In the beginning, there was unlimited promise. A startup born out of an innovative mind and nurtured with federal grants was setting up shop in, of all places, Little Elm—a tiny speck of a suburb on the shores of Lake Lewisville. Some two decades later and for a variety of reasons, however, the company’s once-bright promise remains largely unfulfilled.
Back in 1996, things were different. The idea of a projected 600 jobs coming to Retractable Technologies’ new 22,500-square-foot plant was huge for local officials, who pitched in $300,000 for roads and other improvements. “This is the project of the century for Little Elm,” the town mayor proclaimed at the startup’s announcement.
And Thomas J. Shaw, a mechanical and structural engineer, expected his revolutionary product to make waves beyond Little Elm as well. With the help of $650,000 in grants from the National Institutes of Health, Shaw had developed a medical syringe with an automatic retraction feature. After the plunger is fully depressed, the needle pops back into the syringe’s cavity, where it can’t stick the nurse or technician. The design offered a solution to the roughly 600,000 accidental needle sticks that occurred each year at hospitals—accidental sticks that put medical workers at risk of contracting HIV, hepatitis, and other serious diseases.
Shaw secured patents on his design, began gathering investment cash from North Texas doctors and others who saw promise in the business, and formed Retractable Technologies Inc., a public company trading under the symbol RVP on the New York Stock Exchange.
Soon after launching production, however, Shaw realized he was being shut out of selling to hospitals by an alliance of major medical supply manufacturers and powerful purchasing consortiums that buy supplies in bulk for about 80 percent of the nation’s health systems.
Shaw’s upstart company—which encouraged publicity with press releases decrying the power of the giant group purchasing organizations—was soon gathering national media attention that painted Retractable as the victim of a market rigged against innovative entrants. And, there was ample evidence that the portrait was valid, though many accounts left out the caveat that the purchasing systems had been established to help hospitals cut their expenses and tamp down healthcare costs.
Despite having the most foolproof “safety needle” on the market, Shaw told reporters, his company was rejected by most of the more than 2,000 hospitals his salespeople had visited because, among other things, they were bound by agreements to buy from incumbent companies. “There’s an AIDS and hepatitis C epidemic, and we can’t even show our retractable safety needles in most hospitals,” he told the Houston Chronicle. “Free competition as it stands in healthcare is dead.”
Shaw’s complaint eventually took the form of a federal lawsuit naming as defendants several of the purchasing organizations, as well as several rival medical supply manufacturers, including industry heavyweight Becton Dickinson and Co., of Franklin Lakes, N.J. The 119-year-old company, often referred to as BD, currently has about $10 billion in annual revenue and as much as 80 percent of the total needle and syringe market. On the eve of trial in 2004, and in a series of earlier settlements, the defendants paid out a total of $100 million to Shaw’s company to drop its federal suit.
The award, which was cut nearly in half by legal fees and costs, still was several times Retractable’s net annual sales that year of $21 million. Last year, a dozen years after the big settlement, Retractable would have shown an operating loss had it not collected yet another jury award: a $7 million judgment from BD for patent infringement arising from BD’s attempt to market its own retractable syringe. As of this writing, Retractable is awaiting an appellate court decision in still another antitrust case it brought against BD in 2007—that one involving its rival’s contracting and advertising.
Retractable may have winning ways in court—and in media stories portraying it as a noble David in a world of anti-competitive Goliaths—but, more than 20 years on, it still can’t find much traction or sales growth in the marketplace. In fact, its net sales have been flat or down for the last five years. According to a BD court filing, Retractable’s share of the “safety” market, a subset of the total needle and syringe maket, stood in 2010 at just 6 percent, compared to 49 percent for BD. And, after outsourcing much of its production to China, Retractable’s workforce now numbers 136, down from the 175 it employed 15 years ago.
Company executives say Retractable continues to be the victim of its rivals’ anti-competitive schemes. But, some observers say Retractable has ridden that horse a bit too long. Some of the company’s growth problems, they contend, have been self-made, or an honest consequence of normal competition. Just because you believe your product is aces—as Sony did in the 1980s with its Betamax videotape system—doesn’t mean that you automatically get to win.
‘A Different League’
Shaw, who is president, chairman, and CEO of the company and owns about half its stock, declined to be interviewed for this story, saying through a company lawyer that he could not discuss Retractable while it’s involved in pending litigation. But the feisty 65-year-old has given so many interviews over the years, the story of the company and its founding is well documented.
Shaw grew up in Mexico and Arizona, where his father worked as a chemist. As he related in a 2010 Washington Monthly story, a chalkboard hung over the family dinner table where math and science problems were puzzled out. Shaw went on to study engineering at the University of Arizona and eventually launched his own small engineering firm in Lewisville. He began tinkering with the idea of a safer syringe in the late ’80s, after being moved by a news story about a California doctor who was infected with HIV after being accidentally pricked with a used, contaminated needle. It took four years and more than 150 design changes for Shaw to arrive at a working prototype.
Retractable Technologies accused its bigger rival of using bundling, rebating, loyalty discounts, and other sales incentives to “keep hospital doors shut to Retractable.”
Since he started producing and marketing his syringe, Shaw has insisted that not only is he marketing a product, he is saving lives. Along with California-based healthcare system Kaiser Permanente and the Service Employees International Union, Shaw was a major proponent of a groundbreaking law passed in California requiring hospitals to transition to safer needles. The federal government followed suit in 2000, and President Bill Clinton recognized Shaw’s role in the measure’s passage by inviting him to the signing ceremony and giving him a pen used to sign the bill into law.
Shaw, who by 2002 was several years into the lawsuit he’d filed against rival BD and the hospital buying groups, hoped that year to convince the federal government to ban nearly all syringes from the market—save for the one he produced under exclusive patents.
