New Jersey Is First State to Adopt ‘Adverse Events’ Reporting Regulations
Bridgewater, NJ, March 29, 2008 — On March 3, 2008, New Jersey became the first state in the nation to track adverse events involving the use of reprocessed single-use medical devices. Regulations adopted by the New Jersey Department of Health and Senior Services, 40 N.J.R 1049(a), will require hospitals, surgical centers, and long term care facilities to report to the Department that an adverse event involves a reprocessed single-use device.
Patient Groups United Against Reprocessing Dangers (PatientGUARD) is a coalition of 22 patient advocacy and health care organizations praised the state′s actions. PatientGUARD was formed to raise awareness among physicians and the public about the potential risks from reprocessed single-use medical devices.
“I commend the New Jersey Department of Health and Senior Services for recognizing the concerns associated with the use of reprocessed single-use devices and taking action to address this issue,” stated Hon. Bob Franks, President of the HealthCare Institute of New Jersey and a founding member of PatientGUARD. “Documenting adverse events involving reprocessed single-use devices will empower the Department to take future regulatory action and will incentivize health care facilities to be more circumspect in deciding to use a single-use device on more than one patient.”
Single-use devices (SUDs) are medical instruments specifically designed, manufactured and approved by the U.S. Food and Drug Administration to be used one time on one patient and then thrown away.
“We are pleased that some progress is being made on this important patient-safety issue,” said Kelly Rosso Leight, Executive Director of the CARES Foundation, Inc. of Union, NJ. “We want patients to be informed when there is an incident involving reprocessed single-use devices, just as they are routinely informed about the risks certain medical treatments may involve. I am happy to see New Jersey is taking the lead in protecting patient safety.”
The rule adoption requires New Jersey health care facilities to create patient or resident safety committees to analyze adverse events and medical errors within their facilities and to correct actions to prevent serious errors from occurring in the future. These committees will consist of a group of health care experts in the facilities and will be required to conduct root-cause analysis for patients′ errors which cause serious injury or death. Injury or death involving reprocessed single-use devices will be included in the root-cause analysis.
Patient GUARD (Patient Groups United Against Reprocessing Dangers) comprises the following organizations: Action CF, Advanced Medical Technology Association, Arthritis Foundation–New Jersey Chapter, Autism Family Services of New Jersey, Brain Injury Association of New Jersey, Caregivers of New Jersey, CARES Foundation, Community Health Charities of New Jersey, Creutzfeldt-Jakob Disease Foundation, Diabetes Foundation, Epilepsy Foundation of New Jersey, Family Resource Network, HealthCare Institute of New Jersey, Hyacinth AIDS Foundation, Latino Leadership Alliance of New Jersey, LUPUS Foundation of America–New Jersey Chapter, Multiple Sclerosis Association of America–New Jersey Chapter, New Jersey 2-1-1 Partnership, New Jersey Health Care Quality Institute, New Jersey Association of Mental Health Agencies, New Jersey Pharmacists Association, and Spina Bifida Association Tri-State Region.