- Email: [email protected]
In reply to Associate Professor Murphy's letter
Healthcare Infection
Letters to the editor
disposable containers with penetration force >12.5N would cost each manufacturer of disposable containers between $USD 5 and 10 million and cause extended delays to supply (A. McLean, Becton Dickinson, Sydney, pers. comm., November 2007). These costs would inevitably flow on to an already cash-strapped healthcare system. Second, there are no independent, peerreviewed, controlled, published studies that demonstrate the need for or superiority of sharps containers of penetration force >12.5N to prevent needle penetration. Finally, an increase in Australian requirements for sharps container penetration to 20N will effectively create a commercial monopoly for manufacturers of reusable sharps containers and eliminate the current workable options where Australian healthcare workers can be provided with safe sharps containers that are either reusable or disposable. The issues raised in this response highlight the requirement for judicious preparation of the eventual sharps container Standard by Committee HE-011. They also highlight the importance of AICA members contributing to that preparation either by providing comment to the author in their capacity as AICA HE-011 representative and/or through the public consultation process.
Conflict of interest Associate Professor Cathryn Murphy is a Managing Director – Infection Control Plus and at the time of writing this response was
In reply to Associate Professor Murphy’s letter Sue Atkins BN, CIC Royal District Nursing Service, 31 Alma Road, St Kilda, Vic. 3182, Australia. Email: [email protected] The intention of the letter published in the first issue of this year’s Healthcare Infection,1 was not to bypass the Standards process for feedback as intimated by Associate Professor Murphy, but to share our experiences to aid the Committee’s deliberations on increasing the penetration test force for non-reusable sharps container. There is limited published data on this issue. Professor Murphy’s calculations on the incidence of container penetration injuries (CPI) are of interest; however, at Royal District Nursing Service (RDNS) there were four CPI out of a total of 104 sharps injuries (SI) over 5 years, giving a CPI rate of 38/1000 SI. This rate is extremely high and very disturbing. In addition, there were two further container penetration incidents that did not cause SI. All occurred with containers compliant with the current Standard for non-reusables, which requires the lowest Penetration Test of Standards in OECD member countries.
the designated AICA nominated member of the Standards Australia Committee HE-011. From time to time, Associate Professor Murphy is a casual consultant to Becton Dickinson (BD) Australia/New Zealand, Asia Pacific and BD USA. No funding or input was sought or received from either source in relation to this paper.
References 1. Atkins S. Strengthening of Australian Sharps Container Standard. Healthcare Infect 2008; 13: 20. doi:10.1071/HI08007 2. Standards Australia. Committee Members – Their Roles and Responsibilities. Sydney: Standards Australia; 2002. 3. Standards Australia. A Guide for Nominating Organizations Standardization Guide No. 8. Vol. 2008. Sydney: Standards Australia; 2005. 4. Royal District Nursing Service. Where we are. Available online at: www.rdns.com.au/About/Where+we+are+today.htm [accessed 1 April 2008]. 5. Cardo DM, Culver DH, Ciesielski CA, Srivastava PU, Marcus R, Abiteboul D, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med 1997; 337: 1485–1490. doi:10.1056/NEJM199711203372101 6. Beltrami EM, Williams IT, Shapiro CN, Chamberland ME. Risk and management of blood-borne infections in health care workers. Clin Microbiol Rev 2000; 13: 385–407. doi:10.1128/CMR.13.3.385-407.2000
Professor Murphy’s statement is accepted regarding the risk of an RDNS healthcare worker acquiring a blood borne pathogen (BBP) from a used sharp piercing a sharps container is ‘negligible’. So too is the BBP transmission risk in facility-based healthcare. However, this does not lessen the anxiety for the injured staff member. Furthermore, whether the risk is low or not, the management of these injuries remains the same as for other needle-stick injuries, which comes at a cost to the health service. But most importantly, we must aim to eliminate SI. Elimination of SI is the Center for Disease Control objective2 and should be the objective of every healthcare institution and medical industry association. RDNS continually evaluates the performance of all safety devices available, including sharps containers, in an effort to increase sharps safety for our staff. It is this vigilance that alerted us to the fact that our staff are suffering CPI with containers compliant with the Australian Standard. Australian Standards are a, ‘Published document which sets out specifications and procedures designed to ensure that a material, product, method or service is fit for its purpose and consistently performs in the way it was intended’.3
31
Healthcare Infection
Our evidence confirms stronger containers are needed to give ‘fit for purpose’ assurance. Fear of a commercial monopoly for manufacturers of reusable sharps containers as suggested by Professor Murphy is not shared. In fact, the opposite will occur. RDNS has found there are limited sharps containers available that withstand the rigors of use within the uncontrollable environment and constant transportation requirements of home healthcare – if penetration force is raised to that of re-usables, it would give healthcare providers a greater choice in containers. It is agreed that safety engineered devices, used correctly, reduces the risk of CPI. However, most prefilled syringes are not manufactured with engineered safety features; it is this type of finer needle that is a frequent cause of our penetration incidents. Furthermore, RDNS does not provide equipment to the client. The client is informed on admission of equipment required for their care; they then purchase this equipment which is delivered directly to their home. Ultimately, the choice of product is theirs, but all sharps containers must contain these products safely in the home and allow safe handling and transportation. Professor Murphy states that changing moulds will result in increased costs and cause extended delays to supply. There is no difference in this process from that when needle safety devices were first offered. After seeking advice from the plastics industry, the information was that increasing the penetration force of containers does not necessarily require a change to the mould – in fact it is commonly achieved by changing the grade or type of plastic. These changes are far less costly than mould changes and reduce possible time delays. Importantly, the cost of plastic is minimal compared to the end-cost of the container. If mould changes were necessary, each mould is capable of producing many millions of containers, over which the cost can be amortised (R. Brown, Polymers International Australia, Victoria, pers.
