Manufacturer’s Instructions Colleen Landers Registered Nurse MDRD Technician
Manufacturer’s Instructions • The written directions provided by the manufacturer or distributor of a product that contain the necessary information for the safe and effective use of the product. Notes: 1) See CAN/CSA-Z17664. 2) Verbal instructions can assist the user in understanding the manufacturer's instructions, but they are not a substitute for written instructions. 3) Care should be taken to ensure that the manufacturer's instructions are correct for the product. Any questions or discrepancies regarding the appropriateness of the instructions should be resolved before the product is used.
Medical Device Reprocessing General Requirements CSA Z314.0 • Section 5 Evaluation and purchase of reusable medical devices and reprocessing equipment.
Section 5.1.1 • The health care setting shall have procedures for the evaluation and purchase of reusable medical devices. These procedures shall include clearly defined responsibilities, be consistent with the requirements in Clause 4, and be maintained as specified in Clauses 4.3 and 4.4. • Where it is not possible to acquire reusable equipment and supplies, or to safely implement processes required for adequate reprocessing (e.g., remote health care settings without dedicated, trained reprocessing personnel), single-use devices may be considered in lieu of reusable devices.
5.1.2 • When purchasing a reusable medical device, the health care setting shall confirm that a) it is properly licensed in Canada; b) procured from a distributor with an establishment license; and c) meets applicable Canadian standards (e.g., written MIFUS, CAN/CSA-60601 series). • Devices not manufactured for medical use shall not be used on patients.
5.1.3 • Prior to purchasing or trialling, decisions for reusable medical devices shall involve representatives from the departments in the health care setting that will procure, use, reprocess, and maintain the devices. • The following departments should be involved as appropriate to the complexity, risk class, and intended use of the device: a) medical device reprocessing; b) purchasing; c) OR or other unit/department that will use the device; d) risk management; e) infection prevention and control; f) occupational health and safety; g) patient services; h)support services (e.g. environmental services); and i) biomedical engineering..
5.1.4 • For devices that are difficult to reprocess effectively (e.g., devices with sharp or sharp components, small lumens), single-use devices or components should be considered (see Clause 5.1.1). This decision should be made in consultation with the health care setting’s personnel or department responsible for infection prevention and control and risk management.
5.2 Reprocessing Equipment 5.2.1 The health care setting shall have procedures for the evaluation and purchase of reprocessing equipment e.g., washer-disinfectors, sterilizers, and ultrasonics. 5.2.2 Purchasing decisions for reprocessing equipment shall involve Representatives from the departments in the health care setting that will use or maintain the devices. The following departments should be involved as appropriate: a) MDRD; b) physical plant/engineering; c) biomedical engineering; d) risk management; e) infection prevention and control; f) occupational health and safety; and g) end user.
5.2.3 • Before considering any piece of reprocessing equipment for purchase, the health care setting shall obtain manufacturer's technical data, specifications, and other information specific to the equipment for required utilities and connections (e.g., electrical, steam, water, plumbing, air supply, and ventilation), and minimum service space requirements. • New equipment information shall include, but not be limited to, the following: a) installation, operational, and performance qualification (e.g., start up, calibration, and commissioning); b) requirements for consumables (e.g., paper, ink, filters, gaskets, cleaning); c) the respective responsibilities of the health care setting and the manufacturer with regard to the installation, operation, and maintenance of the equipment, specifically i) routine care (e.g., activities performed daily or weekly by the MDRD or hospital engineering department); and ii) preventive maintenance (e.g., quarterly, semi-annually, and annually pre- scheduled activities performed by the hospital engineering department, the manufacturer, or the manufacturer's representative) (see Clause 22.214.171.124); d) life cycle information, including maximum expected service time; and e) storage requirements of drug and GMP products.
5.3 Manufacturer's instructions • 5.3.1 The health care setting shall obtain device-specific manufacturer's instructions for reprocessing, which contain, at a minimum, the information required in CAN/CSA-Z17664. They shall be received and maintained in printed form (e.g., in binders, manuals, or monographs) or in electronic format, so as to facilitate device maintenance, as well as personnel training and education. The manufacturer information or manufacturer's instructions shall be placed in a location where they are readily accessible to those needing access, and they shall be updated as required.
5.3.2 • Before purchase or evaluation of a new medical device, health care setting personnel shall review the manufacturer's written instructions to ascertain that the recommended reprocessing, disinfection, and sterilization procedures a) are complete and in accordance with the level of reprocessing required for the device's intended use; b) are device specific, legible, and understandable; c) clearly indicate which parts need to be disassembled and provide clear disassembly instructions, including illustrations where necessary; d) include instructions for cleaning, type of sterilization or level of disinfection required, and cycle parameters; e) can be achieved, given the reprocessing resources of the health care setting; f) are in accordance with the intended use of the device; g) state whether or not the device is immersible; h) specify the necessary materials (e.g., detergents, enzymatic solutions) and equipment for proper cleaning and maintenance of the device; i) specify if there is a limit to the number of times the device can be reprocessed or if reprocessing will contribute to degradation of the medical device; and j) include maintenance instructions and instructions for return to the manufacturer for repair if required.
