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Page 1 of 14

  • 14 - Preventing Medical Device-Borne Outbreaks
  • from Part IV - The Impact of Medical Device Regulation on Patients and Markets
  • Edited by I. Glenn Cohen, Harvard Law School, Massachusetts, Timo Minssen, University of Copenhagen, W. Nicholson Price II, University of Michigan, Ann Arbor, Christopher Robertson, Boston University, Carmel Shachar, Harvard Law School, Massachusetts
  • Book: The Future of Medical Device Regulation
  • Published online: 31 March 2022
  • Print publication: 07 April 2022, pp 192-202
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    Summary

    This chapter examines the FDA’s role in regulating ART devices. The FDA’s statutorily defined purview to regulate devices includes [things] “used in” or “intended to affect…man or other animals.” This chapter considers the FDA’s jurisdiction over devices that affect or diagnose pre-embryos, embryos, or fetuses that are not generally considered people or animals under US law. It discusses the legal and ethical implications of the FDA’s claim over ART devices without changing or clarifying its regulatory charge to include such organisms and whether or not the FDA has overstepped its power by regulating these instruments as devices. It also reviews the FDA’s existing classification of devices involved in ART (Class II). In light of the catastrophic and painful consequences that can follow malfunction of these devices (such as cryobanks thawing or embryo swapping) and that anecdotal accounts suggest such malfunctions are happening more frequently, this chapter questions if ART devices should be reclassified or if an alternative regulatory mechanism could more effectively protect consumers in the ART industry.

  • Effectiveness of a vancomycin dosing protocol guided by area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) with multidisciplinary team support to improve hospital-wide adherence to a vancomycin dosing protocol: A pilot study
  • Panipak Katawethiwong, Anucha Apisarnthanarak, Kittiya Jantarathaneewat, David J. Weber, David K. Warren, Nuntra Suwantarat
  • Journal: Infection Control & Hospital Epidemiology , First View
  • Published online by Cambridge University Press: 12 July 2021, pp. 1-6
  • View abstract
    Background:

    Limited data are available on the implementation of an area under the concentration-time curve (AUC)–based dosing protocol with multidisciplinary team (MT) support to improve adherence with vancomycin dosing protocol.

    Objective:

    To evaluate the effectiveness of an AUC-based dosing protocol with MT support intervention with adherence to a hospital-wide vancomycin dosing protocol at Thammasat University Hospital.

    Method:

    We conducted a quasi-experimental study in patients who were prescribed intravenous vancomycin. The study was divided into 2 periods; (1) the preintervention period when the vancomycin dosing protocol was already applied in routine practice and (2) the post-intervention period when the implementation of an AUC-based dosing protocol with MT support was added to the existing vancomycin dosing protocol. The primary outcome was the rate of adherence, and the secondary outcomes included acute kidney injury events, vancomycin-related adverse events, and 30-day mortality rate.

    Results:

    In total, 240 patients were enrolled. The most common infections were skin and soft-tissue infections (24.6%) and bacteremia (24.6%). The most common pathogens were coagulase-negative staphylococci (19.6%) and Enterococcus spp (15.4%). Adherence with the vancomycin dosing protocol was significantly higher in the postintervention period (90.8% vs 55%; P ≤ .001). By multivariate analysis, an AUC-based dosing protocol with MT support was the sole predictor for adherence with the vancomycin dosing protocol (adjusted odds ratio, 10.31; 95% confidence interval, 4.54–23.45; P ≤ .001). The 30-day mortality rate was significantly lower during the postintervention period (8.3% vs 20%; P = .015).

    Conclusions:

    AUC-based dosing protocol with MT support significantly improved adherence with vancomycin dosing protocol and was associated with a lower 30-day mortality rate.

  • The impact of patient-reported penicillin or cephalosporin allergy on surgical site infections
  • Jessica L. Seidelman, Rebekah W. Moehring, David J. Weber, Deverick J. Anderson, Sarah S. Lewis
  • Journal: Infection Control & Hospital Epidemiology , First View
  • Published online by Cambridge University Press: 09 June 2021, pp. 1-5
  • View abstract
    Objective:

    To determine the impact of a documented penicillin or cephalosporin allergy on the development of surgical site infections (SSIs).

    Background:

    Appropriate preoperative antibiotic prophylaxis reduces SSI risk, but documented antibiotic allergies influence the choice of prophylactic agents. Few studies have examined the relationship between a reported antibiotic allergy and risk of SSI and to what extent this relationship is modified by the antibiotic class given for prophylaxis.

    Methods:

    We conducted a retrospective cohort study of adult patients undergoing coronary artery bypass, craniotomy, spinal fusion, laminectomy, hip arthroplasty and knee arthroplasty at 3 hospitals from July 1, 2013, to December 31, 2017. We built a multivariable logistic regression model to calculate the adjusted odds ratio (aOR) of developing an SSI among patients with and without patient-reported penicillin or cephalosporin allergies. We also examined effect measure modification (EMM) to determine whether surgical prophylaxis affected the association between reported allergy and SSI.

    Results:

    We analyzed 39,972 procedures; 1,689 (4.2%) with a documented patient penicillin or cephalosporin allergy, and 374 (0.9%) resulted in an SSI. Patients with a reported penicillin or cephalosporin allergy were more likely to develop an SSI compared to patients who did not report an allergy to penicillin or cephalosporins (adjusted odds ratio, 3.26; 95% confidence interval, 2.71–3.93). Surgical prophylaxis did not have significant EMM on this association.

    Conclusions:

    Patients who reported a penicillin or cephalosporin allergy had higher odds of developing an SSI than nonallergic patients. However, the increase in odds is not completely mediated by the type of surgical prophylaxis. Instead, a reported allergy may be a surrogate marker for a more complicated patient population.

Page 1 of 14