Graham Reynolds, West Pharmaceutical Services Inc.02.14.14
A nurse, distracted by a coworker, attempts to recap a needle without looking, resulting in an injury. A home healthcare worker disposes of a properly capped needle, only to be stuck by a previously used needle that had been placed in the sharps bin without a cover. A patient with a chronic condition that may require routine injections grows careless with an unprotected system, resulting in an injury to a family member. The World Health Organization estimates that more than 2 million healthcare workers worldwide will suffer an accidental needlestick injury this year. The most common causes of needlestick injuries are two-handed recapping and the unsafe collection and disposal of sharps waste.
Needlestick injuries can transmit a variety of blood borne pathogens, including the hepatitis B and C viruses and HIV. Treatment costs can exceed more than $3 billion per year in the United States, according the Occupational Safety and Health Administration. The Centers for Disease Control and Prevention estimates that more than 500,000 injuries occur in the United States annually, and approximately half of those (nearly 1,000 per day) occur in hospitals. The direct cost for such an injury, according to the American Hospital Association, ranges from hundreds of dollars to more than $1,000 for medical evaluation and follow-up treatment. When the possibility of HIV is involved, that cost soars to more than $500,000 for an infected healthcare worker.
In July 2001, the Needlestick Safety and Prevention Act mandated that employers identify, evaluate and implement safer medical devices to help reduce or eliminate needlestick injuries. Similar legislation was implemented in Europe in 2013, and many other countries have introduced guidance to help ensure healthcare worker safety. Thanks to this legislation and the increasing awareness of the cost of injuries, many pharmaceutical companies now are pursuing the use of safety systems that are incorporated as part of a pre-filled syringe system.
The pre-filled syringe is the preferred choice for many liquid injectables, especially where the convenience of simple injection with fewer steps is needed. Hospitals may use pre-filled syringes to ensure proper dosing and ease of injection during emergency situations. Often, patients with chronic conditions require multiple injections in order to adhere to treatment regimens, and adherence to such regimens can be a painful and stressful daily routine. Should a safety system require an extra step, the precaution may be lost in the need for speed during an emergency situation or through apathy on the part of a weary patient who has grown tired of the burden of a chronic condition. In addition, there could be the potential that the design of a safety system may not take into account the patient’s condition or ability to assemble the system.
While the healthcare industry has seen advances in needlestick prevention, there needs to be ongoing development to create safer systems and practices. Systems that incorporate a safety mechanism can lower the risk of accidental needlesticks significantly. This may help to reduce the spread of infectious disease and reduce costs associated with the treatment of needlestick injuries.
A range of new technologies now is available to help protect healthcare workers, patients and caregivers from accidental needlestick injuries. Many of these systems have been designed to trigger automatically at any point after the needle is inserted into the patient’s body, and before completion of the full dose. Such a design helps to ensure protection even if the dose is partially administered in circumstances where, for instance, a patient struggles so the needle is removed and healthcare workers or caregivers are exposed to a contaminated sharp in a dangerous situation.
It Begins With Design
Protection begins with a design that incorporates a thorough understanding not only of the drug and its containment system, but also the interactions between the delivery system and the patient, caregiver and healthcare professional. Ease of use is a priority when it comes to needlestick prevention. Many syringe systems require affixing a needle prior to injection. Incorrect assembly of a needle system can create its own challenges, and recent U.S. Food and Drug Administration guidance recommends the use of bonded or staked needle systems.
A successful integrated system must be designed to enhance the drug delivery experience for the patient or caregiver. Automatic safety systems should be capable of being deployed using a single-handed technique to shield the exposed needle. In addition, such systems should be designed to prevent pre-activation.
As technology advances, the option to design a passive integrated safety system that fits on the end of an insert needle
syringe may offer a new and innovative option for pre-fillable syringe systems. Such a design would allow for the addition of the safety system directly to the manufacturing process since it would enable the syringe to fit into a tub for normal filling and inspection, and would require minimal additional handling after filling. Such a process would help optimize the size and functionality of the system and mitigate risk and cost for pharmaceutical manufacturers while providing the healthcare worker or patient with an intuitive, passive system.
Many pharmaceutical manufacturers work closely with drug delivery device manufacturers at an early stage of development to ensure there is efficient development of an overall system that enables cost-effective drug delivery. However, drug manufacturers must take responsibility for providing end-users of their products with systems that ensure safe and effective delivery of the medication, but also provide safety to the nurse, caregiver or patient as it relates to needlestick prevention. If the system contains a needle (whether for direct injection or reconstitution/transfer), the drug company should consider the addition of a safety system.
