Decontamination Toolkit. for Peri-operative staff

Transcription

1 Decontamination Toolkit for Peri-operative staff

2 Your details Name: Health Board: Date from: Date to: 1 Decontamination Toolkit for Peri-operative staff

3 Contents Introduction 3 Module 1: Basic Principles of Decontamination 6 Module 2: Storage and Transportation 13 Module 3: Procurement, Loan Sets, Repair and Disposal 18 Module 4: Harm Minimisation, Surgical Instruments 22 Activities: Questions and Answers 26 References 37 2 Decontamination Toolkit for Peri-operative staff

4 Introduction This workbook is primarily concerned with reusable medical devices that are processed through a Central Decontamination Unit (CDU); historically these departments have gone by many names e.g. Theatre Sterilization Service Unit (TSSU). Some reference is also made to single use devices due to: their use in specific procedures is directed by National policy e.g. small implants, tonsillectomy instruments several shared issues (relating to both single use and reusable medical devices) This workbook is designed to support the education of all peri-operative staff but particularly those in roles banded Agenda for Change (AfC) 2-7. It is intended that the theatre education staff will provide support where needed. This may include facilitating discussion around issues raised in the workbook and where necessary coordinating with experts such as infection control teams and decontamination managers to enhance the learners experience. 3 Decontamination Toolkit for Peri-operative staff

5 Introduction Background Following the publication of the The Glennie Framework and in accordance with the Glennie Technical Requirements (2001) 1 decontamination services for surgical instruments in Scotland were centralised and decontamination leads appointed at board level to manage reusable medical device processing. This removed the involvement of theatre staff in many of the process elements of medical device management; however, peri-operative staff still play a vital role in medical device management. With this in mind, a self reporting survey was commissioned by NHS Education for Scotland in which perioperative staff from four NHS Scotland health boards ranging from AfC bands 2-7 identified their involvement with medical device management and their knowledge gaps regarding medical devices. The results of this survey confirmed that peri-operative staff were still involved in many aspects of medical device management and also indicated that an education tool would be beneficial for peri-operative staff in regard to medical device management. 2 Acquisition 1. Purchase 2. Loan Disinfection Cleaning Inspection Transport At all stages: Location Facilities Equipment Management Policies/Procedures Packaging Disposal 1. Scrap 2. Return To Lender Use Sterilization Storage Transport The diagram above has been widely accepted as an accurate representation of the sequences that make up the lifecycle of reusable medical devices 3 required to be sterile and fit for purpose. The diagram and associated literature, for the most part, focus on the processes within central decontamination units (CDU) which provide decontamination services for operating departments. All Central Decontamination Units in Scotland must be accredited to an international quality standard; BS EN ISO 13485: 2003 Medical Devices Quality management systems Requirements for regulatory purposes, and departments regularly submit to independent (external) audits to ensure the standard is continually met. 4 Decontamination Toolkit for Peri-operative staff

6 Introduction The decontamination elements of external transport cleaning disinfection inspection packaging and sterilization are the responsibility of the CDU. However, peri-operative staff will have extensive involvement in the remaining elements of the lifecycle: acquisition storage use and disposal (terminal, return to lender and repair, and maintenance). Peri-operative staff therefore require the knowledge and skills to enable them to fulfil their responsibilities in these areas. They also require a collaborative working relationship with the CDU. The role of peri-operative staff in medical device management can impact significantly on the ability of the CDU to successfully decontaminate instrumentation and, therefore, the maintenance of clinical activity. NB: It is important to note, when referencing this diagram, that peri-operative staff are not involved in external transportation. They may however have a role in internal transfer to a dispatch area. Knowledge of safe transport practice is therefore essential. 5 Decontamination Toolkit for Peri-operative staff

7 Module 1 Basic Principles of Decontamination Learning Outcomes 1. Demonstrate an understanding of the cause of infection 2. Demonstrate a general understanding of how surgical intervention may lead to infection 3. Describe the three levels of intervention first proposed by E H Spaulding 4. Demonstrate an understanding of the importance of additional precautions when dealing with vcjd risk procedures/patients 5. Understand the importance of supplying sterile products fit for clinical procedure e.g. correct functional instruments sets, free from contaminants and rust etc. 6. Understand the decontamination process and explain your role in it 6 Decontamination Toolkit for Peri-operative staff