32
Letters to the editor
comm., April 2008). Even so, the extra cost of stronger containers is far less than needle safety devices are over standard needles. Requiring stronger non-reusable sharps containers will incentivise manufacturers to achieve this cost effectively. The fact that there is no ‘independent, peer reviewed, controlled, published studies’ indicating the need for strengthening sharps containers, does not mean these injuries are not occurring in clinical practice (as identified by RDNS). Few state and territory jurisdictions publish their SI data; furthermore, the incidence of CPI is low as many studies do not identify this type of injury separately. RDNS data and that from international jurisdictions, clearly support an increase in penetration force for non-reusable sharps containers. The evidence available on CPI caused France to strengthen their Standard in 1999 and Canada to strengthen theirs in 2007. Australia must do the same. Anyone working within healthcare that has knowledge of CPI occurring within their organisation is urged to share this information with Standards Australia or the Australian Infection Control Association.
References 1. Atkins S. Strengthening of Australian Sharps Container Standard. Healthcare Infect 2008; 13: 20–. doi:10.1071/HI08007 2. Centers for Disease Control. CDC’s Seven Healthcare Safety Challenges. Issues in Healthcare Settings. Division of Healthcare Quality Promotion. Atlanta: Centers For Disease Control. Available online at: http://www.cdc.gov/ncidod/dhqp/about_challenges.html [verified 1 May 2008]. 3. Standards Australia. What is a standard? Sydney: Standards Australia. Available online at: http://www.standards.org.au/cat.asp?catid=2 [verified 1 May 2008].
Letters to the editor
disposable containers with penetration force >12.5N would cost each manufacturer of disposable containers between $USD 5 and 10 million and cause extended delays to supply (A. McLean, Becton Dickinson, Sydney, pers. comm., November 2007). These costs would inevitably flow on to an already cash-strapped healthcare system. Second, there are no independent, peerreviewed, controlled, published studies that demonstrate the need for or superiority of sharps containers of penetration force >12.5N to prevent needle penetration. Finally, an increase in Australian requirements for sharps container penetration to 20N will effectively create a commercial monopoly for manufacturers of reusable sharps containers and eliminate the current workable options where Australian healthcare workers can be provided with safe sharps containers that are either reusable or disposable. The issues raised in this response highlight the requirement for judicious preparation of the eventual sharps container Standard by Committee HE-011. They also highlight the importance of AICA members contributing to that preparation either by providing comment to the author in their capacity as AICA HE-011 representative and/or through the public consultation process.
Conflict of interest Associate Professor Cathryn Murphy is a Managing Director – Infection Control Plus and at the time of writing this response was
In reply to Associate Professor Murphy’s letter Sue Atkins BN, CIC Royal District Nursing Service, 31 Alma Road, St Kilda, Vic. 3182, Australia. Email: [email protected] The intention of the letter published in the first issue of this year’s Healthcare Infection,1 was not to bypass the Standards process for feedback as intimated by Associate Professor Murphy, but to share our experiences to aid the Committee’s deliberations on increasing the penetration test force for non-reusable sharps container. There is limited published data on this issue. Professor Murphy’s calculations on the incidence of container penetration injuries (CPI) are of interest; however, at Royal District Nursing Service (RDNS) there were four CPI out of a total of 104 sharps injuries (SI) over 5 years, giving a CPI rate of 38/1000 SI. This rate is extremely high and very disturbing. In addition, there were two further container penetration incidents that did not cause SI. All occurred with containers compliant with the current Standard for non-reusables, which requires the lowest Penetration Test of Standards in OECD member countries.
the designated AICA nominated member of the Standards Australia Committee HE-011. From time to time, Associate Professor Murphy is a casual consultant to Becton Dickinson (BD) Australia/New Zealand, Asia Pacific and BD USA. No funding or input was sought or received from either source in relation to this paper.
