- Email: [email protected]
Quarantining implants; multipack sutures; glutaraldehyde sterilization; surgical zippers; OR turnover time
APRIL 1998, VOL 67, N O 4 C L I N I C A L ISSUES
Quarantining implants; multipack sutures; glutaraldehyde sterilization; surgical zippers; OR turnover time
e
uestion: As a member of an OR director's networking group I recently learned that implants are to be quarantined until the biological indicator is read as negative. We have no quarantine policy at our facility. Exactly what is needed regarding these implants?
A
nswer: The preferred method for sterilizing orthopedic and other implants is to prepackage the items and run them for a full sterilization cycle in either a gravity displacement or a prevacuum sterilizer. A biological indicator should be run with the load, and the implants should be quarantined until a negative readout of the biological indicator occurs at 48 hours after sterilization. Only then should the items be released to the OR for implantation into a patient. Occasionally the above scenario is not possible. When implants must be sterilized nearer to the time of use, it is possible to run a biological indicator that provides a readout at one hour if you are using a gravity-displacement sterilizer. Even when this indicator is used, however, the implant must be quarantined (ie, isolated and not used) until the indicator has been read and a negative result has been obtained. When the implant must be sterilized imrnediately before use, the sterilized implant should be quarantined on a separate mini sterile field created for this purpose. The mini field
can be isolated on the sterile side of the OR away from the sterile field being used for the procedure. After the negative biological reading at one hour, the implant may be added to the surgical field and the separate mini field may be discarded. Subsequent indicator readings should be taken and recorded at intervals specified by the product manufacturer. It is imperative that a quarantine policy be developed and recorded in the policy and procedure manual so that all surgical and central processing departments staff members are consistent in their practice. All staff members in each department should be familiar with the policy and its interpretations and implications in the practice setting. If you are scheduled for a Joint Commission on Accreditation of Healthcare Organizations survey in the near future, the surveyor may wish to review your policy with you and your staff members.
e
uestion: We frequently use multipack sutures in our OR and have a question regarding counting these needles. Should the packet be opened when the initial count is performed so that all needles can be visualized, or is it acceptable to count needles based on the suture packet label?
A
nswer: It is acceptable practice to count needles based on the suture packet label, regardless of whether you use 870 AORN JOURNAL
multipacks or single sutures. To do otherwise would necessitate opening all packets. It is just as possible to find a single suture packet with no needle as it is to find a multipack with an incorrect number of needles. It is the scrub person's responsibility to verify needles at the time the suture packet is opened. The scrub person may wish to count the needles with the circulator when the multipack is opened because there is a greater chance of error when counting several needles at one time.
e
uestion: For many years I have used glutaraldehyde for high-level disinfection. Now I have a colleague who insists that glutaraldehyde is a steMant. Which is correct? Is it possible for it to be both?
A
nswer: Glutaraldehyde is both a high-level disinfectant and a chemical sterilant. The primary difterence is in the exposure time. Glutaraldehyde is most useful as a high-level disinfectant and is most often used for lensed instruments (eg, cystoscopes, bronchoscopes). Glutaraldehyde has minimal deleterious effects on the lens cement and is noncorrosive to the metal. Its low surface tension permits easy penetration and rinsing. By definition, liquid chemical sterilants must destroy all forms of microbial life, including bacterial and fungal spores, tubercle bacilli, and viruses. Activated
APRIL 1998, V01.67. N O 4
aqueous glutaraldehyde 2%)is recognized as an effective liquid chemosterilant. To achieve stcrilization. instruments must be free from bioburden and completely immersed in activated aqueous glutaraldehyde solution for 1 0 hours. Any period of immersion less than 10 hours will not kill spores that may be present and must be considered as only a disinfection process. Durin,0 ’immersion, all instrument surfaces must be contacted by the liquid chemosterilant for the entire exposure period. After the 10hour immersion, instruments must be rinsed thoroughly with sterile distilled water before being used.
e
uestion: I work in a pediatric hospital in which we recently performed the fourth iaparotomy in a seven-day period on a neonate with necrotiring enterocolltk and peritonitis. As we finished the fourth procedure, someone suggested that we should be using a zipper on this particular patient. Is there such a thing as a zipper for a surgical procedure?
