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How do Medical Device Amendments affect OR nurses?
The experts research
How do Medical Device Amendments affect OR nurses?
Q
I’ve always thought medical devices were things like cardiac pacemakers and anesthesia machines. 1 understand the Medical Device Amendments cover more than just such complicated items. Under the law, what is a medical device? How does the law affect me as an OR nurse?
A
The Medical Device Amendments (PL 94-295), passed by Congress in 1976,define a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: (1) recognized in the official National Formulary, or the United States Pharmacopoeia. . . , (2) intended for use in the diagnosis of disease, or other conditions, or in the cure, mitigation,treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolizedfor the achievement of any of its principal intended purposes.’ Almost everything we use in the operating room, from instruments to drapes, sponges,
596
a:
and syringes, is encompassed by this definition. The law places the responsibility for implementation and enforcement with the Bureau of Medical Devices of the US Foodand Drug Administration (FDA). The primary impact of the Bureau’s regulations falls on the maker of a device. Manufacturersmust comply with what the FDA considers “good manufacturing practices.” These practices include such things as record keeping and environmental control of the manufacturing area to minimize the possibility of adulteration by unwanted materials. Also included are the procedures for manufacturers sterilizing devices for which sterility is a requirement.2 Other regulations cover the type and amount of investigation and data submission necessary before marketing a device3; the labeling of a device, including instructions for use; and procedures for clinical trials of investigational device^.^ The purpose of the act is to assure both the user (nurse, physician, dentist, physical therapist, etc) and the consumer (the patient) that a device is safe and effective for the intended condition or situation. For the OR nurse, this means you will be seeing changes in the labeling of some devices. Directions or instructions will probably become more complete. There will be a tightening of controls on investigational devices. Manufacturers and clinicians will have to meet requirements regarding informed consent of the consumer, qualifications of the investigator, record keeping, and notification of FDA about problems that might be related to the device. This may mean a decrease in the inhospital alteration of devices and instruments to meet a particular
AORN Journal, October 1978, Vol28, No 4
need. It also implies an added patient advocacy role for the nurse in checking that the patient has given consent for the use of an investigational device. There will be a proliferation of performance standards for devices over the next several years.5 Some of these will be from the private sector and may remain voluntary. Others will be from the FDA and will be regulatory.Nurses responsible for selecting items for purchase will need to become informed on these standards as they develop. The AORN Journal is a good source for this type of information. Another possible effect of the act is that some device manufacturers may drop out of the market. They may decide that the changes necessary to comply with regulations and the personnel needed to communicate with the regulatory bureaucracy are too costly or extensive to continue manufacturingthe product. The OR nurse may see the cost of compliance with regulations reflected in price increaseson products. The FDA indicates “no major impact will result,”6 but there is much disagreement on this subject. At a time when the dollars available for health care are being more closely monitored, such price increaseswould require even more skillful decision making within the hospital. This would put increased pressure on the OR nurse in a leadershipposition to use sound fiscal management principles in budgeting. It is difficult to discuss all the possible implicationsfor OR nurses since the rules and regulations are still being written. Each month, new “Proposed rules” or “Final rules” are published in the Federal Register. We will keep you informed.
is often sufficiently taxing to an individual’s olfactory senses without adding the smell of fresh paint in a confined space. Drop cloths, paint buckets, and brushes are often not kept acceptably clean for use in the surgery suite without floor decontamination following their use. It also seems a human necessityto touch a surface on which a “wet paint” sign has been placed. Personnel in the OR should not have fresh paint adhering to their hands or clothing. This paint could conceivably end up as a wound contaminant causing untoward tissue reaction. Also, in most ORs, the added traffic confusion could seriously interrupt the movement of patients, supplies, and personnel. Painting should be done at times when the OR suite is not occupied with patient care activities. It may not be necessary to interrupt or suspend operations if there is sufficienttime for painting, drying, and cleanup during evenings, nights, or weekends.
Q The OR suite at our hospital needs re-
tentative final regulations relating to investigational device exemptions,” Federal Register 43 (May 12, 1978) 93, 20,726. 5. William C Beck, ”The age of standards proliferation,”The Guthrie Bulletin 47 (Summer 1977) 49. 6. US Food and Drug Administration, “Good manufacturing practices for medical devices; availability of the economic impact assessment,” Federal Register 43 (July 7, 1978) 131, 29,359.
painting. We have funds budgeted for materials and labor, but another question has arisen. Can this work safely be done during daytimehours without interruptingthe scheduling of surgery?
A While the hospital may wish to minimize
Janet K Schultz, RN and the Professional Advisory Committee Notes 1. Bureau of Medical Devices, Everything You Always Wanted to Know about the Medical Device Amendments. . . and Weren’t Afraid to Ask, 017012-00260-9 (Washington, DC: US Government Printing Office, 1977) 1. 2. US Food and Drug Administration, “Regulations establishing good manufacture, packing, storage and installationof medical devices,”Federal Register 43 (July 21, 1978) 141, 31,506-31532. 3. US Food and Drug Administration, “Classification procedures.” Federal Register 43 (July 28, 1978) 146, 32,988-32,999. 4. US Food and Drug Administration, “Proposed
labor costs by painting during conventional working hours and avoiding overtime or special shift cost, this does not seem to be a wise decision. The proliferation of odors in the OR from anesthetic agents and cleaning solutions
598
AORN Journal, October 1978, Vol28, No 4
How do Medical Device Amendments affect OR nurses?
