Medtronic ENT Rev. C Ref. 9.0 Page 1 of 5 1.0 PURPOSE: 1.1. The personal protective equipment (PPE) program is provided to decrease exposure to job-related hazards. This program identifies responsibilities, procedures for assessment and PPE selection, training and medical requirements, inspection and maintenance requirements, and enforcement procedures. PPE is a protective measure that is taken only when engineering or administrative controls for eliminating or reducing a hazard are not available or feasible. 2.0 SCOPE: 2.1. This procedure applies to all Medtronic Xomed Jacksonville, FL employees, non-exempt and exempt, in Jacksonville, FL. 2.1. Medtronic employees employed by or belonging to other Medtronic entities are not required to be trained to this procedure. 3.0 ASSOCIATED DOCUMENTS: 3.1. Applicable Documents 3.1.1. QCFM 594 Hazard Assessment and Personal Protective Equipment Recommendations 3.1.2. Hazard Assessment Forms (available on site builder) 3.1.3. Prescriptive Eyewear Program (available on site builder) 3.1.4. Glove Selection Guide (available on site builder) 3.1.5. Safety Shoe Program (available on site builder) 3.2. Reference Documents 3.2.1. 29 CFR 1910 Code of Federal Regulations, OSHA General Industry Regulations 3.2.2. 29 CFR 1910 Subpart I (Includes 132-139, Appendix A & B) - Code of Federal Regulations, Personal Protective Equipment 4.0 GENERAL: 4.1. RESPONSIBILITY: 4.1.1. All Medtronic Xomed Jacksonville, FL employees are responsible for wearing appropriate PPE and complying with the requirements of this program. 4.1.2. The Supervisor will be responsible for the implementation and enforcement of all PPE requirements in this program. This includes, but is not limited to: providing PPE, inspecting PPE. 4.1.3. The Supervisor will be responsible for initial evaluation and hazard assessments of any new chemical, task, or operation that requires the use of PPE. 4.1.4. HS will be responsible for providing assistance in the development and approval of new hazard assessments and general training of employees. 4.1.5. EHS will be responsible for annual review and update of this program as needed. 4.2. GENERAL PPE REQUIREMENTS: 4.2.1. Medtronic Xomed Jacksonville, FL employees will wear (PPE) when it is reasonably expected that the use of the equipment would prevent illness and/or injury. 4.2.2. All required PPE will be provided or subsidized by Medtronic Xomed Jacksonville, FL. 4.2.3. Visitors will be required to wear appropriate PPE when entering laboratory or production areas. 4.2.4. Medtronic Xomed Jacksonville, FL employees who do not comply with the requirements if this program may be subject to disciplinary action as defined in Medtronic Xomed Jacksonville, FL policy. 4.2.5. Types of PPE: 4.2.5.1. Eye and Face Protection. Regulated by 29 CFR 1910.133(a): specified in ANSI Z87.1, Eye and Face Protection. Eye and face protection equipment includes face shields, safety glasses, splash hoods, and goggles. 4.2.5.2. Head Protection. Regulated by 29 CFR 1910.135, specified in ANSI Z89.1, Safety Requirements for Industrial Head Protection. Head protection equipment includes hardhats, hardhat liners, hoods, and protective hair coverings. 4.2.5.3. Foot protection. Regulated by 29 CFR 1910.136, specified in ANSI Z41.1, Safety Footwear. Foot protection equipment includes safety shoes, boots, and over boots. 4.2.5.4. Hand (and arm) protection. Regulated by 29 CFR 1910.138, Hand Protection. Hand and arm protection equipment includes disposable gloves, reusable gloves and sleeves.