A
nswer: There are scveral surgical zippers available in today’s marketplace. They mostly are used in etapenlavage; however, there are several other uses for surgical zippers. Etapenlavage is a series of planned multiple surgical procedures that are used to reexplore the patient’s abdomen. The procedures are performed at 24hour intervals.’ One of the more common reasons for reexploration is to diffuse peritonitis with or without necrotic abdominal contents.’
l h e practice of zipping the abdomen is not new; presterilized surgical zippers. however, are a recent addition to thc cadre of available closure materials. Many surgeons still obtain zippers from local fabric stores and have them sterilized in their hospitals before use. This is not considered acceptable practice in today’s environment because prcsterilized surgical zippers are commercially available. 1:abric zippers come in contact with or are made with oils, lubricants, detergents. dyes, and other coninion chemicals. According to their manufacturers. these zippers are not intended for surgical purposes, and illness or injury could result if the zippers are used in that manner.: In addition to using zippers for interniittent abdominal closurc, zippers have been uscd for temporary closure o f the sternum.‘ Although not a zipper in the usual sense. a zipping procedure also has been used for temporary tarsorrhaphy procedures for trauma patients suffering eyelid injurics. The zipper is created by suturing bolsters to the eyelids and then threading a separate suture between the bolsters to draw the lid over the cornea. A simple snip of the approximating suture allows the lid to be opened and neurological checks to be performed.5 A new suture then can be threaded through the bolsters, again closing the lid and protecting the cornea.
P
uestion: We believe we are very efficient in our OR turnover time; however, we constantly are being told to decrease our time. Is there a standard or average for turnover time? 872 AOKK JOUKNAL
A
nswer: AOKN is aware of n o standard or average for turnover time, and, in fact, such a number would be meaningless at this time. Unless all facilities have the same physical constraints, staffing complement, patient population, and so forth, a comparison of turnover time would be meaningless because one would not be comparing like items. As we become niore sophisticated i n tracking and reporting data through indicator measurement systems, aggregate and facility-specific repoits will allow us to review our performance in relation to other facilities with similar characteristics. To make comparisons, i t will be imperative that terms be defined in a standard manner. The Association of Anesthesia Clinical Directors has developed the Glossut;y of Times Userifor S~~liedidiricq rind Motiitoritig of Diugtiostic utid Tlier-upeiiticProc.cd14re.s(’that AORN and other organizations have endorsed. Using these standard definitions for terms such as fiwtioiw rime will facilitate comparison and performance improvement. The glussary of terms is published in the 1998 AORN Stuiidurds, Recottitticwtled Ptmtice.7, citirl Giiideliries and other periodicals.
0
uestion: We have a disagreement about cleaning floors between procedures in our OR. We no longer clean the entire room each time, but clean around the OR bed and the traffic way to the door. Our ophthalmic surgeons do not want us to mop any of the floor between procedures. They say it is unnecessary and increases turnover time. What Is AORN‘s opinion?
APRIL 1998, VOL 67, NO 4
A
nswer: According to AORN’s “Recommended practices for environmental cleaning in the surgical practice setting,”’ it is only necessary to clean the floor in a 3-ft to 4-ft perimeter around the surgical field when it is visibly soiled. The key phrase here is, “when it is visibly soiled.” If there is no floor soil associated with the procedures you are performing, there is no need to clean the floor between procedures.
e
uestion: We recently did a brain biopsy on a patient believed to have Creutzfeldt-Jakob disease. Although we are not familiar with this disease specifically, we have routine cleaning protocols that we believe to be adequate for cleaning after each procedure, regardless of whether the patient‘s infection status is known. Our infection control nurse was concerned and required us to take special precautions for cleaning and decontaminating the instruments and supplies used for this procedure. What is Creutzfeldt-Jakob disease and what special precautions are necessary and why?
