Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices
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Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices

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This presentation provides important details on how to save time and money in the process of reusable medical device design. The main focus is on how device material choice and design affects the ...

This presentation provides important details on how to save time and money in the process of reusable medical device design. The main focus is on how device material choice and design affects the cleaning and disinfection process, and what considerations design engineers need to make when creating reusable medical devices.

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  • Hello everyone! I am Diana Louie. My work at Pacific Biolabs revolves highly around cleaning and disinfection validations of reusable medical devices. As some of you may know, launching a medical device into the market is not as easy as one-two-three anymore, not that it ever has. There are so many things to consider and so much research and testing involved. And not only that, sometimes you have to jump hurdles just to get by each phase prior to FDA submissions. Wouldn’t you agree that if you have a better understanding of the system and each phase better from the beginning, all preceding phases would be a piece of cake? Well that is where we come in today to help you better understand reprocessing validations and how early design considerations with relation to cleaning of your device will help you get through this phase quick and painless. We will clarify what cleaning, disinfection and sterilization validations are and the different categories of reusable medical devices with association of their acceptance criteria. Then we will reiterate and stimulate your minds with a few case studies that we have put together for you. And finally we will go over some important design considerations for a reprocessing friendly device.There will be time at the end of the webinar to discuss any questions you may have for us.
  • Some of the goals we have for you today is to get a more thorough understanding of what a cleaning, disinfection and sterilization validation is.At the end of the webinar, we want everyone to take note on the different design considerations there are and how you can increase the suitability of your device for reprocessing and reuse.Considering the designing of your device early on for clean ability will save you time and money.
  • Now that I have a better idea of where everyone is at with designing, I will first start with the basics. What is the purpose of having a reprocessing procedure validated? To set standards and prove that the reprocessing procedure will render a device safe for patient use.How does the FDA define cleaning/disinfection/sterilization of a device?According to the FDA, cleaning is the physical removal of organic soil from a device to the extent for further processing or for intended patient use.Disinfection destroys pathogens and other microorganisms by physical or chemical means.Sterilization renders a product free from any viable microorganisms. How are we supposed to go about validating this procedure? How do we know its validated?
  • Well, lets break it down.First, what is a cleaning validation?As a reminder, cleaning is defined as the removal of soil residues whether it be organic, inorganic or biological.Recovery is the process in which you check to see what is remaining on the device after cleaning.
  • And how we go about validating a cleaning procedure is by…First inoculating the device with representative organic soils and microorganisms at the most challenging locations to simulate the worst case scenario.Organic soil may consist of anything that would be contaminated on the device during clinical use.Same goes for inoculation of microorganisms. We inoculate microorganisms representative of the intended environment of your device.After the introduction of soils, we subject the device to the recommended cleaning procedure. This procedure usually involves cleaning with water and detergents but the recommended procedure can be suggested by the chemical manufacturer or established between the sponsor and the consulting lab.After we have cleaned the devices, we extract and quantitate residuals remaining from the cleaned devices. There are a few ways we can go about recovering the residuals which can include a microbial test (bioburden), protein, hemoglobin and etc.
  • Based on the results from recovery, we can determine whether the validation has passed.First we inspect that the device is visually clean after the cleaning procedure. For those of you with long lumens or channels in your device, this visual inspection will include observance of clear liquid coming out of those channels or lumens.Since we inoculated with a known concentration of soil, we can calculate the reduction in soil by comparing the positive controls with the cleaned devices. For microorganisms, a minimum of a 3 log reduction must be met.A screening for residuals must prove to be below certain limits. In ug/squared cm, protein must be less than 6.4, Hemoglobin at less than 2.2, Carbohydrate less than 1.8 and endotoxin less than 2.2.If your device meets these limits, the cleaning procedure is validated.
  • Now that the cleaning procedure is validated, the device can be subjected to the next step in reprocessing which can be disinfection or sterilization depending on your device. But first, we can cover what a disinfection validation is.As a reminder, disinfection is the process that kills pathogenic and other microorganisms by physical or chemical means.
  • In order to validate a disinfection procedure,We first inoculate the device with representative microbes and organic soil.Then we clean the devices with the previously validated cleaning procedure before subjecting the devices to a proposed disinfection procedure using disinfectants or thermal applications generally with use of water under 100°C.Afterwards, we recover and enumerate any microbes remaining on the devices.
