Changing practice to using pre-filled syringes for flushing IV cannulas.

In the UK, the Medicines and Healthcare products Regulatory Agency classifies 'pre-filled syringes' for flushing Intravenous (IV) cannulas and IV access devices as 'borderline' devices and offers some advice on how control measures can help mitigate risks. The Medicines Act (1968) and Medical Device Regulations try to address the legal position of these devices and allow each employer to identify those groups of staff allowed to use them. In turn, this may help address anomalies around the need to prescribe and document their use. This article describes how one large university health board in Wales implemented a change in products and practice and explores the issues around adopting and using CE-marked pre-filled, sterile syringes of 0.9% sodium chloride in place of manually drawing up an IV flush (the CE mark indicates devices that conforms with European legal requirements). Whether the use of individual components or a single pre-filled device can lead to a streamlined and cost-effective way to manage the flushing of IV cannula and vascular access devices was explored. Additional risk factors were identified, and the legal status clarified in line with current guidelines and regulations. As 0.9% sodium chloride in ampoules and vials is classified as a prescription-only medicine, the administration needs control via formal prescription or a patient group direction. Adopting and using these pre-filled syringes as CE-marked medical devices requires careful consideration and sign-off from each employing authority, before implementing them for flushing IV cannulas and IV access devices.

Technique to Fabricate Custom Nasal Pillows and Monoblock Mandibular Advancement Device Using A Digital Workflow for Combination Therapy of Obstructive Sleep Apnea.

Combination therapy using continuous positive airway pressure and oral appliance therapy is an effective non-surgical treatment for obstructive sleep apnea. However, the laboratory expense and additional chairside time prevent it from being a preferred option. This article describes a technique for fabricating custom nasal pillows and monoblock mandibular advancement device with potential lower cost and accelerated timeline using a digital workflow.

Long-Term Results of Treating Large Posttraumatic Tibial Plateau Lesions with Fresh Osteochondral Allograft Transplantation.

BACKGROUND: The use of fresh osteochondral allograft (FOCA) transplantation is a treatment option for large posttraumatic tibial osteochondral defects in young, high-demand patients. We aimed to assess the long-term outcomes of this procedure and factors impacting graft survivorship. METHODS: Evaluated were patients with a posttraumatic tibial plateau defect of >3 cm in diameter and >1 cm in depth who were treated with use of a FOCA, with or without a realignment osteotomy, before September 2007. The primary outcome was survivorship according to Kaplan-Meier analysis, with conversion to arthroplasty or another allograft procedure as the end point. The secondary outcome was the functional outcome of knees with a surviving FOCA, as assessed using the modified Hospital for Special Surgery (mHSS) scoring system. Multivariate Cox regression analysis of the role of potential variables was performed for both outcomes. RESULTS: Included were 113 patients (67 female) with a mean age at the time of the index surgery of 43 years (range, 24 to 72 years) and a mean follow-up of 13.8 years (range, 1.7 to 34 years). Forty-eight conversions to arthroplasty or another FOCA procedure had been performed at a mean of 11.6 years (range, 1.7 to 34 years) after the index surgery. The remaining 65 patients had a mean follow-up of 15.5 years (range, 4.3 to 31.7 years). The mean mHSS score among those with a surviving FOCA was 85.5 (range, 56 to 100) at the most recent follow-up, which was significantly higher than the preoperative value of 69 (range, 48 to 85) (p < 0.001). Graft survivorship was 90% at 5 years, 79% at 10 years, 64% at 15 years, and 47% at 20 years. Complications included infection (1.8%), nonunion (0.9%), and knee pain from hardware (8.8%). Multivariate analysis revealed that older age at the time of surgery, involvement of the medial plateau, and a higher number of previous surgeries were inversely associated with graft survivorship. Having a Workers' Compensation file was associated with less improvement in the mHSS score, and the score tended to decline over time for knees with a surviving FOCA. CONCLUSIONS: FOCA transplantation is a viable option for posttraumatic tibial osteochondral defects, with satisfactory survivorship and functional outcome. Although approximately half of the patients in our study demonstrated graft failure by 20 years, FOCA was an excellent option that delayed the need for arthroplasty. Older patients, those with medial defects, and those with multiple previous surgeries had a less favorable prognosis. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Distal Femoral Fresh Osteochondral Allografts: Follow-up at a Mean of Twenty-two Years.