A
nswer: Creutzfeldt-Jakob disease (CJD) is an infectious, degenerative neurologic disorder. Depending on the area of the brain infected, the disease is characterized by progressive dementia, cerebellar ataxia, and myoclonic jerking with rapid progression to coma and death. Physiologically, the infection produces no inflammatory process: however, it does result in neuronal loss.* Diagnosis is by
means of an abnormal, but characteristic electroencephalogram or by isolation of the infectious agent known as a prion by a brain biopsy. Brain tissue examined at postmortem resembles that of other spongiform encephalopathies seen in humans and other species.4 The incidence of CJD is approximately one case per million people. The disease is always fatal. Little is known about the natural transmission of CJD, but iatrogenic cases have occurred as a result of brain tissue transplants, injection of contaminated human pituitary derived growth hormone, and contaminated surgical items (eg, neurosurgical instruments, cortical electrodes, corneal transplants, dura mater grafts).1° Destroying the infectious prions of CJD is a serious infection control concern. These prions are extremely hardy and resistant to heat, formaldehyde, glutaraldehyde, ionizing radiation, freezing, drying, and organic detergents.” Sodium hydroxide has been found to be the most effective agent in decreasing or eliminating the infectivity of the CJD prion. Other agents are either ineffective or only partially effective. Steam sterilization in a gravity-displacement sterilizer for 60 minutes at 132” C (270” F) after a 60-minute exposure to sodium hydroxide has been shown to be effective. If a prevacuum sterilizer is used after the 60-minute exposure to sodium hydroxide, the items should be sterilized for 18 minutes at 134” C (374” F). Sterilization of tissue that first is fixed with formaldehyde is virtually impossible.
873 AORN JOIJRNAL
e
uestion: We are looking at ways to reduce costs in our OR. Presently we open and set up for an open procedure each time we do an endoscopic abdominal or joint procedure. We rarely use the open setup and tear it down and discard it at the end of the procedure. This can be expensive if we have several procedures each day. We are concerned about wasted supplies and wasted dollars. Is it always necessary to open a full setup when an endoscopic procedure is to be done, even when there is very little likelihood that the procedure will progress to an open procedure?
A
nswer: The AORN recommended practices for endoscopic minimal access surgery indicate only that “instrumentation and supplies for an open procedure should be readily available.”” Certainly when it is necessary to convert to an open procedure, the conversion should be made in an efficacious manner. This does not mean, however, that the supplies must be opened ahead of time. The supplies should be gathered and placed where they are immediately accessible should they be needed. Then, if the procedure progresses to an open procedure, the supplies can be opened quickly and made ready. Often it is possible for additional staff members to lend a hand at the time supplies need to be opened and the open procedure begun. DOROTHY M. FOGG RN, MA PERIOPERATIVE NURSINGSPECIALIST CENTER FOR NURSING PRACTICE, HEALTHPOLICY,AND RESEARCH
APRIL 1998, VOL 67, NO 4
NOTES 1. D H Wittmann et al, “Etapenlavage: Advanced diffuse peritonitis managed by planned multiple laparotomies utilizing zippers, slide fastener, and Velcro analogue for temporary abdominal closure,” World Journal ofsurgery 14 (March/April 1990) 218-226; G Roeyen et al, “Scheduled relaparotomies using a zipper system for the treatment of diffuse generalized peritonitis in children,” Acta Chirurgica Belgica 96 (September/ October 1996) 20 1-205. 2. D Sleeman et al, “Reclosure of the open abdomen,” Journal of the American College of Surgeons 180 (February 1995) 200-204. 3. B J Rubin, “If you snip, don’t zip,” (Letter) New England Journal ofMedicine 3 15 (November 1986) 1234; H H Stone, Letter to the editor, New England Journal of Medicine (Nov 6, 1986) 1234; A G Himes, “More tips on zips,” (Letter to the editor) New England Journal ofMedicine (May 21, 1987) 1348. 4. M M Demirtas, “Delayed sternal closure with sternal zipper,” Annals of Thoracic Surgery 64 (October 1997) 1226-1227. 5. G G Hallock, “Temporary tarsorrhaphy ‘zipperu,”’Annals of Plastic Surgery 28 (May 1992) 488-90. 6. Association of Anesthesia Clinical Directors, “Glossary of times used for scheduling and monitoring of diagnostic and therapeutic procedures,” in AORN
Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1998) 87-93. 7. “Recommended practices for environmental cleaning in the surgical practice setting,” in AORN Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1998) 209-214. 8. Centers for Disease Control and Prevention, National Center for Infectious Diseases, Hospital Infections Program, “Creutzfeldt-Jakob Disease: Epidemiology, Risk Factors, and Decontamination,” (Jan 21, 1997). Available from http://www.cdc.gov/ncidod/ diseases/hip/cjd.htm. Accessed 18 Feb 1998. 9. V M Steelman, “Creutzfeldt-Jakob disease: Recommendations for infection control,” American Journal oflnfection Control 22 (October 1994) 312-318. 10. Centers for Disease Control and Prevention, National Center for Infectious Diseases, Hospital Infections Program, “Creutzfeldt-Jakob Disease: Epidemiology, Risk Factors, and Decontamination,” (Jan 21, 1997). 11. Ibid. 12. “Recommended practices for endoscopic minimal access surgery,” in AORN Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1998) 203-208.