  • Based on the microbial recovery of the devices, we can compare the positive controls with the cleaned devices to determine if a 6 log reduction of microbes is achieved. If the device is both visually clean and satisfies 6 log reduction, the disinfection procedure would be validated.For a side note, According to the AAMI guidelines, you may want to consider screening for harmful residuals remaining from your disinfectant and its potential risk to the patient. Obviously if you apply thermal applications, a screening would not be necessary.As you can see, in disinfection, only a 6 log reduction of microbes is required. But some devices are required to be sterile…
  • For devices which are required to be sterile, sterility is the only option after cleaning.Sterilization is a process that renders a product free from viable microorganisms and is measured by the sterility assurance level. This is the probability that a product is non-sterile. For example, SAL 10-6 is a one in a million chance of a non-sterile event.
  • I have just gone over quite a bit of material. It may still be a little confusing, but simply put, to validate the reprocessing procedure, we have to….This whole validation procedure doesn’t look so confusing now right?
  • This table briefly presents the different types of the reprocessing procedures we have discussed.There are two methods of cleaning; Manual which is cleaning with or without use of brushes and specialized tools. If your device is complex and requires meticulous cleaning, you may want to consider designing specialized cleaning tools for your device.The 2nd cleaning method is automated cleaning with the use of ultrasonic and medical washers.There are four classifications of disinfection – low, medium and high disinfection. Determined by how thoroughly the disinfectant kills microorganisms. In high level disinfection, there is a potential to render the device sterile. If your device cannot be sterilized or disinfected with chemicals, another option is thermal disinfection, which is the use of high temperature water under 100CThe level is categorized by the microorganisms that the process kills or is effective against.The level of disinfection will also depend on the type of disinfectant you decide to use. Most chemical manufacturers categorize their chemicals as high, intermediate or low level disinfectants.There are five common types of sterilization - high and low temperature, chemical, gas and radiation sterilization.
  • Now that we’ve got the procedure down, we have to figure out which end process we should use for our device. Will the device’s reprocessing procedure end at the cleaning level, disinfection or sterilization?We distinguish that by classifying our reusable medical device.Your device is classified as critical, if it is introduced directly into the bloodstream or other sterile areas of the body. Examples include surgical instruments, needles, catheters, implants and invasive endoscopes.Your device is classified as semi-critical, if it only contacts intact mucous membranes of the body and does not penetrate the bloodstream or other sterile areas of the body. Examples include non-invasive flexible and rigid fiber optic endoscopes, aspirator tubes and respiratory therapy equipment.Your device is classified as non-critical, if it only comes in contact with intact skin. Examples include blood pressure cuffs, stethoscopes and external sensors.
  • Each device classification will have its own acceptance criteria.Critical devices must be sterile with a sterility assurance level of 10^ -6.Semi-critical devices but be sterilize with a sterility assurance level of 10^ -6 or disinfected with a 6 log reduction of microbes.Non-critical devices do not need to be sterile and and therefore are the most versatile when it comes to reprocessing. The reprocessing can vary from being cleaned, disinfected or sterilized and the acceptance criteria is no where as stringent as critical or semi-critical devices. It is important here to use good scientific judgement to determine the best reprocessing procedure for your device.Now with a general idea of what a reprocessing validation is, lets tie everything together in three case studies we have put together for you.
  • So what we did was first, clean the forceps with Alconox and a sponge because alconox is a detergent which is effective, widely used in hospitals and more importantly, will not cause corrosion. The sponge helps remove residuals that may be trapped in the grooves of the forcep.Step two is very important. After cleaning in the Alconox detergent, we rinsed the forceps under running water. Not only will this help wash away loosened debris, it will also remove any remnants of the detergent. This is true of any chemicals that you may use on your device. If the rinsing is not adequate, residuals from disinfectants can potentially be very harmful to patients.Next, we screened the forceps for organic carbon which could originate from either the soil or the detergent. The screening helped confirm that the residual levels are acceptable.
  • Then we disinfected the device with the same Sani-cloth wipes only this time, we left the device wet with the wipes for 5 minutes. This rendered the device disinfected without the use of high heat. The use of wipes were also convenient and did not require immersion of the device.So you can see with the first two case studies that I have gone over, each had its own limitations and each had a different procedure in reprocessing. I have just presented examples of a simple device to a moderate device. Now I would like to turn the attention to my colleague Beth who will go over one of the more complicated devices we have encountered.