8 Module 1 Basic Principles of Decontamination Causes of Infection The chain of infection is a familiar idea for most people working in health care. Chain of Infection 1. The Infectious Agent 2. The Reservoir 3. The Portal of Exit 4. The Mode of Transmission 5. The Portal of Entry 6. The Susceptible Host The Infectious Agent An infectious agent is a pathogen (disease causing: Path=disease Genesis=cause/the start of). Infectious agents can be divided into groups based on taxonomy (biological classification). Six categories are listed below in the figure. Bacteria Helminth e.g. Clostridium difficile Virus e.g. Thread worms Protozoa Fungi e.g. Influenza virus e.g. Plasmodium falciparum Prion e.g. Aspergillus fumigatus e.g. vcjd 7 Decontamination Toolkit for Peri-operative staff

9 Module 1 Basic Principles of Decontamination The Reservoir This is any area were potential infectious agents are found. An endogenous (endo = inside) reservoir means that the source of the infection arises from our own microbial flora, that is micro-organisms that usually do no harm but which can gain access to a susceptible site following a surgical procedure - for example, gastrointestinal flora causing a wound infection following bowel surgery. An external or exogenous (exo = outside) reservoir of infection can include many potential sources. It can be useful to divide these into active and passive reservoirs of infection. Active reservoirs are those in which the number of infectious agents can increase over time for example, people incubating colds or milk left out on a bench. Passive reservoirs are those in which the number of micro-organisms does not increase dramatically over time; these include environmental areas such as work surfaces, and storage areas including cardboard boxes and door handles. Portal of Exit This is the route that an infectious agent leaves the reservoir. A common reservoir of infection is people. The portal of exit can be by excretions through urine or vomit; secretions of blood or body fluid; droplet from the mouth or nose or by skin scales. The Mode of Transmission Most infectious agents are not very mobile on their own. They rely on a method of transport to take them from one host to another. Transmission can take place via a number of routes including direct spread, indirect spread or by air-borne spread. Limiting the direct spread of infectious agents is the reason hand hygiene is so important in operating theatres and other clinical environments. Indirect spread is the main focus of our concern in decontamination. We can imagine that surgical instruments are a potential link between one patient and another. Through a quality controlled decontamination process we reduce the risk of an infectious agent being transferred in this way. 8 Decontamination Toolkit for Peri-operative staff

10 Module 1 Basic Principles of Decontamination The Portal of Entry A portal of entry is quite simply the way an infectious agent gets into an area where it can cause disease. One of our key defences against potentially harmful agents is intact skin. Clinical procedures often break this defensive barrier. Clinical procedures are divided into three categories depending on the level of risk of transmission. This system of categorisation is called the Spalding classification. 4 It is important as it guides the level of decontamination required. Table 1. The Spaulding System of classification. Critical Definition Example Level of Decontamination Required Invasive device enters tissue that is usually sterile or enters the vascular system. This includes contact with breaches in the skin and/or mucous membrane Most surgical instruments Sterilization Semi-critical Definition Example Level of Decontamination Required Device contacts intact mucous membrane but does not penetrate sterile tissue Anaesthetic equipment, mouth gags, many flexible endoscopes Sterilization preferred where practicable. High level disinfection Non-critical Definition Example Level of Decontamination Required Device only contacts intact skin Stethoscope, sphygmomanometer cuff. Cleaning. It is important to note that the presence of some infectious agents may require that non-critical instruments are disinfected between uses. This would be considered a transmission based additional precaution in addition to the standard precaution of cleaning. Advice should be sought from your infection control department. 9 Decontamination Toolkit for Peri-operative staff

11 Module 1 Basic Principles of Decontamination The Susceptible Host Microbe Host Intact skin Polymorphs Antibodies Genetic } susceptibility Immune status Natural defences Commensal flora Capsule Toxins Endotoxin } Pathogenicity Virulence factors Mode of transmission Micro-organisms are a vital part of all our lives. The majority of micro-organisms either do us no harm or are beneficial. There are however some micro-organisms that have the capability to cause disease. In most cases the potential to cause disease is dependent on the relationship between the micro-organisms and the host s immune system. As mentioned above surgical intervention often bypasses the body s first line of defence, intact skin. There are several other conditions found in operating theatres that may tip the balance in favour of pathogenic micro-organisms. These include: general weakening of the patient through blood loss periods under general anaesthetic the disproportionate representation of the ill and elderly whose immune status may already be compromised through disease or malnutrition. The Decontamination Process Many people believe that sterilization is a stand alone process; however, the decontamination process is not a single procedure. It is an essential combination of procedures that render a medical device safe for use; cleaning, disinfection, and, where applicable, sterilization. In order to ensure patient safety it is vital that medical devices are inspected prior to sterilization for cleanliness, dryness and functionality. Complex equipment and surgical sets must be re-assembled to required specification. Many more micro-organisms are removed during the cleaning section of the process than at any other point. This number is further reduced during the thermal disinfection stage which will kill most micro-organisms. By reducing bioburden (the number of micro-organisms on an item) through effective cleaning and disinfection we decrease the chances of a viable organism surviving the final sterilization phase. As well as infectious agents it is important that medical devices are also free of all contaminates and maintain optimal functionality. To ensure this the decontamination process also includes appropriate storage. 10 Decontamination Toolkit for Peri-operative staff