FDA Sets Record in Medication Approval Times The US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) achieved the fastest median approval times in I997 for medications that are supported by user fees, and approved the second highest total of important new products. The median approval time for last year’s 121 new original medications was 14.4 months- 6% less than the 15.4 months in 1996. The median CDER review time for these products was 12.2 months- 18% less than the year before. Thirty-nine of the new original medications were new molecular entities (NMEs), which contain an active substance that had never been approved for marketing in the United States. Nine of the NMEs were priority medications that received an accelerated review because they represent a major advance in medical treatment. These medications included Viracept-a new protease inhibitor for treatment of HIV infection, approved in 2.6 months; Evista-a medication indicated to prevent osteoporosis in postmenopausal women, approved in
less than six months; and Rezulin and Prandin, medications to treat patients with type I1 diabetes, also approved in less than six months. The CDER also increased its approvals of generic medications and antibiotics that are not user fee supported. The total of approved generic medications in 1997 was 43 I-the highest number of generic approvals in this decade and up 80 from 1996. The decrease in medication approval times reflects the importance of the agency’s managerial reforms and the additional resources provided by the industry under the Prescription Drug User Fee Act (PDUFA) of 1992. Recognizing PDUFA’s contribution, Congress further enhanced the user fee program and extended it for another five years. The FDA Modemization Act of 1997 calls for still shorter review times and defines new administrative goals designed to further accelerate the medication development process. FDA Drug Approvals in 1997 Set New Records (press release, Rcckville, Md: US Food and Drug Administration, Jan 14, 1998) 1-3.
- 874 AORN JOURNAL
Quarantining implants; multipack sutures; glutaraldehyde sterilization; surgical zippers; OR turnover time
e
uestion: As a member of an OR director's networking group I recently learned that implants are to be quarantined until the biological indicator is read as negative. We have no quarantine policy at our facility. Exactly what is needed regarding these implants?
A
nswer: The preferred method for sterilizing orthopedic and other implants is to prepackage the items and run them for a full sterilization cycle in either a gravity displacement or a prevacuum sterilizer. A biological indicator should be run with the load, and the implants should be quarantined until a negative readout of the biological indicator occurs at 48 hours after sterilization. Only then should the items be released to the OR for implantation into a patient. Occasionally the above scenario is not possible. When implants must be sterilized nearer to the time of use, it is possible to run a biological indicator that provides a readout at one hour if you are using a gravity-displacement sterilizer. Even when this indicator is used, however, the implant must be quarantined (ie, isolated and not used) until the indicator has been read and a negative result has been obtained. When the implant must be sterilized imrnediately before use, the sterilized implant should be quarantined on a separate mini sterile field created for this purpose. The mini field
can be isolated on the sterile side of the OR away from the sterile field being used for the procedure. After the negative biological reading at one hour, the implant may be added to the surgical field and the separate mini field may be discarded. Subsequent indicator readings should be taken and recorded at intervals specified by the product manufacturer. It is imperative that a quarantine policy be developed and recorded in the policy and procedure manual so that all surgical and central processing departments staff members are consistent in their practice. All staff members in each department should be familiar with the policy and its interpretations and implications in the practice setting. If you are scheduled for a Joint Commission on Accreditation of Healthcare Organizations survey in the near future, the surveyor may wish to review your policy with you and your staff members.
e
uestion: We frequently use multipack sutures in our OR and have a question regarding counting these needles. Should the packet be opened when the initial count is performed so that all needles can be visualized, or is it acceptable to count needles based on the suture packet label?