  • After those 2 cases, I will be discussing the 3rd case which is a diagnostic device used to visually examine the interior of a hollow organ (colon). This device is considered semi-critical because it usually comes in contact with intact mucosal surface. It is required to be cleaned and disinfected if not close to being sterile. Designing an appropriate cleaning and disinfection process for a complex device like this depends upon many considerations. The efficacy of the cleaning process can be affected by its complexity and limitations.
  • Let us understand better what are these limitations. First, is the Complexity of the design……. it is difficult to design a cleaning process that is both easy to perform and effective. The simpler the device the easier to clean. More complex device needs more time to perform the cleaning process.This device is composed of metals, silicone and glass which are more susceptible to scratch and deformities. Some of these materials are not compatible with some cleaning agents, as their use can result in corrosion or release of toxic byproducts. Knobs and screws are potentially trouble spots for retaining high levels of residuals.Not all parts can be immersed in fluid….we have to be extra careful to protect the delicate parts to prevent breakage of lens, camera, or destroy any electronic components. Repeated re-processing can affect the functionality of the device.
  • So…how do we clean this device? And how do we validate this procedure for repeated use and come up with the same cleanliness result…….First we need to identify the most challenging areas where we should concentrate on developing an appropriate procedure to clean them.Because of the limitations from the previous slides we have designed a cleaning and disinfection process that is easy and doable . This device is cleaned using a lint-free soft sponge to avoid scratching…. Wiping with the a sponge and water also helped in the removal of visible contaminants. The long flexible tube is immersed into Cidex OPA while scrubbing it with a soft sponge. Partial immersion accommodates the limitations of the device yet still allows high efficacy of the cleaning procedure….All parts that cannot be immersed in fluid were cleaned using the sponge and disinfectant, these are usually the parts that don’t come in contact directly with the patient’s mucosal surface. All the parts that were immersed in fluid were rinsed thoroughly in clean water (DI) to remove any residuals from the soil and chemicals used for cleaning.
  • Since this is a semi-critical device….it needs to be disinfected or at least close to sterile. High temperature is not an option for this particular device….hence the only way to make it safe for re-use is to subject the device to disinfection process after cleaning….the immersible part was soaked in Cidex for 12 minutes…..which is the time indicated in the manufacturer’s manual for instruction. The exposure time varies from one disinfectant to another. After soaking, thorough rinsing was performed to remove chemical residuals. How do we know it’s acceptable?....we have to perform TOC testing to screen the device to ensure that any organic residuals….. Are within acceptable limits. Alternatively, other screening tests can be utilized such as analytical testing/ quantitative analysis. Proper cleaning and disinfection and adequate rinsing will surely render a medical device safe for reuse. If in the evaluation, it passes all the acceptance criteria, then the process is validated.That is all I have for this case….I will move on the next slides which are about device design and what design factors are important to assure the efficacy of the cleaning and disinfection or sterilization processes.
  • Why is design important in manufacturing reusable medical devices?Design is the most important aspect in manufacturing reusable medical devices…. Because…. A medical device intended for re-use must be properly designed to ensure that it will perform safely and effectively throughout its useful life. It is now required to have validated reprocessing instructions before a product can be labeled as reusable.…A well designed device can be thoroughly cleaned and effectively disinfected or sterilized……a poorly designed device is difficult to clean and more likely to be damaged as compared to a well-designed product.
  • There are 4 design aspects to consider in manufacturing reusable medical devices….Material design, physical design, total system design and misuse-related design considerations. Let us discuss these one at a time……. Designing a device is not typically done by a single person. There are so many issues and complications that come with every design we think about……all these issues can be addressed effectively if design development is conducted by manufacturers and engineers, in consultation with users and professional organizations…….. meaning inputs should come from those who use the device and those that are responsible in reprocessing it,…….. so that the design can address the needs of all parties.