12 Module 1 Basic Principles of Decontamination In decontamination departments the processes of cleaning disinfection inspection packaging and sterilization are already subject to rigorous quality control procedures. In order to guarantee that the product remains sterile until it is used on the patient, the integrity of packaging internal transfer and storage of the device in theatre suites must also be quality controlled. Although the cleaning, disinfection and sterilization processes are no longer conducted in the theatre, theatre staff still play a vital role in increasing the chances of a successful decontamination cycle. One of the key steps is the timely removal of gross contaminants e.g. cement, before it hardens. Hardened cement is difficult to remove and forces needed to remove it can damage instruments and even trace amounts can provide shelter for micro-organisms. All opened sets and reusable supplementary instruments, regardless of whether used or not must be returned to the CDU. Variant Creutzfeldt-Jakob Disease (vcjd) One of the main reasons that quality management has become the cornerstone of decontamination services is the risk of the iatrogenic* transfer of the prion associated with Variant Creutzfeldt-Jakob Disease. Animal models 5 have demonstrated that prion proteins are still capable of causing disease even after being exposed to the temperatures used for sterilization of surgical instruments. This means that thorough cleaning, which has always been important to the decontamination process, takes on an even more vital role. * Iatrogenic: Any undesirable condition in a patient occurring as the result of treatment by a doctor (or other healthcare professional), in particular, infections acquired by the patient during the course of treatment. For high risk procedures on at risk patients, quarantining of instrumentation is required. High risk procedures are define by National Institute for Clinical Excellence NICE guidelines (2006) Appendix C, It is important to ask the patient or their representative whether they have been diagnosed in relation to CJD risk. 11 Decontamination Toolkit for Peri-operative staff

13 Module 1 Basic Principles of Decontamination Table 2. List of questions that should be asked of a patient undergoing surgery or Neuro-Endoscopy on high risk tissue. 6 Have you ever been notified that you are at risk of CJD or vcjd for public health purposes? Have you any history of CJD or other prion disease in your family? Have you ever received growth hormone or gonadotrophin treatment? Have you had surgery on your brain or spinal cord at any time in the past? Since 1980, have you had any transfusions of blood or blood components (red cells, plasma or platelets)? Further information on national requirements regarding vcjd can be found at: 1. The National Institute for Health and Clinical Excellence (NICE) 2. Advisory Committee on Dangerous Pathogens (ACDP) A key component of decontamination quality management is full traceability. This ensures that every set of instruments can be associated with every patient. The old saying that a chain is only as strong as its weakest link was never truer than in the case of medical device traceability. The following factors may affect the ability of the decontamination department to provide full traceability. Migration of Instruments Migration of Instruments is a term used to describe the movement of instruments from one set to another or the unauthorised replacement of instruments. Migration of instruments can decrease the ability of the decontamination services to provide full traceability of medical devices. This is not only a requirement of quality management systems but is also a key element of patient safety. To ensure that a quality process is maintained throughout the whole decontamination lifecycle theatre staff should ensure sets are complete and that supplementary items are kept separate. Patient Association Most theatres have an agreed system in place identifying where instrument sets and supplementary instruments are associated with a specific patient for a specific case. It is vital that once instruments are associated with one patient they are returned to the decontamination department prior to being used on another patient unless there is a stringent disassociation process in place that eliminates risk of cross contamination. 12 Decontamination Toolkit for Peri-operative staff

14 Module 2 Storage and Transportation Learning Outcomes 1. Demonstrate a general understanding of risks to sterile pack integrity 2. Identify and interpret symbols on packaged items in line with EN Decontamination Toolkit for Peri-operative staff