5.3.3 • Written confirmation that the reprocessing instructions have been validated shall be available from the device manufacturer. • The health care setting should ensure that the reprocessing conditions for validation that were used by the device manufacturer reflect the clinical conditions under which the device will be used in the health care setting.
5.3.4 • If the instructions are unclear, incomplete, or inadequate, the manufacturer shall be contacted for clarification or additional information. If clear, validated instructions are unavailable for a device, it shall not be reprocessed or purchased. • Health care settings that are not able to obtain the relevant instructions should report this to Health Canada at a) 1-800-267-9675; b) firstname.lastname@example.org; or c) http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-devices-materiaux/index-eng.ph
Manufacturer’s Instructions 5.3.5 The health care setting shall ensure that it can perform the reprocessing procedures as outlined by the manufacturer either internally or through an external arrangement. 5.3.6 Loaned, reusable medical devices supplied to the Health care setting shall be managed in accordance with this Standard and CAN/CSA-Z314.22.
Manufacturer’s Instructions 5.3.7 If the manufacturer's instructions specify limits on the number of uses for A medical device, the device shall be individually identified (e.g., by a device Identification number). A tracking method shall be developed and maintained in the department that is responsible for the reprocessing of the device to ensure that the device is not used beyond that limit. Note: These might also be called reposable. 5.3.8 Marking techniques used to identify instruments should be done in accordance with the device and marking device manufacturer's instructions. 5.9 Consumables for reprocessing Purchase agreements for consumables for reprocessing shall be developed. See CSA Z314.3, CAN/CSA-Z314.8, CSA Z314.10.1, CSA Z314.10.2, CSA Z314.14, and CSA Z314.23 for more information.
Accreditation Canada Diagnostic Imaging 8.4 The team follows the organization's policies and procedures and manufacturers' instructions to contain and transport contaminated devices and equipment to the medical device reprocessing department or external provider. 8.8 The team follows the organization's policies and procedures and manufacturer's instructions to select appropriate cleaning, disinfecting, and reprocessing methods. 8.9 The team follows the organization's policies and procedures and manufacturer's instructions for cleaning and reprocessing diagnostic devices and equipment.) 8.10 The team stores clean diagnostic devices and equipment according to manufacturer's instructions and separate from soiled equipment and waste. 8.11 The team has a process to track all reprocessed diagnostic devices and equipment so they can be identified in the event of a breakdown or failure in the reprocessing system.
Accreditation Canada Diagnostic Imaging Services 8.4 The team follows the organization's policies and procedures and manufacturers' instructions to contain and transport contaminated devices and equipment to the medical device reprocessing department or external provider. 8.8 The team follows the organization's policies and procedures and manufacturer's instructions to select appropriate cleaning, disinfecting, and reprocessing methods. 8.9 The team follows the organization's policies and procedures and manufacturer's instructions for cleaning and reprocessing diagnostic devices and equipment. 8.10 The team stores clean diagnostic devices and equipment according to manufacturer's instructions and separate from soiled equipment and waste. 8.11 The team has a process to track all reprocessed diagnostic devices and equipment so they can be identified in the event of a breakdown or failure in the reprocessing system.
Accreditation Canada Reprocessing Medical Device 4.5 The team maintains up-to-date manufacturers' information, instructions, and recommendations for each medical device. 4.6 The team documents and maintains policies, SOPs, standards of practice, and manufacturers' instructions in a manual. 4.7 The team trains staff prior to implementing a new or amended policy, SOP, practice standard, or manufacturers' instruction. 4.9 The team leaders review and update the policies and procedures on a regular basis and in response to critical incidents or adverse events; changes in laws, regulations, or standards; results of internal or external audits; and new evidence-based information. 4.10 The team tracks changes to policies, SOPs, standards of practice, and manufacturers' instructions using a document control procedure. 4.11 The team leaders approve in writing new and updated SOPs.
Accreditation Canada Reprocessing Medical Device 7.4 When installing reprocessing equipment, the organization follows the manufacturers' instructions and contacts the manufacturer directly for clarification or additional information, as needed. 8.4 Prior to decontamination, the team follows manufacturers' recommendations to clean and rinse equipment and devices. 8.5 The team follows manufacturers' instructions to select and perform appropriate cleaning methods. 8.6 The team follows manufacturers' instructions and accepted standards of practice to perform manual cleaning. 8.7 The team verifies that detergents, solutions, and disinfectants are compatible with the devices being reprocessed, the equipment used for washing or sterilization, and the decontamination or sterilization processes used.