Passive, integrated safety systems can minimize changes to drug administration practices, may be designed to avoid major changes to the pharmaceutical production process and eliminate extra activation steps to help reduce risk of accidental injury.
Graham Reynolds is vice president of marketing and innovation for West Pharmaceutical Services Inc., an Exton, Pa.-based designer and manufacturer of pharmaceutical packaging and delivery systems.
Needlestick injuries can transmit a variety of blood borne pathogens, including the hepatitis B and C viruses and HIV. Treatment costs can exceed more than $3 billion per year in the United States, according the Occupational Safety and Health Administration. The Centers for Disease Control and Prevention estimates that more than 500,000 injuries occur in the United States annually, and approximately half of those (nearly 1,000 per day) occur in hospitals. The direct cost for such an injury, according to the American Hospital Association, ranges from hundreds of dollars to more than $1,000 for medical evaluation and follow-up treatment. When the possibility of HIV is involved, that cost soars to more than $500,000 for an infected healthcare worker.
In July 2001, the Needlestick Safety and Prevention Act mandated that employers identify, evaluate and implement safer medical devices to help reduce or eliminate needlestick injuries. Similar legislation was implemented in Europe in 2013, and many other countries have introduced guidance to help ensure healthcare worker safety. Thanks to this legislation and the increasing awareness of the cost of injuries, many pharmaceutical companies now are pursuing the use of safety systems that are incorporated as part of a pre-filled syringe system.
The pre-filled syringe is the preferred choice for many liquid injectables, especially where the convenience of simple injection with fewer steps is needed. Hospitals may use pre-filled syringes to ensure proper dosing and ease of injection during emergency situations. Often, patients with chronic conditions require multiple injections in order to adhere to treatment regimens, and adherence to such regimens can be a painful and stressful daily routine. Should a safety system require an extra step, the precaution may be lost in the need for speed during an emergency situation or through apathy on the part of a weary patient who has grown tired of the burden of a chronic condition. In addition, there could be the potential that the design of a safety system may not take into account the patient’s condition or ability to assemble the system.
While the healthcare industry has seen advances in needlestick prevention, there needs to be ongoing development to create safer systems and practices. Systems that incorporate a safety mechanism can lower the risk of accidental needlesticks significantly. This may help to reduce the spread of infectious disease and reduce costs associated with the treatment of needlestick injuries.
A range of new technologies now is available to help protect healthcare workers, patients and caregivers from accidental needlestick injuries. Many of these systems have been designed to trigger automatically at any point after the needle is inserted into the patient’s body, and before completion of the full dose. Such a design helps to ensure protection even if the dose is partially administered in circumstances where, for instance, a patient struggles so the needle is removed and healthcare workers or caregivers are exposed to a contaminated sharp in a dangerous situation.
It Begins With Design
Protection begins with a design that incorporates a thorough understanding not only of the drug and its containment system, but also the interactions between the delivery system and the patient, caregiver and healthcare professional. Ease of use is a priority when it comes to needlestick prevention. Many syringe systems require affixing a needle prior to injection. Incorrect assembly of a needle system can create its own challenges, and recent U.S. Food and Drug Administration guidance recommends the use of bonded or staked needle systems.
A successful integrated system must be designed to enhance the drug delivery experience for the patient or caregiver. Automatic safety systems should be capable of being deployed using a single-handed technique to shield the exposed needle. In addition, such systems should be designed to prevent pre-activation.
As technology advances, the option to design a passive integrated safety system that fits on the end of an insert needle
syringe may offer a new and innovative option for pre-fillable syringe systems. Such a design would allow for the addition of the safety system directly to the manufacturing process since it would enable the syringe to fit into a tub for normal filling and inspection, and would require minimal additional handling after filling. Such a process would help optimize the size and functionality of the system and mitigate risk and cost for pharmaceutical manufacturers while providing the healthcare worker or patient with an intuitive, passive system.
Many pharmaceutical manufacturers work closely with drug delivery device manufacturers at an early stage of development to ensure there is efficient development of an overall system that enables cost-effective drug delivery. However, drug manufacturers must take responsibility for providing end-users of their products with systems that ensure safe and effective delivery of the medication, but also provide safety to the nurse, caregiver or patient as it relates to needlestick prevention. If the system contains a needle (whether for direct injection or reconstitution/transfer), the drug company should consider the addition of a safety system.
Passive, integrated safety systems can minimize changes to drug administration practices, may be designed to avoid major changes to the pharmaceutical production process and eliminate extra activation steps to help reduce risk of accidental injury.
Graham Reynolds is vice president of marketing and innovation for West Pharmaceutical Services Inc., an Exton, Pa.-based designer and manufacturer of pharmaceutical packaging and delivery systems.