Q
I’ve always thought medical devices were things like cardiac pacemakers and anesthesia machines. 1 understand the Medical Device Amendments cover more than just such complicated items. Under the law, what is a medical device? How does the law affect me as an OR nurse?
A
The Medical Device Amendments (PL 94-295), passed by Congress in 1976,define a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: (1) recognized in the official National Formulary, or the United States Pharmacopoeia. . . , (2) intended for use in the diagnosis of disease, or other conditions, or in the cure, mitigation,treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolizedfor the achievement of any of its principal intended purposes.’ Almost everything we use in the operating room, from instruments to drapes, sponges,
596
a:
and syringes, is encompassed by this definition. The law places the responsibility for implementation and enforcement with the Bureau of Medical Devices of the US Foodand Drug Administration (FDA). The primary impact of the Bureau’s regulations falls on the maker of a device. Manufacturersmust comply with what the FDA considers “good manufacturing practices.” These practices include such things as record keeping and environmental control of the manufacturing area to minimize the possibility of adulteration by unwanted materials. Also included are the procedures for manufacturers sterilizing devices for which sterility is a requirement.2 Other regulations cover the type and amount of investigation and data submission necessary before marketing a device3; the labeling of a device, including instructions for use; and procedures for clinical trials of investigational device^.^ The purpose of the act is to assure both the user (nurse, physician, dentist, physical therapist, etc) and the consumer (the patient) that a device is safe and effective for the intended condition or situation. For the OR nurse, this means you will be seeing changes in the labeling of some devices. Directions or instructions will probably become more complete. There will be a tightening of controls on investigational devices. Manufacturers and clinicians will have to meet requirements regarding informed consent of the consumer, qualifications of the investigator, record keeping, and notification of FDA about problems that might be related to the device. This may mean a decrease in the inhospital alteration of devices and instruments to meet a particular
AORN Journal, October 1978, Vol28, No 4
need. It also implies an added patient advocacy role for the nurse in checking that the patient has given consent for the use of an investigational device. There will be a proliferation of performance standards for devices over the next several years.5 Some of these will be from the private sector and may remain voluntary. Others will be from the FDA and will be regulatory.Nurses responsible for selecting items for purchase will need to become informed on these standards as they develop. The AORN Journal is a good source for this type of information. Another possible effect of the act is that some device manufacturers may drop out of the market. They may decide that the changes necessary to comply with regulations and the personnel needed to communicate with the regulatory bureaucracy are too costly or extensive to continue manufacturingthe product. The OR nurse may see the cost of compliance with regulations reflected in price increaseson products. The FDA indicates “no major impact will result,”6 but there is much disagreement on this subject. At a time when the dollars available for health care are being more closely monitored, such price increaseswould require even more skillful decision making within the hospital. This would put increased pressure on the OR nurse in a leadershipposition to use sound fiscal management principles in budgeting. It is difficult to discuss all the possible implicationsfor OR nurses since the rules and regulations are still being written. Each month, new “Proposed rules” or “Final rules” are published in the Federal Register. We will keep you informed.
is often sufficiently taxing to an individual’s olfactory senses without adding the smell of fresh paint in a confined space. Drop cloths, paint buckets, and brushes are often not kept acceptably clean for use in the surgery suite without floor decontamination following their use. It also seems a human necessityto touch a surface on which a “wet paint” sign has been placed. Personnel in the OR should not have fresh paint adhering to their hands or clothing. This paint could conceivably end up as a wound contaminant causing untoward tissue reaction. Also, in most ORs, the added traffic confusion could seriously interrupt the movement of patients, supplies, and personnel. Painting should be done at times when the OR suite is not occupied with patient care activities. It may not be necessary to interrupt or suspend operations if there is sufficienttime for painting, drying, and cleanup during evenings, nights, or weekends.
Q The OR suite at our hospital needs re-
tentative final regulations relating to investigational device exemptions,” Federal Register 43 (May 12, 1978) 93, 20,726. 5. William C Beck, ”The age of standards proliferation,”The Guthrie Bulletin 47 (Summer 1977) 49. 6. US Food and Drug Administration, “Good manufacturing practices for medical devices; availability of the economic impact assessment,” Federal Register 43 (July 7, 1978) 131, 29,359.
painting. We have funds budgeted for materials and labor, but another question has arisen. Can this work safely be done during daytimehours without interruptingthe scheduling of surgery?
A While the hospital may wish to minimize
Janet K Schultz, RN and the Professional Advisory Committee Notes 1. Bureau of Medical Devices, Everything You Always Wanted to Know about the Medical Device Amendments. . . and Weren’t Afraid to Ask, 017012-00260-9 (Washington, DC: US Government Printing Office, 1977) 1. 2. US Food and Drug Administration, “Regulations establishing good manufacture, packing, storage and installationof medical devices,”Federal Register 43 (July 21, 1978) 141, 31,506-31532. 3. US Food and Drug Administration, “Classification procedures.” Federal Register 43 (July 28, 1978) 146, 32,988-32,999. 4. US Food and Drug Administration, “Proposed
labor costs by painting during conventional working hours and avoiding overtime or special shift cost, this does not seem to be a wise decision. The proliferation of odors in the OR from anesthetic agents and cleaning solutions
598
AORN Journal, October 1978, Vol28, No 4