Accreditation Canada Reprocessing Medical Device 8.8 For each detergent, solution and disinfectant, the team follows manufacturers' recommendations for use, contact time, shelf life, storage, appropriate dilution, testing for appropriate 8.10 The team prepares each device or set of devices for sterilization according to manufacturers' instructions, including drying, lubrication, and disassembly. 9.4 The team follows manufacturers' instructions while operating the sterilizer.
Accreditation Canada Infection Control 12.2 For each contaminated device and piece of equipment, a trained staff person uses a recognized classification system to determine whether sterilization is required. 12.6 For each disinfectant, the organization follows manufacturers' recommendations for use, contact time, shelf life, storage, appropriate dilution, and required PPE.
Accreditation Canada Leadership 9.3 The organization's leaders have a formal and open process for selecting and buying medical devices and equipment, and for selecting qualified suppliers. 9.4 The organization's leaders have a process to provide education for service providers on the safe operation of medical devices and equipment. 9.7 The organization's leaders implement an effective preventive maintenance program for medical devices, medical equipment, and medical technology. 9.7.1 There is a preventive maintenance program in place for all medical devices, medical equipment, and medical technology. 9.7.2 There are documented preventive maintenance reports. 9.7.3 The organization's leaders have a process to evaluate the effectiveness of the preventive maintenance program. 9.7.4 There is documented follow-up related to investigating incidents and problems involving medical devices, equipment, and technology.
Accreditation Canada OR 12.3 The organization selects disinfectants based on compatibility with the devices being disinfected, compatibility with other agents used in disinfection or sterilization, the intended use of the devices being disinfected, and client, staff, and environmental safety. 12.4 For each disinfectant, the team follows manufacturers' recommendations for use, contact time, shelf life, storage, appropriate dilution, and required PPE.
PIDAC Best Practices • When formulating written policies and procedures, the following steps in reprocessing must be included, a) collection at point-of-use, containment and transport; b) disassembly (if required); c) inspection; d) cleaning; e) disinfection/sterilization (including establishment of the level of reprocessing required for items, based on the risk class and manufacturer’s instructions); f) rinsing (following disinfection); g) drying/aeration; h) reassembly and functional testing; i) quarantine of non-implantable items in processed loads pending results of biological indicator (BI) testing (if load quarantine is not possible, evaluation of a Class 5 or 6 chemical indicator (CI) and specific cycle physical parameters may be used to justify the release of loads); j) quarantine of each load containing implantable devices pending results of BI testing; k) clean transportation; and l) storage.
PIDAC Best Practices Policies and procedures for cleaning medical equipment/devices shall be based on the manufacturer’s instructions and must be developed in consultation with Infection Prevention and Control, Occupational Health and Safety, Biomedical Engineering and Environmental Services. Full PPE shall be worn for handling and cleaning contaminated equipment/devices.
PIDAC Best Practices 46. The chemical disinfectant used for disinfecting medical equipment/devices must be compatible with both the equipment/device manufacturer’s instructions for disinfection and the cleaning products involved in the reprocessing of the equipment/device. 48. Manufacturer’s instructions for installation, operation and ongoing maintenance of pasteurizing equipment must be followed to ensure that the machine does not become contaminated
Manufacturer’s Instructions • For parts of equipment that come in contact with patients • manuals must describe the cleaning, disinfection, or sterilization methods that may be used • must identify suitable sterilization agents • a list of temperature, pressure, and humidity requirements • time limits that the equipment can tolerate the sterilization method • the limits to which the equipment was tested during the tests • ISO 17664 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices CAN/CSA-Z17664-06
Information to be provided by the medical device manufacturer 3.1 Reprocessing instructions • At least one validated method for reprocessing the medical device shall be specified. • The following information shall be stated where it is critical to the maintenance of the intended function of the medical device and the safety of the user(s) and the patient: details of process steps; a description of special equipment and/or accessories; specification of process parameters and their tolerances. 3.2 Limitations and restrictions on reprocessing • The manufacturer shall determine if processing in accordance with the provided instructions leads to a degree of degradation that will limit the useful life of the medical device. Where such degradation is established, the manufacturer shall provide an indication of the number of reprocessing cycles that can normally be tolerated, or some other indication of the end of the medical device’s ability to safely fulfil its intended use.
3.3 Preparation at the point of use prior to processing • Requirements for preparation at the point of use to ensure satisfactory reprocessing of the medical device, shall be specified, if applicable. • Where appropriate, at least the following information shall be included: the containers for transportation; a description of the support systems; the maximum period of time that may elapse between use and cleaning; a description of the pre-cleaning techniques critical to further processing; the requirements for transportation.