  • Let me discuss the material considerations first. Selection of materials to manufacture devices plays an important role in design process…..It is important to consider its biocompatibility, as well as its compatibility with the cleaning reagents and disinfectants. Materials selected ….stable in the presence of chemical and under expected reprocessing conditions…temperature, pressure, humidity and other environmental conditions. … Combination of the material and chemical reagents may potentially release a toxic byproducts which could be harmful to users……in this sense it should be compatible with most of the cleaning and disinfection reagents commonly used in health care facilities or readily available in the market for home uses…..leaching of materials can happen as a result of repeated use and processing…..If any materials in a device can be adversely affected by the cleaning, disinfection or sterilization process…..we should determine the limit of its re-usability. It is recommended to perform a degradation study or exhaustive exposure to determine how many times the device can be reusable.These materials should also be evaluated for their capacity to retain unacceptable levels of residuals. For example, Porous materials are prone to residual retention as compared to non-porous materials. Smooth materials are preferred compared to rough surfaces for easy cleaning…..some materials are prone to scoring caused by the cleaning tools used…….for example metal ends of brushes that scratches the device surface. In effect, this can attribute to retention of residuals and tissue penetration which makes cleaning more difficult. Metals as compared to polymeric materials are more susceptible to corrosion especially if they come in contact with bleach and hydrogen peroxide. Metals with coatings can be adversely affected by ultrasonic cleaning and also mechanical cleaning. These coatings can leach out from the device and may affect the user…….. Whereas, polymers commonly react to chemicals making them incompatible with some cleaning and disinfecting agents…. It may result to discoloration or release of toxic byproducts as a result of the exposure.
  • Let’s move to the physical design……In physical design consideration, manufacturers/engineers should establish that the size, shape, and configuration will not impose any constraints in the ability to clean, disinfect and sterilize these devices. It poses a challenge to any health care personnel assigned to perform the cleaning process if they are confronted with the following design features. Such as Long, narrow internal channels with small openings, devices with multiple internal channels, ...are considered very challenging because they are not freely accessible. These are the areas that are difficult to reach when cleaning is performed. A small opening is a very good site for corrosion ….because, it allows an aggressive/strong solution to stagnate and possibly form a red rust around its narrow opening. One thing more…it may not permit a common brush to pass through and clean the interior surface……unless a special kind of brush is designed for that particular device.Rough, irregular and discontinuous surfaces that are both external and internal; presence of ridges, crevices, sharp angles and joints are difficult to clean….these areas can trap or retain microorganisms and impurities such as patient‘s blood and other body fluids or the patient’s tissues which are good reservoir for microbial growth. ……The next thing to consider will be the ease of disassembly and reassembly…….A multi component device needs to be disassembled to allow thorough cleaning……We need to take into account the number and size of parts in a device that requires disassembly….and the potential for incorrect reassembly by the users. It is important to consider the probability of loosing parts or breaking the device….. resulting to a non-functional device. As a consequence, the personnel performing the cleaning process will become reluctant to disassemble the device ending up with a device that is not properly cleaned.We have to avoid or at least limit the use of additional agents in reassembly such as adhesive chemicals or lubricants which later become toxic or harmful to users. If a device cannot be disassembled but has inner channels to which patient’s blood or other body fluids can gain access to… it is important to include an opening or a port that facilitates flushing through the inner channels. ….. Brushing should also be taken into consideration during the designing process of the device. It is beneficial to design a brush appropriate for the device for ease of proper cleaning.
  • When we say Total System Design Considerations we are looking at the whole systems and how reprocessing affects the overall device…..the design elements such as the components, subassemblies and the complete device itself should be evaluated…. how it is affected by the stress imposed by cleaning, disinfection and sterilization procedures and other stresses from mechanical, electrical and environmental source….. All of these conditions, should be evaluated in terms of any potential effect on the device’s compatibility with other devices in the intended operating system….for example, Stainless steel should not be mixed with aluminum, brass, copper or chrome plated devices as it can cause electro-chemical reaction (oxidation-reduction reaction)What are the effects of selected cleaning process on delicate instruments? Choosing the appropriate method in reprocessing depends on how it affects the device…… For example, the use of ultrasonic washers; this method of cleaning is popular because of its efficacy in removing debris from hard to reach areas; It maybe perfect to serve this purpose but consider the fact that ultrasonic energy can loosen tiny screws of delicate instruments and might destroy coatings, glues and amalgam in the devices. We have to bear in mind that adequate reprocessing of re-usable devices is vital to protecting patient’s safety. What about the effect of re-processing? Will it have an effect when the cycle is repeated over and over again? How long can a device be re-processed and still safe to use? That repeated processing of a device can produce toxic byproducts, may cause corrosion, scratches and deformity. At this time the device have reached its limitation…..because of this, we have to determine how many cycles can a device withstand. What about the functionality? One of the effects of reprocessing that we have to consider is the functionality of the device after repeated re-use and exposures. Can we still get the same performance in its intended use? This is another aspect that we need to prove. The areas of concern will be the electronics, microchips, lens and other delicate components installed within the device. Cleaning procedures should include extra precautions for delicate parts or components like this.
