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Sharps safety has long been a concern of healthcare workers (HCWs), and countless safety devices have been implemented to improve the safety of nurses, techs, and other healthcare personnel. Some primary prevention efforts have even eliminated sharps entirely. Despite these measures, HCWs are still being stuck with contaminated needles and other sharps, and are not always receiving the proper post-exposure prophylaxis and follow-up.
The Occupational Safety and Health Administration (OSHA) estimates that 8 million HCWs are at risk of occupational exposure to bloodborne pathogens. And, according to the Centers for Disease Control and Prevention (CDC) in March 2000, more than 385,000 percutaneous injuries occur among HCWs from needles and other sharps used in the healthcare setting. Published studies have noted that the actual number could be as much as 70 percent higher. Data collected by hospitals that participate in the Exposure Prevention Information Network (EPINet) indicate that the average hospital has approximately 30 needlestick and sharp-object injuries per 100 beds each year. Industry analysts estimate that 80 percent of these cases could be prevented with the use of safer sharps devices such as safety syringes and needleless IV injection systems.
According to EPINet, the No. 1 device causing 35 percent of the needlestick injuries reported in 2002 is the disposable syringe. Their data indicate:
For example, a pre-filled cartridge syringe that has to be disassembled after use poses a risk. Recapping of needles following use can account for as much as 5 percent of all needlesticks. In addition, needlesticks occur through improper disposal or the use of overfilled sharps disposal containers.
The epidemic proportions and severe impact of needlestick incidents prompted the U.S. Congress to take action. The Needlestick Safety and Prevention Act became law in 2000, and revised the 1991 Bloodborne Pathogen Standard to require the use of safe medical devices when there is a risk of exposure to bloodborne pathogens.
In early 2001, OSHA published its revised bloodborne standard that required hospitals and other healthcare facilities to:
Why Sticks Still Happen
Since nurses are the caregivers that handle the most sharps, this is the group that is most commonly affected, observes Barbara DeBaun, RN, MSN, CIC, director of patient safety and infection control at the California Pacific Medical Center in San Francisco. Many of the sticks that occur in our institution happen before activation of the device is indicated (e.g., the nurse is still in the process of performing the procedure, the patient moves, the needle becomes exposed, and the nurse gets stuck).
Despite the enactment of the Needlestick Act nearly seven years ago, needlestick injuries remain a significant problem and a tremendous cause for concern for both nurses and directors of infection control, says Gareth Clarke, chief executive officer of Inviro Medical Devices. The continuation of this problem since the legislation may be attributed to the design of safety syringes available in the marketplace. The vast majority of products supplied to the market are essentially retro-fitted designs the traditional non-safety syringe with an added-on piece.
The Ideal Design
Does the perfect safety syringe exist? There appears to be strong consensus between the CDC, OSHA, directors of infection control, and nurses on the characteristics of the ideal safety syringe, says Clarke.
From that base, nurses and directors of infection control, in an independent 2006 study, had very similar views regarding improvements on the design of existing safety syringes. These included the following characteristics:
Its not always possible to improve on an existing design of a safety feature. There is no truly passive safety syringe. All devices currently on the market require some type of extra movement, DeBaun adds. Certain designs just arent practical, including syringes with needles that are not detachable, she points out.
Following the passage of the Needlestick Act, the existing suppliers to the market essentially substituted retro-fitted designs for their standard syringes. The practicality of those designs for all applications has to be questioned, particularly as needlestick injuries continue to be a problem, along with clear evidence indicating the continued substantial usage of non-safety syringes within healthcare institutions, Clarke adds.
There is a strong case for ensuring that newer safety syringe designs, particularly the manually and automatically retractable designs, are reviewed at least once every year to ensure that institutions take advantage of technological improvements.
Only recently have custom-designed safety syringes, with the safety feature integral to the design, become widely available. Some of the first custom-designed products were offered by RTI, with its automatic retractable syringe, and, Inviro Medical, with a range of manually retractable syringes.
There is a great deal of opportunity for manufacturers to offer HCWs technologically-improved alternatives.
Consistent anecdotal reports from the market indicate that the safety features on the retro-fits are often removed or not engaged, with some nurses considering them more of a problem than a benefit, says Clarke.