References 1. Atkins S. Strengthening of Australian Sharps Container Standard. Healthcare Infect 2008; 13: 20. doi:10.1071/HI08007 2. Standards Australia. Committee Members – Their Roles and Responsibilities. Sydney: Standards Australia; 2002. 3. Standards Australia. A Guide for Nominating Organizations Standardization Guide No. 8. Vol. 2008. Sydney: Standards Australia; 2005. 4. Royal District Nursing Service. Where we are. Available online at: www.rdns.com.au/About/Where+we+are+today.htm [accessed 1 April 2008]. 5. Cardo DM, Culver DH, Ciesielski CA, Srivastava PU, Marcus R, Abiteboul D, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med 1997; 337: 1485–1490. doi:10.1056/NEJM199711203372101 6. Beltrami EM, Williams IT, Shapiro CN, Chamberland ME. Risk and management of blood-borne infections in health care workers. Clin Microbiol Rev 2000; 13: 385–407. doi:10.1128/CMR.13.3.385-407.2000
Professor Murphy’s statement is accepted regarding the risk of an RDNS healthcare worker acquiring a blood borne pathogen (BBP) from a used sharp piercing a sharps container is ‘negligible’. So too is the BBP transmission risk in facility-based healthcare. However, this does not lessen the anxiety for the injured staff member. Furthermore, whether the risk is low or not, the management of these injuries remains the same as for other needle-stick injuries, which comes at a cost to the health service. But most importantly, we must aim to eliminate SI. Elimination of SI is the Center for Disease Control objective2 and should be the objective of every healthcare institution and medical industry association. RDNS continually evaluates the performance of all safety devices available, including sharps containers, in an effort to increase sharps safety for our staff. It is this vigilance that alerted us to the fact that our staff are suffering CPI with containers compliant with the Australian Standard. Australian Standards are a, ‘Published document which sets out specifications and procedures designed to ensure that a material, product, method or service is fit for its purpose and consistently performs in the way it was intended’.3
31
Healthcare Infection
Our evidence confirms stronger containers are needed to give ‘fit for purpose’ assurance. Fear of a commercial monopoly for manufacturers of reusable sharps containers as suggested by Professor Murphy is not shared. In fact, the opposite will occur. RDNS has found there are limited sharps containers available that withstand the rigors of use within the uncontrollable environment and constant transportation requirements of home healthcare – if penetration force is raised to that of re-usables, it would give healthcare providers a greater choice in containers. It is agreed that safety engineered devices, used correctly, reduces the risk of CPI. However, most prefilled syringes are not manufactured with engineered safety features; it is this type of finer needle that is a frequent cause of our penetration incidents. Furthermore, RDNS does not provide equipment to the client. The client is informed on admission of equipment required for their care; they then purchase this equipment which is delivered directly to their home. Ultimately, the choice of product is theirs, but all sharps containers must contain these products safely in the home and allow safe handling and transportation. Professor Murphy states that changing moulds will result in increased costs and cause extended delays to supply. There is no difference in this process from that when needle safety devices were first offered. After seeking advice from the plastics industry, the information was that increasing the penetration force of containers does not necessarily require a change to the mould – in fact it is commonly achieved by changing the grade or type of plastic. These changes are far less costly than mould changes and reduce possible time delays. Importantly, the cost of plastic is minimal compared to the end-cost of the container. If mould changes were necessary, each mould is capable of producing many millions of containers, over which the cost can be amortised (R. Brown, Polymers International Australia, Victoria, pers.
32
Letters to the editor
comm., April 2008). Even so, the extra cost of stronger containers is far less than needle safety devices are over standard needles. Requiring stronger non-reusable sharps containers will incentivise manufacturers to achieve this cost effectively. The fact that there is no ‘independent, peer reviewed, controlled, published studies’ indicating the need for strengthening sharps containers, does not mean these injuries are not occurring in clinical practice (as identified by RDNS). Few state and territory jurisdictions publish their SI data; furthermore, the incidence of CPI is low as many studies do not identify this type of injury separately. RDNS data and that from international jurisdictions, clearly support an increase in penetration force for non-reusable sharps containers. The evidence available on CPI caused France to strengthen their Standard in 1999 and Canada to strengthen theirs in 2007. Australia must do the same. Anyone working within healthcare that has knowledge of CPI occurring within their organisation is urged to share this information with Standards Australia or the Australian Infection Control Association.
References 1. Atkins S. Strengthening of Australian Sharps Container Standard. Healthcare Infect 2008; 13: 20–. doi:10.1071/HI08007 2. Centers for Disease Control. CDC’s Seven Healthcare Safety Challenges. Issues in Healthcare Settings. Division of Healthcare Quality Promotion. Atlanta: Centers For Disease Control. Available online at: http://www.cdc.gov/ncidod/dhqp/about_challenges.html [verified 1 May 2008]. 3. Standards Australia. What is a standard? Sydney: Standards Australia. Available online at: http://www.standards.org.au/cat.asp?catid=2 [verified 1 May 2008].