Wednesday, December 21, 2011
Wednesday, December 14, 2011
Safer Needle Devices
Safer Needle Devices
Most needlestick injuries result from unsafe needle devices rather than carelessness by healthcare workers (JSHQ, 1998, Summer).
Safer needle devices have built-in safety control devices, such as those that use a self-sheathing needle, to help prevent injuries before, during, and after use through safer design features.
The Centers for Disease Control and Prevention (CDC) estimated in March of 2000 that 62 to 88 percent of sharps injuries in the hospital setting could be preventing by using safer medical devices.
According to the Bloodborne Pathogens Standard, employers with the help of employees, must select safer needle devices to use in work environments.
- There are different types of safety features that are available for safer needle devices such as:
- Needleless devices
- Passive safety features: remain in effect before, during and after use.
- Integrated safety design: have a safety feature that is built in as an integral part of the device and cannot be removed. This design feature is usually preferred.
- Integrated safety design: have a safety feature that is built in as an integral part of the device and cannot be removed. This design feature is usually preferred.
- Active devices: require the worker to activate the safety mechanism.
- Accessory safety devices: have safety features that are external to the device and must be carried to, or be temporarily or permanently fixed to, the point of use. This design is dependent on employee compliance and according to some researchers, is less desirable.
- Accessory safety devices: have safety features that are external to the device and must be carried to, or be temporarily or permanently fixed to, the point of use. This design is dependent on employee compliance and according to some researchers, is less desirable.
- Desirable Characteristics of Safety Devices include:
- The device is needleless.
- The safety feature is an integral part of the device.
- The device is easy to use and practical.
- The device performs reliably.
- The safety feature cannot be deactivated and remains protective through disposal.
- The devices work effectively and reliably, and are acceptable to the healthcare worker, and do not adversely affect patient care.
- The Food and Drug Administration (FDA) is responsible for clearing medical devices for marketing in the US. It recommends safer needle devices with a fixed safety feature that:
- Provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker's hands to remain behind the needle at all times.
- Is an integral part of the device and not an accessory.
- Is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety.
- Is as simple as possible, and requires little or no training to use effectively.
- Provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker's hands to remain behind the needle at all times.
- The device is needleless.
- Needleless Connector Systems: Needleless connectors for IV delivery systems (e.g., blunt cannula for use with prepierced ports and valved connectors that accept tapered or luer ends of IV tubing) (Figure 1).
- Self-Sheathing Safety Feature: Sliding needle shields attached to disposable syringes and vacuum tube holders (Figures 2A and 2B).
- Disposable scalpels with safety features such as a sliding blade shield (Figure 6).
- Retractable Technology: Needles or sharps that retract into a syringe, vacuum tube holder, or back into the device.
- Self Blunting Technology: Self-blunting phlebotomy and winged-steel "butterfly" needles (a blunt cannula seated inside the phlebotomy needle is advanced beyond the needle tip before the needle is withdrawn from the vein (Figure 4), (Figure 5).
- Hinged Safety Feature: Hinged or sliding shields attached to phlebotomy needles, winged steel needles, and blood gas needles (Figure 7).
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Saturday, December 10, 2011
Clarification of the Use and Selection of BBP Safety Devices.
Dr. William A. Hyman
Texas A&M University
Department of Environmental Engineering
233 Zachry Engineering Center
3120 TAMU
College Station, TX 77843-3120
Dear Dr. Hyman:
Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). Your letter requests OSHA's interpretation of several provisions under 29 CFR 1910.1030, the Bloodborne Pathogens standard. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA's responses. We apologize for the delay in providing our response.
Question 1: The OSHA Bloodborne Pathogens Standard requires employers to use engineering controls, such as appropriate "safety engineered" sharps. Can an employer select a device that is not expressly labeled by the manufacturer as a safety device and that does not have corresponding safety claims that have been cleared by the Food and Drug Administration (FDA)?
Response 1: As you know, employers are required to use engineering and work practice controls to protect employees [29 CFR 1910.1030(d)(2)(i)]. The standard defines engineering controls as ". . . controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." [29 CFR 1910.1030(b)]. With regard to safety-engineered devices used for preventing needlesticks and other sharps injuries, many circumstances would involve the use of safety-engineered devices which are expressly manufactured to replace conventional ones (i.e., sharps with safety engineered sharps injury protections, SESIPs). These devices generally bear a manufacturer's label indicating the type of safety feature along with specific instructions for use. However, the key to preventing needlesticks and other sharps injuries is the isolation or removal of the hazard, and in some circumstances, this may be achieved by completely removing the sharp (needleless technology) or substituting a safer alternative that is not necessarily labeled as such.