In an urgent-sounding letter to the FDA in September 2002, Shaw wrote, “We suggest that both ‘conventional’ (non-safety) syringes and ineffective so-called ‘safety’ syringes be removed from the market and outlawed by the FDA. A sincere concern for the health, welfare—and very lives—of this nation’s dedicated frontline healthcare workers demands no less.” He went on to criticize the effectiveness of his competitors’ safety designs—which include sliding-sleeve syringes, shielding needles, and pivoting needles—and asserted that it is “well-documented, scientific fact” that Retractable’s products “are in a different league from many so-called ‘safety’ needle devices.”
Some of the proof, he insisted at the time, was being “suppressed” by Kaiser Permanente hospitals in California, which had done a study showing problems with BD’s shield-design safety syringe. He wrote that BD and another large competitor were “ramping up the production of their so-called ‘safety’ products” and relying on faulty studies. The situation, he wrote, “should wave Enron flags” around BD and another company he had sued in his 1998 antitrust complaint.
The FDA, however, declined to take Shaw’s suggestion that it hand him most, if not all, of the $3 billion-a-year syringe and injection-needle market.
An Early Disaster
That Shaw would ascribe sinister motives to Kaiser Permanente, his one-time ally in the push for safer syringes, would seem strange, were it not for the fact that, by the early 2000s, Retractable Technologies and the California-based hospital group had a bit of unpleasant history together.
In its earliest days, when Retractable was shut out from the hospital market, it relied on contracts with government agencies such as the Veteran Affairs Administration, prisons, Indian reservations, and organizations too small to be part of the giant group purchasing systems. But in 1999, Kaiser Permanente signed a landmark, one-year contract to buy Retractable’s syringes. Before the year was up, however, Kaiser was complaining about the Little Elm company’s reliability as a supplier as well as the quality of its product. As a Kaiser spokesman explained later, Kaiser ordered 2,239 boxes of syringes but received only 343. There were also instances of product failure, Kaiser reported, including one in which the needle detached from the syringe and remained in the thigh of a 7-month-old baby.
“That is erroneous,” Michele Larios, Retractable’s vice president and general counsel, said in a recent interview. She said the contract was cancelled instead as the result of a $30 million grant for a safety-needle study that BD gave Kaiser just a month after Retractable got in the Kaiser door. “They interfered,” she said. “We delivered the orders that were placed in a timely fashion.”
In filings in the lawsuit to which Larios referred, Retractable complained that Kaiser ordered the company’s products “in sizes and quantities which did not reflect actual usage,” and that “reported minor defects” were “within standard tolerances.”
Whichever version of these stories is true, the Kaiser chapter was an early disaster for an upstart company seeking to gain momentum with a top-shelf customer.
Highest-priced Safety Syringe
Since those days, Retractable has enjoyed some successes. It gained access to several group purchasing organizations and, through its most recent lawsuit, was able to force BD to correct several wrongful claims it made about Retractable’s products that Retractable says hurt its ability to compete. In notices to the industry published in February 2015, BD admitted that its comparative advertising had misstated the amount of medication wasted by its syringes compared to Retractable’s, and that its claim of having the “World’s Sharpest Needle” was also false and misleading.
Still, Larios says, the anti-competitive activity—she calls it “lying to customers” —continues. “Our ability to engage the market has been significantly impacted by the anti-competitive activity that has been engaged in,” she says. She declined to detail how that continues beyond what was alleged in the company’s second lawsuit against BD, which covers a period ending in 2010. When asked what BD might have done specifically to contribute to Retractable’s 15 percent decline in revenues in 2015 compared to the year before, Larios declined to say.
BD contends in its court filings that there are plenty of reasons in the realm of fair market competition to explain why Retractable has had trouble. For example, testimony in the 2013 trial showed Retractable’s syringe was the highest-priced safety syringe among the various types offered. It sells syringes it manufactures for 13 cents for as much as 31 cents. In contrast, prices for BD safety syringes and those of its two biggest rivals fell in a range of 21 to 23 cents. During the period at issue in the case—2004 to 2010—Retractable’s prices were between 41 percent and 71 percent higher than its competitors,’ the filings said.
Testimony also pointed out that Retractable’s primary product, the “VanishPoint” safety syringe, has less utility for hospitals than some of the competing designs with removable needles. Although more expensive, it can’t be used for tasks such as giving injections with pre-filled syringes, withdrawing fluid from the body, or attaching to a needle-less IV system. A defense witness, Dr. Carl Vartian, an infectious disease expert from Houston, testified that Retractable’s design “has very limited use within hospitals.” Safety syringes using removable needles have greater utility and hence are better sellers, BD maintains.
Retractable addressed just that issue when, earlier this year, it announced that it is adding a new removable-needle syringe to its product line. The so-called EasyPoint will allow clinicians to change needles and perform such functions as using pre-filled syringes and collecting blood, the company said in a release.
Jack Duncan, a writer/editor at Retractable who fields media inquiries, said in an interview that the company has been able to be listed with some purchasing organizations that buy for hospitals. “But just because they list you in the catalog doesn’t mean they’re going to do much business with you,” he said. BD’s contracts with potential customers are still a big barrier for the company, he added.
Indeed, BD’s contracts were a major issue in Retractable’s 2007 antitrust lawsuit against the industry giant that went to a jury in Marshall, Texas, in 2013. The case is currently before the U.S. Fifth Circuit Court of Appeals in New Orleans. “BD’s exclusive contracts with hospitals make competition based on price and quality impossible,” Retractable asserted in its filings. It accused its bigger rival of using bundling, rebating, loyalty discounts, and other sales incentives to “keep hospital doors shut to Retractable.”
But the judge in the Marshall case instructed the jury that volume and market-share discounts, like other low prices, are not anticompetitive under the law merely because smaller sellers cannot match them without losing money. And the jury found BD’s contracts were not anticompetitive, rejecting Retractable’s claims that BD’s contracts restrained trade, decreased competition, or injured the Texas company.