A
nswer: It is acceptable practice to count needles based on the suture packet label, regardless of whether you use 870 AORN JOURNAL
multipacks or single sutures. To do otherwise would necessitate opening all packets. It is just as possible to find a single suture packet with no needle as it is to find a multipack with an incorrect number of needles. It is the scrub person's responsibility to verify needles at the time the suture packet is opened. The scrub person may wish to count the needles with the circulator when the multipack is opened because there is a greater chance of error when counting several needles at one time.
e
uestion: For many years I have used glutaraldehyde for high-level disinfection. Now I have a colleague who insists that glutaraldehyde is a steMant. Which is correct? Is it possible for it to be both?
A
nswer: Glutaraldehyde is both a high-level disinfectant and a chemical sterilant. The primary difterence is in the exposure time. Glutaraldehyde is most useful as a high-level disinfectant and is most often used for lensed instruments (eg, cystoscopes, bronchoscopes). Glutaraldehyde has minimal deleterious effects on the lens cement and is noncorrosive to the metal. Its low surface tension permits easy penetration and rinsing. By definition, liquid chemical sterilants must destroy all forms of microbial life, including bacterial and fungal spores, tubercle bacilli, and viruses. Activated
APRIL 1998, V01.67. N O 4
aqueous glutaraldehyde 2%)is recognized as an effective liquid chemosterilant. To achieve stcrilization. instruments must be free from bioburden and completely immersed in activated aqueous glutaraldehyde solution for 1 0 hours. Any period of immersion less than 10 hours will not kill spores that may be present and must be considered as only a disinfection process. Durin,0 ’immersion, all instrument surfaces must be contacted by the liquid chemosterilant for the entire exposure period. After the 10hour immersion, instruments must be rinsed thoroughly with sterile distilled water before being used.
e
uestion: I work in a pediatric hospital in which we recently performed the fourth iaparotomy in a seven-day period on a neonate with necrotiring enterocolltk and peritonitis. As we finished the fourth procedure, someone suggested that we should be using a zipper on this particular patient. Is there such a thing as a zipper for a surgical procedure?
A
nswer: There are scveral surgical zippers available in today’s marketplace. They mostly are used in etapenlavage; however, there are several other uses for surgical zippers. Etapenlavage is a series of planned multiple surgical procedures that are used to reexplore the patient’s abdomen. The procedures are performed at 24hour intervals.’ One of the more common reasons for reexploration is to diffuse peritonitis with or without necrotic abdominal contents.’
l h e practice of zipping the abdomen is not new; presterilized surgical zippers. however, are a recent addition to thc cadre of available closure materials. Many surgeons still obtain zippers from local fabric stores and have them sterilized in their hospitals before use. This is not considered acceptable practice in today’s environment because prcsterilized surgical zippers are commercially available. 1:abric zippers come in contact with or are made with oils, lubricants, detergents. dyes, and other coninion chemicals. According to their manufacturers. these zippers are not intended for surgical purposes, and illness or injury could result if the zippers are used in that manner.: In addition to using zippers for interniittent abdominal closurc, zippers have been uscd for temporary closure o f the sternum.‘ Although not a zipper in the usual sense. a zipping procedure also has been used for temporary tarsorrhaphy procedures for trauma patients suffering eyelid injurics. The zipper is created by suturing bolsters to the eyelids and then threading a separate suture between the bolsters to draw the lid over the cornea. A simple snip of the approximating suture allows the lid to be opened and neurological checks to be performed.5 A new suture then can be threaded through the bolsters, again closing the lid and protecting the cornea.
P
uestion: We believe we are very efficient in our OR turnover time; however, we constantly are being told to decrease our time. Is there a standard or average for turnover time? 872 AOKK JOUKNAL
A
nswer: AOKN is aware of n o standard or average for turnover time, and, in fact, such a number would be meaningless at this time. Unless all facilities have the same physical constraints, staffing complement, patient population, and so forth, a comparison of turnover time would be meaningless because one would not be comparing like items. As we become niore sophisticated i n tracking and reporting data through indicator measurement systems, aggregate and facility-specific repoits will allow us to review our performance in relation to other facilities with similar characteristics. To make comparisons, i t will be imperative that terms be defined in a standard manner. The Association of Anesthesia Clinical Directors has developed the Glossut;y of Times Userifor S~~liedidiricq rind Motiitoritig of Diugtiostic utid Tlier-upeiiticProc.cd14re.s(’that AORN and other organizations have endorsed. Using these standard definitions for terms such as fiwtioiw rime will facilitate comparison and performance improvement. The glussary of terms is published in the 1998 AORN Stuiidurds, Recottitticwtled Ptmtice.7, citirl Giiideliries and other periodicals.