As an example, the use of plastic hypodermic syringes has largely replaced the use of glass syringes as an effective safer alternative. Plastic syringes are less prone to accidental breakage and, therefore, offer protection from potential percutaneous injuries from broken contaminated glass. Plastic syringes however, do not necessarily bear a legend of this safety benefit. Another example is the use of alternatives to glass capillary tubes which break easily. In a joint safety advisory on hazards associated with the use of glass capillary tubes, the FDA, NIOSH and OSHA recommended the use of capillary tubes that are not made of glass and glass capillary tubes wrapped in a puncture-resistant film. These alternatives also represent safety-engineered features in that they remove or isolate the sharps hazard.
It is important that employers perform a thorough hazard assessment and fully evaluate the feasibility and appropriateness for use of any engineering control before instituting its use [29 CFR 1910.1030(c)(1)(iv)(B)]. The substitution of a type of device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. Additionally, employers should consult device manufacturers prior to making any after-market modifications to medical devices. Unauthorized modifications to medical devices may interfere with their intended use, may violate the FDA's approval of the device, or may create a greater hazard to patients and/or employees. You may wish to contact the FDA directly for additional information on the criteria which manufacturers must meet and the specific labeling requirements for all medical devices, including those with claims of safety-engineering features or capabilities.
Question 2: May an employer make an independent judgment that a device marketed with other claims and for other purposes provides the type of safety-engineered protection anticipated by the standard? If so, what level of documentation or testing is the employer required to have to demonstrate the validity of such judgments?
Response 2: As stated in response #1, the substitution of an alternative device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. The requirement for evaluation and selection of a safety device is a performance-oriented provision which depends greatly on the specific medical device and medical procedure(s) in question. Devices must be evaluated for their ability to prevent occupational exposures to blood or other potentially infectious materials (OPIM) in each procedure. The final determination of what safer device is selected for use is a responsibility of the employer; however, when evaluating and selecting safer devices, employers must solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps [29 CFR 1910.1030(c)(1)(v)]. The input from affected employees must be factored into the employer's judgment of the appropriateness for use of a particular safety device.
With regard to the documentation needed to justify selection of safety devices, employers are required to have an exposure control plan which includes the initial exposure determination required by 29 CFR 1910.1030(c)(2) as well as the documentation of the methods of compliance, which includes implementation of engineering controls [29 CFR 1910.1030(c)(1)(ii)(A) and 1910.1030(c)(1)(ii)(B)]. The exposure control plan must be reviewed and updated annually to include documentation of the employer's consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A) and 1910.1030(c)(1)(iv)(B)]. The standard does not specify the level of detail that must be included in this documentation; however, sufficient information must be provided to substantiate the facility's judgment. As discussed in the preamble of the Final Rule, consideration and implementation of safer medical devices could be documented in the Exposure Control Plan by describing the safer devices identified as candidates for adoption; the method or methods used to evaluate devices and the results of the evaluations; and justification for selection decisions. [See 66 Federal Register 5319, under discussion of paragraph 1910.1030(c)(1)(iv).]
Question 3: OSHA has previously clarified, in the context of Group Purchasing Organizations (GPOs), that price and contractual availability cannot be the sole basis for selecting a safety device. May other contractual requirements provide a basis for selecting a particular device? For example, if a multi-product manufacturer offers a contract that has a cost basis associated with being the employer's exclusive provider of a range of medical devices, and/or offers overall volume discounts that would be impacted by selecting another manufacturer's safety device, is a decision to use the contracting supplier's safety engineering sharps devices on this basis acceptable?