Still, other parts of the mixed verdict amounted to a big win for Retractable. Jurors found that BD made false claims about Retractable’s products—the needle sharpness and wasted-medication advertising—and attempted to monopolize the market through “deception.” They awarded Retractable $113 million in damages, an amount that was automatically trebled under antitrust law. There was also an automatic award of attorneys’ fees, which amounted to $12 million. So, should it prevail in the appeal, Retractable stands to collect a total of $340 million from BD—an award equal to nearly 15 times its current annual sales.
Myriad legal issues surround the case, which drew the interest of a group of legal scholars who filed a friend-of-the-court brief.They were concerned that the “heavy artillery” of antitrust law, with its trebling of damages, was being used in what was essentially a false advertising case.
In its appeal filings, BD doesn’t dispute that its advertising was false. But it’s seeking to overturn the verdict because, it says, false product advertising is not an antitrust violation, and there was no evidence it did anything to exclude Retractable from the market. During the period when it allegedly was trying to gain a monopoly, BD’s market share declined nearly 10 percent, the company points out.
Larios, Retractable’s general counsel, says the case is about more than just false advertising, and that jurors heard a variety of evidence that BD had attempted to monopolize the safety syringe market, including its violation of Retractable’s patents.
In their appeal filings, Retractable’s lawyers pointed out that testimony showed BD planned to sell low-cost retractable syringes and dominate as much as 70 percent of that market as soon as Retractable’s patents began expiring in 2015. As early as 2007, a BD project team had concluded that while Retractable was “weak” financially, its intellectual property position was “strong” until 2015, when the 20-year patents protecting its chief product would expire.
It was compelling evidence of BD’s drive to dominate the market. During the period covered by the lawsuit, it was noted that Retractable had nearly 70 percent of the retractable syringe market—a position protected by its patented technology.
But, that lawsuit aside, how does the patent issue bear on Retractable Technology’s future? In its 2015 annual report, published this spring, Retractable said that although some patents on its VanishPoint syringe were expiring in 2015 and 2016, another patent “will continue to provide patent coverage for VanishPoint syringes until 2020.”
So, with its chief product facing patent expiration in less than four years, another existential challenge lies on the horizon for the plucky little company from Little Elm. There’s little doubt that when it happens, bigger and more established players will be ready to pounce. Again.
The acquisition of needle-stick injuries (NSI) in a healthcare setting poses an occupational hazard of transmitting blood-borne pathogens from patients to healthcare workers (HCWs). The objective of this study was to systematically review the evidence about the efficacy and safety of using safety-engineered intravenous devices and safety-engineered phlebotomy devices by HCWs.
We included randomized and non-randomized studies comparing safety-engineered devices to conventional/standard devices that lack safety features for delivering intravenous injections and/or for blood-withdrawal procedures (phlebotomy). The outcomes of interest included NSI rates, and blood-borne infections rates among HCWs and patients. We conducted an extensive literature search strategy using the OVID interface in October 2013. We followed the standard methods for study selection and data abstraction. When possible, we conducted meta-analyses using a random-effects model. We used the GRADE methodology to assess the quality of evidence by outcome.
We identified twenty-two eligible studies: Twelve assessed safety-engineered devices for intravenous procedures, five for phlebotomy procedures, and five for both. Twenty-one of those studies were observational while one was a randomized trial. All studies assessed the reduction in NSIs among HCWs. For safety-engineered intravenous devices, the pooled relative risk for NSI per HCW was 0.28 [0.13, 0.59] (moderate quality evidence). The pooled relative risk for NSI per device used or procedure performed was 0.34 [0.08,1.49] (low quality evidence). For safety-engineered phlebotomy devices, the pooled relative risk for NSI per HCW was 0.57 [0.38, 0.84] (moderate quality evidence). The pooled relative risk for NSI per device used or procedure performed was 0.53 [0.43,0.65] (moderate quality evidence). We identified no studies assessing the outcome of blood-borne infections among healthcare workers or patients.
There is moderate-quality evidence that the use of safety-engineered devices in intravenous injections and infusions, and phlebotomy (blood-drawing) procedures reduces NSI rates of HCWs.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-016-1705-y) contains supplementary material, which is available to authorized users.
Keywords: Systematic review, Healthcare workers, Healthcare setting, Needle-stick injuries, Safety-engineered devices, Intravenous, Phlebotomy, Meta-analysis, Blood-borne pathogens
Healthcare workers (HCWs) worldwide face the serious occupational health hazard of sharps injuries, commonly referred to as Needle-Stick Injuries (NSIs) . According to the World Health Organization (WHO), there are approximately two million occupational exposures to blood-borne pathogens per year out of the total 35 million estimated HCWs worldwide . In the United States, it was estimated that about 384,325 NSIs occur annually in hospital-based health-care personnel . These injuries account for about one third of all occupational accidents encountered by HCWs in a healthcare setting .
Phlebotomy (blood-drawing) procedures alone account for 13 to 62 % of the injuries reported to the Hospital Occupational Health Services [5, 6]. The annual incidence rate of injuries amongst phlebotomists is about 407 per 1000 HCWs, with these blood-drawing procedures accounting for an estimate of 13.3 % of total reported injuries . Similarly, intravenous-access procedures such as the administration of parenteral injections and infusion therapies account for 15.7 % of all reported injuries . In short, blood-involving procedures have higher risks of transferring blood-borne infections than other procedures [8, 9].
Needle-stick injuries are hazardous due to their potential for transmission of blood-borne pathogens, particularly hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) [10, 11]. Indeed, about 40 % of each of HBV and HCV reported cases and about 4.4 % of HIV acquisitions in HCWs are attributable to NSIs . The risk of transmission following a percutaneous injury is 35 % for HBV, 3 to 10 % for HCV, and 0.2 to 0.5 % for HIV . A study published in 2005 reported that up to that date, approximately 66,000, 16,000, and 1000 global HCWs got infected with HBV, HCV, and HIV respectively, due to sharps injuries alone .