0
uestion: We have a disagreement about cleaning floors between procedures in our OR. We no longer clean the entire room each time, but clean around the OR bed and the traffic way to the door. Our ophthalmic surgeons do not want us to mop any of the floor between procedures. They say it is unnecessary and increases turnover time. What Is AORN‘s opinion?
APRIL 1998, VOL 67, NO 4
A
nswer: According to AORN’s “Recommended practices for environmental cleaning in the surgical practice setting,”’ it is only necessary to clean the floor in a 3-ft to 4-ft perimeter around the surgical field when it is visibly soiled. The key phrase here is, “when it is visibly soiled.” If there is no floor soil associated with the procedures you are performing, there is no need to clean the floor between procedures.
e
uestion: We recently did a brain biopsy on a patient believed to have Creutzfeldt-Jakob disease. Although we are not familiar with this disease specifically, we have routine cleaning protocols that we believe to be adequate for cleaning after each procedure, regardless of whether the patient‘s infection status is known. Our infection control nurse was concerned and required us to take special precautions for cleaning and decontaminating the instruments and supplies used for this procedure. What is Creutzfeldt-Jakob disease and what special precautions are necessary and why?
A
nswer: Creutzfeldt-Jakob disease (CJD) is an infectious, degenerative neurologic disorder. Depending on the area of the brain infected, the disease is characterized by progressive dementia, cerebellar ataxia, and myoclonic jerking with rapid progression to coma and death. Physiologically, the infection produces no inflammatory process: however, it does result in neuronal loss.* Diagnosis is by
means of an abnormal, but characteristic electroencephalogram or by isolation of the infectious agent known as a prion by a brain biopsy. Brain tissue examined at postmortem resembles that of other spongiform encephalopathies seen in humans and other species.4 The incidence of CJD is approximately one case per million people. The disease is always fatal. Little is known about the natural transmission of CJD, but iatrogenic cases have occurred as a result of brain tissue transplants, injection of contaminated human pituitary derived growth hormone, and contaminated surgical items (eg, neurosurgical instruments, cortical electrodes, corneal transplants, dura mater grafts).1° Destroying the infectious prions of CJD is a serious infection control concern. These prions are extremely hardy and resistant to heat, formaldehyde, glutaraldehyde, ionizing radiation, freezing, drying, and organic detergents.” Sodium hydroxide has been found to be the most effective agent in decreasing or eliminating the infectivity of the CJD prion. Other agents are either ineffective or only partially effective. Steam sterilization in a gravity-displacement sterilizer for 60 minutes at 132” C (270” F) after a 60-minute exposure to sodium hydroxide has been shown to be effective. If a prevacuum sterilizer is used after the 60-minute exposure to sodium hydroxide, the items should be sterilized for 18 minutes at 134” C (374” F). Sterilization of tissue that first is fixed with formaldehyde is virtually impossible.
873 AORN JOIJRNAL
e
uestion: We are looking at ways to reduce costs in our OR. Presently we open and set up for an open procedure each time we do an endoscopic abdominal or joint procedure. We rarely use the open setup and tear it down and discard it at the end of the procedure. This can be expensive if we have several procedures each day. We are concerned about wasted supplies and wasted dollars. Is it always necessary to open a full setup when an endoscopic procedure is to be done, even when there is very little likelihood that the procedure will progress to an open procedure?