Response 3: 29 CFR 1910.1030 does not address contractual arrangements between employers and device manufacturers. Therefore, the standard does not specifically preclude the use of GPOs as long as the employer is still able to meet the intent of the standard. As stated in the response to question #2, non-managerial employees involved in patient care must be afforded the opportunity to provide feedback in the evaluation and selection of safer devices. If an employer enters into an exclusive contractual arrangement with a manufacturer, the availability and variety of devices may be restricted. As technology advances, it is difficult to determine whether a safer and more appropriate device might become commercially available from a competitor of the exclusive supplier. Employees may be limited in the variety of available safety devices, particularly with regard to equipment that has few available choices. Additionally, each employer must review and update the exposure control plan annually and the annual review must include documentation of the consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A)]. Advances in technology might not be captured if an employer is bound by contract to only evaluate devices from a single manufacturer. Finally, 29 CFR 1910.1030(d)(2)(i) requires that employers eliminate or minimize, i.e., reduce to the lowest extent feasible, occupational exposure. Thus, irrespective of the arrangements used in obtaining safety devices, the determination of an employer's compliance will be based on whether the requirements of the standard are being met.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
______________________________________________________
www.QDSyringeSystems.com
www.QDSyringe.com
Texas A&M University
Department of Environmental Engineering
233 Zachry Engineering Center
3120 TAMU
College Station, TX 77843-3120
Dear Dr. Hyman:
Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). Your letter requests OSHA's interpretation of several provisions under 29 CFR 1910.1030, the Bloodborne Pathogens standard. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA's responses. We apologize for the delay in providing our response.
Question 1: The OSHA Bloodborne Pathogens Standard requires employers to use engineering controls, such as appropriate "safety engineered" sharps. Can an employer select a device that is not expressly labeled by the manufacturer as a safety device and that does not have corresponding safety claims that have been cleared by the Food and Drug Administration (FDA)?
It is important that employers perform a thorough hazard assessment and fully evaluate the feasibility and appropriateness for use of any engineering control before instituting its use [29 CFR 1910.1030(c)(1)(iv)(B)]. The substitution of a type of device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. Additionally, employers should consult device manufacturers prior to making any after-market modifications to medical devices. Unauthorized modifications to medical devices may interfere with their intended use, may violate the FDA's approval of the device, or may create a greater hazard to patients and/or employees. You may wish to contact the FDA directly for additional information on the criteria which manufacturers must meet and the specific labeling requirements for all medical devices, including those with claims of safety-engineering features or capabilities.
Question 2: May an employer make an independent judgment that a device marketed with other claims and for other purposes provides the type of safety-engineered protection anticipated by the standard? If so, what level of documentation or testing is the employer required to have to demonstrate the validity of such judgments?
Response 2: As stated in response #1, the substitution of an alternative device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. The requirement for evaluation and selection of a safety device is a performance-oriented provision which depends greatly on the specific medical device and medical procedure(s) in question. Devices must be evaluated for their ability to prevent occupational exposures to blood or other potentially infectious materials (OPIM) in each procedure. The final determination of what safer device is selected for use is a responsibility of the employer; however, when evaluating and selecting safer devices, employers must solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps [29 CFR 1910.1030(c)(1)(v)]. The input from affected employees must be factored into the employer's judgment of the appropriateness for use of a particular safety device.
Question 3: OSHA has previously clarified, in the context of Group Purchasing Organizations (GPOs), that price and contractual availability cannot be the sole basis for selecting a safety device. May other contractual requirements provide a basis for selecting a particular device? For example, if a multi-product manufacturer offers a contract that has a cost basis associated with being the employer's exclusive provider of a range of medical devices, and/or offers overall volume discounts that would be impacted by selecting another manufacturer's safety device, is a decision to use the contracting supplier's safety engineering sharps devices on this basis acceptable?
Response 3: 29 CFR 1910.1030 does not address contractual arrangements between employers and device manufacturers. Therefore, the standard does not specifically preclude the use of GPOs as long as the employer is still able to meet the intent of the standard. As stated in the response to question #2, non-managerial employees involved in patient care must be afforded the opportunity to provide feedback in the evaluation and selection of safer devices. If an employer enters into an exclusive contractual arrangement with a manufacturer, the availability and variety of devices may be restricted. As technology advances, it is difficult to determine whether a safer and more appropriate device might become commercially available from a competitor of the exclusive supplier. Employees may be limited in the variety of available safety devices, particularly with regard to equipment that has few available choices. Additionally, each employer must review and update the exposure control plan annually and the annual review must include documentation of the consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A)]. Advances in technology might not be captured if an employer is bound by contract to only evaluate devices from a single manufacturer. Finally, 29 CFR 1910.1030(d)(2)(i) requires that employers eliminate or minimize, i.e., reduce to the lowest extent feasible, occupational exposure. Thus, irrespective of the arrangements used in obtaining safety devices, the determination of an employer's compliance will be based on whether the requirements of the standard are being met.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
______________________________________________________
www.QDSyringeSystems.com
www.QDSyringe.com
The use of safety-engineered devices and work practice controls in operating rooms; hospital responsibility to protect independent practitioners under BBP standard
January 18, 2007
Mr. Erik Frederick
Director of Safety
Baptist Medical Center
111 Dallas Street
San Antonio, Texas 78224
Dear Mr. Frederick:
Thank you for your letter to the United States Occupational Safety and Health Administration (OSHA). Your letter was forwarded to the Directorate of Enforcement Programs (DEP) for a response. You have questions about the use of safety-engineered devices and work practice controls, such as implementing safe zones in operating rooms. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA's response. We apologize for the delay in addressing your concerns.