Rev. C Ref. 9.0 Page 2 of 5 4.2.5.5. Protective clothing. Not regulated individually. Protective clothing equipment includes lab coats, tyvec suits, fully encapsulating and non encapsulating suits, aprons, leggings, sleeve protectors, flame/fire retardant coveralls, and cooling garments. 4.2.5.6. Note: Respiratory protection and Hearing protection will be addressed in a separate SOP. 4.3. DEFINITIONS: 4.3.1. Carcinogen A substance or agent that can cause cancer. 4.3.2. Corrosive A substance or agent that can cause significant damage to skin and mucus membranes including burns. 4.3.3. Cryogenic The use of extremely low temperatures. 4.3.4. Degradation The loss of or change in the fabric's chemical resistance or physical properties due to exposure to chemicals, use, or ambient conditions (e.g., sunlight). 4.3.5. Hypothermia The lowering of internal body temperature that may cause cell damage and serious injury, even death. 4.3.6. Nuisance Dust Dust which contains no toxic materials no asbestos and less than 1% silica. 4.3.7. Penetration The movement of chemicals through zippers, stitched seams or imperfections (e.g., pinholes) in a protective clothing material. 4.3.8. Permeation The process by which a chemical dissolves in and/or moves through a protective clothing material on a molecular level. 4.3.9. Toxic A chemical or agent that has a poisoning effect on an organism. 5.0 PROGRAM (COMPONENTS): 5.1. Hazard Assessment 5.1.1. A written hazard assessment must be completed for all tasks that require the use of PPE to prevent injury or illness from contact with physical, chemical, or biological hazards. 5.1.2. Hazard assessments will be completed using QCFM 594. The Supervisor will be responsible for ensuring that an initial evaluation and completion of the hazard assessments for any new chemical, task, or operation that requires the use of PPE is completed. 5.1.3. New Hazard Assessments will be forwarded to EHS for review and approval before implementing the new procedure. 5.1.4. Hazard assessments for all presently identified hazards are located on the Jacksonville EHS Sitebuilder site. 5.2. LAB COATS AND PROTECTIVE CLOTHING 5.2.1. Medtronic Xomed Jacksonville, FL employees working in laboratories and manufacturing may be required to wear lab coats or protective clothing as specified in the hazard assessments for the specific work area. 5.2.2. Lab coats and protective clothing are prohibited in cafeterias, restrooms, conference rooms, and administrative areas. 5.2.3. Additional protective clothing (ie. Tyvec suits, aprons, etc.) may be required as specified in the hazard assessments for tasks which require greater physical, chemical or biological protection. 5.2.4. Chemical Protection Selection Criteria - When selecting personal protective equipment the following criteria should be evaluated: 5.2.5. Concentration of the Chemical 5.2.6. Physical State - The physical state of a chemical determines the exposure route and potential for toxicity. 5.2.7. Length of Exposure - The length of time a material is exposed to a chemical increases the probability of breakthrough. It should be kept in mind that during permeation testing, usually a pure (100% composition) liquid is placed in direct contact with the material producing a worst-case situation. 5.2.8. Abrasion - The use of leather gloves and a heavy apron over regular protective clothing will prevent damage to the PPE and protect against exposures during manual material handling. 5.2.9. Dexterity required to perform the necessary tasks. 5.2.10. Garments are selected for use by their resistance to permeation, degradation, and penetration. Charts are available from most manufacturers indicating the resistance of their products to degradation, permeation or penetration of a variety of chemicals. 5.2.11. Ability to Decontaminate