3.4 Preparation before cleaning • Requirements for the preparation of the medical device prior to cleaning shall be specified if applicable. Where appropriate, instructions for at least the following procedures shall be given: the requirements for capping/opening of ports; disassembly of the device; leak testing the device; soaking/brushing techniques required; ultrasonic treatment of the device. • If special tools are required for disassembly/re-assembly, these shall be specified in the instructions.
3.5 Cleaning • A validated method of manual cleaning shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued. • Where appropriate, at least the following information shall be included: a description of the accessories required for cleaning process; identification and concentration of chemicals required for cleaning; identification of water quality to be used for the process; limits and monitoring of chemical residues remaining on the device; limits on temperature, concentration of solution(s), exposure time to be used; the process temperature(s) to be used; the techniques to be used including rinsing.
3.6 Disinfection • A validated non-automatic method of disinfection shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process. • Where appropriate, at least the following information shall be included: a description of the accessories required for the disinfection process; the contact time of the disinfectant; identification and concentration of chemicals required for the disinfection process; identification of water quality required for the process; the limits and monitoring of chemical residues remaining on the device; the limits on temperature, concentration of solution(s), exposure time; the process temperature(s) to be used; the techniques to be used including rinsing.
3.7 Drying • Where drying is necessary, a validated method of drying shall be specified. Where appropriate at least the following information shall be included: the accessories required for the drying process; the maximum temperature and exposure time for the device; specifications of the drying agent to be used; the techniques to be used.
3.8 Inspection, maintenance and testing • When methods are required at any stage of processing to confirm the cleanliness or performance or both, of the medical device, these shall be stated. Where particular maintenance actions are required during processing to ensure the proper performance and safety of the medical device, these shall be stated. Where appropriate, these shall include details such as any part or component that requires routine replacement and/or calibration and where necessary, details for return to the manufacturer or other qualified organization. • Where appropriate at least the following information shall be given: the method to be used for adjustment/calibration of the device; a description of the lubrication to be used; the performance criteria for the device to ensure its safe use; the instructions for re-assembly of the device; the method to be used for the replacement of components; a description of special tools to be used to maintain the device; the requirements for visual inspection.
3.9 Packaging 3.10 Sterilization • If a specific method for packaging or containing the medical device during and after sterilization is • required, it shall be stated and be compatible with the sterilization process and the medical device. 3.10 Sterilization • A validated method of sterilization shall be specified. • Where appropriate, at least the following information shall be given; this shall include set points and the upper and lower limits of critical process parameters that are capable of achieving sterility of the medical device: the accessories required for sterilization of the medical device; the identification and concentration of the sterilant required for the sterilization process; the identification of maximum values of contaminants in condensate from steam, used in moist heat, ethylene oxide and/or steam and formaldehyde sterilization; the humidity required for the sterilization process; the minimum holding or exposure time of sterilant; a description of post-sterilization techniques/activities; pressure required for the sterilization process; a description of the techniques to be used; the required temperature of the sterilant. Wherever possible, moist heat sterilization is recommended.
3.11 Storage • Any specific limitations for the time or conditions of storage of the reprocessed medical device prior to use shall be stated.
4 Presentation of the information 4.1 Where applicable, the information required by clause 3 shall accompany the medical device, e.g. in the instructions for use supplied with the medical device, or on the medical device label or packaging. 4.2 The information specified in clause 3 shall take into account the nature of the medical device, its intended use and the knowledge and training of the persons involved in the processing. 4.3 The equipment or materials necessary in the specified processes shall be identified by its generic names or specification. Only in those cases where this does not provide sufficient information, trade names may be given in addition.
5 Validation of the reprocessing information provided • The manufacturer shall validate that any process identified in the information provided is capable of reprocessing the medical device for its intended use. • NOTE Where the manufacturer supplies a number of different medical devices which share common features and attributes, the validation specified may be performed with respect to these medical devices as a group or family, provided that the manufacturer can demonstrate the commonality of the medical devices and that the tests and assessments address the “worst case” feature or attribute of the group or family. 6 Risk analysis • In the risk analysis performed by the medical device manufacturer to determine the content and detail of the information to be provided, the medical device manufacturer shall take into account: the nature of the medical device; the intended use of the medical device; the likely training and knowledge of the processor; the equipment likely to be available to the processor.
OEM IFU’s identify the scientific-based validated methods for Preparation Cleaning Inspection & Assembly Packaging Sterilization Modality Storage Labeling
Reprocessing of Medical Devices : Who is responsible for What ?? • Manufactures validate that an instrument can be reliably cleaned and sterilized / disinfected and is appropriate for reuse – with repeatable outcomes • Users verify that cleaning / sterilization equipment is working and that in-hospital cleaning / sterilization methods are consistently performed
Sites Handling of Manufacturer’s Instructions • North Bay Jeffrey Phelps • Sault Ste Marie Tammy Bennardo
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