Question 1: Members of our hospital operating room (OR) committee, including surgeons, nurses, and technicians, are requesting an interpretation of what the hospital's responsibility is in evaluating and implementing the use of sharps with engineered sharps injury protections (SESIPs) and safe zones for hands-free passing of sharps in the surgical suite. What does the bloodborne pathogens standard at 29 CFR §1910.1030 require in this regard?
Reply 1: OSHA's bloodborne pathogens standard requires that employers use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent [29 CFR §1910.1030(d)(2)(i)]. One type of engineering control is a SESIP. 29 CFR §1910.1030(b) (definition of "[e]ngineering controls"). Therefore, where feasible, hospitals must implement the use of SESIPs and proper work practices, such as designated neutral or safe zones, which allow hands-free passing of sharps, to prevent sharps injuries in operating rooms. See CPL 2-2.69, XIII D.2 (2001) ("eliminating hand-to-hand instrument passing in the operating room" noted as engineering control in directive implementing the standard). The practitioner's preference is not an excuse for failure to use engineering controls and work practices. In many cases, surgeons may simply need additional practice or training to feel comfortable using a new and different device or work practice. However, if the use of a particular device or work practice could adversely affect the performance of a particular procedure and, ultimately, the safety of a patient, the device or practice does not have to be used. A determination not to use a particular device or work practice must be documented in the facility's exposure control plan (ECP), 29 CFR §1910.1030(c)(1)(iv).
if a hospital-selected safety device or work practice would adversely affect patient safety, the hospital must ensure that an alternative safe device or practice is implemented for the handling of sharps in the OR. For example, in a situation where all practicable engineering devices have been implemented and it is not feasible to perform the surgical procedure safely using a neutral zone, the hospital must ensure that surgeons and other staff in the operating room do not perform "hand-to-hand" passing of devices without first verbally notifying each other. In this way, operating room nurses, technicians, and surgeons will not be caught off-guard and will thus avoid "blind" retrieval of contaminated sharps.
Question 2: The surgeons in our facility are independent practitioners and are not employees of the hospital. What are the responsibilities of the hospital and the surgeons to protect hospital personnel in the OR under the bloodborne pathogens standard in this situation?
Reply 2: The hospital is responsible under the OSH Act for affording the protections of the bloodborne pathogens standard to its employees, regardless of the independent practitioners performing surgery in its operating rooms. It may not absolve itself of these responsibilities. We assume that the independent practitioners you discuss are surgeons with staff privileges at the hospital. The relationship between a hospital and a surgeon or other physician with staff privileges at the hospital is contractual. Therefore, the practitioner has a contractual responsibility to comply with hospital procedures as set forth in the contract, and the surgeon has an obligation to follow them. Hospitals have the right to make a practitioner's adherence to the hospital's procedures a condition of staff privileges.
Furthermore, the practitioner or the medical practice with which he or she is associated, like a partnership or a professional corporation, usually would also be obligated to comply with the OSH Act and its standards, like the bloodborne pathogens standard, so as to protect employees. Surgeons or their medical practices usually employ at least one employee, such as a secretary or receptionist, and thus are employers under the OSH Act. 29 USC §652(5). Under the OSHA multi-employer worksite doctrine, an employer (here, the practitioner or his or her medical practice), that creates or controls a hazard, is obligated to comply with the standard so as not to endanger hospital employees.1 See CPL 2-2.69 XI D (2001), which refers to CPL 2-0.124, Multi-Employer Citation Policy. These directives are available on OSHA's web site, http://www.osha.gov.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of General Industry Enforcement at (202) 693-1850.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
------------------------------------------------------------------------
http://www.qdsyringesystems.com
http://www.qdsyringe.com
Mr. Erik Frederick
Director of Safety
Baptist Medical Center
111 Dallas Street
San Antonio, Texas 78224
Dear Mr. Frederick:
Thank you for your letter to the United States Occupational Safety and Health Administration (OSHA). Your letter was forwarded to the Directorate of Enforcement Programs (DEP) for a response. You have questions about the use of safety-engineered devices and work practice controls, such as implementing safe zones in operating rooms. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA's response. We apologize for the delay in addressing your concerns.