Long after passage of the Needlestick Safety Act, HCWs still say there is significant room for improvement to protect them from needlestick injuries. In the Inviro Initiative: Evaluating the State of Needlestick Prevention roundtable, sponsored by Inviro Medical, some of the nations top experts voiced their current concerns on June 12, 2006. At the program, which was held during the annual meeting of the Association for Professionals in Infection Control (APIC), participants identified crucial factors that could further diminish needlestick injuries: better safety syringe design and improved training, as well as enhanced reporting processes and data collection.
Participants indicated that many HCWs find many of the current designs cumbersome, and suggested designing a syringe from scratch with input from those who use it.
This is not to say that there has not been great improvement since the Needlestick Act was passed. The market has been penetrated with safety devices, points out Karen Daley, PhD, MS, MPH, RN, a needlestick prevention advocate and Boston College doctoral student. It doesnt mean weve penetrated them with the best devices, and we dont know if we have better educated people. I think in certain places the culture has changed and that has been happening probably in bigger cities and hospitals.
But there is always room for more improvement. We have no definition of what a safety feature is. There is no FDA requirement regarding safety features, points out June M. Fisher, MD, project director of the Training for Development of Innovative Control Technologies Project (TDICT), based at the Trauma Foundation at San Francisco General Hospital.
Anybody can call it a safety feature, and it may be a bad or good design, but thats the first problem. The second problem is, the feature may not be appropriate for the device or for that procedure. The hospitals tend to order devices in a universal way, but one syringe for all the different hospital departments doesnt work, because different units have different needs.
They use a document that includes an inventory of what you have, and a list of what procedure uses it. There may be more features in common between similar departments pediatric wards at different hospitals in different states than between different departments in the same healthcare facility. That has to be taken into account when ordering devices, Fisher adds. And that makes it difficult for the hospital, because you have to order different devices in the same category.
There is also the problem of safety features that function differently with different sizes of one device. We recommend that you determine what sizes you need and then evaluate the device in all sizes, Fisher says. One of the things our project recommends is systematic evaluation, not just if it looks good.
According to Fisher, there are several steps to the evaluation process. We make recommendations based on our own instruments weve developed because weve seen the issues. Im not talking about pilot testing many people jump in with pilot testing. You must test first for usability, and that has four steps. Step 1 is to do some screening. If youre looking at a device, you have determined where it is going to be used and what size you want, and every offering in that every device that is on the market. We say that because a lot of them are not good devices. But the bad device teaches you a lot it teaches you what you dont want to have. You must go through screening using systematic criteria. You look for failure. If you look at ten devices, you can screen them fairly quickly. You may find two or three that satisfy your needs, and you then get a hundred of each and see at a tabletop if the engagement process works or not.
Fisher continues, At the time of testing, you will know at what stage of manufacturing the device is, and you want to consider only devices that are in the final stage, as there are several stages in production. Go through them and see how they engage. If that works, say you had four devices, and two didnt work very well, so youre left with two. You then go to the second stage in which you create simulations or scenarios, so you create a clinical environment similar to what people will have in real life. Only at this point will you be ready to conduct pilot testing. There are no good protocols for pilot testing, and we need national attention to that, Fisher stresses. My own desire would be to have a national consensus with not more than ten questions, using the same questions, and each device is evaluated at the time of use. You would need to determine how many people would be involved and set standards for the country. When evaluating a product, it is extremely difficult to get people to fill out the evaluation form, she observes. They are overwhelmed, and forms are often filled out much later, or people do it by focus groups three weeks later. It becomes the squeaky wheel at that point; I dont know of a pilot program I feel very happy with. The thing is, you would know in a very short time whether that device is good or not.
Reporting of Needlesticks and Near-Misses
Reporting is crucial, all experts agree. Its also extremely important to report near-misses, Fisher says. [In the hospital], theyve had a notice go out for near-misses revising the form for them and it has been extremely valuable. It was posted on every unit and people were encouraged to report near-misses. We came up with solutions to problems before a stick happened.
