Dr. Theodore Cooper, Assistant Secretary for Health, U.S. Department of Health. Education and Welfare will deliver the annual American Society of Law & Medicine Oration on Monday, June 21, 1976 in Boston. Dr. Cooper's address will focus on the federal government's role in the health care field and will take place at the Society's annual dinner meeting being held in conjunction with a two day national conference on the medicolegal implications of patient injury from medical products. devices and drugs. The Conference and oration will take place June 21 and 22 at the Copley Plaza Hotel in Boston.

During the business meeting Monday evening, the Assistant Secretary for Health will also receive the ASLM's Honorary Life Membership Award for his outstanding contributions in medicolegal education and for his distinguished service in government and medicine.

by Gordon Needleman, Esq.

On May 28 1976 President Ford signed the Medical Device Amendments of 1976 (Amendments) to the Federal Food Drug and Cosmetic Act (FDCA) which substantially increase regulatory control of medical devices The Amendments are the first major Federal legislation concerning the regulation of medical devices since the FDCA of 1938 This article presents a summary of the background leading to the Amendments and 115 important provisions.

Background

The legislative history of the 1938 Act indicates it was intended to provide limited Food and Drug Administration (FDA) control over medical devices In 1938 most medical devices were of simple Construction and operation allowing health practitioners to easily determine if the devices were functioning properly Under the 1938 Act, the FDA functions were mainly surveillance and policing Tho policing was accomplished through the Federal Court system an expensive and time-consuming Process.

One of the most significant aspects of P.L. 93-641, the National Health Planning and Resources Development Act of 1974 is the requirement that States adopt certificate of need laws as a method of health facilities regulation. This demonstrates a certain Congressional dissatisfaction with health planning alone and a desire to be more active in the actual distribution of health care facilities.

Over the years Congress has made a number of attempts to institute federal programs that would insure an adequate supply of health services to all people In 1946 it passed the Hill-Burton Act which was designed to respond to Congress perception that an inadequate supply of hospital beds existed in the United Slates. In addition to providing funds for the actual building of hospital beds, Hill-Burton required states to conduct surveys of bedding patterns and to participate in some rudimentary planning.

While most courtroom confrontations involving childbirth concern parents seeking damages for alleged physician and hospital negligence, a number of recent cases have involved parents seeking simply to have their babies with a minimum of medical intervention. Courts, however, have consistently deferred to “expert” medical opinion in this area.

The extreme reluctance of courts to substitute their judgment for that of hospital boards is nowhere better illustrated than in the cases involving fathers in the delivery room. While most hospitals with maternity wards currently permit “husband-coached' (Lamaze or psychoprophylactic being the most common method) childbirth, in which the father is with the mother throughout labor and delivery, supplying physical and emotional support, lawsuits to compel a change in the policies of those institutions that do not, have been universally unsuccessful to date.