Question 1: Members of our hospital operating room (OR) committee, including surgeons, nurses, and technicians, are requesting an interpretation of what the hospital's responsibility is in evaluating and implementing the use of sharps with engineered sharps injury protections (SESIPs) and safe zones for hands-free passing of sharps in the surgical suite. What does the bloodborne pathogens standard at 29 CFR §1910.1030 require in this regard?
Reply 1: OSHA's bloodborne pathogens standard requires that employers use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent [29 CFR §1910.1030(d)(2)(i)]. One type of engineering control is a SESIP. 29 CFR §1910.1030(b) (definition of "[e]ngineering controls"). Therefore, where feasible, hospitals must implement the use of SESIPs and proper work practices, such as designated neutral or safe zones, which allow hands-free passing of sharps, to prevent sharps injuries in operating rooms. See CPL 2-2.69, XIII D.2 (2001) ("eliminating hand-to-hand instrument passing in the operating room" noted as engineering control in directive implementing the standard). The practitioner's preference is not an excuse for failure to use engineering controls and work practices. In many cases, surgeons may simply need additional practice or training to feel comfortable using a new and different device or work practice. However, if the use of a particular device or work practice could adversely affect the performance of a particular procedure and, ultimately, the safety of a patient, the device or practice does not have to be used. A determination not to use a particular device or work practice must be documented in the facility's exposure control plan (ECP), 29 CFR §1910.1030(c)(1)(iv).
if a hospital-selected safety device or work practice would adversely affect patient safety, the hospital must ensure that an alternative safe device or practice is implemented for the handling of sharps in the OR. For example, in a situation where all practicable engineering devices have been implemented and it is not feasible to perform the surgical procedure safely using a neutral zone, the hospital must ensure that surgeons and other staff in the operating room do not perform "hand-to-hand" passing of devices without first verbally notifying each other. In this way, operating room nurses, technicians, and surgeons will not be caught off-guard and will thus avoid "blind" retrieval of contaminated sharps.
Question 2: The surgeons in our facility are independent practitioners and are not employees of the hospital. What are the responsibilities of the hospital and the surgeons to protect hospital personnel in the OR under the bloodborne pathogens standard in this situation?
Reply 2: The hospital is responsible under the OSH Act for affording the protections of the bloodborne pathogens standard to its employees, regardless of the independent practitioners performing surgery in its operating rooms. It may not absolve itself of these responsibilities. We assume that the independent practitioners you discuss are surgeons with staff privileges at the hospital. The relationship between a hospital and a surgeon or other physician with staff privileges at the hospital is contractual. Therefore, the practitioner has a contractual responsibility to comply with hospital procedures as set forth in the contract, and the surgeon has an obligation to follow them. Hospitals have the right to make a practitioner's adherence to the hospital's procedures a condition of staff privileges.
Furthermore, the practitioner or the medical practice with which he or she is associated, like a partnership or a professional corporation, usually would also be obligated to comply with the OSH Act and its standards, like the bloodborne pathogens standard, so as to protect employees. Surgeons or their medical practices usually employ at least one employee, such as a secretary or receptionist, and thus are employers under the OSH Act. 29 USC §652(5). Under the OSHA multi-employer worksite doctrine, an employer (here, the practitioner or his or her medical practice), that creates or controls a hazard, is obligated to comply with the standard so as not to endanger hospital employees.1 See CPL 2-2.69 XI D (2001), which refers to CPL 2-0.124, Multi-Employer Citation Policy. These directives are available on OSHA's web site, http://www.osha.gov.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of General Industry Enforcement at (202) 693-1850.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
------------------------------------------------------------------------
http://www.qdsyringesystems.com
http://www.qdsyringe.com
Friday, December 9, 2011
Needlestick Safety and Prevention Act and the requirement to include safety- engineered sharps devices in pre-packaged surgical kits and trays.
February 20, 2003
Ms. Wendy Gallart
Senior Marketing Manager
BD Advanced Protection Technologies
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Dear Ms. Gallart:
Thank you for your October 29, 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the requirement for employers to use engineering controls (e.g., safer medical devices) under the bloodborne pathogens standard [29 CFR 1910.1030]. Your question is restated below followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence.
