Ordinance No. 36 Clinical Tests for Medical Devices (hereinafter referred to as "Medical Device GCP" or “JGCP”)
YAKUSHOKUKIHATSU No. 0720005 Administration of Good Clinical Practice for Medical Devices
YAKUSHOKUKIHATSU No. 070720 Essential documents for criteria concerning clinical tests for medical devices
YAKUSHOKUHATSU No. 0720004 Criteria for Clinical Trials for Medical Devices
YAKUSHOKUHATSU No. 0331006 Handling of clinical study data based on clinical study that is carried out in a foreign country
MHLW Administrative Correspondence from June 23, 2006 Q&A on the Handling of Tests Records from Clinical Studies on Medical Devices Conducted Overseas

FDA Guidance on Computerized Systems Used in Clinical Investigations

Scope of this guidance

Computerized systems that contain data that support a marketing application
–Case histories
–Analytical test results (e.g., LIMS)
–Data captured from analytical instruments
–Electronic transcription of hardcopy source data
it Does not apply to:
–Computerized medical devices

Study Protocols
•Identify computerized system use within the trial process
•Computerized systems must:
–Satisfy process requirements defined in study protocol
–Have built-in error prevention

•Challenges
–More complicated protocols
–Some automated processes may not be defined at protocol authoring stage – Unnecessary protocol revisions

SOPs and system documentations

•Specific to computerized system
–Setup/Installation instructions
–Operating manual
–Validation
–Data collection and handling
–System maintenance
–Security controls
–Change control
–Backup/Restore
–Disaster recovery/contingency planning
–Data collection contingencies
–Training
–Roles and responsibilities

•Challenges
–Guidance states “Such SOPs should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records, and the SOPs should be made available for use by personnel and for inspection by FDA.”

Source Documentation and Retention
•Original observations entered directly in computer = source document
•Investigator must retain source data, or a copy
•If source data not generated and stored at clinical site, a copy must be provided to clinical site or a designated site
–Copies must be made contemporaneously with data entry

•Challenges
–Does contemporaneous mean simultaneous?
•Initial impressions from FDA = Yes
•Often not logical and sometimes demonstrably impossible
•CDISC eSDI guidance on Electronic Source Data within Clinical Trials: “as soon as possible after the event to which it refers
–FDA’s concern: If Investigator does not retain a copy of the source data, the records can be modified and original data obscured
–Although Investigator may be able to remotely access data at Sponsor site, it is not under his/her control
–No longer acceptable to just send investigator copy of data at end of study

Access control

–Individual accounts
–Limit log-in attempts and record failed attempts
–Work only under own password/account
–Do not share password
–Password aging
–Procedural or automatic log-offs or lock-outs
–The system should not allow an individual to log onto the system to provide another person access to the system*

•Challenges
–“The system should not allow an individual to log onto the system to provide another person access to the system”
–How does the system control this?
•Should you not allow concurrent logins?
•Should you require periodic user checkpoints in the system?
•Does “system” include both the computerized application and procedural controls?

Document control as per ISO 13485

Document control is

•Required by both FDA (in Federal, Food, Drug, and Cosmetic Act) and European Community (in ISO 13485)
•Has always been a requirement, from 1976 (GMPs) and 1996 (ISO)
•Cited regularly by both FDA inspectors and notified body auditors as deficient
•Often ignored by upper management as an area for possible streamlining
Requirements of FDA

1>Sec. 820.40(a) Document approval and distribution
–Approval
•…designate an individual(s) to review for adequacy and approve …all documents.
–Approval - date and signature(s) - shall be documented.
–Distribution
•Documents …shall be available at all [necessary] locations
•All obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

2>Sec. 820.40(b) Document changes
–Changes to documents shall be reviewed/approved by an individual(s) in the same function/organization that performed the original review/approval, unless designated otherwise.
–Approved changes shall be communicated to the appropriate personnel in a timely manner.
–Each manufacturer shall maintain records of changes to documents. Change records shall include: •a description of the change
•identification of the affected documents
•the signature of the approving individual(s)
•Approval date
•Effectivity date

ISO 13485 requirements

•Clause 4.2.3 - Control of Documents
–A documented procedure shall be established
a) review and approve documents prior to issue
b) review and update as necessary and re-approve
c) ensure that changes and current revisions are identified
d) ensure that relevant versions of applicable documents are available at points of use
e) ensure that documents remain legible/identifiable
f) ensure that documents of external origin are identified and their distribution controlled
g) prevent unintended use of obsolete documents, and apply suitable identification if retained
–Changes to documents must be reviewed/approved either by original approving function or another designated one that has access to pertinent information upon which to base its decisions.

