Spinal devices in the United States-investigational device exemption trials and premarket approval of class III devices.

BACKGROUND CONTEXT: Recently, there has been increased public awareness of regulatory actions by the United States Food and Drug Administration (FDA) on spinal devices. There has also been increased scrutiny of the pivotal clinical trials of these devices. PURPOSE: To investigate the premarket approval (PMA) of class III spinal devices in the United States since the turn of the century. To explore clinically relevant issues that affect the interpretation of investigational device exemption trials. STUDY DESIGN: Literature review. METHODS: From 2000 to 2015, data on PMA applications for spinal devices were obtained from two sources. First, meetings of FDA's Orthopaedic and Rehabilitation Devices Panel were identified from the Federal Register. Second, the FDA database of approved PMA applications was queried. For each device, two authors reviewed all archival data. There was no external source of funding. RESULTS: Twenty-one devices met the study criteria. There were 76.2% that received approval and 47.6% that went to panel. Arthroplasty devices were most common (52.4%), least likely to go to panel (3 of 11), and most likely to be approved after panel (3 of 3). Biologic devices were most likely to go to panel (3 of 3) and least likely to be approved after panel (1 of 3). Before and after 2009, there was no decrease in the number of spinal devices approved. All 21 devices were studied in a pivotal clinical trial. All trials except one were randomized controlled trials, and all trials except one were two-arm noninferiority designs. CONCLUSIONS: There has been no decrease in the number of new FDA-approved class III spinal devices since the turn of the century. The majority of devices have been for cervical arthroplasty. By contrast, biologic devices were most likely to go to panel and least likely to be approved after panel. The pivotal trials for nearly all devices were randomized, two-arm, noninferiority trials.

Taking a Concept to Commercialization: Designing Relevant Tests to Address Safety.

Taking a product from concept to commercialization requires careful navigation of the regulatory pathway through a series of steps: (A) moving the idea through proof of concept and beyond; (B) evaluating new technologies that may provide added value to the idea; (C) designing appropriate test strategies and protocols; and (D) evaluating and mitigating risks. Moving an idea from the napkin stage of development to the final product requires a team effort. When finished, the product rarely resembles the original design, but careful steps throughout the product life cycle ensure that the product meets the vision.

[The introduction of new medical devices]. / De introductie van nieuwe medische implantaten.

Regulation of the introduction of new or improved medical devices is fundamentally different from that of new drugs and is inadequate in its current form. This was recently demonstrated by large-scale problems with medical devices in various specialist fields. Steps have been taken by scientific professional associations, regulating authorities and industry to prevent these problems from happening in the future. However, these steps have not yet been implemented or have not been sufficiently well implemented, and have not been completely coordinated. The practitioner therefore needs to remain extremely critical when using new medical devices.

Risk assessment of accidental exposure of surgeons to blood during orthopedic surgery. Are we safe in surgical gloves?

AIM: To analyze tears in sterile surgical gloves used by surgeons in the operating theatre of the Trauma and Orthopedic Surgery Department, Copernicus Memorial Hospital, Lódz, Poland. MATERIALS AND METHOD: This study analyzes tears in sterile surgical gloves used by surgeons by ICD-9 and ICD-10 codes. 1,404 gloves were collected from 581 surgical procedures. All gloves were tested immediately following surgery using the test method described in Standard EN455-1 (each glove was inflated with 1,000 ± 50 ml of water and observed for leaks for 2-3 min.). RESULTS: Analysis of tears took into consideration the role of medical personnel (operator, first assistant, second assistant) during surgical procedure, the type of procedure according to ICD-9 and ICD-10 codes, and the elective or emergency nature of the procedure. The results of the study show that these factors have a significant influence on the risk of glove tears. Significant differences were observed in tear frequency and tear location depending on the function performed by the surgeon during the procedure. CONCLUSION: The study proved that the role performed by the surgeon during the procedure (operator, first assistant, second assistant) has a significant influence on the risk of glove tearing. The role in the procedure determines exposure to glove tears. Implementing a double gloving procedure in surgical procedures or using single gloves characterized by higher tear resistance should be considered.