15 Module 2 Storage and Transportation Background Decontamination can be seen as a series of process components and the success of decontamination as a whole depends on every component being completed successfully. Acquisition Acquisition 1. Purchase 2. Loan Disinfection 1. Purchase 2. Loan Disinfection Cleaning Cleaning Inspection Inspection Transport At all stages: Location Facilities Equipment Management Policies/Procedures Packaging Disposal 1. Scrap 2. Return To Lender Transport At all stages: Location Facilities Equipment Management Policies/Procedures Packaging Disposal 1. Scrap 2. Return To Lender Use Use Sterilization Sterilization Storage Transport Storage Transport Figure 1 Figure 2 Figures 1 and 2 demonstrate this graphically, with Figure 2 highlighting those parts of the process that take place within the operating theatre environment. The definition of sterile An instrument is sterile if the probability that there are viable microbes on the instrument is equal to or less than 1 in a million (10-6 ) by a validated process. BS EN ISO 17665:1: 2006 ISO/TS 11139:2006 In module 1 we considered the elements necessary to produce a sterile set of medical devices, however in order to ensure the set arrives in theatre in the same sterile state recontamination must be avoided throughout the transportation and storage phases. We can use the chain of infection model to explain RESERVOIR: A wet shelf or excess cardboard packaging material, dust or waste stored near sterile packages could be potential reservoirs. MODE of TRANSMISSION: Water on a wet shelf, pests in the storage area or dirty hands of staff could be seen as a mode of transmission. PORTAL OF ENTRY: A tear, wet paper backing on a peel pouch or a loose piece of wrapping tape can provide a portal of entry. To ensure the quality of the decontamination process a package must not become contaminated prior to use. Traceability systems should be able to identify the location of all surgical sets at each stage of the process including storage. 14 Decontamination Toolkit for Peri-operative staff

16 Module 2 Storage and Transportation Consideration should be given to: integrity and condition of packaging, e.g. dryness recording on traceability system cleanliness of dedicated storage area for sterile instruments non conforming items should be reported immediately to CDU cleaning, frequency of storage area manual handling first in first out (FIFO) (check expired date and labelling) transport trolley for internal transport (if applicable). Advice on general principle of sterile storage can be found in Scottish Health Planning Note (SHPN )13 part 1, available from Health Facilities Scotland Packaging Symbols There is a standardised method of labelling medical devices. These symbols are listed in the European Standard EN 980: It is vital that all staff using medical devices are familiar with these symbols to avoid: contamination of aseptic field by introduction of non sterile items using items that are past their expiry date damage to expensive equipment through incorrect storage risk to patient safety through damage caused by incorrect storage. Below are some of the symbols you should be able to recognise Single Use An item with this symbol must not be reused. The manufacture has designated it a single use only and will not take responsibility if it is reused. It will not be reprocessed in a sterile services department in Scotland. It is not acceptable to reuse this item even on the same patient. It should be disposed of immediately after single use according to local policy/ guidelines Date of manufacture This is the symbol that details when an item was manufactured. You will see this symbol on sterile packs. In the case of reusable medical devices, the symbol identifies when the item was last processed. Manufacturer This is the symbol that details who manufactured an item. This enables full process traceability. Biohazard This symbol may seem out of place, however any contaminated items should have this symbol clearly visible during storage and transport. It is vital that theatre staff recognise this symbol to ensure adequate segregation of contaminated instruments. 15 Decontamination Toolkit for Peri-operative staff

17 Module 2 Storage and Transportation Expiry Date This is the date after which an item must not be used. In the case of reusable medical devices they may be returned to the sterile services department. If single use symbol is also found on the packaging of an item past the expiry date, then the item must be disposed of. Note: You must not rely on this symbol as proof of sterility. It is vital that the package is checked for damage prior to use even if the set is well within its expiry date. Serial Number A serial number is unique and assigned to a medical device on manufacture. This unique number ensures that an item can be traced throughout its life from initial use through to disposal and linked to every process, procedure and patient. Lot/Batch Number Unlike the serial number the batch number links a medical device to a process event such as sterilization. Modern sterile services departments have sterilizers capable of processing many sets and supplemental devices in the one cycle. The lot number allows all items processed by the same cycle to be traced. This is of vital importance if a fault is detected retrospectively and items need to be recalled. Reference/Catalogue/Model Number This is the number used to identify a type of instrument. While there may be thousands of individual items produced with the same reference number, their specification should be identical. You may notice that reference numbers are standardised depending on the manufacture. Some may have distinguishable extra information indicating minor model variation - for example, colour or year and even month of manufacture. Sterilization Cycle This symbol indicates that the device has successfully completed a sterilization cycle, according to the manufacturer. It is important to note that, as with the expiry date, the product can only be considered sterile if the packaging is undamaged. There are several variations on this symbol that give us information on how the device was sterilized. Sterilized Using Thermal Energy The device has been sterilised using thermal energy. This is the most common symbol you will see as it is used, although not exclusively, to indicate steam sterilization. The most common steam cycle used in Scotland is 134 C C for 3-3½ minutes. Sterilized Using High Energy Radioactivity You may see this symbol on many of the single use items that are provided as sterile. This symbol means that the device was sterilized using high energy radiation. This is especially common for dressings and plastic items. Sterilized Using Ethylene Oxide You may notice the EO symbol on a package looks like it has come from the central sterile department. You should compare the tape used to wrap the product with the tape used to wrap the thermally sterilized packs, you may notice a difference. The symbol means that the item was sterilized using ethylene oxide gas. This is usually reserved for items that can not tolerate the 134 C steam cycle. 5 C Minimum Temp a Product Should be Exposed to The minimum temperature that a product should be exposed to. 16 Decontamination Toolkit for Peri-operative staff