Safety needle devices possess built-in safety controls that reduce and potentially prevent NSIs . These devices allow needle-safe IV insertion and delivery, blood collection, and intramuscular, intra-dermal and subcutaneous injections [3, 15–17]. We have already systematically reviewed the evidence for intramuscular, intra-dermal and subcutaneous injections (under review for publication). Although individual studies have found a decrease in the number of percutaneous injuries occurring during phlebotomy procedures  and intravenous injections [3, 18] upon the use of safety-engineered devices, no reviews to date have analyzed the efficacy of such devices across studies using meta-analysis techniques.
We conducted this study was to gather the evidence necessary for the development by WHO of a policy guidance on use of safety-engineered devices by healthcare workers to deliver a number of procedures, including intravenous and/or phlebotomy procedures. The objective was to systematically review the evidence about the efficacy and safety of using safety-engineered intravenous devices and safety-engineered phlebotomy devices by HCWs in reducing NSIs and/or infection transmission rates.
We opted to review this evidence separately from that of intramuscular and subcutaneous devices whose review we published a while ago , for a number of reasons. First, the two types of devices are not interchangeable, so it reasonable to expect that their effects might not be the same. Second, intravenous and phlebotomy devices are associated with a higher rate of infection, compared with intramuscular and subcutaneous devices, given they come in direct contact with blood [20, 21]. Third, very few studies have assessed the two types of devices together. Even those that did, presented the data for the two types of devices separately. Finally, the WHO that commissioned this work was only interested in the evidence for intramuscular and subcutaneous devices.
The specific questions were:
What is the efficacy of safety-engineered intravenous devices versus conventional intravenous devices in preventing accidental needle stick injuries when used by HCWs in a health-care setting to perform infusion therapies, and/or intravenous drug administration?
What is the efficacy of safety-engineered phlebotomy (blood-withdrawal) devices versus conventional phlebotomy devices in preventing accidental needle stick injuries when used by HCWs in a health-care setting to withdraw blood from patients?
While we did not develop a protocol specifically for this systematic review, we based our work on a protocol previously developed for a systematic review on sharp injury prevention syringes for intramuscular, subcutaneous, and intradermal injections . This study adhered to the PRISMA guidelines .
Types of studies included
Randomized and non-randomized trial studies, including cohort studies, case-control studies, before and after, and time-series analyses. We excluded abstracts of scientific meetings and conferences, research letters, qualitative studies, letters to the editor, reviews, case reports, and case series.
Types of participants and settings
HCWs delivering intravenous therapies and infusions, or drawing blood (venipuncture). We excluded all studies addressing HCWs in non-healthcare settings (e.g. dental clinics, drawing blood at home, or home-based IV therapies). We excluded studies of HCWs delivering intramuscular, intradermal, subcutaneous, articular, intra-cardiac, and intra-peritoneal injections. We excluded studies of blood drawing through capillary sampling (i.e. using lancets).
Types of interventions
Introduction into the healthcare setting of a safety device to replace conventional intravenous and/or phlebotomy devices. We included passive but not active devices given the evidence showing the higher efficacy of the former over the latter in reducing NSI . Unlike active devices, passive devices activates automatically during device use and therefore do not require additional steps to initiate the safety mechanism. The intervention could have been accompanied by training of HCWs on how to use the safety-engineered devices and/or by a surveillance system to monitor implementation of the new devices.
Examples of eligible intravenous-related safety devices include: needle-free (or “needle-less”) IV systems, Luer-activated IV administration systems, safe IV catheters with blunt cannula replacing sharp needle, blunt implantable port needles and Needle-less adaptors, and guarded arterio-venous fistula needles. Examples of eligible phlebotomy-related safety devices include: blunt-fill cannulae, vacuum-tube blood collection devices, safety winged butterfly steel needles, and self-retracting and/or self-sheathing (recapping) blood syringes. Ineligible devices include intramuscular, intradermal, subcutaneous, articular, intra-cardiac, and intra-peritoneal needles/syringes. We included studies assessing the introduction of both eligible and ineligible devices, as long as they reported data for eligible devices separately. Additionally, we included studies in which both safety-engineered intravenous devices and safety-engineered phlebotomy devices were introduced as long as they reported separate data for these two types of devices.
Types of comparisons
Traditional/conventional non-safety device, such as the ‘single use disposable syringes’, as the comparators.
Outcomes of interest
NSI injuries among HCWs as well as HBV, HCV, and/or HIV infections following a NSI among HCWs.
We used the OVID interface to electronically search MEDLINE, EMBASE, CINHAL, and Cochrane Central Register of Controlled Trials (CENTRAL). The searches covered the period beginning with the database inception date and October 2013. We used no language or date restrictions. The Appendix lists the search strategies employed for each database. In addition, we reviewed the references lists of relevant papers, searched personal files for both published and unpublished studies, and contacted experts in the field.
Four reviewers participated in calibration exercises to clarify the eligibility criteria. Then, they screened the titles and abstracts of identified citations for potential eligibility in duplicate (i.e., each citation was screened by two reviewers) and independently using the above described eligibility criteria. We retrieved the full text for any citation judged as potentially eligible by at least one reviewer. Then, the reviewers screened the full texts for eligibility, in duplicate (i.e., each full text was screened by two reviewers) and independently. They used a standardized, pilot-tested full-text screening form. They compared their results and resolved any disagreements through discussion, or with the help of a third reviewer.
Data extraction and management process
Reviewers extracted data from the eligible studies in a duplicate and independent fashion using a pilot-tested and standardized data-extraction form. They resolved disagreements by discussion or with the help of a third reviewer. For non-English papers, we obtained the translation via Google Translate®.
