Control of Hazardous Energy - 29 CFR Why is Lockout/Tagout necessary? Blocks (Locks, Blocks, Chains, Multi-lock hasps, Wheel valve covers, Ball valve cove) flow of energy (Electricity, Hydraulic, Pneumatic, Steam, Thermal, Chemical, Gravity) from power source to the equipment. Provides means of warning (tag) When Must LOTO Be Used? Unexpected start-up could occur Either of these could harm an employee Affected Employee Responsibilities Notify maintenance, etc., when equipment needs repair or adjustment Leave all LOTO devices in place Verify equipment is safe to operate following LOTO Follow all safety rules while operating the equipment Lockout/Tagout It refers to specific practices and procedures to safeguard employees from the unexpected energization or startup of machinery and equipment, or the release of hazardous energy during service or maintenance activities.

Medical Device Reporting (MDR) Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or healthcare professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Forms FDA 3500 (voluntary reporting) and FDA 3500A (mandatory reporting) have been revised and re- authorized through 10/31/2008. Voluntary form 3500 The FDA Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events related to products, devices, drugs, or biologics noted in the course of clinical care. 1. Adverse experiences: Medications (drugs or biologics), Medical devices (including in-vitro diagnostics), Special nutritional products (dietary supplements, medical foods, infant formulas), Cosmetics, Medication errors. 2. Product problems - quality, performance or safety concerns: Suspected counterfeit product, Suspected contamination, Questionable stability, Defective components, Poor packaging or labeling, Therapeutic failures. 3. Serious adverse event. An event is serious when patient outcome is: Death, Life-threatening (real risk of dying), Hospitalization (initial or prolonged), Disability (significant, persistent or permanent), Congenital anomaly, Required intervention to prevent permanent, impairment or damage. Report even if: You're not certain the product caused the event, You don't have all the details.

Medical Device Reporting (MDR) Good risk management suggests that certain steps be followed when injury results from the use of a piece of equipment. Procedures should require you to: 1. Turn off and store the equipment away from an area where it might be used and in a safe place. Affix a "do not use" sticker to the device and a note stating what's wrong with it. 2. Inform a designated supervisor, such as the risk manager, of the incident. 3. Complete, within 24 hours, an incident report including information about the patient and the device and a description of the event. Request that a doctor examine your patient to document the extent of the injuries.

Laser Hazards Healthcare employees can be exposed to lasers used in the operating rooms during excision and cauterization of tissue. Class 3b and 4 lasers are most often used. Exposure usually occurs from unintentional operation and/or when proper controls are not in effect. The high electrical energy used to generate the beam is a potential shock hazard. Direct beam exposure can cause burns to skin and eyes possibly resulting in blindness. Electric shock and fire are also potential hazards when using lasers. All personnel in the operating room during laser surgery should wear goggles to protect the cornea, conjunctive, and other ocular tissue. The wavelength of the laser output is the most important factor in determining the type of eye protection to be used. Skin Protection can best be achieved through engineering controls. If the potential exists for damaging skin exposure, particularly for ultraviolet lasers ( nm), then skin covers and or "sun screen" creams are recommended. Laser Plume During surgical procedures that use a laser or electro-surgical unit, the thermal destruction of tissue creates a smoke byproduct. An estimated 500,000 healthcare workers are exposed to laser or electro-surgical smoke each year, including surgeons, nurses, anesthesiologists, and surgical technologists. Engineering Controls: Use portable smoke evacuators and room suction systems. According to NIOSH research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bio-aerosols, dead and live cellular material (including blood fragments), and viruses.

