The New OSHA Regulations on. Sharps Safety Requirements

Transcription

1 The New OSHA Regulations on Sharps Safety Requirements 2001 ASOA Congress on Ophthalmic Practice Management April 29, 2001 San Diego, California By Page 1 of 12

2 BACKGROUND Numerous workers who are occupationally exposed to bloodborne pathogens have contracted fatal and other serious viruses and diseases, including HIV, hepatitis B, and hepatitis C from exposure to blood and other potentially infectious materials in the workplace. In 1991 the Occupational Safety and Health Administration (OSHA) issued a standard (29 CFR ) regulating occupational exposure to bloodborne pathogens, including HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV). Compliance with the Bloodborne Pathogens Standard has significantly reduced the risk that workers will contract bloodborne disease in the course of their work. o Example: In 1995 an estimated 800 healthcare workers were infected with HBV, as opposed to 17,000 in 1983 (Source [CDC unpublished data]). Nevertheless, sharps injuries continue to be a serious problem. It is estimated that up to 800,000 percutaneous injuries occur annually among healthcare workers. Such injuries can involve needles or other sharps contaminated with bloodborne pathogens, such as HIV, HBV, or HCV. Since publication of the Bloodborne Pathogens Standard in 1991, there has been a substantial increase in the number and assortment of effective engineering controls available to employers (devices with sharps injury protection). Numerous studies have demonstrated that the use of safer medical devices, such as needleless systems and sharps with engineered sharps injury protections can be extremely effective in reducing accidental injuries. The Centers for Disease Control and Prevention (CDC) estimates that 62-88% of all sharps injuries can be prevented by the use of safer medical devices. The OSHA 200 Log, as it is currently maintained, does not sufficiently reflect injuries that may involve exposure to bloodborne pathogens in healthcare facilities. Training, education, and staff involvement in selection of devices is an important element to achieving a reduction in sharps injuries. Accordingly, Congress and the President have enacted legislation to modify the 1991 Standard to help further reduce exposure incidents. Page 2 of 12

3 MAGNITUDE OF SHARPS INJURY ISSUE More than 8,000,000 healthcare workers in the United States work in hospitals and other healthcare settings. It is estimated that up to 800,000 percutaneous injuries occur annually among US healthcare workers. This is one sharps-related injury for every ten workers each year. Healthcare workers in hospital settings account for approximately 40% of healthcare workers in the US. According to CDC survey data, approximately 384,000 percutaneous injuries occur annually in hospitals, with about 61% (236,000) resulting from hollowbore needlestick injuries. Data suggests that at an average hospital, workers incur approximately 30 needlestick injuries per 100 beds per year. At least 1,000 healthcare workers are estimated to contract serious infections annually from sharps-related injuries. RISKS FACED BY HEALTHCARE WORKERS Needlestick injuries are a significant risk for healthcare workers because these injuries expose workers to diseases from bloodborne pathogens. The primary diseases of concern in current occupational settings are AIDS (from HIV), hepatitis B (from HBV), and hepatitis C (from HCV). More than 20 other infections can be transmitted through needlesticks, including: tuberculosis, syphilis, malaria, and herpes. Between 1985 and June 1999, cumulative totals of over 55 Adocumented@ cases and 136 Apossible@ cases of occupational HIV transmission to US healthcare workers were reported to the CDC. Percutaneous injury was associated with 89% of the documented transmission. Of these, the vast majority involved hollow-bore needles. The rate of HIV transmission to healthcare workers is 0.3% after a single needlestick exposure to an HIVinfected patient. The rate of HBV transmission to susceptible healthcare workers is as high as 30% after a single needlestick exposure to an HBV- infected patient. The risk of a healthcare worker becoming infected with HCV following exposure through a needlestick or other percutaneous injury is 1.8%. Page 3 of 12