  • Why do we have to consider Misuse- related designs in manufacturing medical devices?…….. Because it does not only affect the functionality of the device but may also imposed danger to users. It is important to anticipate and determine what harmful effect can happen if any incorrect cleaning, disinfection, or sterilization process is used. With this in mind we can include a margin of safety just in case it happens. What happens if improper cleaning is performed? …….. The device might be deformed, screws may become loose, it may result to scratches and can lead to leaching of device materials. Like wise if an incorrect disinfection or sterilization process is used…it may result in corrosion or a toxic byproducts might be released ..it can also lead to other physical changes like discoloration and rust formation. Consequences of improper reassembly includes breakage of the device or lose small parts…..this may cause damage to important equipment in use. Subsequently loss of time to reprocess can happen. In order to prevent any harmful effect, manufacturers should include a warning in the Instruction For Use (IFU), especially if it is known that serious damage could occur related to the device misuse. A good example of this is accidental immersion of powered equipment or devices……..not only does it affect the functionality of the device but poses great danger to users as well.
  • In summary, Cleaning and Disinfection or sterilization validation is a major part of FDA approval. It is required to have a validated re-processing instruction for re-use prior to release of product in the market. However, for those products already out in the market were recalled to comply with the same requirement.Many design factors can positively or negatively impact validation. Understanding the effect of cleaning and disinfection or sterilization process will help in designing a device that can be easily validated and re-processed.

Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices Presentation Transcript

  • Design Considerations for Engineers
  • Webinar Overviewo What is a cleaning and disinfection/sterilization validation? • Types of cleaning, disinfection, and sterilization validations  Residuals • Categories of reusable medical devices • Acceptance criteriao Case Studies • Surgical Forceps • Blood Glucose Meter • Colonoscopeo Design Considerationso Questions Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 2
  • Today’s Goalso Develop a more thorough understanding of the cleaning, disinfection, and sterilization processeso Learn what to consider when designing a device to increase suitability for reprocessing for reuse Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 3
  • What is a cleaning and disinfection/sterilization validationo Purpose and need for validating procedure • Set standards for the reprocessing procedure to render device safe for patient use.o What does the FDA say? • “Cleaning is the physical removal of organic soil from an item to the extent necessary for further processing or for intended use” • “Disinfection destroys pathogens and other microorganisms by physical or chemical means” • “Sterilization validation renders a product free from viable microorganisms” Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 4
  • What is a Cleaning Validation?o Cleaning: Removal of soil residues. Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 5
  • Cleaning Validation Procedureo Inoculate the device. • Organic Soils • Microorganismso Subject device to cleaning procedure. • Usually with use of water and detergents.o Extract remaining residues. • Microbial, protein, hemoglobin, carbohydrate, endotoxin Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 6
  • Cleaning Validation Acceptance Criteriao Visually Cleano Microorganisms – minimum of 3-log reductiono Residual Limits Levels: • Protein < 6.4µg • Hemoglobin < 2.2µg • Carbohydrate < 1.8µg • Endotoxin < 2.2µg Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 7
  • What is a Disinfection Validation?Definition: Process that kills pathogenic and other microorganisms by physical or chemical means Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 8
  • Disinfection Validation Procedureo Inoculate device with microbes and organic soilo Process device with validated cleaning procedureo Subject device to disinfection procedure: • Disinfectants • Thermal applications (under 100°C)o Perform microbial recovery Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 9
  • Disinfection Validation Acceptance Criteriao Visually cleano Microorganisms: 6-log reductiono Total Organic Carbon (TOC) screen for residual disinfectant Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 10
  • What is a Sterilization Validation?o Definition: A process that renders a product free from viable microorganismso Measured by SAL (sterility assurance level): probability that a product is non-sterile • Ex: SAL 106 is a one in one million chance of a non-sterile event Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 11
  • Sterilization Validation Procedureo Introduce biological indicators to device • Biological sporeso Subject device to sterilization processo Retrieve biological indicators and perform sterility test Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 12