The Needlestick Safety and Prevention Act is not enforceable on its own, but rather the Occupational Safety and Health Act of 1970, which requires compliance with OSHA standards. The OSHA bloodborne pathogens standard requires the institution of safety measures in workplaces where there is occupational exposure to blood or other potentially infectious materials (OPIM). Under the standard, as revised by the NSPA, employers are required to evaluate, select, and use engineering controls (e.g., sharps with engineered sharps injury protections or needleless systems) to eliminate or minimize exposure to contaminated sharps [29 CFR 1910.1030(d)(2)(i)].
In healthcare settings this requirement is easily interpreted to mean that employers must implement the use of "safety-engineered devices" or sharps with engineered sharps injury protection (SESIPs) when performing medical procedures with sharps, regardless how they are packaged or supplied. If, during surgical procedures, as your letter specifies, physician specialists or other healthcare personnel are using medical instruments supplied in pre-packaged kits, those packages must include engineering controls appropriate for the specific procedures being performed. Employees using these devices must have the opportunity to provide feedback on appropriate and effective safer devices [29 CFR 1910.1030(c)(1)(v)].
We understand that physician specialists (e.g., surgeons, anesthesiologists, etc.) often are not employees of healthcare facilities where they have staff privileges. Under OSHA's bloodborne pathogens compliance directive (OSHA Instruction CPL 02-02-069 [formerly CPL 2-2.69]) the status of the physician as an employer or employee is important to establish in order to determine the application of OSHA standards. According to the paragraph XI.D. in the directive, physicians "... may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges in accordance with the multi-employer worksite guidelines of CPL 02-00-124 [formerly CPL 2-0.124], Multi-Employer Citation Policy."
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
--------------------------------------------------
www.QDSyringeSystems.com
www.QDSyringe.com
Ms. Wendy Gallart
Senior Marketing Manager
BD Advanced Protection Technologies
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Dear Ms. Gallart:
Thank you for your October 29, 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the requirement for employers to use engineering controls (e.g., safer medical devices) under the bloodborne pathogens standard [29 CFR 1910.1030]. Your question is restated below followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence.
Does compliance with the updated bloodborne pathogens directive enforced by the Needlestick Safety and Prevention Law require that pre-packaged kits include safety-engineered devices?The Needlestick Safety and Prevention Act (NSPA) was signed into law in November 2000. It mandated OSHA to revise its bloodborne pathogens standard to include specific additional definitions and requirements. OSHA published "Revision to OSHA's Bloodborne Pathogens Standard -- Technical Background and Summary -- Needlestick Fact Sheet (2001, May 9)," which clearly details the changes to the standard. We have attached it for your convenience. It is also available on our website, along with other informative outreach materials on the hazards associated with exposure to blood and other potentially infectious materials (OPIM), see [the Bloodborne Pathogens Technical Links Page].
Note: These pre-packaged kits or trays may be prepared by outside vendors specifically for physician specialists in operating rooms and surgical centers.
The Needlestick Safety and Prevention Act is not enforceable on its own, but rather the Occupational Safety and Health Act of 1970, which requires compliance with OSHA standards. The OSHA bloodborne pathogens standard requires the institution of safety measures in workplaces where there is occupational exposure to blood or other potentially infectious materials (OPIM). Under the standard, as revised by the NSPA, employers are required to evaluate, select, and use engineering controls (e.g., sharps with engineered sharps injury protections or needleless systems) to eliminate or minimize exposure to contaminated sharps [29 CFR 1910.1030(d)(2)(i)].
In healthcare settings this requirement is easily interpreted to mean that employers must implement the use of "safety-engineered devices" or sharps with engineered sharps injury protection (SESIPs) when performing medical procedures with sharps, regardless how they are packaged or supplied. If, during surgical procedures, as your letter specifies, physician specialists or other healthcare personnel are using medical instruments supplied in pre-packaged kits, those packages must include engineering controls appropriate for the specific procedures being performed. Employees using these devices must have the opportunity to provide feedback on appropriate and effective safer devices [29 CFR 1910.1030(c)(1)(v)].
We understand that physician specialists (e.g., surgeons, anesthesiologists, etc.) often are not employees of healthcare facilities where they have staff privileges. Under OSHA's bloodborne pathogens compliance directive (OSHA Instruction CPL 02-02-069 [formerly CPL 2-2.69]) the status of the physician as an employer or employee is important to establish in order to determine the application of OSHA standards. According to the paragraph XI.D. in the directive, physicians "... may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges in accordance with the multi-employer worksite guidelines of CPL 02-00-124 [formerly CPL 2-0.124], Multi-Employer Citation Policy."