4 REDUCTION OF NEEDLESTICK INJURIES IN HOSPITALS According to a report by the General Accounting Office issued in November 2000, 236,000 of the 364,000 percutaneous injuries occurring annually in US hospitals result from hollow-bore needles. Of these, 177,000 are felt to be preventable, with 69,000 incidents preventable by the use of needles with safety features. Additionally, 109,000 needlesticks are preventable by eliminating the unnecessary use of needles and by using safer work practices. Between 1993 and 1996, the phlebotomy service at a major institution decreased the needlestick injury rate among its phlebotomists from 1.5 to 0.2 per 10,000 venipunctures performed by implementation of devices with safety features, changes in worker education, and changes in work practices. LEGISLATIVE/REGULATORY ACTIVITY Bloodborne Pathogens Standard OSHA Request for Information 09/ California 1st of 17 states to pass Safety Needle Laws 05/ OSHA report on RFI 11/ OSHA Directive to Compliance Officers 11/1999 CDC s NIOSH Safety Alert 11/ Needlestick Safety and Prevention Act signed by President Clinton 04/18/ Effective date of Needlestick Safety and Prevention Act SHARPS SAFETY - WHY BE CONCERNED? Employee welfare o Percutaneous injuries may expose healthcare workers to a number of serious and potentially fatal infections with bloodborne pathogens. o Even when a serious disease is not transmitted, the emotional distress of a needlestick injury can be severe and long lasting, often requiring counseling. In one study of 20 healthcare workers with an HIV exposure, 11 reported acute severe distress, 7 had persistent moderate distress, and 6 quit their jobs as a result of the exposure. o In addition to the exposed healthcare worker, colleagues and family members may suffer emotionally. Page 4 of 12

5 Financial impact of sharps injuries o Costs of initial post-exposure treatment vary widely and depend upon the situations faced by injured workers. Published estimates run from 500 to 3,000 per injury sustained. o One study found the cost to an average hospital of sharps injuries was 25,000 per year. o The average annual cost of treating a person with HIV has been estimated between 20,000 and 24,700 in o According to the American Hospital Association, one case of serious infection by bloodborne pathogens can soon add up to 1,000,000 or more in expenditures for treatment, testing, lost time, and disability payments. o Fears of HIV and other infections have led many healthcare workers to pursue legal action for compensation for a disease acquired at work. Even in cases where diseases have not been transmitted, healthcare workers are successfully suing for compensation for the emotional distress experienced while waiting for test results. There is no data available concerning the dollar amounts awarded for compensation. GAO: SAFETY DEVICES PAY FOR THEMSELVES The United States General Accounting Office (GAO) estimates that use of safety devices mandated by the Needlestick Safety and Prevention Act are expected to cost hospitals 70 to 352 million a year. Yet, under reasonable assumptions, the same facilities could recoup those added expenses plus anywhere from 9 million to 90 million in costs for testing injured workers and treating employees who contract hepatitis or HIV. The GAO admits that if a facility chooses very costly safety devices, reducing the cost of post-exposure treatment will not offset safety device costs. Other costs also would be reduced, but these cost reductions are difficult to quantify as they are highly dependent on specific situations. These costs include medical treatment for healthcare workers who become infected after sustaining a needlestick; wages and time lost by these workers; emotional distress suffered by injured workers, their colleagues, and family members; reduced quality of life; and lives lost. Needles with safety features may reduce liability and worker s compensation costs. Page 5 of 12