Medical devices in orthopedic applications.

Orthopedic medical devices have been extremely successful in restoring mobility, reducing pain, and improving the quality of life for millions of individuals each year. Their success is reflected in the worldwide biomaterials market, in which orthopedic devices dominated sales at approximately $14 billion in 2002. Of this, approximately $12 billion was spent on joint replacements. In spite of their overwhelming benefits and successes, orthopedic medical devices are not without risk of adverse effects. Most adverse joint replacement outcomes are thought to be mediated by degradation products generated by wear and electrochemical corrosion. Infection and flaws in device manufacturing are other noteworthy causes of orthopedic device failure. This article illustrates and discusses the uses, general properties, and limitations (including adverse outcomes) of orthopedic biomaterials, which are fundamental to understanding requirements for improving current orthopedic medical devices.

An assessment of the reliability of the Scoliometer.

Accurate noninvasive measurements of spinal curvature are crucial in planning treatment and assessing curve progression in adolescent idiopathic scoliosis. An inter-rater agreement trial and an intrarater agreement trial were undertaken to estimate the reliability of axial rotation measurement using the Scoliometer (Orthopedic Systems, Inc., Haywood, California). In the inter-rater trial, two orthopedic surgeons and two orthopedic surgery residents independently measured the thoracic and lumbar axial rotations of 22 patients with idiopathic scoliosis using the Scoliometer. In the intrarater, trial a single orthopedic surgeon measured the thoracic and lumbar axial rotations of 25 patients on four separate occasions with the Scoliometer. Inter-rater agreement using the Scoliometer to estimate the magnitude of the hump (in centimeters) in the thoracic and lumbar regions was poor (intraclass correlation coefficient, Rho = 0.57 and Rho = 0.76 for the thoracic and lumbar regions, respectively). Inter-rater agreement using the Scoliometer to estimate the degree of axial trunk rotation was better (Rho = 0.81 and Rho = 0.82 for the thoracic and lumbar regions, respectively). Intrarater agreement using this device to estimate the magnitude of the hump (in centimeters) in the thoracic and lumbar regions was good (Rho = 0.90 and Rho = 0.84 for the thoracic and lumbar regions, respectively). Intrarater agreement using the Scoliometer to estimate the degrees of curvature was outstanding (Rho = 0.995 and Rho = 0.998 for the thoracic and lumbar regions, respectively). These results indicate that the Scoliometer can be a reliable noninvasive method for repetitively assessing spinal axial rotation when used by a single trained observer.

[The standard hip--evaluation of physical function and health care utilization following hip fracture]. / Rikshöft--utvärdering av fysisk funktion och vårdkonsumtion efter höftfraktur.

All 441 cases of hip fracture admitted to Sahlgrenska sjukhuset, Göteborg, during a one-year period were followed in accordance with a form developed by the Swedish Medical Research Council. Osteosynthesis was the method used in over 97 per cent of the cases. There were 336 women, mean age 80.0 (+/- 9.9) years, and 105 men, mean age 77.1 (+/- 11.8). A rehabilitation programme for non-institutionalised patients (68 per cent of the total of 441) reduced the length of stay at the orthopaedic department from 22 days to an average of 15 days in 1986, and the proportion of patients able to return home was increased from 81 per cent in 1982 to 90 per cent in 1987-88. Thus, the use of rehabilitation or nursing home facilities was reduced, and the length of stay there was reduced. The findings of the study also showed the rehabilitation to be time-consuming, and that few hip fracture patients ever regain complete pre-fracture function. Therefore it is suggested that the follow-up should be extended to cover a longer period than four months. Otherwise, the form is well designed, and its use improves the comparability of different studies.