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
--------------------------------------------------
www.QDSyringeSystems.com
www.QDSyringe.com
Employer's Responsibility To Re-evaluate Engineering Controls, i.e., Safer Needle Devices, At Least Annually
January 20, 2004
Mr. Marty Salanger
Manager of Safety, Policy and Government Relations
BD Advanced Protection Technologies
1 Becton Drive
Franklin Lakes, NJ 07417
Dear Mr. Salanger:
Thank you for your October 29, 2003 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question(s) not delineated within your original correspondence. You had specific questions regarding an employer's responsibility to re-evaluate engineering controls under OSHA's bloodborne pathogens standard (29 CFR 1910.1030). Your question is restated below followed by OSHA's response. We apologize for the delay in responding.
Question: If an employer has selected a particular safety-engineered device based on employee feedback, and a reduction in needlestick injuries can be shown as a result of the adoption of the current device, to what extent does an employer need to re-evaluate their chosen device?
Reply: As you are aware, OSHA's bloodborne pathogens standard requires employers to review and update their Exposure Control Plan (ECP) at least annually [29 CFR 1910.1030(c)(1)(iv)]. It is also a requirement that: 1) annual reviews and updates of ECPs reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and 2) employers document annually their consideration and implementation of appropriate commercially available and effective safer medical devices [29 CFR 1910.1030(c)(1)(iv)(A-B)].
If, after employee input, an employer selects an engineering control that is effective in reducing needlestick injuries, it is not necessary to evaluate all newly emerging engineering controls each year. The employer must simply keep abreast of new and emerging technologies and solicit input from non-managerial employees to determine if the facility's chosen device remains preferable to any newly developed products. This should be documented in the ECP.
Since the requirements of the standard are performance-based, OSHA determines compliance with the standard on a facility-by-facility, instance-by-instance basis, based on the employer's consideration of safer medical devices, solicitation of input from employees, documentation in an employer's ECP, and employee interviews.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
--------------------------------------------------------
http://www.qdsyringesystems.com
http://www.qdsyringe.com
Mr. Marty Salanger
Manager of Safety, Policy and Government Relations
BD Advanced Protection Technologies
1 Becton Drive
Franklin Lakes, NJ 07417
Dear Mr. Salanger:
Thank you for your October 29, 2003 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question(s) not delineated within your original correspondence. You had specific questions regarding an employer's responsibility to re-evaluate engineering controls under OSHA's bloodborne pathogens standard (29 CFR 1910.1030). Your question is restated below followed by OSHA's response. We apologize for the delay in responding.
Question: If an employer has selected a particular safety-engineered device based on employee feedback, and a reduction in needlestick injuries can be shown as a result of the adoption of the current device, to what extent does an employer need to re-evaluate their chosen device?
Reply: As you are aware, OSHA's bloodborne pathogens standard requires employers to review and update their Exposure Control Plan (ECP) at least annually [29 CFR 1910.1030(c)(1)(iv)]. It is also a requirement that: 1) annual reviews and updates of ECPs reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and 2) employers document annually their consideration and implementation of appropriate commercially available and effective safer medical devices [29 CFR 1910.1030(c)(1)(iv)(A-B)].
If, after employee input, an employer selects an engineering control that is effective in reducing needlestick injuries, it is not necessary to evaluate all newly emerging engineering controls each year. The employer must simply keep abreast of new and emerging technologies and solicit input from non-managerial employees to determine if the facility's chosen device remains preferable to any newly developed products. This should be documented in the ECP.
Since the requirements of the standard are performance-based, OSHA determines compliance with the standard on a facility-by-facility, instance-by-instance basis, based on the employer's consideration of safer medical devices, solicitation of input from employees, documentation in an employer's ECP, and employee interviews.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
--------------------------------------------------------
http://www.qdsyringesystems.com
http://www.qdsyringe.com
Thursday, December 8, 2011
Safer medical devices must be selected based on employee feedback and device effectiveness, not Group Purchasing Organizations.
November 21, 2002
Ms. Audrey Taffet
Manager, Business Development
Terumo Medical Corporation
2101 Cottontail Lane
Somerset, NJ 08873
Dear Ms. Taffet:
Thank you for your July 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the application of the requirement in the Bloodborne Pathogens Standard (29 CFR 1910.1030) to use safer medical devices, specifically for facilities working under Group Purchasing Organization (GPO) contracts. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. Your letter is paraphrased below followed by OSHA's response.