  • Sterilization Validation Acceptance Criteriao Non-critical device: SAL 10-3o Critical device: SAL 10-6 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 13
  • Simply Put…o We have to contaminate the device, clean it and disinfect or sterilize the device according to the procedure being validated.o Then we have to check the level of contamination remaining on the device after the cleaning/disinfection/sterilization procedure.o If all checks are acceptable, the procedure will be validated for use. Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 14
  • Types of Cleaning, Disinfection and Sterilization Processes Cleaning Disinfection SterilizationManual Low Level High TemperatureCleaning with or without use Kills most vegetative bacteria, Moist heat/steamof brushes, specialized tools some viruses and some fungi. Dry heatAutomated Cleaning Intermediate Level Low TemperatureUltrasonic Kills vegetative bacteria, OzoneMedical Washers viruses, fungi and mycobacterium. Chemical Liquid - Steris High Level Hydrogen peroxide Kills all microbial organisms – potential to render device Gas sterile. Ethylene Oxide Hydrogen peroxide (gas Thermal plasma) - Sterrad Disinfection via thermal applications under 100°C. Radiation-Gamma, E-beam Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 15
  • Reusable Device Classification Device Definition ExamplesClassification •Introduced directly into bloodstream •Surgical instruments, needles, Critical or other normally sterile areas of the catheters, Implants, invasive body endoscopes •Non-invasive flexible and rigid •Intact mucous membranes fiber optic endoscopes, aspirator Semi-Critical •Does not penetrate the bloodstream tubes, respiratory therapy or normally sterile areas of the body equipment •Blood pressure cuffs, Non-Critical •Intact skin of patient stethoscope, external sensors*Adapted from AAMI Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 16
  • Acceptance Criteria Summary Device Classification Treatment Options Criteria Critical Sterilization •Sterilization: SAL – 10-6 (Must be Sterile) Sterilization •Sterilization: SAL – 10-6 Semi-Critical or •Disinfection: 6 log (Sterile or disinfected) High Level Disinfection reduction Simple cleaning •Sterilization: SAL – 10-3 or Non-Critical •Cleaning: Removal of Low level disinfection (Does not need to be residuals, visually clean or sterile) •Disinfection: 3-log Intermediate level reduction disinfection*Note: Devices must be cleaned prior to disinfection or sterilization Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 17
  • Case Study #1: Surgical Forcepso Use: For surgical procedures and may potentially contact bloodstreamo Device Category: Criticalo Complexity: Simpleo Requirements: Cleaned and Sterilized Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 18
  • Forceps Limitations and Riskso Limitation: Stainless steel is not compatible with many chemicals • Risk: Rust and corrosion can occuro Limitation: Uneven grooves on tip and grip points • Risk: High levels of residuals may be trapped in grooves Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 19
  • Forceps Cleaning Procedureo Step 1: Cleaned with sponge and Alconox Detergent • Alconox is widely used in hospitals and will not cause corrosion • Sponge aids in removing residue from grooveso Step 2: Rinsed device under running water • Rinsing removes residuals and detergent residueso Step 3: Screened for total organic carbon from both soil and detergent • Screening confirms that levels of residuals are acceptable Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 20
  • Forceps Sterilization Procedureo Steam sterilization using an autoclave was validated • Autoclaves are readily available • High heat of an autoclave sterilizes devices • No chemicals are involved Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 21
  • Case Study #2: Blood Glucose Metero Use: Repeatedly used for blood glucose monitoring. Body of meter may contact bloodo Category: Semi-criticalo Complexity: Medium complexity. Has electronic partso Requirements: Cleaned and disinfected Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 22
  • Glucose Meter Limitations and Riskso Limitation: Cannot be immersed • Risk: Difficult to clean and disinfect without immersion, which could affect electronicso Limitation: Button and crevices limit cleaning ability • Risk: Residuals may become trapped if procedure is not effectiveo Limitation: Device cannot withstand high heat • Risk: Steam sterilization of thermal disinfection cannot be used because they could damage the device Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 23
  • Glucose Meter Cleaning Procedureo Step 1: Cleaned with Sani-Cloth wipes • Wipes are widely used in hospitals for quick and thorough cleaningo Step 2: Screened for TOC • Screening will confirm if unacceptable levels of residuals are present Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 24
  • Glucose Meter Disinfection Procedureo Disinfected with Sani-Cloth wipes; liquid left on device for 5 minutes • Wipes are convenient • Does not use high heat • Does not require immersion of device Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 25