Fatures of a document control system

1.Requester of change red-lines documents and completes change request
2.Requester submits red-lined documents and change request to Document Control
3.Document Control supervisory personnel reviews red-lined documents and change request to assure completeness and accuracy
4.Document Control personnel incorporates changes into current documents
5.Document Control personnel distributes revised documents for review/approval
6.Approval of document package
7. Distribution of new documents to appropriate work areas
8. Work areas either destroy obsolete versions or return them to Document Control

How to Streamline a document control process

1.Requester of change red-lines documents and completes change request
•If MS Word document, use Tools/Track Changes/ Highlight Changes
2.Requester submits red-lined documents and change request to Document Control
•Via e-mail
3.Doc Control supervisory personnel reviews red-lined documents and change request
4.Document Control personnel incorporates changes into current documents
•Tools/Track Changes/Accept or Reject Changes
5.Document Control personnel distributes revised documents for review/approval
•Via e-mail
6.Approval of document package
•In Outlook, New Message/Options/Voting and Tracking Options/Use Voting Buttons
7.Distribution of new documents to appropriate work areas
•Document Control scans originals
•Puts them in appropriate directory
8.Little or no need for destruction/return of obsolete versions

USE error and medical device recall

FDA's definition of USE error though the word USE error is not used officially.

“Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001
Many research suggests that the frequency and consequences of medical device use errors may far exceed those arising from device failures

•A study of patients 65 and older found that those who couldn’t understand basic written medical instructions were much more likely to die within six years than those who had no problems. The difference in death rates “was much higher than we expected.”
Ref - Dr. David Baker, Chief of General Internal Medicine at Northwestern University’s Feinberg School of Medicine, 2007
•Most people have difficulty understanding pharmaceutical label instructions, regardless of their cultural background and level of education.
Ref - Mining Complex Clinical Data for Patient Safety Research, George Hripcsak, M.D., 2002


•Recent FDA reports show that more than 1/3 of medical device incident reports involve use error, and More than 1/2 the recalls due to design problems can be traced to design of the user interface. Hence design of user interface and the labelling is one of the main causes of recall.
To get out of the problem FDA suggests manufacturers go for Human Factor Engineering and also follow the guidance documents provided as below.

•Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Reviewers
•Do It By Design: An Introduction to Human Factors in Medical Devices
•Human Factors Principles for Medical Device Labeling
•ANSI/AAMI HE75: Human factors design principles for medical devices (adopted by the FDA later part of 2008)
http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/HE48preview.pdf

Human Factors Engineering - Medical Device

HFE is a scientific discipline concerned with the understanding of interactions among human and other elements of a system
it is Also called:
•Usability engineering
•Customer-centric design
•User-centered design
- A series of FDA standards and guidelines intended to ensure:
-“Each manufacturer shall establish and maintain procedures to ensure that the design requirement related to a device are appropriate and address the intended use of the device, including the needs of the users and patients.” (QSR paragraphs c, f, and g of Section 820.30)
-Ability to use a device safely and effectively is a primary “user need”
-Includes hardware, software and labeling

Cleaning validation and Labelling Requirement for reusable medical devices

FDA regulatory requirements as follows

- Most of the complex medical device instruments require premarket notification [510(k) or even a PMA (premarket approval)
- 510(k) and PMA Guidance Documents include requirements for reprocessing instructions for the user:
-Detailed cleaning instructions, including disassembly.
-Detailed disinfection & sterilization instructions with specific sterilization parameters.
-Expected end of life & how this can be determined by user.
-Roles and Responsibilities
-21CFR 820.30 Design Controls
-21 CFR 820.70 Production & Process Controls
-21CFR 820.75 Process Validation

EU Regulatory Requirements

-European Medical Device Directive, MDD 93/42/EEC.
-Annex I, Essential Requirements
para 7,8, & 13.6 (h)
-ISO 13485:2003
-7.3 Design & Development
-7.5.1.2.1 Cleanliness of Product

Instructions for USE need to be developed as follows

- Start with determining intended use.
- Consider intended use during design.
- Obtain FDA guidance documents.
- Obtain & review consensus standards.
- Develop validation protocol.