Waste Anesthetic Gases The anesthetic gas and vapors that leak out and into the surrounding room during medical procedures are considered waste anesthetic gases. At any given time more than 250,000 people who work in hospitals, operating rooms, dental offices and veterinary clinics, might be exposed unnecessarily to harmful levels of waste anesthetic gases. The waste anesthetic gases and vapors of concern are nitrous oxide and halogenated agents (vapors) such as halothane, enflurane, methoxyflurane, trichloroethylene, and chloroform. Some potential effects of exposure to waste anesthetic gases are nausea, dizziness, headaches, fatigue, and irritability, as well as sterility, miscarriages, birth defects, cancer, and liver and kidney disease, among operating room staff. Turn off vaporizers of anesthesia machines when not in use. Also, proper face masks, sufficiently inflated endotracheal tubes, and prevention of anesthetic spills will decrease the amount of waste anesthetic gases in the operating room. Inspect and maintain the anesthesia machine at least every four months. This should be done by factory service representatives or other qualified personnel. Leakage of gas should be less than 100 ml/min during normal operation. Good work practice recommends complete check of all anesthesia equipment prior to each day's use (connectors, tubing, etc.) spills of liquid anesthetic agents cleaned up promptly.

Ethylene Oxide Gas (EtO) EtO is used within central supply as a sterilant for items that can not be exposed to steam sterilization. Exposure usually results from improper aeration of the ethylene oxide chamber after the sterilizing process or during off-gassing of sterilized items or poor gas-line connections. It can also occur in outpatient surgery clinics, cardiac catheterization laboratories, operating rooms, dental labs, autopsy labs and other areas. In liquid form, Ethylene oxide can cause eye irritation and injury to the cornea, frostbite, and severe irritation and blistering of the skin upon prolonged or confined contact. Ingesting EtO can cause gastric irritation and liver injury. Acute effects from inhaling EtO vapors include respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis. Exposure has also been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization. Ethylene oxide has been shown to cause cancer in laboratory animals and has been associated with higher incidences of cancer in humans. Adverse reproductive effects and chromosome damage may also occur from EtO exposure. Do not occupy the sterilizer loading and mechanical rooms while operating the sterilizer unit. Operators should avoid close contact with newly sterilized un-aerated loads. Use appropriate PPE when changing cylinders including butyl apron, gloves, and a canister respirator. Use EtO detector systems and room monitors to signal any leakage of gas, and passive dosimeters for personal exposure monitoring.

Compressed Gases Potential Hazards: Fire, explosion, and toxicity of compressed gases. These effects arise from the compression of the gas and the health effects of the chemical itself. Compressed gases within a healthcare facility are usually either fixed piped gas systems or individual cylinders of gases. The contents of any compressed gas cylinder must be clearly identified. Such identification should be stenciled or stamped on the cylinder or a label. All gas lines leading from a compressed gas supply should be clearly labeled to identify the gas, the laboratory or area served, and the relevant emergency telephone numbers. If a leaking cylinder is discovered, move it to a safe place (if it is safe to do so) and inform your supervisor. Under no circumstances should any attempt be made to repair a cylinder or valve. Gas cylinders must be secured at all times to prevent tipping.

Radiation Safety Healthcare employees can be exposed to Radiation from X-ray machines as they are used in diagnostics. The degree of exposure depends on the amount of radiation, the duration of exposure, the distance form the source and the type of shielding in place. POTENTIAL HEALTH EFFECTS ACUTE: Erythema and dermatitis. Large whole-body exposures cause nausea, vomiting, diarrhea, weakness, and death. CHRONIC: Skin cancer and bone marrow suppression. Genetic effects may lead to congenital defects in the employee's offspring. CONTROLS X-ray rooms are equipped with a barrier wall with a lead-plated glass window so technician can step behind barrier wall to take the x-ray, and avoid radiation exposure. Lead aprons and lead gloves offer some protection for employees and patients and should be worn in the direct x-ray field. Opaque goggles are to be worn in the direct x-ray field. Only the operator and the patient should be in the room when an exposure is made. All entrance doors to an x-ray room should be kept closed while a patient is in the room. Use a separate storage area for radioactive sources. This area should be adequately shielded. Only authorized personnel should have access to storage areas.

Be Safe! Tony Soares, Safety Director Compensation Solutions, Inc. Tel: Ext. 192