  • Case Study #3: Colonoscopeo Use: Non-invasive diagnostic device used to examine the colono Device Category: Semi-critical (contacts mucosal surfaces)o Complexity: High complexityo Requirements: Cleaned and Disinfected Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 26
  • Colonoscope Limitations and Riskso Limitation: Complex design o Limitation: Knobs and screws • Risk: Difficult to design a • Risk: May retain high cleaning process that is both residuals levels simple and effective o Limitation: Not all parts areo Limitation: Device composed of immersible multiple materials including • Risk: Immersion could metals, silicone, and glass destroy camera or • Risk: Susceptible to scratches electronics and deformities o Limitation: Repeatedo Limitation: Not compatible with reprocessing some cleaning agents • Risk: Reprocessing could • Risk: Corrosion or release of affect device functionality toxic byproducts Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 27
  • Colonoscope Cleaning Procedureo Step 1: Clean with sponge and water • Initial cleaning removes visible contaminants • Soft sponge will not scratch deviceo Step 2: Device partially immersed in Cidex OPA • Some parts are immersible; these are best cleaned by soakingo Step 3: Wipe non-immersed parts with Cidex OPAo Step 4: Rinse with water • Removes excess chemicals and soil Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 28
  • Colonoscope Disinfection Procedureo Step 1: Wiped and disinfected with Cidex Activated for 12 minutes • Autoclaving not an option, disinfection appropriate • Using same type of reagent is convenient • Longer time of exposure needed to achieve disinfectiono Step 2: Rinsed under running watero Step 3: Screened for residuals with TOC Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 29
  • The Importance of Design1. Proper design ensures device will perform and function correctly and safely2. Good design allows the device to be thoroughly cleaned and effectively disinfected or sterilized Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 30
  • Design Considerationso Material Designo Physical Designo Total System Designo Misuse-related Design Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 31
  • Material Design Considerationso Biocompatibility • Non-toxic • Compatible with cleaning/disinfection reagentso Potential release of toxic byproducts • Reactivity to reagents • Leaching of materialso Capacity to retain residuals • porous/non-porous • Scoring by cleaning materials • Smooth vs. rough surfaceso Metals vs. polymeric materials • Polymers may react to chemicals • Metals are susceptible to corrosion and pitting Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 32
  • Physical Design Considerationso Size, shape, and configuration • Long, narrow interior channels/lumens • Rough or discontinuous surfaces, ridges, crevices, sharp angles, joints • Small openingso Will the device be disassembled and reassembled? • Should be easy • Limit use of adhesives or lubricants • Small pieces may be losto Is there an interior space? • Consider adding an open port to facilitate flushing soil fluids Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 33
  • Total System Design Considerationso Design elements • All components and subassemblies should handle stress of reprocessing procedure • Certain materials don’t mix  Ex: Stainless steel and aluminum, brass, copper, or chrome platingo How does cleaning process affect delicate instruments • Small screws • Coatings, glues, and amalgamo Effects of reprocessing • Will toxic byproducts be released? • Possibility of corrosion? • Are there electronics? Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 34
  • Misuse-related Design Considerations Goal: Identify any potential damage to the device resulting from improper use or reprocessingo Effects of improper cleaning o Consequences of improper • Device deformities reassembly • Scratches and leaching • Broken deviceso Effects of incorrect sterilization or • Lose parts disinfection • Damage equipment • Corrosion • Loss of time • Toxic byproducts • Rust or discoloration Note: Manufacturer should attach warning to instructions for use (IFU) if serious damage could occur Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 35
  • Summaryo Cleaning and Disinfection/Sterilization Validation is a major factor in achieving FDA approvalo Many design factors can positively or negatively impact validationo An understanding of cleaning, disinfection, and sterilization processes will aid in designing a more easily validated and reprocessed device. Thank you! Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 36
  • Referenceso ANSI/AAMI ST58:2005 – Chemical Sterilization and High-Level Disinfection in Health Care Facilitieso AAMI TIR 12:2010 – Designing, Testing and Labeling Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturerso AAMI TIR 30:2011 – A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Deviceso ASTM Designation E2314-03(2008) – Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)o FDA Guidance on Reprocessing of Reusable Medical Devices Cleaning, Disinfection, and Sterilization Validations: Design Considerations 2/28/2012 37