Medical organizations of any form of ownership and departmental affiliation on requirements for personnel management; patient identification; epidemiological safety; drug safety; quality control and safety of medical devices; organization of emergency and urgent care in hospitals; organization of the emergency room; continuity of medical care; surgical safety; prevention of risks associated with transfusion of donor blood and its components; products from donors’ blood stem cells; medical management of sepsis patients; investigation of errors of the use of medical products and medical devices.
Papers filed for the ISPMH and CEHRM guidelines must be published in medical journals within three years of final publication. The CEHRM guidelines are also available for consultation through the AEHRM Program by appointment, email and phone. A list of publications can be found online.
Recommendations made in the ISPMH and CEHRM guidelines follow the principles of complete and independent patient safety. The recommendations for regulatory organizations must be set forth in the form of recommendations to protect patients, but must also ensure compliance with federal requirements. The guidelines do not create new requirements and only include well-established guidelines.
Education, engagement and consultation with medical and patient communities are integral parts of the process of developing clinical guidelines and ensuring patient safety.
The CEHRM recommends providers regularly engage with patients, advocates, government agencies, industry, peers, policymakers and others to discuss the practical aspects of clinical practice. The CCRM, while an extension of the CEHRM, includes the additional provision of guidelines for every medical specialty.
Ed Dietsch is the Associate Director of Clinical Research for the Association of Medical Centers for the Care of the Sick and the Young. Ed was a participant in the peer review of ISPMH and CEHRM guidelines. For more information, visit the CEHRM Program website at www.cfurh.org.
Ed Dietsch, PHR, MS is the Associate Director of Clinical Research for the Association of Medical Centers for the Care of the Sick and the Young. Ed was a participant in the peer review of ISPMH and CEHRM guidelines.
Medical device consulting compliance
Representative product quality compliance has become a need in healthcare, in which evidence based improvements in manufacturing standards are needed for ensuring compliance with industry best practices. This task falls within the regulatory responsibility of health care organizations in consultation with advisory groups and consumer and patient advocacy organizations. Consultations may be done by medical device consulting compliance or organizations in the consumer or patient communities.
The CEHRM recommends consulting with at least one group in the medical community (and a major health advocacy group), including patient or advocacy groups (at least at first), to obtain patient input prior to developing or promulgating guidelines or applying for FDA clearance or certification.
Consultations, education, and involvement are required from organizations in medical organizations and the medical community regarding regulations and changes. The CEHRM guidelines and advisory guidelines may be used as a resource to educate and involve medical institutions in industry concerning their obligation to fulfill information requirements.
This article was written in conjunction with, and has been submitted to CEHRM for possible inclusion as part of the CEHRM guidelines.
A Comparative Review of Medical Device Evaluation Regimens for Regulatory Compliance
The CEHRM is working to develop and establish guidelines that address medical device development and establishment. The CEHRM is a non-profit organization dedicated to the development of medical device guidelines. The CEHRM has developed guidance and guidelines for:
the development and evaluation of clinical trials in medical device development investigations of the effects of medical devices on health outcomes approaches to product safety and regulatory compliance public education, training and involvement in clinical research.
The CEHRM is working to address the current market landscape for medical devices and further establish principles for ensuring the continual advancement of medical device research and development to ensure safer and more effective products for patients. The CEHRM developed a strategy to engage the medical community in advisory groups and patient advocacy groups to establish necessary protocols for development, regulatory oversight, development, and effectiveness of medical devices.
Medical device associations and associations providing professional medical services
The professional medical associations provide services to improve medical device quality and medical practice. The ACMI publishes a quarterly newsletter, which provides updates on new legislation, administrative proceedings, and regulatory changes. The ACMI publishes a quarterly newsletter for its members.