We extracted the following information from each eligible study: the specific attributes and mode of action of the safety-engineered device; the study design; the characteristics of the participants and of the setting; the intervention employed; the control; the outcomes assessed; the funding source; and disclosures of potential conflicts of interest.
Risk of bias assessment in the included studies
Reviewers assessed the risk of bias in each included randomized controlled trials in duplicate and independently using the Cochrane risk of bias tool. They resolved all disagreements by discussion or with the help of a third reviewer. The tool includes an assessment of the following criteria for randomized studies: inadequate sequence generation; inadequate allocation concealment; lack of blinding of participants, providers, data collectors, outcome adjudicators, and data analysts; incompleteness of outcome data; selective outcome reporting; and other bias. As for the non-randomized studies, we used the following criteria for assessing the risk of bias: failure to develop and apply appropriate eligibility criteria; flaws in the measurement of exposure/intervention; flaws in the measurement of the outcome(s) of interest; failure to adequately account for, and control for confounding; and incomplete follow-up . We judged each potential source of bias as “high”, “low”, or “unclear”.
For categorical data, we calculated for each study the risk ratio (RR) then pooled the results across studies using a random-effects model. We evaluated heterogeneity across studies using the I2 test, and considered it to be present when I2 is greater than 50 %. Finally, we planned to create inverted funnel plots in order to check for possible publication bias.
We identified one study that assessed devices for intravenous and/or phlebotomy procedures, in addition to intramuscular, subcutaneous, and/or intradermal injection procedures, without providing outcome data separately for the different procedures . In a post-hoc decision, we included these studies in the main analysis, but excluded them from a sensitivity analysis, in order to determine their impact on the final results.
In order to explain any identified heterogeneity, we planned to conduct subgroup analyses based on the following factors: type of procedure for which the device was intended (intravenous or phlebotomy), the type of the device itself, the level of expertise and skills of HCWs, and the time of the injury (before, during, or after the procedure).
Quality of evidence assessment
We assessed the quality of evidence by outcome, using the GRADE methodology . We then generated a GRADE Evidence Profile to summarize the statistical findings and the quality of evidence obtained for each outcome.
Figure 1 shows the study flow diagram. Out of a total of 6566 identified citations, we assessed 46 full texts for eligibility. Of these, we included 22 studies, and excluded the remaining 26 for the following reasons (see Additional file 1: Table S1): lacking a control or standard (conventional device) to which the exposure (safety-engineered device) data can be compared to (n = 6) [28–33], not involving any actual intervention and being more of a commentary type of study or using simple observation (n = 5) [34–38], being a review, an abstract, or a non-original research paper reporting data from another paper (e.g., magazine articles and monthly issues of hospital reports) (n = 4) [39–42], not reporting any data on NSI rates but rather HCWs’ evaluation of the implemented device or its practicality (n = 4) [43–46], lacking data for the pre- or the post- intervention period (n = 2) [47, 48], lacking sufficient data on study design, population, and device implemented (n = 2) [31, 49], reporting economic analysis and cost-relevant data (n = 1) , not reporting separate data for different procedures (e.g., reporting overall drop in NSI rates where more than one safety device was implemented for different procedures) (n = 1) , and having the implemented devices as non-safety-engineered devices (n = 1) . One of the studies was reported in two peer-reviewed papers (duplicate publication) [5, 6].
Additional file 2: Table S2 provides a listing of the twenty-two included studies with detailed description of their characteristics. We summarized these characteristics in the subsequent sections.
Types of injection
Out of the 22 included studies, twelve studies assessed the introduction of IV safety devices [53–64], five studies assessed the introduction of phlebotomy safety devices [5, 26, 65–67], and five studies assessed the simultaneous introduction of IV and phlebotomy safety devices [68–72]. Four of the studies of the “IV safety devices” category also reported data for subcutaneous, intramuscular, and/or intradermal injection devices separately [68, 70–72]. Five studies of the “phlebotomy safety devices” category also reported data for subcutaneous, intramuscular, and/or intradermal injection devices [26, 68, 70–72], with one of these studies  not reporting data separately.
Brands of devices
Sixteen out of the 22 studies specified the brand name and/or the manufacturing company of the implemented device(s): VanishPoint™ by Retractable Technologies, Inc , SafetyGlide™ needles, SafetyGlide TNT insulin units and blunt fill cannulae by Becton-Dickinson , Eclipse™, Saf-T E-Z Set™,Preserts™, and Insyte Autoguard™ by Becton Dickinson , Surshield™and Versatus-S™ by Terumo , Provent Plus™ and Protective Plus™ by Smiths Medical , Safety-Lok™ by Becton Dickinson [6, 59, 67], Saf-T Clik™ by Ryan Medical, Inc , Clearlink System™ by Baxter Healthcare Corp ., Interlink System™ by Baxter Healthcare Corp [54, 56–60, 63]., MasterGuard Anti-Stick Needle Protector™ by Medisystems Corp ., Safesite System™ by Braun Medical, Inc , Lifeshield™ by Abbott Laboratories , Saf-Site™ by Burron Medical , Punctur-Guard™ by Bio-Plexus, Inc , and Venipuncture Needle-Pro™ by Smiths Medical . The remaining six studies mentioned neither the brand name of the device nor the manufacturer or supplier.
Nine out of the 22 studies reported their funding sources; these include:
Becton Dickinson; 
National Institute of Allergy and Infectious Diseases; the Centers for Disease Control and Prevention; and the Prevention Epicenters; 
The Directorate General of Public Health of the Autonomous Community of Valencia, Spain; 
The Educational Resource Centers, Inc, at the National Institute for Occupational Safety and Health; 
New York State Department of Health and Braun Medical, Inc. 
The Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health; Mr. William E. Flanagan Jr; 
The French Ministry of Health and la Mutuelle Nationale des Hospitaliers and the following companies: Becton-Dickinson, Bristol-Myers-Squibb, Glaxo Wellcome, Johnson & Johnson Medical, Kendall Sherwood David & Geck, MAPA Hutchinson, Merck Sharp & Dohme Chibret, Sanofi Winthrop, SIMS France, and Terumo; 
Baxter Healthcare Corporation [53, 59].
Disclosure of conflicts of interest
Only two studies had their authors declare in writing at the end that they have no conflicts of interest [68, 71]. The remaining 20 studies did not report any disclosures about potential conflicts of interest.
Only one study was a randomized controlled trial  and assessed the introduction of IV safety devices with a prospective data collection design. The remaining 21 studies were non-randomized employing a before-and-after study design. Of these 21 studies, four collected data retrospectively throughout the study period [53, 57, 62, 68], three collected data retrospectively for the “before” period and prospectively for the “after” period [54, 64, 66], eight collected data prospectively throughout the study period [26, 55, 59, 67, 69–72], and one collected data retrospectively for the “before period” but was unclear with regards to the “after” period . The five remaining non-randomized studies did not specify their data collection approach [6, 58, 60, 61, 63].
The included studies involved hospital-based nursing staff (n = 20) [6, 26, 53–64, 67–72], clinical staff of hospital-affiliated hemodialysis units (n = 1)  laboratory personnel and non-nursing phlebotomists (n = 7) [6, 55, 57, 62, 65, 68, 70], ancillary/outpatient staff (n = 3) [26, 55, 70], housekeeping staff (n = 7) [53, 57, 58, 62, 70–72], hospital aide (n = 1) , surgical and operation room staff (n = 7) [26, 53, 58, 59, 62, 68, 70], ambulatory care HCWs (n = 1) , attending physicians (n = 9) [26, 53, 58, 59, 62, 68, 70–72], interns, residents, and fellows (n = 6) [6, 26, 57, 59, 70, 71], medical students (n = 3) [6, 59, 68], and nursing students (n = 2) [59, 71].
The included studies were all conducted in high-income countries, as follows: United States (n = 13) [6, 54–57, 59–62, 64–66, 70], Canada (n = 2) [53, 63], France (n = 2) [67, 69], United Kingdom (n = 1) , Germany (n = 1) , Spain (n = 1) , Australia (n = 1) , and New Zealand (n = 1) .
Interventions involved the introduction of a variety of IV and/or phlebotomy safety devices, specified above under “Device brand”, into a healthcare setting. In 17 out of the 22 included studies, the HCWs received some form of educational intervention and/or training on the use of the newly implemented device [26, 54–57, 59–64, 66–68, 70–72].
Nineteen out of the 22 included studies mentioned that the standard of comparison to which the exposure was compared, was the use of “conventional”, “standard”, “traditional”, or “alternative” devices for the corresponding IV and/or Phlebotomy procedure(s) under study [6, 53–56, 59–71] Only three studies did not specify the nature of the device used as control [57, 58, 72]. Additionally, one of the studies used “standard education” and “enhanced training” in both the control and exposure groups to make the availability of the safety device(s) under study the only variable between the two groups .
All of the included studies assessed NSI among HCWs with and without the introduction of a safety device. Only one of the included studies reported data narratively on patient infection(s) with blood-borne pathogens (HBV, HCV, and HIV) upon acquiring NSIs . All other studies reported no valuable data on any of the outcomes of interest other than NSIs.
Risk of bias within studies
Additional files 3 and 4: Table S3 and S4 detail the risk of bias assessment and the underlying judgments for the included randomized study , and the remaining non-randomized studies respectively. These assessments are summarized graphically in Fig. 2 (the randomized study), Fig. 3 (non-randomized studies of intravenous devices) and Fig. 4 (non-randomized studies of phlebotomy devices).
Risk of bias summary diagram for the single included randomized study assessing IV safety devices
Risk of bias summary diagram for all the included non-randomized studies assessing IV safety devices
Risk of bias summary diagram for all the included non-randomized studies assessing Phlebotomy (blood-drawing) safety devices
Meta-analysis for intravenous safety devices
The eligible studies that reported NSI data used three main types of statistics: incidence of NSI per HCW (n = 5) [55, 57, 68, 70, 72], incidence of NSI per devices used or procedures performed (n = 4) [54, 58, 69, 71], and incidence of NSI per year (n = 6) [53, 59–61, 63, 64]. The randomized study reported the incidence of NSIs per patient-days . We performed distinct meta-analyses for these different statistics.
We did not include one of the studies in any meta-analysis because it did not report the statistical data in any of the three types of statistics mentioned above . That study reported a 39 % decrease of needle-stick injuries over a 4-year period following the introduction of a safety-designed needle-free IV access system.
NSI per HCW
The meta-analysis of four studies [55, 57, 68, 70, 72] resulted in a pooled relative risk of 0.28 [95 % CI 0.13, 0.59]. The I2 value was 83 % (Fig. 5). We were not concerned about heterogeneity given most studies showed benefit and the heterogeneity reflected the variation in the degree of that benefit. We rated up the quality of evidence from low (observational data) to moderate due to the large effect size, while acknowledging some concern about risk of bias in the included studies.
Needle stick injury data of the studies assessing IV safety devices reported as rates of injuries per number of healthcare workers
NSI per device or procedure performed
The meta-analysis of four studies [54, 58, 69, 71] resulted in a pooled relative risk of 0.34 [95 % Confidence Interval (CI) 0.08,1.49]. The I2 value was 80 % (Fig. 6). We were not concerned about heterogeneity given most studies showed benefit and the heterogeneity reflected the variation in the degree of that benefit. While the large observed effect would typically warrant rating up the quality of evidence from low to moderate, we did not do so because of the imprecision of the results. We judged the quality of evidence as low.