6 BLOODBORNE PATHOGENS STANDARD Notable elements of this standard include the following: o A written exposure control plan designed to eliminate or minimize worker exposure to bloodborne pathogens. o Compliance with universal precautions (an infection control principle that treats all human blood and other potentially infectious materials as infectious). o Engineering controls and work practices to eliminate or minimize worker exposure. o Personal protective equipment (if engineering controls and work practices do not eliminate occupational exposures). o Prohibition of bending, recapping, or removing contaminated needles and other sharps unless such an act is required by a specific procedure or has no feasible alternative. o Prohibition of shearing or breaking contaminated needles. o Free hepatitis B vaccinations offered to workers with occupational exposure to bloodborne pathogens. o Worker training in appropriate engineering controls and work practices. o Post-exposure evaluation and follow-up, including post-exposure prophylaxis when appropriate. The Needlestick Safety and Prevention Act modifies the Bloodborne Pathogens Standard. REVISIONS TO THE BLOODBORNE PATHOGENS STANDARD FROM THE NEEDLESTICK SAFETY AND PREVENTION ACT OF 2000 The definition of Engineering Controls (at 29 CFR (b)) shall include as additional examples of controls the following: safer medical devices, such as sharps with engineered sharps injury protections and needleless systems. The term Sharps with Engineered Sharps Injury Protections shall be added to the definitions (at 29 CFR (b)) and be defined as a non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids with built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. The term Needleless System shall be added to the definitions (at 29 CFR (b)) and be defined as a device that does not use needles for: (A) the collection of bodily fluids or withdrawal of bodily fluids after initial venous or arterial access is established; (B) the administration of medication or fluids; or (C) any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps. Page 6 of 12

7 In addition to existing requirements concerning Exposure Control Plan (29 CFR (c)(1)(iv)), the review and update of such plans shall be required to also - o reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens ; and o document annually consideration and implementation of appropriate commercially available and effective medical devices designed to eliminate or minimize occupational exposure. The following record keeping requirements shall be added to the Bloodborne Pathogens Standard (at CFR (h): the employer shall establish and maintain a Sharps Injury Log for the recording of percutaneous injuries from contaminated sharps. The information in the Sharps Injury Log shall be recorded and maintained in such manner as to protect the confidentiality of the injured employee. The Sharps Injury Log shall contain, at a minimum - o (A) the type and brand of device involved in the incident, o (B) the department or work area where the exposure incident occurred, and o (C) an explanation of how the incident occurred.. The requirement for such Sharps Injury Log shall not apply to any employer who is not required to maintain a log of occupational injuries and illness under (29 CFR 1904) and the Sharps Injury Log shall be maintained for the period required by (29 CFR ). The following new section shall be added to the Bloodborne Pathogens Standard: An employer, who is required to establish an Exposure Control Plan shall solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation, and selection of effective Engineering and Work Practice Controls and shall document the solicitation in the Exposure Control Plan.. KEY POINTS OF THE LAW Expanded definition of Engineering Controls to include devices with engineered sharps injury protection. Written Exposure Control Plan reflecting changes in technology that reduce exposure to bloodborne pathogens. Documentation of annual consideration and implementation of sharps safety devices. Sharps Injury Log detailing department where the injury occurred, type and brand of device involved, and explanation of how injury happened. Must maintain confidentiality of the injured worker. Page 7 of 12

8 Document participation of non-managerial employees in the identification, evaluation, and selection of effective engineering and work practice controls. This must be documented in the written Exposure Control Plan. OSHA s revised Bloodborne Pathogens Standard (Needlestick Safety and Prevention Act) was published in the Federal Register on January 18, The effective date for the revised Standard is April 18, However, OSHA has announced that, following the effective date, there will be a ninety day period of education and outreach before it starts enforcing the new requirements in the revised standard. Healthcare facilities should already be actively evaluating and implementing safetyengineered devices. OSHA made clear that this was a requirement in its November 1999 revised Compliance Directive (CPL D) for the Bloodborne Pathogens Standard. Since it issued the Compliance Directive, OSHA has been citing healthcare facilities for failure to use safer devices. STATE LAW Seventeen states have passed needle safety legislation. The elements of the new federal law that are part of many state laws include: o Required use of sharps injury prevention devices o Written Exposure Control Plan that is updated annually to reflect consideration and use of safety devices. o Sharps Injury Log with information on the type and brand of device and description of the incident. o Involvement of frontline workers in selection, evaluation, and implementation of safety devices. If a state needle safety law has requirements above and beyond what the federal law requires, the additional state requirements must be followed. (For instance, some states require healthcare facilities to report needlestick injury data to a state agency.) If a state needle safety law is less stringent than the federal law, the federal law s requirements must be followed. OBSTACLES TO IMPLEMENTATION Devices with safety features may vary considerably in clinical efficacy and effectiveness in reducing injuries. Increased purchase price of safety devices. Staff resistance to change. Time required to train staff in the use of new devices. Page 8 of 12