Rev. C Ref. 9.0 Page 3 of 5 5.2.12. Climatic Conditions - Protective clothing add a burden of additional weight, restriction of movement as well as limiting natural cooling, contributing to heat stress. Some material act differently when they are very hot or very cold. 5.2.13. Types of Protective Material - The following material are generally used in protective garments: 5.2.13.1. Cellulose or paper 5.2.13.2. Natural and synthetic fibers (Tyvek, Nomex) 5.2.13.3. Eastomers (Polyethylene, Saran, Polyvinyl chloride, Neoprene, Butyl rubber, Chlorapel, Viton) 5.3. EYE AND FACE PROTECTION 5.3.1. Eye and/or face protection (safety glasses, goggles, face shields) shall be required where there is a reasonable probability of injury that can be prevented by such equipment. Eye protection equipment referred to includes protection against impact, penetration, chemical and biological splashes, and dusts. 5.3.2. All eye and face protective equipment shall comply with ANSI Z87.1, "American National Standard Practice for Occupational and Educational Eye and Face Protection," which is incorporated by reference as specified in Sec. 1910.6. 5.3.3. The protective equipment must be appropriately selected for the hazard. Hazard assessments have been conducted for all identified hazards and are available on the EHS Sitebuilder. 5.3.4. Medtronic Xomed Jacksonville, FL employees requiring correction (prescription) lenses will be provided prescription safety glasses with side shields. This procedure can be found on the EHS Sitebuilder. 5.3.5. Medtronic Xomed Jacksonville, FL employees who do not require corrective lenses will be provided safety glasses with side shields or goggles unless specifically required by the hazard assessment. Face shields may also be required for some operations. 5.3.6. Visitors will be required to wear safety glasses when entering areas requiring eye protection. Visitor glasses are available at the entrance to the designated areas. 5.4. HAND PROTECTION (GLOVES) 5.4.1. Hand protection should be used when there is a potential for skin absorption of harmful substances, contact with potentially infectious materials, cuts or lacerations, abrasions, punctures, chemical burns, thermal burns and temperature extremes. 5.4.2. The hand protection must be appropriately selected for the type of hazard that may be encountered. The selection process should include an evaluation of the tasks to be performed, conditions, duration of use and the identified hazards. Selection guides for chemical use can be found are available on the EHS Sitebuilder. 5.5. FOOT PROTECTION 5.5.1. Foot protection shall be required when there is a reasonable probability of injury without the protection. 5.5.2. Medtronic Xomed Jacksonville, FL employees working in the following departments will be required to wear safety shoes: Shipping department, Facility and Maintenance department, and Raw Materials department. 5.5.3. Medtronic Xomed Jacksonville, FL employees requiring safety shoes will be provided shoes via our approved vendor. The procedure can be found on the EHS Sitebuilder. 5.5.4. Open toed or heeled shoes are prohibited in the distribution center, laboratories or manufacturing areas. 5.5.5. Shoes shall be shall comply with ANSI Z41, "American National Standard for Personal Protection- Protective Footwear," which is incorporated by reference as specified in Sec. 1910.6, or shall be demonstrated by the employer to be equally effective. 5.5.6. Over boots may be required for chemical protection during specific tasks. 5.6. HEAD PROTECTION 5.6.1. Head protection (hard hat) is required where Medtronic Xomed Jacksonville, FL employees are subjected to head injuries from falling, flying or moving objects, from splashing hazardous chemicals and other liquids, from limited electric shock and burns, and from bumps caused by working in limited space where the head may come in contact with equipment or objects or when other individuals are working above them. 5.6.2. All head protection equipment must meet with ANSI Z89.1, "American National Standard for Personnel Protection-Protective Headwear for Industrial Workers" which is incorporated by reference as specified in Sec. 1910.6, or shall be demonstrated to be equally effective.