Needle stick injury data of the studies assessing IV safety devices reported as rates of injuries per number of devices or procedures performed
NSI per year
The meta-analysis of six studies [53, 59–61, 63, 64] resulted in a pooled relative risk of 0.28 [95 % CI 0.16, 0.49]. The I2 value was 58 % (Fig. 7). We were not concerned about heterogeneity given most studies showed benefit and the heterogeneity reflected the variation in the degree of that benefit. We rated up the quality of evidence from low (observational data) to moderate due to the large effect size, while acknowledging some concern about risk of bias in the included studies.
Needle stick injury data of the studies assessing IV safety devices reported as rates of injuries per year
In a separate analysis, we included the only randomized controlled trial  whose relative risk ratio turned out to be 0.57 [95 % CI 0.27, 1.22] (Fig. 8). We rated the quality of evidence as low due to concern about risk of bias and imprecision.
Needle stick injury data of the randomized trial assessing IV safety devices, reported as rates of injuries per patient-days
Meta-analysis for phlebotomy safety devices
The eligible studies that reported NSI data used two main types of statistics: incidence of NSI per HCW (n = 3) [68, 70, 72], and incidence of NSI per devices used or procedures performed (n = 7) [6, 26, 65–67, 69, 71]. We performed distinct meta-analyses for these different statistics. We excluded only one study from the meta-analysis because it had an interrupted-time series design (ITS) . That study reported an overall reduction of 48 % in percutaneous injuries per 100,000 phlebotomies performed.
NSI per HCW
The meta-analysis of two studies [68, 70, 72] resulted in a pooled relative risk of 0.57 [95 % CI 0.38, 0.84]. The I2 value was 0 % (Fig. 9). We rated up the quality of evidence from low (observational data) to moderate due to the large effect size.
Needle stick injury data of the studies assessing phlebotomy safety devices reported as rates of injuries per number of healthcare workers
NSI per device or procedure performed
The meta-analysis of six studies [6, 26, 65, 66, 69, 71] resulted in a pooled relative risk of 0.52 [95 % CI 0.38, 0.72]. The I2 value was 13 % (Fig. 10). We rated up the quality of evidence from low (observational data) to moderate due to the large effect size.
Needle stick injury data of the studies assessing phlebotomy safety devices reported as rates of injuries per number of devices or procedures performed
One study  reported blood-borne pathogen infection rates in patients, and not HCWs, for the year before introducing the safety devices and in the year afterwards. It stated: “Infection with HBV, HCV or HIV in needle-stick index patients was high in both years, with a prevalence of 6.7 % in 2007 and 9.0 % in 2009 for all three blood-borne viruses together”. No information about statistical significance was provided. Another study  stated: “No significant increase in bloodstream infections was detected during the study period”, without any numerical evidence included to support that statement. None of the other studies reported similar data relevant to these other outcomes of interest such as reduction in HBV, HCV, and HIV infections among HCWs and/or patients, or reduction in any other blood-borne infection in HCWs and/or patients.
The post-hoc sensitivity analysis excluding the one study not providing outcome data separately for the different types of procedures , did not substantively impact the results of the main analysis. We were not able to conduct planned subgroup analyses because of the relatively small number of studies per analysis. Another reason was the lack of sufficient and clearly reported data on some of the factors we planned to conduct the analyses based upon such as: the type of device, the level of expertise of HCWs using the devices, the time of injury (before, during, or after the injection/withdrawal), and the mechanism of action/use of the specific device under study.
In summary, we identified moderate quality evidence that intravenous safety devices and phlebotomy safety devices reduce the risk of NSIs amongst HCWs performing such procedures. We did not identify substantial evidence about the effects on HCWs infection(s) with blood-borne pathogens (HBV, HCV, and HIV).
We have identified a systematic review published in 2006 addressing the same question . That review concluded that “a reduction in injury rate of ~50–60 % might be possible with phlebotomy devices”, which is less than the current review’s estimates. We believe our findings are more reliable for a number of reasons. First, that review addressed the efficacy of safety devices with either active or passive safety features. Our review focused on passive devices given there is evidence showing their higher efficacy compared with active devices . Additional advantages of our review include the use of a systematic approach to study selection and data abstraction, the assessment of risk of bias of included studies, and the grading of the quality of evidence by outcome using the GRADE methodology. The reviewers included seven studies in common with our review [56, 57, 59, 63, 65, 67, 70]. They also included four studies that we excluded for different reasons: the lack of an actual implementation of a safety device , not reporting data separately for separate procedures , being an abstract and not a published full-text , and not reporting comparative data for the conventional device . Thus, compared with the 2006 review, our systematic review included 15 additional studies [6, 26, 53–55, 58, 60–62, 64, 66, 68, 69, 71, 72].
We have identified a more recently published Cochrane systematic review addressing a related but distinct research question . In fact, that review had a wider scope and addressed types of safety devices other than intravenous and/or phlebotomy (e.g., sharps containers for on-spot disposal of used sharps) and in settings other than hospitals (e.g., dental clinics). Also, the Cochrane review included studies of safety-devices with active features, which we excluded as justified above under ‘Types of interventions’. Unlike our review, the Cochrane review excluded before and after studies.
The Cochrane review found very low quality evidence that safety-engineered blood-collection (i.e., phlebotomy) and IV devices can lower NSIs compared to the conventional non-safety-engineered devices. However, one of their two estimates of relative risk based on one trial was higher than ours (0.62 (95 % CI 0.27 to 1.41) while their other estimate of relative risk based on one controlled before and after study was lower than ours (0.06 (95 % CI 0.0 to 1.09). This discrepancy between the two reviews is due to the different eligibility criteria, particularly in terms of our inclusion of six non-controlled before and after studies [53–55, 57, 61, 72].
There are two main explanations for the differences in rating the quality of evidence between the Cochrane review and our review. First, the inter-rater reliability of using the GRADE approach for assessing the quality of evidence is not perfect, with an inter-rater reliability (IRR) of 0.72 among members of the GRADE working group. Second, there is a debate on how to rate the quality of evidence from observational studies, with some advocating rating evidence from studies using ITS analysis as moderate quality . Our approach was to start with low quality rating for the evidence from uncontrolled before and after studies, then rating them up for large effect .
