Safety needles
May/04/10 15:02 Filed in: Vaccines | Medical devices
I was speaking to someone recently about safety engineered needle technology, and how much has it entered the medical device market. Safety needles are medical devices that retract or protect the needle after use, so that needlestick injuries can be prevented. The consequences of these type injuries are multifold: spread of blood-borne pathogens such as hepatitis, HIV and other viruses and bacteria, lost productivity of the healthcare worker after injury, and economic and psychological costs of prophylactic treatments or, in a worst case scenario, chronic treatments.
In response to both healthcare workers, industry and politicians, several US Federal and State Agencies began to push for adoption of safety needle products by hospitals and other healthcare settings, mostly from late 1990’s through the early 2000’s. For example, NIOSH (the National Institute of Occupational Safety and Health) announced several recommendations for healthcare workers. OSHA (the Occupational Safety and Health Administration) established regulations for healthcare environments regarding needlestick injuries. Congress passed and the President signed into law the Needlestick Safety and Prevention Act that required regulations to prevent needlestick injuries.
Basically, these regulations have several provisions:
Basically, they require the use of safety engineered needles. But what is reality? How widely have these needles been adopted in the healthcare market after 10 years?
Quick answer: not all that much.
The reasons are complex. First is cost. Second is clinical acceptance. And they are intertwined.
The best safety-engineered devices are “passive”, that is, the needle is made safe automatically without any steps taken by the healthcare worker. These are the most expensive items. The cheapest safety-engineered devices are active, which means the user must take an additional one or more steps to render the needle safe. From my observation of sales of these products, these are in conflict with each other.
The least expensive safety needle products, such as the Eclipse Needle from BD, a large US manufacturer of medical devices, which is about 2X the price of non-safety engineered needles. This product is an “active” one, which means the healthcare worker has to remember to make it safe. If they don’t, then the hospital or medical office has spent a lot of money to not use its full capabilities. On the other hand, passive safety needle products, such as BD’s Integra syringe, Unilife’s Unifill syringe, or Retractable Technologies Inc. Vanishpoint syringe. All of these passive devices seem to be preferred by users, but they cost 5-10X as much active devices or non-safety devices.
The costs are so high for the passive syringes that adoption has been limited. In my experience, less than 5% of sales to the end-user encompassed passive devices. Yet, if you talk to the end-user, they just don’t like the non-passive devices, so revert to either not using the safety technology or just using standard needles.
It makes good business strategy to price the best devices at a premium price. But if the companies take this direction, they’ll need to make a better case for hospitals to purchase them, because right now, they’re not.
By Michael W Simpson
In response to both healthcare workers, industry and politicians, several US Federal and State Agencies began to push for adoption of safety needle products by hospitals and other healthcare settings, mostly from late 1990’s through the early 2000’s. For example, NIOSH (the National Institute of Occupational Safety and Health) announced several recommendations for healthcare workers. OSHA (the Occupational Safety and Health Administration) established regulations for healthcare environments regarding needlestick injuries. Congress passed and the President signed into law the Needlestick Safety and Prevention Act that required regulations to prevent needlestick injuries.
Basically, these regulations have several provisions:
- Requires health care employers to document in their exposure control plan that they have evaluated and implemented safety-engineered sharp devices and needle-less systems in order to reduce employees' occupational exposure to HIV, hepatitis C and other bloodborne diseases; and
- Requires that exposure control plans be reviewed and updated at least annually to reflect changes in sharps safety technology.
- Requires each health care facility to maintain a sharps injury log with detailed information on percutaneous injuries (including type and brand of device involved in exposure incident, department where exposure occurred and an explanation of how it occurred).
- Requires employers to solicit input from non-managerial (e.g., frontline) health care workers when identifying, evaluating and selecting safety-engineered sharp devices, and to document this process in the exposure control plan.
- Expands the definition of "engineering controls" to include devices with engineered sharps injury protection.
Basically, they require the use of safety engineered needles. But what is reality? How widely have these needles been adopted in the healthcare market after 10 years?
Quick answer: not all that much.
The reasons are complex. First is cost. Second is clinical acceptance. And they are intertwined.
The best safety-engineered devices are “passive”, that is, the needle is made safe automatically without any steps taken by the healthcare worker. These are the most expensive items. The cheapest safety-engineered devices are active, which means the user must take an additional one or more steps to render the needle safe. From my observation of sales of these products, these are in conflict with each other.
The least expensive safety needle products, such as the Eclipse Needle from BD, a large US manufacturer of medical devices, which is about 2X the price of non-safety engineered needles. This product is an “active” one, which means the healthcare worker has to remember to make it safe. If they don’t, then the hospital or medical office has spent a lot of money to not use its full capabilities. On the other hand, passive safety needle products, such as BD’s Integra syringe, Unilife’s Unifill syringe, or Retractable Technologies Inc. Vanishpoint syringe. All of these passive devices seem to be preferred by users, but they cost 5-10X as much active devices or non-safety devices.
The costs are so high for the passive syringes that adoption has been limited. In my experience, less than 5% of sales to the end-user encompassed passive devices. Yet, if you talk to the end-user, they just don’t like the non-passive devices, so revert to either not using the safety technology or just using standard needles.
It makes good business strategy to price the best devices at a premium price. But if the companies take this direction, they’ll need to make a better case for hospitals to purchase them, because right now, they’re not.
By Michael W Simpson