BACKGROUND: Osteochondral defects of the knee in young, active patients represent a challenge to the orthopaedic surgeon. Our study examined long-term outcomes of the use of fresh allograft for posttraumatic osteochondral and osteochondritis dissecans defects in the distal aspect of the femur. METHODS: We reviewed the cases of sixty-three patients who underwent osteochondral allograft transplantation to the distal aspect of the femur between 1972 and 1995. Five patients who resided out of the country were lost to follow-up. Indications for the allograft procedure were an age of less than fifty years and a unipolar posttraumatic osteochondral or osteochondritis dissecans defect in the distal aspect of the femur that was larger than 3 cm in diameter and 1 cm in depth. RESULTS: Fifty-eight patients ages eleven to forty-eight years at the time of surgery (mean age, twenty-eight years) were followed for a mean of 21.8 years (range, fifteen to thirty-two years). Thirteen of the fifty-eight cases required further surgery; three underwent graft removal, nine were converted to total knee arthroplasty, and one underwent multiple debridements followed by above-the-knee amputation. Three patients died during the study due to unrelated causes. A Kaplan-Meier analysis of graft survival showed rates of 91%, 84%, 69%, and 59% at ten, fifteen, twenty, and twenty-five years, respectively. Patients with surviving grafts had good function, with a mean modified Hospital for Special Surgery (HSS) score of 86 at fifteen years or more following the allograft transplant surgery. Late osteoarthritic degeneration on radiographs was associated with lower HSS scores and poorer clinical outcomes. CONCLUSIONS: Fresh osteochondral allograft was found to provide a long-term solution for large articular cartilage defects in the distal aspect of the femur in young, active patients. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Analysis of infusion pump error logs and their significance for health care.

Infusion therapy is one of the largest practised therapies in any healthcare organisation, and infusion pumps are used to deliver millions of infusions every year in the NHS. The aircraft industry downloads information from 'black boxes' to help design better systems and reduce risk; however, the same cannot be said about error logs and data logs from infusion pumps. This study downloaded and analysed approximately 360 000 hours of infusion pump error logs from 131 infusion pumps used for up to 2 years in one large acute hospital. Staff had to manage 260 129 alarms; this accounted for approximately 5% of total infusion time, costing about £1000 per pump per year. This paper describes many such insights, including numerous technical errors, propensity for certain alarms in clinical conditions, logistical issues and how infrastructure problems can lead to an increase in alarm conditions. Routine use of error log analysis, combined with appropriate management of pumps to help identify improved device design, use and application is recommended.

Structural allograft as an option for treating infected hip arthroplasty with massive bone loss.

BACKGROUND: Revision of the infected hip arthroplasty with major bone loss is difficult. Attempts to restore bone stock with structural allograft are controversial. QUESTIONS/PURPOSES: We assessed the (1) reinfection rate; (2) rerevision rate; (3) radiographic graft union, resorption, and implant migration; (4) Harris hip scores at 1 year and at last followup compared with before surgery; and (5) other major complications associated with the use of bulk structural allograft to treat massive bone loss in infected hip arthroplasty. METHODS: We retrospectively reviewed 27 patients who underwent two-stage revision arthroplasty using structural allograft to treat massive bone defects in infected hip arthroplasty. There were 17 proximal femoral grafts, three acetabular major column grafts, two acetabular minor column grafts, and 10 cortical strut grafts used. Five patients had combinations of two allografts. The minimum followup was 1.1 years (mean, 8.2 years; range, 1.1-16.8 years). RESULTS: One of 27 patients had reinfection. The Kaplan-Meier survivorship was 93% at 10 years with rerevision for aseptic loosening as the end point. Radiographically, three patients had nonunion at the graft-host junction. All patients except two had graft resorption, of which all were mild except two, which were severe. Three patients had implant migration. The mean modified Harris hip scores were 39.2 points (range, 25-60) preoperatively, 67.3 points (range, 40-91) at 1-year followup, and 70.3 points (range, 46-81) at last followup. Other major complications included one patient with dislocation and one patient with transient sciatic nerve injury. CONCLUSIONS: Based on our data, we believe the use of structural allografts is a reasonable option for treating massive bone loss in infected hip arthroplasties. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Long-term results for minor column allografts in revision hip arthroplasty.

