Lancaster County, PA, September 27, 2017 – Saxton & Stump’s Darlene K. King was an invited speaker at the Pennsylvania Association for Health Care Risk Management (PAHCRM) Annual Fall Conference on September 21-22, 2017 held at Reading Hospital. Ms. King presented FDA Medical Device Reporting and Investigation Overview together with Karen Karpovich, Director of Risk Management for Reading Health.
During Ms. King’s portion of the presentation, she provided an overview of FDA device reporting regulations for which device user facilities must comply. She reviewed in detail the meaning of the regulations and the differences between real time vs delayed discovery reporting. In addition, she addressed opening a Medical Device Reporting (MDR) file, what to include in the file, how the file is to be maintained, and the importance of developing clear processes and protocols for reporting and annual submission of reports.
PAHCRM is an affiliate of the American Society for Healthcare Risk Management (ASHRM). The purpose of PAHCRM is to promote, within the entire healthcare community, safe, proactive and innovative enterprise wide risk management solutions.
Ms. King is Chair of Saxton & Stump Risk Mitigation & Safety Group. She concentrates her practice in the representation of hospitals, doctors and health care professionals in health care litigation. She guides health care clients with issues involving risk management, crisis management, patient care and liability exposure. Ms. King has many years of comprehensive health care litigation experience encompassing all aspects of professional negligence litigation from inception to trial. She also has advised clients concerning compliance with federal and state statutes and regulations and has represented health care clients before the state licensing board.
Based in Pennsylvania, Saxton & Stump is a legal and consulting firm that represents health care professionals and other businesses. The firm represents their clients in a wide range of legal and consulting services, including health care litigation and risk mitigation, labor and employment, corporate insurance coverage and bad faith matters, and construction litigation. In addition to a team of experienced lawyers and paralegals, the firm employs physicians, nurses, psychologists, physician reimbursement specialists, health policy thought leaders and business consultants.