Determine Intended USE

The Center for Disease Control & Prevention (CDC) recommends disinfection or sterilization based on three end use categories (CDC, 1985):
1>Critical Items
Devices in direct contact with blood or areas of the body not usually in contact with contaminants. Examples include biopsy forceps, endo cavity probes, and implants. Sterilization is required for these devices.
2>Semi-critical items
These devices are non-invasive and normally contact intact mucous membranes. Examples include endotracheal tubes, specula. High level disinfection is a minimum process requirement for these device.
3>Non-critical Items
Devices not in contact with patient, or only with intact skin, such as blood pressure cuffs, hospital beds, crutches, etc. High, intermediate, and/or low level disinfection is recommended

Intended USE during design
1 -Cleaning ports -Ease of use.
2- Minimize hard to reach areas.
-Narrow lumens
-Dead ends, rough surfaces, luer locks
-Crevices, hinges, areas between insulation and device
3-Compatibility with cleaning agents & sterilants.
-Ethylene Oxide
-Gamma Radiation
-Hydrogen Peroxide
-Chemical disinfectants & sterilants
4-Ease of disassembly & reassembly.
-The easier to do so, the more likely a thorough job.
-Disassembly/reassembly instructions are often lost/misplaced

Obtain FDA guidance documents
Labeling for reprocessing reusable medical devices.
- FDA - Guidance document for washers and washer-disinfectors intended for reprocessing reusable medical devices. June 2, 1998
- FDA - Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance. April 1996.
- FDA - Questions and answers for the FDA reviewer guidance: Labeling reusable medical devices for reprocessing in health care facilities. September 1996.
- 510(k) guidance for specific devices
www.fda.gov/cdrh/guidance.html

Obtain and Review consesus standards

1>ANSI/AAMI ST81:2004 - Sterilization of medical devices-Information to be provided by manufacturers for reprocessing of resterilizable medical devices.
2>AAMI TIR-12:2003 Designing, testing, and labeling reusable medical devices for healthcare facilities: a guide for medical device manufacturers.
3>AAMI TIR-30:2003 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
4>AAMI ST:2004 – Information provided by manufacturers for the processing of resterilizable medical devices
5>ISO/TS 15883-5:2005 – Washer-disinfectors – Part 5: Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors.

Develop validation protocol

1>Cleaning is the most important activity.
-Often inadequate, hard to confirm cleaning efficacy.
-Definition of cleaning is the removal of visible contaminants. The manufacturer must design the test to demonstrate that a soiled device can be rendered free from contamination to the degree that the device is free of soil. The accepted endpoints depend on the degree of disinfection recommended. FDA has guidance documents on validating sterilization processes8.
-Cleaning must be validated as well as sterilization.
2>Organic material works as a shield to Ethylene Oxide, steam, other sterilants.
-Blood & tissue
-Carbohydrates, fat
-Fluids introduced during medical procedures

Salient Features of cleaning validation

-Reusable devices must be designed to function safely & effectively following multiple cleaning/disinfection/sterilization cycles.
-Most devices composed of cleaning and sterilant tolerant materials will withstand more than 100 cycles
- Testing should be designed to address not only cleaning & sterilization efficacy, but also bio-compatibility & functional performance.
- Not just the sterilization cycles, but the simulated soils added, disassembly must also occur after cycles
-The cleaning process must remove blood, protein, fat, carbohydrates, endotoxins, microorganisms from all joints, lumens, crevices.
-Test soils have been developed to test the efficacy of cleaning as well as testing methods in AAMI TIR 303 .
-No single test soil is appropriate for all medical devices.
-Depends on contact points, mucosa, intact skin, blood pathways, etc.
-For example, intravascular devices should be tested with whole blood and serum.
-Simulated blood or body fluids may be formulated using a mixture of calf serum, dry milk powder, and a 1:1 rabbit blood/saline mixture (Miles, 1991).
-One method proposed by AAMI is to add Geoacillus stereothermopilis spores @ about 104 to 105 organisms.
-The soiled device is then cleaned according the given directions and the remaining spores are recovered & enumerated.
-The recovery technique must be validated prior to determining the efficacy of cleaning.
-Cleaning efficacy can then be determined by subtracting the spores recovered from the device after cleaning from the spores recovered from a control sample (soiled w/o cleaning).
-Ensure the cleaning procedure can be duplicated in the health care facilities.
-A good benchmark bioburden reduction level should show at least a three log reduction. This was demonstrated as possible for flexible endoscopes (Alfa, et. Al, 1999)
- Markers such as protein & carbohydrates can be used to evaluate the cleaning effectiveness.
-Blood cells contain hemoglobin which can be tested from extracts of the device. (Alfa, et. Al, 1999)
-Endotoxins (gram negative bacterial cell wall molecule) are found in tap water & can cause systemic pyrogenic reactions.
-Endotoxin levels extracted from a device can be analyzed by various methods. (ANSI/AAMI ST 72)
-The phenol-sulfuric acid assay can be used to measure both mono and poly saccharides.
-The bicinchonic acid (BCA) protein assay is a highly sensitive reagent for the photometric determination of protein.