BACKGROUND: While acetabular structural allografts provide an important alternative for reconstructions, concerns remain with long-term graft resorption, collapse, and failure. Midterm studies of minor column (shelf) allograft suggest reasonable survival but long-term survival is unknown. QUESTIONS/PURPOSES: We therefore assessed long-term graft/cup survivorship, functional scores, radiographic resorption, and complications associated with minor column allograft. METHODS: We retrospectively reviewed 74 patients (85 hips) with a mean age of 54 years (range, 28-83 years) undergoing acetabular cup revision using a minor column allograft. A minor column allograft was used in uncontained acetabular bone defects sized between 30% and 50% of the acetabulum. Graft failure was considered to occur when the graft required revision with another graft, metal augment, reconstruction cage, or excision arthroplasty. The minimum followup was 5 years (mean, 16 years; range, 5.3-25 years). RESULTS: Twenty-three patients (27 hips) had rerevision for all causes at a mean time to rerevision of 6.9 years (range, 0.1-23). Fifteen grafts failed at a mean time-to-rerevision of 6.1 years (range, 0.5-23.2). The 15- and 20-year Kaplan-Meier survivorships were 61% and 55% for cups and 78% for grafts with rerevision for all causes as end point. With rerevision for aseptic loosening as end point, survivorships were 67% and 61% for cups and 81% for grafts. The mean modified Harris hip scores were 41 (range, 20-60) preoperatively, 73 (range, 40-95) at 1 year postoperatively and 73 (range, 26-93) at last followup. CONCLUSION: The data may provide a long-term benchmark by which future treatments for Type III defects can be measured.

Polymerase chain reaction can detect bacterial DNA in aseptically loose total hip arthroplasties.

Identifying low-grade infection in failed total hip arthroplasties is an important but difficult task. This study investigated the ability of the polymerase chain reaction to identify low-grade infection during revision of total hip arthroplasties that failed from aseptic causes. One hundred thirteen specimens from 31 total hip arthroplasties revised for aseptic loosening were compared with 105 control specimens from 28 primary total hip arthroplasties. All surgeries were done in laminar flow operating rooms. No primary or revision specimen had positive microbiologic cultures. No revision specimen had histologic evidence suggestive of infection. Using the polymerase chain reaction with a detection threshold of 10 organisms per cubic centimeter of specimen, bacterial DNA was identified in 39 of 85 revision tissue specimens (46%) compared with 18 of 84 primary tissue specimens (21.4%). Bacterial DNA was identified in the synovial fluid of three specimens taken from 28 revision total hip arthroplasties (10.7%) and in two specimens taken from 21 primary total hip arthroplasties (9.5%). As multiple specimens were sent for each hip, a maximum of 16 of 31 revision total hip arthroplasties (52%) and eight of 28 primary total hip arthroplasties (29%) were considered to be infected. Bacterial DNA can be found in many specimens obtained from revised total hip arthroplasties considered to be aseptically loose. Because bacterial DNA identified at primary total hip arthroplasty was assumed to be attributable to contamination rather than present in healthy tissues, the overall specimen contamination rate of 19% and case contamination rate of 29% indicate that the polymerase chain reaction has poor specificity at this sensitivity level for diagnosing infection in revision total hip arthroplasty.

Contamination of primary total hip replacements in standard and ultra-clean operating theaters detected by the polymerase chain reaction.

BACKGROUND: Many organisms that are responsible for low-grade infection after total hip replacement (THR) are not recognized by routine culture. PATIENTS AND METHODS: We examined wound contamination during primary total hip replacement performed in standard and ultra-clean operating theaters. 20 THRs were performed in each type of theater. Paired tissue specimens taken at the beginning and end of surgery were analyzed by bacterial culture and for the presence of bacterial DNA by the polymerase chain reaction (PCR). In total, 160 specimens (80 for culture, 80 for PCR) from 40 THRs were tested. RESULTS: In standard theaters, none of the 20 specimens taken at the start of surgery were positive by culture, but 3 were positive by PCR (15%). Of the 20 specimens taken at the end of surgery, 2 were positive by enriched culture and 9 were positive by PCR. All specimens positive by culture were also positive by PCR. In ultra-clean theaters, none of the 20 specimens taken at the start of surgery were positive by culture, but 2 were positive by PCR. Of the 20 specimens taken at the end of surgery, none were positive by culture, but 6 were positive by PCR. All specimens that were positive by culture were positive by PCR. INTERPRETATION: Wound contamination of primary THR occurs frequently in both standard and ultra-clean operating theaters and contamination is greater at the end of surgery than at the beginning (p=0.04). In this small series, we found no differences in wound contamination between standard and ultra-clean theaters (p=0.1).