18 Module 2 Storage and Transportation 55 C Maximum Temp a Product Should be Exposed to The maximum temperature that the device should be exposed to. Read Manufacturer s Instructions This symbol means that the manufacturer s instructions should be read prior to use. Caution Potential Hazard CAUTION: See accompanying documentation. This symbol alerts the user to a potential hazard. More information should be sought prior to using this device. This information can be found in the manufacturer s instructions. Transportation of Used Devices Once items have been used in theatre we must be concerned with the potential hazard they pose while being transported internally and externally. Although the medical devices we are transporting back to the CDU are reusable, they are considered potentially infectious as they are contaminated with body fluids. Transportation containers should be safe and secure and are required to be robust enough to withstand the transport phase without breakage or leakage. This includes remaining intact when dropped from a height of 1.2 m. The words Used Medical Device or Used Medical Equipment should be visible on all transport containers. 7 HFS will soon release a more detailed transport guidance document; this will be accessible through the HFS website 17 Decontamination Toolkit for Peri-operative staff

19 Module 3 Procurement, Loan Sets, Repair and Disposal Learning Outcomes 1. Demonstrate a general understanding of the implications of the medical devices directive 93/42/EEC 2. Demonstrate a basic knowledge of the implications of BS EN ISO 13485: medical devices, Quality Management Systems 3. Demonstrate a general knowledge of the transportation requirements for contaminated medical devices 4. List general considerations for purchasing single use and reusable medical devices 5. List those involved in purchasing decisions/specification and briefly describe their role and the process 6. List the required steps for receiving loan equipment 18 Decontamination Toolkit for Peri-operative staff

20 Module 3 Procurement, Loan Sets, Repair and Disposal Background The manufacturer of a reusable medical device has a responsibility to provide validated instruction for decontamination of equipment. Therefore, at procurement, it is important to assess that manufacturer s instructions for decontamination are compatible with the decontamination processes used by your CDU. marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation and gives assurances that the products are acceptable to European standards without the need for adaptation or rechecking. The directive compliance of the product may be subject to audit and will be identified by a four digit number identifying the notifying body under the CE mark. In the case of medical devices the relevant directive is the Medical Device Directive 93/42/EC. In the UK the Medical Device (Amendment) Regulations 2008 transposes the requirements of the directive into law. It is stressed in the Medical Device Regulations that a medical device should only be used for its intended purpose. Equipment should not be used or modified for a purpose other than that specified by the manufacturer. Procurement An NHS Hospital s annual budget is dependent on a number of factors: the size of the hospital; patient capacity and the medical and surgical needs of the catchment population. From this overall budget a proportion is designated for procurement. It would not be considered out of place for well over 10% of the entire annual budget to be spent on products and services from external suppliers. It is important that this vast amount of money spent on procurement actually supports the delivery of safe, effective and timely patient care. Just like best practice is a vital concept in clinical care, best value procurement is a key consideration to ensure effective use of limited available funding. Most nurses will be familiar with the 5 rights of medication administration Right Patient Right Medication Right Time Right Dose Right Route of Administration Procurement has it own 5 rights Right Product Right Place of Delivery Right Time of Delivery Right Quantity Right Price 19 Decontamination Toolkit for Peri-operative staff