9 TEN STEPS TO TAKE NOW Analyze needlestick and other sharps-related injuries in your workplace to identify hazards and injury trends. Set priorities and prevention strategies by examining local and national information about risk factors for sharps-related injuries. Train employees in the safe use and disposal of sharps. Modify work practices that pose a needlestick injury hazard to make them safer. Promote safety awareness in the workplace. Establish procedures for and encourage the reporting and timely follow-up of all needlestick and other sharps-related injuries. You must establish a Sharps Injury Log. Evaluate the effectiveness of prevention efforts and provide feedback on performance. Eliminate the use of sharps where safe and effective alternatives are available. Implement the use of sharps devices with safety features and evaluate their use to determine which are most effective and acceptable. Establish a team including non-managerial frontline employees to determine which devices are most effective and acceptable. DESIRABLE SHARPS SAFETY CHARACTERISTICS Needleless. Safety feature is an integral part of the device. The device preferably works passively (i.e., it requires no activation by the user). If user activation is necessary, the safety feature can be engaged with a single-handed technique and allows the worker s hands to remain behind the exposed sharp. The user can easily tell whether the safety feature is activated. The safety feature cannot be de-activated and remains protective through disposal. The safety feature works effectively and reliably. The device is easy to use and practical. Page 9 of 12

10 The device is safe and effective for patient care. SELECTING AND EVALUATING SHARPS SAFETY DEVICES Form a multi-disciplinary team that includes non-managerial employees to: o Develop, implement, and evaluate a plan to reduce sharps-related injuries in the workplace. o Evaluate sharps devices with safety features. Identify priorities based on assessments of how injuries are occurring, patterns of device use in the institution, and local and national data on injury and disease transmission trends. Give the highest priority to the devices with safety features that will have the greatest impact on preventing occupational infection. When selecting a safer device, identify its intended scope of use in the healthcare facility and any special technique or design factors that will influence its safety, efficiency, and user acceptability. Seek published, Internet, or other sources of data on the safety and overall performance of the device. Conduct a product evaluation, making sure that the participants represent the scope of eventual product users. The following steps will contribute to a successful product evaluation: o Train healthcare workers in the correct use of the new device. o Establish clear criteria and measures to evaluate the device with regard to both healthcare worker safety and patient care. o Conduct onsite follow-up to obtain informal feedback, identify problems, and provide additional guidance. Monitor the use of a new device after it is implemented to determine the need for additional training, solicit information and feedback on healthcare worker experience with the device, and identify possible adverse effects of the device on patient care. Page 10 of 12

11 DEVICE SAMPLES Diamatrix Safety handle Medisys o Only line of ophthalmic knives with sharps protection feature. o Simple handle design - one-handed use. o Safety handle available in all blade configurations and price points Diamond blades with Titanium handles straight, angle or stepped Sapphire blades with Aluminum handles straight, angle or stepped Metal blades with plastic handles straight or angle. o Stainless Steel blades are FDA approved re-usable when sold non-sterile. (see attached letter) o Cost effective. Stainless Steel only 7% more expensive than comparable knives with no safety features Diamond and Sapphire blades in Safety handles are the same price as regular handles o Company information: Diamatrix, Ltd 2203 Timberloch Place, Suite 130 The Woodlands, TX Phone: Fax: info@diamatrix.com ASCRS Booth 505 Page 11 of 12

12 DATA AND INFORMATION WAS COMPILED FROM THE FOLLOWING SOURCES: CDC NIOSH Publication No: November, 1999 GAO Publication No: GAO-01-60R Needlestick Safety and Prevention Act 2000 (H.R. 5178) OSHA Standard Bloodborne Pathogens Regulatory Text California Sharps Injury Control Program USEFUL WEB SITES (for Sample of Model Exposure Control Plan ) (for sample of Needlestick Injury Log ) (for sample of Needlestick Injury Log ) Doc V Page 12 of 12