A
nswer: The AORN recommended practices for endoscopic minimal access surgery indicate only that “instrumentation and supplies for an open procedure should be readily available.”” Certainly when it is necessary to convert to an open procedure, the conversion should be made in an efficacious manner. This does not mean, however, that the supplies must be opened ahead of time. The supplies should be gathered and placed where they are immediately accessible should they be needed. Then, if the procedure progresses to an open procedure, the supplies can be opened quickly and made ready. Often it is possible for additional staff members to lend a hand at the time supplies need to be opened and the open procedure begun. DOROTHY M. FOGG RN, MA PERIOPERATIVE NURSINGSPECIALIST CENTER FOR NURSING PRACTICE, HEALTHPOLICY,AND RESEARCH
APRIL 1998, VOL 67, NO 4
NOTES 1. D H Wittmann et al, “Etapenlavage: Advanced diffuse peritonitis managed by planned multiple laparotomies utilizing zippers, slide fastener, and Velcro analogue for temporary abdominal closure,” World Journal ofsurgery 14 (March/April 1990) 218-226; G Roeyen et al, “Scheduled relaparotomies using a zipper system for the treatment of diffuse generalized peritonitis in children,” Acta Chirurgica Belgica 96 (September/ October 1996) 20 1-205. 2. D Sleeman et al, “Reclosure of the open abdomen,” Journal of the American College of Surgeons 180 (February 1995) 200-204. 3. B J Rubin, “If you snip, don’t zip,” (Letter) New England Journal ofMedicine 3 15 (November 1986) 1234; H H Stone, Letter to the editor, New England Journal of Medicine (Nov 6, 1986) 1234; A G Himes, “More tips on zips,” (Letter to the editor) New England Journal ofMedicine (May 21, 1987) 1348. 4. M M Demirtas, “Delayed sternal closure with sternal zipper,” Annals of Thoracic Surgery 64 (October 1997) 1226-1227. 5. G G Hallock, “Temporary tarsorrhaphy ‘zipperu,”’Annals of Plastic Surgery 28 (May 1992) 488-90. 6. Association of Anesthesia Clinical Directors, “Glossary of times used for scheduling and monitoring of diagnostic and therapeutic procedures,” in AORN
Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1998) 87-93. 7. “Recommended practices for environmental cleaning in the surgical practice setting,” in AORN Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1998) 209-214. 8. Centers for Disease Control and Prevention, National Center for Infectious Diseases, Hospital Infections Program, “Creutzfeldt-Jakob Disease: Epidemiology, Risk Factors, and Decontamination,” (Jan 21, 1997). Available from http://www.cdc.gov/ncidod/ diseases/hip/cjd.htm. Accessed 18 Feb 1998. 9. V M Steelman, “Creutzfeldt-Jakob disease: Recommendations for infection control,” American Journal oflnfection Control 22 (October 1994) 312-318. 10. Centers for Disease Control and Prevention, National Center for Infectious Diseases, Hospital Infections Program, “Creutzfeldt-Jakob Disease: Epidemiology, Risk Factors, and Decontamination,” (Jan 21, 1997). 11. Ibid. 12. “Recommended practices for endoscopic minimal access surgery,” in AORN Standards, Recommended Practices, and Guidelines (Denver: Association of Operating Room Nurses, Inc, 1998) 203-208.
FDA Sets Record in Medication Approval Times The US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) achieved the fastest median approval times in I997 for medications that are supported by user fees, and approved the second highest total of important new products. The median approval time for last year’s 121 new original medications was 14.4 months- 6% less than the 15.4 months in 1996. The median CDER review time for these products was 12.2 months- 18% less than the year before. Thirty-nine of the new original medications were new molecular entities (NMEs), which contain an active substance that had never been approved for marketing in the United States. Nine of the NMEs were priority medications that received an accelerated review because they represent a major advance in medical treatment. These medications included Viracept-a new protease inhibitor for treatment of HIV infection, approved in 2.6 months; Evista-a medication indicated to prevent osteoporosis in postmenopausal women, approved in
less than six months; and Rezulin and Prandin, medications to treat patients with type I1 diabetes, also approved in less than six months. The CDER also increased its approvals of generic medications and antibiotics that are not user fee supported. The total of approved generic medications in 1997 was 43 I-the highest number of generic approvals in this decade and up 80 from 1996. The decrease in medication approval times reflects the importance of the agency’s managerial reforms and the additional resources provided by the industry under the Prescription Drug User Fee Act (PDUFA) of 1992. Recognizing PDUFA’s contribution, Congress further enhanced the user fee program and extended it for another five years. The FDA Modemization Act of 1997 calls for still shorter review times and defines new administrative goals designed to further accelerate the medication development process. FDA Drug Approvals in 1997 Set New Records (press release, Rcckville, Md: US Food and Drug Administration, Jan 14, 1998) 1-3.
- 874 AORN JOURNAL