21 Module 3 Procurement, Loan Sets, Repair and Disposal NB: In order to meet the Right Product criteria the item must meet the required specification and be of the required quality. As previously noted, all medical devices used in the EU must be manufactured in line with the Medical Device Directive and appropriately CE marked. Reusable medical devices must also be compatible with the decontamination process. This includes the traceability system used locally, and the ability to mark the product with a bar code or other unique identifier. To ensure that all these rights are addressed procurement must be a collaborative process. Some of those who should be involved include Decontamination Lead: advice on reprocessing and turn around times (Right Product/Right Quantity) Clinical lead: fit for purpose (Right Product) Medical physics: structure function resilience (Right Product) Logistics and procurement staff (Right Place/Right Time) Finance and procurement (Right Cost) Ensuring involvement from the correct people in procurement is a key issue. Clearly defining roles, responsibilities and accountability of all those involved in procurement will ensure a more effective and efficient process. Loan Devices One challenging area is the traceability of loan equipment. Loan equipment refers to instruments or sets that are provided by an equipment manufacturer, agent or other health care provider. There may be several reasons for this The equipment may be highly specialised The equipment may be new or being trialled The equipment may be too expensive for outright purchase Equipment may be provided on loan to replace equipment that is being repaired Between hospitals to cover shortfalls or emergencies Regardless of the reason that equipment is being loaned it is unlikely that it will just slot into the tracking and traceability system on site. The equipment will need to be prepared, checked for completeness against the inventory and a check list prepared. For this reason it is essential that there is a clear policy and procedure for receipt of loan equipment. This must include Responsibility for receiving Responsibility for checking compatibility with the decontamination process Agreed preparation time ( NB: this may be hours) Responsibility for checking for completeness and function Responsibility for staff training Responsibility for return and collection (including time frames) Reporting system for complaints or incidents It is also important that liability terms are agreed with the device provider. 20 Decontamination Toolkit for Peri-operative staff

22 Module 3 Procurement, Loan Sets, Repair and Disposal In the near future Health Facilities Scotland (HFS) will be releasing a national loan policy; this will be available through the HFS website. Decontamination Certificates A decontamination certificate is a vital document in the process of transporting medical devices. This certificate states the level and the nature of decontamination to which a device has been subjected. A decontamination certificate should be provided When equipment is sent for repair When loan equipment is sent from the Distributor to the Hospital When loan equipment is returned by the Hospital to the Distributor Decontamination certificates provide vital information on the reprocessing methods that medical devices have been subjected to prior to dispatch. 21 Decontamination Toolkit for Peri-operative staff

23 Module 4 Harm Minimisation, Surgical Instruments Learning Outcomes 1. List possible contributing factors to surgical instrument damage 2. Demonstrate knowledge of the incident reporting system at your site and when to use it Peri-operative staff play a vital role in ensuring that: 1. instruments maintained in sterile state until point of use 2. instrument damage is minimised and optimal functionality maintained 3. instruments are free from gross contaminates that may impact on the success of the decontamination process 4. any issues or incidents associated with medical devices are reported through correct channels to increase patient safety and promote service improvement 22 Decontamination Toolkit for Peri-operative staff

24 Module 4 Harm Minimisation, Surgical Instruments Medical devices are often expensive so high rates of damage can have a dramatic impact on budgets. Damage can also lead to safety issues for patients and staff and must be dealt with accordingly. The Medical Device Regulations make it the responsibility of the manufacturer to provide reprocessing instructions that must be followed by the user. Instructions are specific to each device, however some general practises can have a negative impact on instruments such as: Avoid keeping instruments in saline solution or body fluid for prolonged periods of time. Salt can dramatically increase the likelihood of rust. It is important to remember that blood is quite salty so it is advisable to remove gross contamination with water rather than normal saline. Any rusty instruments must be reported to CDU. Mechanical Damage Stainless steel and the other materials used in medical device manufacture are quite robust, however it is important to note that many medical devices are precision engineered and fragile, therefore, when packing instruments back into sets for transport it is vital to think about the potential damage that can be caused by a mixture of heavy and delicate instruments colliding with each other. Risks to Sterility As previously noted decontamination services go to a great amount of effort to ensure that instrument sets and individual items are sterile on dispatch. However, this sterility can be easily compromised if handling and storage on site is not done with care. Many sets are returned to decontamination services due to compromised packaging. This is extremely costly to the service, wasteful of resources, and incurs a risk of low stock levels. Some of the risks to packaging integrity include: rough handling stacking trays rough or burred shelves storage conditions e.g. rapid air pressure changes rapid temperature changes humidity general environmental cleanliness air quality and flow Systems should be in place to mitigate against these risks. 23 Decontamination Toolkit for Peri-operative staff