People evaluating the device before a final decision is made can note problems with a device and either choose a new device or ask for modifications to the existing device. Sometimes they will say, Get a better device; this is not working. The committee will call up the manufacturer (to inform them of problems with a design). I do know that the manufacturers dont want to have problems with their devices. Occasionally, theyll say its a learning issue. It may be, but if its a near-miss, thats not a learning issue. Its more complicated than that.
We know that in most places that reporting is not 100 percent. Some places can range from 10 percent to 80 percent, 90 percent, she observes. You have to have a campaign to report devices, preferably before introducing the device. You need a good reporting form, which should include the device name, description, and manufacturer. If people cant always remember what they used, in many places, every device will be displayed on a board, so when reporting the stick, they can just look at the board.
The top three reasons cited for under-reporting of needlestick injuries:
These were the results of the 2006 Study of Needlestick Injuries and Safety Devices, an independent nationwide study of directors of infection control (DICs) and nurses released in May 2006.
Reporting is a crucial component of sharps safety. To overcome these objections [to reporting], hospital management clearly needs to create a climate in which such reporting is given critical importance within the context of a supportive employee environment, says Clarke. Nurses should be educated about the critical importance of needlestick reporting, not just for themselves and their family, but also for the safety of their colleagues. They need to react quickly, without hesitation or fear of any job or remuneration consequences.
The problem with reporting as that most institutions compare their data to themselves over time, says DeBaun. The usefulness of this depends upon the validity of the data that has been reported to the hospitals employee health service (or wherever the exposures are reported to).
Training is absolutely critical to ensure that needlesticks are prevented. In some instances, there is no training at all. The staff member may be rotated to some place and never trained on the device, Fisher points out. And training may not be adequate. Theres a learning curve with any device. Its also a design issue but sometimes you have to factor in the fact that a device is not easy to learn. Thats something to be included in pilot testing. You will know it takes four or five uses to be familiar with the device, and you get an idea of what the learning curve is. We have also been promoting the idea of a resource room, where staff members can go back (and try the devices).
Frequently, the manufacturers offer excellent training in use of the safety devices for every staff member who is going to use that device. You have multiple layers in the process, Fisher adds. There is the training; the work environment is another issue for example, if you dont have adequate space. Another issue is that patients will move. If you dont have enough staffing and long hours, that can have impact on needle devices. You cant ask for help if you dont have enough staffing. All these points can be addressed.
There are also issues related to 24-hour coverage of HCWs with needlesticks. In most places, staff members must go to the emergency room (ER), and they will not receive priority in the emergency room. They are kept there for hours because theyre not high priority in terms of an actual accident, but actually, they should be high priority because the recommendation is for post-exposure prophylaxis as quickly as possible, Fisher adds. These staff members arent going to sit there for three or four hours. We need to change the system so the ER knows what to do.Â
The 2006 Study of Needlestick Injuries and Safety Devices revealed that needlestick injuries (NSIs) affect the vast majority of nurses, and nearly half (47 percent) said they had been stuck by a contaminated needle. The national study was comprised of two survey instruments. The first included responses from 147 directors of infection control (DICs), and the second survey consisted of responses from 188 nurses.
The study found the overwhelming majority of DICs and nurses worry about accidental NSIs. In fact, 82 percent of DICs believe NSIs remain a significant hazard, and even more nurses (88 percent) cite NSIs as a serious hazard.
What could better protect healthcare workers?
|Better products or equipment||42 percent||41 percent|
|More training||40 percent||25 percent|
|More time for patient and procedures||40 percent||53 percent|
|Organizational focus and support||33 percent||23 percent|
|More nurses and staff||28 percent||47 percent|
Â Annual Evaluations
The majority of DICs (74 percent) and nurses (57 percent) report their facility conducts yearly evaluations of safety syringes, as required by the Needlestick Act. Ninety-three percent of DICs surveyed said they were able to influence the selection of sharp safety devices used in their facility, and 95 percent think their frontline nurses are able to influence selection. In stark contrast, only 43 percent of the nurses report they are able to influence selection in their facility.
Infection control spending set to increase
About spending. Nearly two out of three DICs (63 percent) said they planned to increase spending on infection control in 2006. Of those who project an increase:
Source: Inviro Medical