Your interpretation is correct. Devices must be selected based on employee feedback (29 CFR 1910.1030(c)(1)(v)). They must be evaluated for appropriateness for each procedure and effectiveness in preventing occupational exposures to blood and other potentially infectious materials (OPIM). If the availability and variety of devices is restricted, the employer may be in violation of the requirements: (1) to review and update the exposure control plan to reflect changes in technology that eliminate or reduce exposure to blood and OPIM (29 CFR 1910.1030(c)(1)(iv)(A)); (2) to review and update the plan annually, documenting the consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure (29 CFR 1910.1030(c)(i)(iv)(B); and (3) to use engineering controls to eliminate or minimize employee exposure (29 CFR 1910.1030(d)(2)(i)).
Remember, selecting a safer device based solely on the lowest cost is not appropriate. Selection must be based on employee feedback and device effectiveness. OSHA compliance officers have issued citations to employers at facilities that were not using effective engineering controls because of the product availability limits of their purchasing contracts. Again, if during an OSHA inspection, it is determined that an employer did not evaluate and select appropriate and effective devices, the employer may be cited. In an effort to best serve the safety and regulatory needs of their clients, GPOs should offer a variety of different safer devices.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
__________________________________________________
www.QDSyringeSystems.com
www.QDSyringe.com
Ms. Audrey Taffet
Manager, Business Development
Terumo Medical Corporation
2101 Cottontail Lane
Somerset, NJ 08873
Dear Ms. Taffet:
Thank you for your July 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the application of the requirement in the Bloodborne Pathogens Standard (29 CFR 1910.1030) to use safer medical devices, specifically for facilities working under Group Purchasing Organization (GPO) contracts. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. Your letter is paraphrased below followed by OSHA's response.
We (Terumo) understand that the evaluation of new sharps safety devices should be conducted by frontline healthcare workers. Many healthcare facilities operate under a Group Purchasing Organization (GPO) contact, intended to organize purchasing and availability of medical supplies. The GPOs typically offer little, if any, variation with regard to needlestick safety products. In light of the OSHA requirements to use safer medical devices dependent on an evaluation performed by healthcare workers, GPOs should not restrict the selection and evaluation of such products. What is OSHA's viewpoint on this?
Remember, selecting a safer device based solely on the lowest cost is not appropriate. Selection must be based on employee feedback and device effectiveness. OSHA compliance officers have issued citations to employers at facilities that were not using effective engineering controls because of the product availability limits of their purchasing contracts. Again, if during an OSHA inspection, it is determined that an employer did not evaluate and select appropriate and effective devices, the employer may be cited. In an effort to best serve the safety and regulatory needs of their clients, GPOs should offer a variety of different safer devices.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.
Sincerely,
Richard E. Fairfax, Director
Directorate of Enforcement Programs
__________________________________________________
www.QDSyringeSystems.com
www.QDSyringe.com
QD Syringe Systems® | QD Syringe | Low Dead Space Syringe
For More information contact: Christopher Green at: QuickDrawSyringe@gmail.com
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Needlestick Injuries, Legislation and More...
* "Today alone over 2,100 health care professionals will incur a needlestick related injury." [NIOSH Study, 1999]
* There have been 57 documented cases of HIV seroconversion among healthcare personnel
* The cost of needlestick injury follow-up in the U.S. per incident is around $3,000.
* Accident follow ups cost the US medical industry $1.2 billion annually.
* Annual treatment for contracted diseases in the US is $1.8 billion.
* A total of $3 billion is spent annually in the US on needlestick injuries.
* In the United Kingdom the number of reported needlestick injuries has risen 49% from 2002 to 2005 (Article – The Times), presently estimated at more than 100,000 per year.
* Thousands of Australian hospital workers suffer needlestick injuries each year and the incidence is increasing.
Global Legislative Outlook
* The United States already has OSHA legislation in place requiring the use of safety injection technology.
* US military planning a policy shift to safety technology
* Spain has begun mandating use of safety technology with a 3-5 year implementation period.
* EU Legislation is pending due to a ground swell of protest from healthcare workers who are concerned about the risk of suffering bloodborne pathogen induced illnesses (eg: Hepatitis B, Hepatitis C and HIV / AIDS) as a direct result of needlestick injury.
* In the UK, the NHS is assessing all suitable safety technology. The transition to safety devices began in 2006.
* Australia and Canada are reviewing policies and are expected to mandate safety technology in the next two-three years.
From Q Stat Safety Syringe
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