Rev. C Ref. 9.0 Page 4 of 5 5.6.3. Head protection in not presently required in any Medtronic Xomed Jacksonville, FL operation. However, all Medtronic Xomed Jacksonville, FL employees entering construction zones where head protection is required will comply with this requirement. 5.7. EMERGENCY PPE 5.7.1. Spill clean up kits are located in various areas within laboratories and processing areas. These kits contain PPE appropriate for either chemical or biological spill clean up. 5.7.2. Monthly inspection of all spill kits must be completed to ensure the PPE is available and in proper condition when needed. 5.7.3. All PPE and other equipment used during a spill clean up must be replaced immediately after the incident or a tag placed on the kit to indicate it is not ready for use. 5.8. USE OF PPE 5.8.1. The protective equipment must be appropriately selected for the hazard. 5.8.2. Protective clothing should be inspected for wear, tears, etc. before each use. 5.8.3. Reusable chemical protective clothing must be adequately decontaminated after each use. 5.8.4. Donning and Doffing The proper methods for donning and doffing of PPE will be included in the Medtronic Xomed Jacksonville, FL employee training, reviewed by the supervisor and practiced to prevent contamination of the wearer and others. 5.9. TRAINING 5.9.1. Training will be completed prior to PPE use in a hazardous environment and repeated as necessary due to changes in the program, equipment or operations. Training must also be repeated for an Medtronic Xomed Jacksonville, FL employee who has not maintained a working knowledge of the requirements of the program. 5.9.2. Training will include: 5.9.2.1. The proper use and maintenance of the selected PPE, including capabilities and limitations. 5.9.2.2. The nature of the hazards and the consequences of not using the PPE. 5.9.2.3. The human factors influencing PPE performance. 5.9.2.4. What tasks require the use of PPE based on written Hazard Assessments 5.9.2.5. Hands on instruction in inspecting, donning and doffing, checking, fitting, and using PPE. 5.9.2.6. The care, cleaning, maintenance, useful life, repair, and disposal of PPE. 5.9.2.7. Emergency procedures in the event of PPE failure. 5.10. INSPECTION 5.10.1. Upon receipt, an inspection and operational testing of equipment received must be conducted. EHS is available to assist with this as necessary. 5.10.2. The employee must conduct an inspection of the PPE at the time of donning. This will prevent injury or illness due to contact from faulty materials or wear. 5.10.3. Reusable PPE must be inspected after use or prior to maintenance to ensure the continued performance of the PPE. 5.10.4. Monthly inspection will be conducted of stored equipment, such as emergency PPE for spill clean up. 5.10.5. Each inspection will cover somewhat different areas in varying degrees of depth. Detailed inspection procedures, where appropriate, are usually available from the manufacturer s instructions.
Rev. C Ref. 9.0 Page 5 of 5 5.11. OBTAINING PPE 5.11.1. PPE will only be distributed to those Medtronic Xomed Jacksonville, FL employees who are physically capable of using the equipment. 5.11.2. Appropriate PPE of the proper size and fit will be distributed to each affected Medtronic Xomed Jacksonville, FL employee according to the findings of the hazard assessment. 5.11.3. Visitors and contracted employees will also be provided with the appropriate PPE for their activities. 5.11.4. Each department is responsible for covering the cost of PPE for their employees. The EHS Staff will order the necessary PPE. PPE ordered will be charged back to the respective department. 5.12. MAINTENANCE 5.12.1. All disposable PPE will be disposed of in accordance with Federal, State and local regulations. 5.12.2. Lab coats used in the Environmentally Controlled Area will be cleaned and repaired as necessary by Medtronic Xomed. Medtronic Xomed Jacksonville, FL employees are prohibited from taking lab coats home for laundering. 5.12.3. All reusable PPE will be cleaned and maintained in accordance with manufacturers recommendations by the department of use. 5.13. STORAGE 5.13.1. PPE must be stored properly to prevent damage or malfunction due to exposure to dust, moisture, sunlight, damaging chemicals, extreme temperatures, and impact. 5.13.2. Potentially contaminated PPE should be stored in an area separate from street clothing, in a well-ventilated area. 5.13.3. Different types and materials of clothing and gloves should be stored separately to prevent issuing the wrong material by mistake. 5.13.4. Protective clothing should be folded or hung in accordance with manufacturers' recommendations. 5.14. RECORDKEEPING 5.14.1. Written Hazard Assessments will be maintained for all tasks that have a potential to cause injury or illness from physical, chemical or biological hazards. These hazard assessments are maintained on the Jacksonville EHS sitebuilder site. 5.14.2. Training records will be maintained for all Medtronic Xomed Jacksonville, FL employees required to wear PPE.