25 Module 4 Harm Minimisation, Surgical Instruments If sterility has been compromised instruments and sets must be returned to the CDU for full processing prior to use. Incident Reporting By recording incidents we can reduce future risks for patients and staff. Adverse Incident An adverse event causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, users or other persons. Local incidents may have implications for other organisations and it is essential that all adverse incidents are reported in order to learn from and avoid serious outcomes such as: death, life-threatening illness or injury deterioration in health the need for medical or surgical intervention unreliable test results leading to inappropriate diagnosis or therapy. Adverse incidents that appear to be caused by human error should also be reported as they might indicate deficiencies in the design of the device or equipment; the instructions for use or local processes or procedures; and help prevent repetition of mistakes recurring. Sharing this can also lead to improvements in design. The Adverse Incident Reporting System is concerned with preventing the occurrence of adverse incidents, not with assigning blame. Incident reporting is an important part of service improvement and it is vital that we have a formal process of incident reporting given the complex nature of surgical intervention and the multidisciplinary team involved. Any given incident will more than likely have a number of causal factors; incident reporting is not about fault finding it s about fact finding. 8 If an incident occurs involving a medical device it is vital that the decontamination manager is informed. In accordance with local policy and guidance incidents can be investigated internally but may need to be further investigated by a third party. In Scotland the Incident Reporting and Investigating Centre (IRIC) co-ordinates the investigation of adverse incidents on behalf of Scottish Government Health and Social Care. Working mainly with NHSScotland and local authorities, they pursue investigations involving medical devices and estates equipment until a satisfactory outcome can be achieved. Where necessary, they issue warnings including Hazard Notices and Safety Action Notices. For further Information see Health Facilities Scotland Incident reporting and investigating centre Further information on Best Practice regarding the management of medical devices can be found at 24 Decontamination Toolkit for Peri-operative staff

26 Activities Questions and Answers

27 Activity 1 The Chain of Infection Chain of Infection 1. The Infectious Agent 2. The Reservoir 3. The Portal of Exit 4. The Mode of Transmission 5. The Portal of Entry 6. The Susceptible Host Insert a tick in the box below appropriate link in the chain of infection. 1. The Infectious Agent 2. The Reservoir 3. The Portal of Exit 4. The Mode of Transmission 5. The Portal of Entry 6. The Susceptible Host A patient with severe burns A dirty forcep Soiled scrubs An IV site Bowel resection A reusable nail brush Spray from a nail brush A catheter A cardboard box 26 Decontamination Toolkit for Peri-operative staff

28 Activity 2 Storage and Transportation C 5 C Definition Number Biohazard: This item is contaminated. Date of manufacture: When was the device manufactured/processed. Manufacturer: Who manufactured the device. Caution: There is a potential hazard; the accompanying documents should be consulted for further information. This number associates the device with a specific process. This device has been sterilized using a thermal method such as steam. This number is unique to this device and remains with it throughout its entire life. This product has been sterilized using radiation. This product could be stored at 20 C. This product has been sterilized using ethylene oxide gas. This is the number you would find associated with a device in the catalogue. Single use only: Not to be reprocessed or reused. Expiry date: The product can be used up until this date assuming the packaging is intact. Refer to manufacturer s instructions. 27 Decontamination Toolkit for Peri-operative staff

29 Activity 3 Procurement, Loan Sets, Repair and Disposal With the assistance of the decontamination department, track a tray through the decontamination process. The Operating Room (Use) 1. Which of the following EN 980 symbols appear on the packaging label? Sterile by thermal Yes//No Single Use Yes/No Expiry date Yes/No Date of Manufacture Yes/No Serial Number Yes/No Manufacturer Yes/No Batch Number Yes/No Temperature range Yes/No 2. How is the tray associated with the patient? (e.g. is part of the label removed and put in patient s notes? Is a barcode on the tray and bar code on patient s I.D. bracelet scanned?) 3. After the procedure which instruments are counted back into the tray? Is a list used? 4. Where are the instruments taken to for return to the Decontamination Unit? 28 Decontamination Toolkit for Peri-operative staff

30 Activity 3 Procurement, Loan Sets, Repair and Disposal Transport 5. What kind of container is used to transport the tray to the CDU? 6. How is the container secured? 7. What indication is present on the outside of the container to identify the contents? Cleaning 8. What articles of PPE do you put on before entering the CDU dirty room? 9. Briefly describe the process the tray undergoes when it arrives at the receipt area of the Decontamination unit. 29 Decontamination Toolkit for Peri-operative staff