Few studies have assessed the use of these devices from the economic point of view. Griswold et al.  assessed StatLock™, a safety-engineered device designed to protect HCWs placing central venous catheters from NSIs. The authors estimated that the use of the device could spare hospitals a cost of $2723 incurred by each NSI acquired by a HCW, and could have saved a minimum of $57,183 over the evaluated four-year study period. Yassi et al. conducted economic-benefit and cost effectiveness analyses for the use of safety devices in intravenous and phlebotomy procedures . They found that the introduction of the safety Interlink system may increase cost to the hospital, but judged that any incremental cost would be offset by the avoidance of costs related to NSIs and infections. One study evaluated the ease of use of the safety devices. Griswold et al. found that surgical residents “seemed to prefer using sutures over the StatLock device” . One participant suggested the need for additional practice with the device before using it in a clinical setting.
The main strength of this review is the use of a rigorous methodology for conducting systematic reviews. The major limitation pertained to the lack of original studies assessing the effects of the safety devices on blood borne infections (particularly HIV, HBV, and HCV) amongst workers healthcare. Also the quality of evidence for some of the outcomes of interest was low, suggesting the need for further studies to strengthen that quality.
The findings of this review have significant implications for HCWs. The introduction into the healthcare setting of safety-engineered devices for intravenous and/or phlebotomy procedures will likely reduce NSIs to HCWs. However, the decision to introduce these devices into healthcare facilities should take into account the costs related to the purchase, training, use of these devices and the impact of their introduction on the sharps waste generated and its safe management. These devices are typically introduced as part of a wider injection safety program, including: education about the risks associated with accidental injuries, training in the safety devices, surveillance and reporting of NSIs, immunization against HBV, post exposure prophylaxis and appropriate sharps waste management. Also, the HCWs would need to be involved in evaluating and selecting the proper devices.
The findings also have important implications for future research. There is a need to further build the evidence base for safety-engineered devices for intravenous and/or phlebotomy procedures. There is also a need for studies assessing the economic impact of these devices, the ease of their use in practice, as well as their acceptability by HCWs. Finally, all included studies were conducted in high income countries; there is a need to undertake such studies in middle- and low- income countries where unsafe injection practices and accidental needle stick injuries in HCWs are still prevalent.
We would like to thank the Service Delivery and Safety Department and the WHO Injection Safety Program at the WHO HQ in Geneva for their financial support. We would like to extend our gratitude to Mrs. Aida Farha from the Saab Medical Library at AUBMC for assisting with the search strategy. We thank Ms. Lara Kahale for her contribution in obtaining the full text articles.
Availability of data and material
All data generated or analysed during this study are included in this published article and its supplementary information files.
Conceiving and designing the review: SK, EA. Coordinating the review: EA. Data extraction: RB, BD, AH, RT. Data analyses: RB, EA. Data interpretation: RB, SK, EA. Writing of the review: RB, EA. Reviewed and approved the final version of the manuscript: All contributing authors.
The authors declare that they have no competing interests.
Consent for publication
Ethics approval and consent to participate
|HBV||Hepatitis B virus|
|HCV||Hepatitis C virus|
|HIV||Human immunodeficiency virus|
Detailed description of the search strategy used with the MeSH terms and keywords employed.
Search strategies used to detect relevant papers
Search strategy used in Medline:
((Healthcare or health-care or (health adj care)) adj2 worker*).mp.
((medical or nurs*or ancillary) adj2 staff*).mp.
(Medical adj2 laboratory adj2 techn*).mp.
exp Needlestick Injuries/
exp Accidents, Occupational/and (syringe* or needle* or inject*).mp.
(injur* adj3 (syringe* or needle* or inject*)).mp.
exp Accidents, Occupational/and (syringe* or needle* or inject*).mp.
exp Accident Prevention/and (syringe* or needle* or inject*).mp.
(blood adj3 collection adj3 (syringe* or needle* or system* or device* or material* or product* or set*)).mp.
((need-less or needless or needle-free or needlefree) adj3 (syringe* or needle* or system* or device* or material* or product* or set* or inject*)).mp.
(Single adj3 “use” adj3 (syringe* or needle* or system* or device* or material* or product* or set* or inject*)).mp.
(prevent* adj3 (syringe* or needle* or system* or device* or material* or product* or set* or inject*)).mp.
(reuse adj3 (syringe* or needle* or system* or device* or material* or product* or set* or inject*)).mp.
(exp Equipment Reuse/or exp Disposable equipment/) and (syringe* or needle* or system* or device* or material* or product* or set* or inject*).mp.
(Disposable adj2 equipment* adj3 (syringe* or needle* or inject*)).mp.
((prefill* or pre-fill*) adj3 (syringe* or needle* or inject*)).mp.
(Autopen or auto-pen).mp.
((prefill* or pre-fill*) adj2 syringe*).mp.
(Kendall’s adj2 Monoject).mp.
(ultrasafe adj passive adj delivery adj system).mp.
“Maxxon safety syringe*”.mp.
Search strategy used in EMBASE:
((Healthcare or health-care or (health adj care)) adj2 worker*).mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
Paramedic*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
((medical or nurs*or ancillary) adj2 staff*).mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
(Medical adj2 laboratory adj2 techn*).mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
Pharmacist*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
physician*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
Hospitalist*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
internist*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
doctor*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
Phlebotomist*.mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
exp Needlestick Injuries/
exp Accidents, Occupational/and (syringe* or needle* or inject*).mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
(injur* adj3 (syringe* or needle* or inject*)).mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
exp Accidents, Occupational/and (syringe* or needle* or inject*).mp. [mp = title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]