31 Activity 3 Procurement, Loan Sets, Repair and Disposal 10. Please explain the tracking system used in this area 11. How many times is the tray scanned prior to entering the Washer Disinfector? times 12. Are any of the tray s components separated for manual washing, if so which instrument and why? 13. Is the tray checked for completeness at this point? o Yes o No 14. What is the maximum temperature that the Washer Disinfector reaches C 15. How long is it at this temperature seconds Packaging Packaging will take place in a designated clean room; traffic through these rooms is carefully controlled. The decontamination manager may consider it not to be practical for you to visit the clean room on your trip. 16. If you were able to visit the clean room what procedures would you undertake prior to entering? 17. Why is packaging conducted in a clean room if the instrument sets are to go through a sterilizer anyway? 30 Decontamination Toolkit for Peri-operative staff

32 Activity 3 Procurement, Loan Sets, Repair and Disposal Sterilization 18. You may have to catch up with your tray again once it has been through the sterilizer. 19. What was the maximum temperature during the sterilization period? C. How long was this temperature held? mins seconds 20. Is this standard in the UK? o Yes o No 21. What checks do the staff in this area perform before your tray is removed from the sterilizer trolley? Label 22. Please describe the information shown on the label attached to the outside of the sterile pack. 23. Where is your tray placed immediately after being taken off the sterilizer trolley? 24. Why is it not placed directly into a transport trolley? 31 Decontamination Toolkit for Peri-operative staff

33 Activity 3 Procurement, Loan Sets, Repair and Disposal Dispatch 25. How is the dispatch container secured after it has been loaded? 26. What identifying labels are placed on the external surfaces of the container? 27. Are these trolleys the same type as those used to carry the contaminated trays? o Yes o No If Yes, what process have they been through while your tray was being decontaminated? 28. What was the maximum temperature that the transport trolley was exposed to C for mins 32 Decontamination Toolkit for Peri-operative staff

34 Answer 1 The Chain of Infection Chain of Infection 1. The Infectious Agent 2. The Reservoir 3. The Portal of Exit 4. The Mode of Transmission 5. The Portal of Entry 6. The Susceptible Host Insert a tick in the box below appropriate link in the chain of infection. 1. The Infectious Agent 2. The Reservoir 3. The Portal of Exit 4. The Mode of Transmission 5. The Portal of Entry 6. The Susceptible Host A patient with severe burns 3 A dirty forcep 3 Soiled scrubs 3 An IV site 3 Bowel resection 3 A reusable nail brush 3 Spray from a nail brush A catheter 3 3 A cardboard box 3 33 Decontamination Toolkit for Peri-operative staff

35 Answer 2 Storage and Transportation C 5 C Definition Number Biohazard: This item is contaminated. 1 Date of manufacture: When was the device manufactured/processed. 2 Manufacturer: Who manufactured the device. 9 Caution: There is a potential hazard; the accompanying documents should be consulted for further information. 13 This number associates the device with a specific process. 12 This device has been sterilized using a thermal method such as steam. 4 This number is unique to this device and remains with it throughout its entire life. 10 This product has been sterilized using radiation. 6 This product could be stored at 20 C. 14 This product has been sterilized using ethylene oxide gas. 7 This is the number you would find associated with a device in the catalogue. 5 Single use only: Not to be reprocessed or reused. 8 Expiry date: The product can be used up until this date assuming the packaging is intact. 3 Refer to manufacturer s instructions Decontamination Toolkit for Peri-operative staff

36 Answer 3 Procurement, Loan Sets, Repair and Disposal As you are tracking a tray through the decontamination process there is no model answer available. However you should check that the process is carried out as described in the workbook. Any deviation should be discussed with your line manager/supervisor and areas for improvement identified. 35 Decontamination Toolkit for Peri-operative staff

37 References

38 References 1. Scottish Government Health Directorates (SEHD) The Glennie Framework (2001) 2. Chapman K, Gilchrist R, Brown M and Maitland H (2011) The development of a decontamination education resource for peri-operative staff Medical Device Decontamination, The Journal of the Institute of Decontamination Sciences, Vol 16. No Microbiology Advisory Committee to Department of Health (2010) MAC manual Part 1 Principles 3rd edition May 2010: 4. Spaulding EH. Chemical disinfection of medical and surgical materials. In: Lawrence C, Block SS, eds. Disinfection, sterilization, and preservation. Philadelphia: Lea & Febiger, 1968: Brown P, Rau EH, Johnson BK, Bacote AE, Gibbs CJ, Gajdusek DC (March 2000) New studies on the heat resistance of hamster-adapted scrapie agent: threshold survival after ashing at 600 degrees C suggests an inorganic template of replication. Proceedings of the National Academy of Sciences of the United States of America 97 (7): Department of Health Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection Annex J: United Nations Economic Commission for Europe UNECE - Multilateral agreement M Scottish Government CEL 43 (2009) Annex F 37 Decontamination Toolkit for Peri-operative staff